Episode 21 | How to Write a Strong Commercialization Plan – Part 3

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Podcast Guest Speakers:

 William Bozza, Ph.D.

William Bozza, Ph.D. serves as a Program Director, managing a portfolio of oncology startups (SBIR & STTR awardees) to facilitate small businesses in technology commercialization for cancer diagnosis and treatment. Dr. Bozza is currently leading the center’s efforts on the Small Business Concept Award for early-stage high-risk/high-reward technologies that target rare and pediatric cancers.  He is also taking the lead on the program’s Peer Learning and Networking Webinar Series to help SBIR companies learn from peers and facilitate collaboration.

Sid Selvaraj, Ph.D.

Sid Selvaraj, Ph.D. is the CEO at Arima Genomics. Dr. Selvaraj received his Ph.D. in Bioinformatics from University of California San Diego. As a graduate student, he used genomic assays and NGS to study the impact of genetic sequence and structure on human health and disease. Dr. Selvaraj's scientific contributions have been published as several manuscripts in Nature and Nature Biotechnology. Dr. Selvaraj has also worked as a software engineer at Carevoyant Technologies, where they used Dexterity, Crystal Reports, MySQL, and MSSQL to build patient-information, medical-record workflows to manage care.

Manijeh Goldberg, Ph.D., M.B.A.

Manijeh Goldberg, Ph.D., M.B.A. is the founder and CEO of Privo. She has over 20 years of experience in the biomedical industry, in large companies and five startups. She has developed US Key Opinion Leader (KOL) relationships, successfully lobbied to get PRV111 into a large, NIH-funded clinical study, planned and executed training, and helped drive on-time trial enrollment. Additionally, Dr. Goldberg is driving the execution of a second-generation Privo’s products. Her current focus is to conduct clinical trials, get PRV111’s second-generation products through the FDA, and explore initiating a second US clinical trial. Additional responsibilities include business development, general management, and driving the overall success of Privo’s research and products. Dr. Goldberg holds a Ph.D. in Biomedical Engineering, an M.S. in Health Sciences and Technology from Harvard Medical School, an M.B.A. from MIT Sloan School of Management, and an M.S. in Computer Science and Mathematics.

Beatrice Langton-Webster, Ph.D.

Beatrice Langton-Webster, Ph.D. is the CEO and director of Cancer Targeted Technology. She has over 30 years of experience in the biopharmaceutical industry with expertise in operational and executive management, licensing and strategic business development, and preclinical & clinical cancer drug development. She helped bring to market: Betaseron for multiple sclerosis, a HER-2 serum diagnostic kit for breast cancer and Fludara for leukemia. Dr. Langton-Webster received her Ph.D. in Medical Microbiology and Immunology at the University of California, Davis.

Madelyn Herzfeld

Madelyn Herzfeld is the co-Founder and vice chairman of Carevive Systems. Ms. Herzfeld was founder, president, and general manager of the Institute for Medical Education & Research, Inc. (IMER), where she led the development of accredited oncology continuing education/continuing medical education programs for nurses, physicians, and other healthcare professionals specializing in oncology for 12 years. IMER was sold in 2007 to United Biosource Corporation, which was acquired by Medco Health Solutions (2010) and later Express Scripts Corporation (2011). She began her career at Bear, Stearns & Co. as a financial analyst in its investment banking healthcare services/pharmaceutical group and subsequently served as an associate for Pinnacle Partners, a boutique investment Ms. Herzfeld earned dual degrees in business (concentration: Health Care Public Policy and Management) and nursing from the University of Pennsylvania’s Wharton School of Business and School of Nursing.

Carlos Castro-Gonzalez, Ph.D.

Carlos Castro-Gonzalez, Ph.D. is the co-founder and CEO of Leuko Labs and has been a healthcare innovator for more than 15 years. Dr. Castro-Gonzalez is an expert in medical image analysis and has previously led multidisciplinary teams developing solutions for cardiac diagnosis and meningitis detection. After his Ph.D., Carlos was selected for the prestigious M+Vision fellowship program at MIT to explore commercialization venues for novel technologies and was awarded top innovator under 35 in 2015 by MIT Technology Review. After MIT, Carlos co-founded Leuko, a medical device startup focused on improving quality of life and outcomes for cancer patients, through the first noninvasive white blood cell monitoring solution. As part of Leuko, Carlos has had ample experience securing dilutive and non-dilutive funding, conducting customer discovery, developing new IPs, and establishing clinical and technical collaborations to bring a new product to market. Carlos holds an M.Sc. in Electrical Engineering from the Royal Institute of Technology (Sweden) and a Ph.D. in biomedical engineering from the Technical University of Madrid (Spain).

