Episode 20 | How to Write a Strong Commercialization Plan – Part 2

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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.

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 referenced in this episode:

•    Investor Initiatives
•    I-Corps at NIH
•    MIT $100K Entrepreneurship Competition
•    Rice Business Plan Competition
•    Mass Challenge

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 last episode, you heard from an SBIR-funded diagnostics company and a therapeutics company on advice for putting together a strong commercialization plan. Today, you will hear advice from a digital health company, a radiopharmaceutical company, and a device company. To kick things off, we have Madelyn Herzfeld, Co-Founder and Vice Chairman of Carevive Systems, who will discuss SBIR project value and revenue stream as well as share considerations for digital health technologies. 

MADELYN HERZFELD:    Hi, everybody. My name is Maddie Herzfeld. I am an oncology nurse by background and I am one of the co-founders of Carevive. And Carevive was established back in 2011 and today we are an oncology care management technology. And we enable nurses to give treatment care plans to patients, we enable nurses to remotely monitor patient symptoms. We have symptom pathways, which we'll talk more about today, for nurses to use evidence-based triage and symptom management guidelines to effectively manage symptoms. And our technology enables nurses to give patients survivorship care plans. 

     We did receive a fast-track Phase 1, Phase 2 SBIR award, so that we would be able to build those symptom pathways, that I was telling you about, so that when patients reported symptoms to nurses using our platform, that the nurses could access what was the latest guidelines for effective triage and management of those symptoms. 

     So, who within the company should have ownership in developing the commercialization plan? And the reality is it takes the whole vision and as I said, team works makes the dream work, and it also really depends on what is the profile of the people on your team to really determine what role people play in that commercialization plan. So, for instance, if you have a CEO who's a visionary CEO, they're going to make a lot of visionary contributions to this commercialization plan, really understanding sort of what's the market need, what's the product vision that you solve for. So, in that instance, the CEO is going to be really active in this commercialization plan. 

     They're also going to know maybe about what your competition is and also be the one responsible for really understanding what's the intellectual property and the legal components. If it's more of an operating leader, then you may rely more heavily on your chief scientific officer, your chief medical officer, nursing officer, who really also has that same sort of strength in understanding what the market need is and what your product differentiators are and benefits. 

     We've always relied on subject matter experts and clinical and scientific advisory boards to get input on our vision and also the competition, what else people are seeing. And then if you have a strong product person, same. So, all of these people can be contributing to the commercialization plan with the same sort of market need, product benefits, competition. Same with your salespeople. So, if you have salespeople who have experience in your space for a long time, they're also going to have sort of those similar visions. 

     Your marketing folks are really going to understand the customer channels and what your social media plans need to be. As well as sort of your corp dev people who really understand, who do you need to make alliances with and partnerships with, who are important sales channels for your organization. And then finally, there's typically a reliance on your chief financial officer or some people in your accounting teams to really help crunch numbers in terms of pricing the product appropriately, so ultimately you could be profitable. 

     OK, so, can the SBIR developed commercialization plan be leveraged for additional fundraising efforts? And of course, so this work will not be just for the SBIR, you're going to need this if your vision requires institutional capital. Any institutional investor is going to want to know all of the components of this commercialization plan, and you have to be prepared to eloquently present these elements to those investors. For us, we had the benefit of being part of the SBIR Investor Initiative Program and it was through that program that we actually, we were invited to participate in a number of digital health and life science investor conferences. 

     And through that, we were able to work with Debio Farm [phonetic], which is a current Carevive investor, and that was a connection made at the Resi [phonetic] Conference back in 2020 that the NCI supported us being there and making those introductions. 

     So, are there specific commercialization plan considerations to highlight for digital health technologies? And being that we've done this for over 10 years now, I would say, you know, using Carevive as a case example, some of the things that would be really important as it relates to our company, lessons learned, is that make sure that there is a meaningful return on investment that's aligned with the right stakeholder. 

     So, with that, I mean, you know, our technology was used to remotely monitor patient symptoms, patients who are typically on cancer treatments, and our goal was to keep patients out of the hospital and we could show that we reduced hospitalizations, but in fact, reducing those hospitalizations actually created a financial benefit to a patient’s insurance companies, but not necessarily a benefit to patient’s care teams who may be in more fee for service relationships. 

     So, over the years until recently, with the advent and growing popularity of value-based care programs, it was hard to create a meaningful financial return on investment and benefit despite having a clinical benefit to our end users. So, one word of caution or advice is making sure that you are going to have a meaningful return on investment that has, you know, two to three times at least return to be able to show the CFO's of hospitals or cancer programs or whoever is your customer. 

     The other thing I would say to be mindful of is any dependencies that your product is going to have outside of your control, and so, for us, that was always the electronic medical record. So, we thought when we first started this business that our technology was going to be so good that it would be okay that clinicians would be willing to use us outside of the record. Well, of course, 10 years later, we learned that is in fact not true, something that's so critical to clinician’s workflow needs to in fact be in the workflow and be in the record, documented in the record. And that was something that was really, really hard for us to attain over the years. So, we did finally achieve several EMR integrations and corporate partnerships, but it did take a lot of time, a lot of money, and without which, we would have never been successful. So just be mindful of things that may be out of your control in order for you to be successful. 