Programs Mentioned in Episode

• Phase IIB Bridge Award
• Early Payors Feedback Program
• SEED Entrepreneurs in Residence (EIRs) Consults
• Investor Initiatives
• Listing of NCI SBIR Program Directors
• I-Corps at NIH
• I-Corps at NSF
• entrepreneurship bootcamp

Transcript

BILLY BOZZA:    Hello and welcome to Innovation Lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute’s Small Business Innovation Research, SBIR Development Center. Our podcast hosts interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting-edge cancer solutions from lab to market. I'm Billy Bozza, a program director at NCI SBIR and today's host. 

     In the previous two episodes on writing a strong commercialization plan, five NCI SBIR funded companies provided insights for putting together this critical Phase 2 SBIR or STTR application component. To conclude this series, we are bringing the speakers together for a panel discussion to answer questions from aspiring applicants. 

     And I have a couple of questions to get us going, if things are going slow. One has come in already from Thomas Taylor. So, when preparing an SBIR Fast Track application they may require Phase 2B to complete larger studies for FDA 510K review, how much detail should be included in the Phase 2 Fast Track commercialization plan? And then I guess maybe just we can lump it in together, a general question on what type of regulatory pathway and information should be included in a commercialization plan? Maybe Carlos, since they're talking about devices and 510K, maybe you could provide some guidance on that. 

CARLOS CASTRO GONZALEZ:    Of course. Yeah. So, the information that we included on the regulatory section of the commercialization plan, including first, when our category or class for the FDA. So, previously to submitting, we have submitted what is called, previously to submitting our SBIR application, we have submitted what is called a 513-J request for classification. So, that's a formal mechanism by which you can request a classification from the FDA for your device. So, we were classified as a Class 2 Denovo [phonetic], so we included that information in the SBIR proposal. We included the team, in particular, that we have been working with for regulatory affairs, particularly our regulatory consultant. That's a good way to reassure reviewers that you have the right expertise to tackle your regulatory pathway. 

     And then we included a lot of details about where we have completed an FDA resubmission. So that's when you meet with the FDA to design the clinical trial and discuss the evidence that they would like to see to get approval for our device. So, in our proposal, we were suggesting to cover the clinical trials that would support FDA approval and we made sure to point out that we had already discussed the design of that trial with the FDA and that we have a clear picture of, you know, sample size indication for use and the endpoints that we needed to meet in order to be successful. So, those were the main areas that we covered in that section. 

BILLY BOZZA:    Great, thanks, Carlos. And so, Thomas clarified that he was referring to a Bridge Award application. So just to put everything in perspective, all Phase 2 applications and the direct to Phase 2 Fast Track grants, contracts, they all require a commercialization plan as well as a Bridge Award application. And the way you organize it and the information that you include is all the same. It's all the different areas that Sarah mentioned. It will just really kind of depend on stage of development. Likely if you're submitting a Bridge Award application, you're little later in development, so, you know, some of those things might shift a little bit further down the pipeline. 

     OK, so now we have a question on reimbursement. So, maybe someone could speak a little on the type of reimbursement information included and if there's any good resources to learn more, you know, about how to understand more about reimbursement and things that payers might cover. And specifically again, this is kind of focused towards medical devices, but I think this is a good question for anyone to jump in on. 

CARLSO CASTRO GONZALEZ:    I can comment on that. I’m happy to hear what the other panelists have to say as well. But on the reimbursement section, we have been working with our reimbursement consultant. So, similarly to the regulatory section, we included that information there, again, to make sure to point out that we have good expertise in the team to tackle that issue. We have conducted some preliminary analysis of potential CPT, existing CPT codes that we should be accessing, so that's also some information we added there. So, make sure that you identify codes or mechanisms that your device could or your drug could access once you get FDA approval. 

     We talked a little bit about the pricing, as well, that would be covered by those codes and how does that make sense with also our business plan and the financial projections for sales. That was some of the information we included. In terms of good resources to find about this, we did a lot of digging in terms of comparable devices, not necessarily competitors, but we are a home monitoring device, so we look at other home monitoring devices, like, monitors for cardiac applications or the glucose monitors for diabetes. So, completely different from the oncology space, but there's still a lot of parallelisms and we kind of learned a lot from them in terms of what were the reimbursement mechanisms that were being used to pay for those products that are already in the market and how we could potentially apply for similar pathways. So, that's how we approach it. 

BILLY BOZZA:    Thanks, Carlos. 

MADELYN HERZFELD:    I can also speak to it. So for us, there was a couple of different sort of revenue streams for us. One was we were targeting purchase providers who are participating in CMS's oncology care model. And so, they got what were called NEOS [phonetic] payments. So, they would use those NEOS payments to buy software such as ours so that they could meet the required redesign activities such as care plans and remote monitoring and survivorship. And then more recently, chronic care management, principal care management, and new navigation codes were relevant to the work that the services that we enabled. 

BILLY BOZZA:    Great, excellent. There's a couple of resources that our office has highlighted and that's in the slides that you all will receive. So, there's something called an Early Payer Feedback Program. That's where you can work together with payers and CRH and FDA and kind of get some feedback at the time you would actually submit a Q-SUB. There's also, through our seed office, we have entrepreneurs and residents, EIR’s, and there's actually a link that's provided in the slide where you can get knowledge guide information on these different kind of reimbursement considerations. That's a really good resource for kind of getting some initial information. 

     And if you're actually an NIH SBIR awardee, you can request consults in this space. And through that same link, you'll be able to request the consult where it will be paired up with one of those entrepreneurs and residents, and you can ask some of those questions, too, to gain some more understanding. 

CARLOS CASTRO GONZALEZ:    If I may, I will add maybe a note on the reimbursement, because I just remember that another thing we added is that we have conducted a lot of customer interviews, and we actually identified some customers, particularly in the accountable care space for some capitated organizations that were actually willing to do commercial pilots with our technology without requiring a reimbursement code initially. 

     So, we thought that was a great opportunity to get some initial traction to get a [unclear] customer so that we could actually develop the evidence that the insurers want to see while doing commercial programs already. So, some examples of these organizations are what is called integrated delivery networks like Kaiser Permanente in California or the Veteran Health Association. So, we got some letters of intent as a consequence of our customer discovery that we attached to the application. And I think that that was some additional information we included in that segment. 

MADELYN HERZFELD:    I have one more thing to add, too, is that for us it wasn't just about revenue enhancements, but also enabling efficiencies within provider organizations. So, the computerized symptom pathways, as an example, which was the SBIR grant, enabled efficiencies with nursing triage that impacted operating costs. So, that's another opportunity as well. 

BILLY BOZZA:    Perfect. At this time, I'd like to let Beatrice say hello and introduce herself. She's our last panel speaker. 

BEATRICE LANGTON-WEBSTER:    I'm Beatrice Langton-Webster. I'm CEO of Cancer Targeted Technology. And we're a small biotech that basically is developing small molecule targeted drugs for prostate cancer. And we've been in the radio diagnostic and radiotherapeutic space and now also in the chemotherapeutic space. So, a long-standing relationship with SBIR. And I've been with the company about 15 years now. Thanks, Billy. 

BILLY BOZZA:    Thanks, Bea. Another question came in, I think this is a programmatic one. I'll do a quick answer here. So, his question is on commercialization plan information for an SBIR STTR Phase 1. So, that's not required for Phase 1 application, but just to be clear, right, there should still be an ability to generate a commercial product. So, you can really carve out a paragraph from the research strategy section to kind of indicate this. You want it to be clear that there's a need for a product to be developed, the potential market exists, and also if there's any barriers to market entry, you can kind of highlight those and how you would kind of handle and address that. 

     This is a good question. I think almost all those speakers can provide some different aspect of this here. So, you know, how does SBIR funding fit into going out and raising funds from either institutional investors or angel investors or strategic partners? Can you speak to potential orders or how it's kind of worked in your history and experience? And maybe, Sid, you can kick us off first on that one maybe. 

SID SELVARAJ:    Sure, this is just my experience and, you know, and my experience may not be universal, right? Our company is a diagnostic company and when we talk to investors, there's a couple value points from SBIR’s, one is it's a credibility on the data that you generate and also it allows you to buy time because, you know, when you build a diagnostic or a device product, it actually takes a long time to build the product and get paid because you have to solve the reimbursement problem, you have to solve the regulatory problem. 

     And for diagnostics, solving regulatory does not mean you get reimbursed. So, it's like independent problems you have to solve. And so, I think it's really a matter of data credibility and time that you buy. But what I – 

BILLY BOZZA:    You said you mentioned you raised some funds as well and of course you've received SBIR awards. So, in your case, you know, what came first? What was the chicken, what was the egg? 

SID SELVARAJ:    SBIR came first because our path was, like, a three-step business model. The first step is to focus on the research market because we have a technology that enables the diagnostics and you can sell the technology to the research market first. And it gives you three benefits. One, a research customer is very influential, because you can influence the physician or biopharma who would then engage with you since its credibility and influence first. 

     Second is it helps you to optimize your product and your workflow. And third is it buys you time. And so, we focused on that market first and then gradually overtime collected data and maturity to focus on diagnostics. And so, to support the research market, which is a very, very small market size, we leveraged SBIR’s to both, like I said, collect credibility on data, but also time. And then with that initial success of revenue and customer advocates, we went to investors and then raised more money, which collectively helped us to focus on the diagnostic market that we're focusing on right now. 

BILLY BOZZA:    Great. Thanks, Sid. And now Maddie, I think you are the opposite of that is. Is that true? 

MADELYN HERZFELD:    Yes, we were the opposite. We did a series A which was like a friends and family raise, then we did a series B. And then there was a perfect SBIR that was announced that would augment the initial product, which we applied for and received. And then part of the SBIR, we were part of the SB, we applied for and were allowed to participate in the SBIR Investor Initiatives, which gave us access to several investor conferences, one of which was Rezi [phonetic], which we went to and we picked up an investor that was part of our series C. So yes, opposite for us. 

BILLY BOZZA:    Great, that’s awesome. Yeah, that’s a good plug for our Investor Initiatives Program that's also listed as a resource on one of the slides. And at its simplest form, some of our awardees can apply, and that's reviewed by our network of pharma and venture capital folks. They provide written feedback and some companies are selected and given funds to go pitch to some of the best conferences across the country, and a lot of times, as in Maddie's case, that can often result in some good deals. 

     Yeah, I think it would be valuable to hear your input too as well and knowledge on the therapeutic side, you know, into organizing. 

BEATRICE LANGTON-WEBSTER:    Yeah, we took a slightly different tactic here. We had some initial money to launch some research and we did research in collaboration with Washington State University. And really, the whole strategic business plan of the company is to take products basically one at a time off the research bench and into the clinic. And so, our really pain point was getting it into the clinic and for us a lot of the early radio diagnostics and radio therapeutics that are being developed merely meet some early clinical data in order to support subsequent financing and/or licensing deals. And that's not uncommon amongst any of the products really, but for particularly radio diagnostics and radio therapeutics, it's very, very helpful to have that clinical data. 

     And so, we went to the SBIR Phase 2 program and the Phase 2B program to get money to leapfrog those forward through clinical trials. And on the basis of our initial clinical trial for our radio diagnostic, I was able to do a very nice licensing deal with Novartis. and Novartis then acts as our development partner for that diagnostic. And then we take in the funds from that licensing deal, initial milestone payments, and now probably in 2026, it'll be commercialized and we'll have some revenue coming in from that. 

     But we take that and then leapfrog forward the next product and again, use SBIR funds to help us with our clinical trial and we already have some candidates now for licensing on our radiotherapeutic. So, we don't develop a whole portfolio of products at one time with a lot of investor money, we very carefully move each one forward and then do a licensing deal to find the development partner that has the expertise because we're not going to become a fully integrated pharmaceutical company, per se. 

     So SBIR has been really, really helpful in that model and moving that model forward to get us initially for the pre-IND enabling studies and then for the subsequent clinical studies. 

BILLY BOZZA:    Thanks, Bea, that was great. Manijeh, anything to add on that note?

MANIJEH GOLDBERG:    We actually started with -- we had some data, some animal data using our product in the early version. We applied to NSF, they had a program on how to optimize, you know, nanotechnology manufacturing scale up. We also, when we were still at academia, we used some of the programs they had on innovation to get some funding to be able to get things moving. After NSF, we got some funds from friends and family that helped us with generating more data to submit fast track to NCI as well as NIDCR. 

     And that really, we were fortunate we got both and we were able to build a small facility, build a lab to generate even more data, so we were less dependent on academia and we were able to do things better faster. In my opinion, when you're dependent on using a lot of resources from academia, things slow down a lot. And once we are able to build even a small facility, things moved much faster, especially in the therapeutics where there's so much, so much testing and things that FDA requires, like CMC, and those are really, really intense and they require a lot of time and resources. So, after that, we raised more funds from investors. 

     And so, we've been working with NCI for a while. We have three programs that we are working on and two of them are in the clinic and one of them is kind of in the getting into the pre-IND stage. So yeah, we've done a combination of what I've heard today. And we also are working with a large pharma in order to get and they paid us some funds to be able to further our research. So, it really, it's a combination of different things. 

BILLY BOZZA:    Yeah, that's a great point. And so the SBIR program as a whole, you go through our three different SBIR phases, it's roughly, you know, $7.5 million in funding. So, you know, a sizeable a portion to get going. And since there's a question on this in the therapeutic space, you can really kind of leverage that for a lot of your pivotal preclinical efficacy studies, IND enabling studies. And actually our largest award, our Phase 2B or Bridge Award is actually designed to help raise matching funds, and it's a requirement for companies to raise matching one to one funds from outside of the federal government. So, if you really kind of take advantage of the whole SBIR program and start to do some of these fundraising activities, that can really help kind of breakthrough that barrier into the clinic. 

BEATRICE LANGTON-WEBSTER:    Billy, I just wanted to mention on that fund, for our Phase 2B that we got, we actually used those Novartis funds to match the Phase 2B. So, you can use a licensing deal as well to help match those funds. 

BILLY BOZZA:    Absolutely. Great point, Bea. Yeah, so for folks that are kind of new to this, just getting started, what are some resources that they can kind of employ into developing a commercialization plan? 

MANIJEH GOLDBERG:    Maybe I can answer that question. My experience has been maybe a little different. We found out that we had to do a lot of leg work before we wrote our commercialization plan. You know, you have to almost do a storyboard and say, let's say if you had all the funds in the world, what would you do and how would you do manufacturing, how would you get your IMD, how would you do your GMP and GMP manufacturing, GLP animal studies? You know, there's a lot of stuff that you have to put on your storyboard. 

     And then start talking to people that are in that space. For example, go to a CDMO and describe what you're doing. Get a CDA, describe what you're doing, and ask them if they are going to work with you, how much would it cost? What were the things they would do for you? And they itemize, they do the work for you, they itemize what they think you should be doing, and that really helped us. 

     Also, when we were writing commercialization plan, we did say that it's important to the reviewers to know that you did that leg work. You can't just refer to publications. You need to say how much legwork you've done. You've talked to people. We even mentioned, we talked to doctor such and such regarding this, we worked, we have a champion, he's an oncologist or a surgical oncologist and, you know, he or she said this and get support letters from them. There is a lot of things that you need to put yourself in the shoes of reviewers and say, how would you convince them that this is not just a side hobby? You're very, very serious about this. 

     So, it's more than a full-time job. You called many people. You asked, you get estimates, you get a feel for how much certain things cost, and it's shocking how much more it costs than you think. So, if you write a commercialization plan and you put things that the reviewer says, clearly, this doesn't make sense. Clearly, it's going to cost more than this, let's say to have your GMP manufacturing for a drug done. So, you need to make sure that things make sense. 

     And then you also have to be transparent and kind of talk about this is what we know, this is what we don't know. So, your money is going to help us go after these few things, which opens up even more doors to the next steps and the next steps. So, it definitely opens up doors. And I'm also not shy to call our program director in NCI and ask questions. Do you recommend I talk to someone? Or, you know, there are resources available in NCI that have been very helpful. 

BILLY BOZZA:    Absolutely. We always encourage you to reach out to your program director. Manijeh, I remember when we connected earlier, you mentioned that you leveraged some kind of university offerings I think somewhat related towards SBA and kind of getting some help in initially and developing the commercialization plan. 

MANIJEH GOLDBERG:    Yeah, we actually, you know, this was at MIT, they had innovation programs competition. So, initially, we applied to these funding innovation programs and we were able to secure two different times, one on scale up of nanotechnology, the other one was on just, you know, working on something that was very translational. So, we were able to secure some funding which kind of helped us build more data and submit it to NSF. And from NSF, then we were able to raise more funding from friends and family, like series A. You know, it just kind of snowballed into the next. 

     Once we had more data, we applied for SBIR and NCI. I know it says you don't have to have data, I personally think you do need data because there's so much competition. This is, as you know, it's a very competitive program. So, in order to be able to convince the reviewer that you've done a lot of work and this is going to translate, you need to have data. 

BILLY BOZZA:    Thanks, Manijeh. Carlos, I think you also leveraged some interesting business plan competitions or MBA students. I think that would be something the audience might want to hear from also. 

CARLSO CASTRO GONZALEZ:    Yeah. No, I guess we have maybe similar experience. We applied to, we came out of MIT as well, so we used some of the innovation programs and resources at MIT. We were awardees of the [unclear] program, which is a program where they don't only provide you with resources or funding for some basic research, but they also pair you with experienced mentors from industry that can help you kind of, like, tune your commercialization plan. 

     We did very successfully leveraged business plan competitions to craft our commercialization plan. And we found that, you know, working with MBA students was a great, it was a great compliment for us. The founding team, we are first time entrepreneurs, we are scientific founders. So, working with MBA students really helped us in the initial stages. 

     And also going through all of these different competitions. We participated in MIT 100K. 

MANIJEH GOLDBERG:    We did too.

CARLOS CASTRO GONZALEZ:    Nice, yeah, it's a classic. We got an award from the Rice Business Plan Competition. We won first prize at Mass Challenge. And when you participate in these competitions, you will often times, like [unclear], you will get a lot of investors or mentors in the audience that will make tough questions that are probably very similar to the questions that reviewers from the SBIR commercialization plan will have. So it's a good thing to work on those questions early, so by the time you submit, you have a well-reviewed plan. 

     So, those were some resources we used. I will mention another one that I think was very important for us, which is participation in I-Corps Program. Actually, I believe NIH offers I-Corps participation to companies once they have received a Phase 1, but NSF has the option to apply for it before you apply for SBIR. So, that's certainly a tool that people can use. There's a customer discovery program where you can get $50,000 to do customer discovery over the course of three months. You need to interview at least 100 customers. You use the Steve Blanks methodology for the business model canvas where you need to identify your customer segments and the value propositions you are offering to them. You start with some basic assumptions of, you know, such and such customers will buy our product because of X&Y reason, and then you get out and try to talk to those people and prove or disprove your hypothesis. 

     And that was a huge help in order to refine our business plan and also make it concrete. Make sure that you add that to your proposal, because I mean, providing evidence that you have talked to customers and that you know your market will go a long way. So, that was very important for both our SBIR and also convincing our investors that we have good evidence that the product would be successful commercially. 

BILLY BOZZA:    Thanks, Carlos. That's a great plug for something else I wanted to mention and you're right, the I-Corps program requires an active Phase 1 award. However, we just launched a few months ago, I think, it's called an entrepreneurship boot camp. It's kind of this mini I-Corps program and it's a little less intensive, and a kind of cool feature of that is an award is actually not required. So, if you're not there yet, but you still want to get some of this help, that opportunity is out there and I'm sure it will be offered again next year. 

BEATRICE LANGTON-WEBSTER:    Billy, I wanted to mention to you that both Manijeh, and it's been mentioned here that the value of getting other people’s comments and other, like, contractors or contract research organizations and their input into what is needed. I'm a strong proponent, as you well know, of being a reviewer on grants, and I think you can really, really get a lot of insight and input. We've all done grant review, scientific grant reviews, but not so many people have really been involved in Phase 2 sort of grant reviews and looking at commercialization plans. 

     And I'll tell you, you know, when I started reviewing for the SBIR program, probably about eight years ago, it really opened my eyes. And I've said it before that when you see a good scientific grant across your desk, you know it. When you see a good commercialization plan with all the essential components that you're looking for cross your desk, you know that too. And that really helps you solidify in your own mind some of the strengths that you want to highlight about your own company and about your own program. So, I highly recommend that if folks can get involved in the SBIR reviewer program, that that would be a really useful resource. 

BILLY BOZZA:    Perfect. Thanks, Bea. There's a question on timeline. I think this may depend, but in general, how long does it take to develop a commercialization plan? 

MANIJEH GOLDBERG:    I'll say something on this. For us, you know, working on a commercialization plan, it's something that we have to do anyways. We need to understand where we are, where we are going, how do we answer investor’s questions and how do we answer FDA's questions, because FDA also wants to know that you know what you're doing and the product, when it's gets to market, that you can commercialize. So, we are always doing leg work. We are always trying to network and ask people, do you know a good person that knows reimbursement models? Do you know a good person that -- Do you recommend somebody that understands CMC, GMP manufacturing? 

     You know, we're always asking for recommendations. And when you talk to someone and you hear the same thing from three different people that were recommended then you know, OK, there's something to this. You know, if I put this in my commercialization plan, I'm not going to embarrass myself and somebody's not going to say, what is she talking about? So, you know, you have to almost, like, test the waters ongoing. We don't just say, oh, we are about to write SBIR, so let's see what we're going to do. You're kind of all along, you're doing this. 

     The thing that SBIR, writing a grant forces us to do is really start collecting all that information, like I-Corps does. Put it all together and do gap analysis. What am I missing? You know, when they have these titles in a commercialization plan or research strategy, you know, those titles are telling you, do I have a good handle on my IP? Do I have a good handle on my approach? Does it make sense? Can I scale it up? 

     You do a gap analysis and that can take time because once you know you're missing something, then you're gonna have to go out there and see who can help you. One thing that Carlos mentioned, I forgot to also say, we are in the same boat. We did a lot of competitions. It's very time consuming. You know, we would take any money, 10 grand here, 50 grand there, you know, nothing was too small. So, in the process you learn. People ask you a lot of tough questions and you kind of build a thick skin that I can handle these questions. 

     These are musts and SBIR is just the way to push you, you know, get out of your comfort zone, and do all these things that maybe you wouldn't think you need. So, it's almost like a guiding light into the real world. 

BILLY BOZZA:    Perfect. Thanks, Manijeh. There's questions related towards like technologies that SBIR would consider funding. So, I recommend, we're not going to cover those now, but definitely reach out to the program director. There's an e-mail inbox at the office level that you can reach out to us and get paired up with a program director and ask those questions. Getting a little close to time, but I think this would be a good one to potentially close on. So, there's a question on, you know, who should kind of take the lead and manage this commercialization plan? And how do you engage different stakeholders for the different sections? So, maybe we can kind of just each quickly touch on this a minute or two each and then wrap things up. 

SID SELVARAJ:    I can give it a shot. My experience is that I found that I-Corps program or I-Corps focuses on customers, but if you think about it, an investor is also a type of a customer. And I think if you are able to collect customer and investor feedback through some mechanism, it could be, you know, like a private one-on-one meeting or it could be like a program, but somehow if you could collect that information, that really, that [unclear] how you write the commercial grant because you get a very clear idea. 

     And so that's why I would strongly recommend I-Corps program and any investor initiative programs, even before you actually write a grant, a Phase 2, to have a clear understanding of what's your product, who's your customer, how are you going to get paid, and why would anybody invest in your company? 

     I think if you nail that, then I think the commercial plan is just like, you know, like putting all the figures together and writing something up. So, it's pretty easy once you get that. But getting that is pretty hard. It takes a lot of time and effort, but that's the challenge, I think. So, I'll stop there. 

BILLY BOZZA:    Thanks. So, in that example, it sounds like a hungry CEO going out and making things happen is someone that who could have good ownership. I can't remember, I think Bea, you had a pretty good video content slide on this. I'd like to hear your thoughts too. 

BEATRICE LANGTON-WEBSTER:    Yeah, again, looking at it a bit from a reviewer perspective, you see the science side a lot. And a lot of people are tempted to put a lot of the science back into the commercialization plan. And while some of that is good, especially if you start thinking about competitive products, etcetera, you really have to stand out from a competitive standpoint, this really should be a business-oriented document. It should be very heavily oriented towards, how are you going to move this product forward to commercialization? It should be heavily oriented to, and something we haven't covered is intellectual property. What's the strength around that product? 

     So, you have a competitive strength, which is a little bit scientific, but you also have an intellectual property strength and then you have a financing strength. How are you going to take that product forward to the next step? And of course, the manufacturing strength and in terms of how you're going to make that product and then the customer base, which we've already covered on here. 

     But I think it really has to be very, very strong from a business perspective. And so, I think the final stakeholder in this plan should be the CEO of the company. You can have various people write the plan, but I really do believe that the final responsibility and the final stakeholder for a commercialization plan like a business plan should reside with the CEO. 

BILLY BOZZA:    Great. Thanks, Bea. And Maddie, you had probably my favorite line of all the videos, teamwork makes the dream work, so anything to add there? 

MADELYN HERZFELD:    Yeah, I would agree with all the other panelists. You know, when we were a small business and I was the CEO, I certainly was pulling together all of the information, but I almost was like, just, I don't want to say just describe, but I certainly, you know, I had a cofounder who was an expert in our space. We had a scientific advisory board, we had a chief commercial officer who really knew sort of the distribution channels, so it was really a culmination of so many different perspectives and experiences. You know, you need the science, but you need the sales and you need a holistic perspective on things. 

BILLY BOZZA:    Thanks, Maddie. And how about just closing sentences from Manijeh and Carlos, and then we'll wrap up. 

MANIJEH GOLDBERG:    I just wanted to say, maybe I forgot to say it in my video, this is logistics. I've noticed that if in the first 2 pages, whether it's research strategy or commercialization plan, if we don't give a really clear understanding of who we are, why do we think we're gonna make a difference in, let's say, oncology market, why we think there is an unmet medical need, if we don't explain it in the first 2 pages, we lose the reviewer. I saw it with my own eyes when I would read my own grant, after the reviewer said there is no way we're going to pay you, and I would read it and I'm like, you know, they're right, I confused them. 

     So, it's really important to have somebody else, maybe more than one person read your grant proposal and say, do they understand what you're talking about? If you get too, too, too into science and lose them, it's not going to work because a reviewer is a scientist, but they are not, you know, they don't know your particular science. So, I know as a reviewer, NCI reviewer, I have to do a lot of leg work to understand what I'm reviewing. So don't make it too hard. 

BILLY BOZZA:    That's great advice, and I think true for all sections of the application really. 

MANIJEH GOLDBERG:    Yeah, exactly. 

BILLY BOZZA:    Carlos, last words. 

CARLSO CASTRO GONZALEZ:    Yes, I would say I would like to echo what's been said. I also believe that the CEO responsibility to own the commercialization plan. Obviously, the commercialization plan covers kind of all the aspects of the company, it’s cross-sectional. So, you will have to bring in chief technology officer, your chief commercialization officer, your chief medical officer, all your consultants on reimbursement, regulatory, etcetera, but ultimately it’s the CEO's responsibility. 

     I mean, a lot of the sections that the commercialization plan covers are things that you need to know at the tip of your fingers. I mean, if you pitch to investors, they will ask you questions about your IP, your reimbursement, your regulatory, your financial projections, when you are going to break even, you need to have like instant answers to all of those questions. I mean, obviously you can use the different resources and people in your company to fill in those blanks, but ultimately the CEO needs to master all of those different areas. 

     I would say maybe one last thing also that is very important to I guess build your credibility in the proposals and like, back everything that you are saying with either research or facts as much as possible, I mean, I guess that the last thing that you want to find is a reviewer saying no. You know, they said that the pricing would be this, and again, in my experience, this is completely off the mark, right? So I mean, I think it's OK to have assumptions or hypothesis, if you do have assumption or hypothesis, make sure that you point out. And then make sure that you articulate some kind of plan to fortify those assumptions or test them. 

     But I mean, there is nothing better, like, having already tested all your assumptions and having some, like, multiple sources. If you have interviews from customers to back that up, mention it. If you get letters of support from people backing what you are saying on the application, that's even better. So, I think that's also very important to establish the credibility as you write the plan. 

BILLY BOZZA:    As always, don't forget to check our website, sbir.cancer.gov, for the latest funding opportunities and commercialization resources to support your journey from lab to market. This was Billy Bozza from NCI SBIR. Please join us again for the next installment of NCI SBIR Innovation Lab and subscribe today wherever you listen. 

     If you have questions about cancer or comments about this podcast, e-mail us at nciinfo@nih.gov or call us at 800-422-6237, and please be sure to mention Innovation Lab 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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