     And then finally, what I would say with all digital health technologies today is that if there is a role in your technology for clinicians, be mindful and sensitive to clinician fatigue and burnout, which is very real and something that we all need to help solve for. So, if your technology itself is intended to improve fatigue and burnout and creates efficiencies, wonderful. If it is secondary, make sure that your technology does not create sort of one more thing for clinicians to do. 

     So, I touched upon this briefly in my introduction, but there is the first question of the SBIR application that says, “What is the value of the SBIR to expected outcomes and impact?” And make sure that you're able to clearly articulate what's your company's vision and how does this SBIR project fit into that vision? And so, for us it was very simple because we already had a remote symptom monitoring platform, and so, it was a natural and organic progression that once these symptoms were reported and the nurses received them, that there was an easy puzzle piece to solve for with this SBIR, where we developed the symptom pathways so that the nurses can easily access, you know, what to do next once these symptoms came in. So, I think really articulating that in this first question is critical to a successful award. 

     And finally, to conclude, you know, of course this is a grant for a business and of course that means show me the money, right? And for us and for all of these commercialization plans, you really need to clearly articulate how this project is going to accelerate your company's revenue and for this, I'll end with a case example for Carevive. We already had a customer base, so, we would be able to upsell to our existing customer base this new product afforded by the SBIR. We were able to get new customers within existing EMR channels we had because the product was more comprehensive now, so, we would be able to better address market needs. The sophistication of the product and the more holistic product allowed us to develop more alliances with other EMR's. There is the opportunity to enter into complementary markets where our product solved a problem. 

     So, for instance, we sold to typically cancer providers, but there are payer care management programs that hire nurses to oversee their members with cancer. So, this was something that could be viable outside of the existing market that we served. We also did some work with life science companies. We got grants to fund cancer symptom management research, using the platform and technology that was built. And we were also able to de-identify our symptom management data and license those data for the purposes of advancing the science. 

     So, I want to wish everybody good luck and of course feel free to reach out if I could be of any more help.

BILLY BOZZA:    Presenting next is Carlos Castro Gonzalez, co-founder and CEO of Leuko Labs, an NCI SBIR funded device company. Carlos will highlight the importance of investor funding, intellectual property, regulatory framework, and reimbursement strategies in a commercialization plan. 

CARLOS CASTRO GONZALEZ:    Hello, everyone and thank you so much for this opportunity to share our experience writing a commercialization plan for SBIR. My name is Carlos Castro Gonzalez and the CEO and Co-Founder of Leuko Labs. We are a medical device startup developing a novel technology to measure white blood cells completely noninvasively. Our first use case is to monitor cancer patients in between chemotherapy cycles to make sure that they are safe and that we avoid infections and hospital readmissions. 

     I have a background as a scientist. I got a PhD in biomedical engineering. I conducted a postdoctoral fellowship on biomedical innovation at MIT, that's where this project started and where I met the rest of the co-founding team. So, we are a team of scientists, founders, and first-time entrepreneurs. We have been funded through one SBR Phase 1, 2 and now two [unclear] with a score between 15 and 20. In parallel to that, we complemented that with fundraising efforts from venture capital and angels, and we raised our seed and series A. 

     In terms of what individuals were used to develop our commercial commercialization plan, we used the whole company executive team. So, myself as the CEO, but also the chief technology officer, our chief medical officer, our PBP offices [phonetic] development, and this is important because we need to cover all of the components of the company. The commercialization plan is really cross-sectional. It covers your technical and clinical development plans, regulatory considerations, go to market, business models, financials, etcetera. So, it's really important to include all the functions of the company. 

     We also work with MBA interns, particularly in the early stages of the company, and this was a great complement for us as a scientific founding team and first-time entrepreneurs to get some of that business experience that we were lacking at the beginning. In that sense, we also work with experienced commercialization advisors and we involved our investors. We work not only with the investors that we currently have in the company, but also with prospective and future investors. This was a great way to get to ask questions and as we were going through due diligence, focus or identify the areas that needed more work to make our commercialization plan more compelling. 

     Finally, the most important individuals to involve in your commercialization plan are your customers. So, make sure to get out, talk to as many customers as possible, and in our case we have more than 100 interviews by the time we submitted our SBIR. This really connects with some of the resources that we used. So, a key resource was the I-Corps program. This is a structured program that can provide up to $50,000 in funding to conduct customer discovery for three months. And the goal is to get at least 100 documented customer interviews. This is a great way to test your hypothesis about customer segments, value propositions. 

     There are different resources that you can access. There are regional I-Corps courses at different universities throughout the country. There is a national program sponsored by the National Science Foundation that you can access before SBIR awarded. And again, it also sponsors a program to [unclear] so you can participate as soon as you get your Phase 1. 

     Another key resource was our participation in business plan competitions. This worked really well, particularly in conjunction with those MBA students and interns, so that there was a measurable and specific aim to work with or to work toward. Some of the competitions we participated in was the MIT $100K, Rice Business Plan Competition, Mass Challenge, etcetera. This was a great way for us to get exposure to outside investors and mentors to pitch, get some tough questions, and iterate on our commercialization plan. 

     I would also like to mention some of the books that were very influential for us, particularly Disciplined Entrepreneurship by Bill Aulet, who teaches entrepreneurship at MIT, The Startup Owner’s Manual by Steve Blank, who teaches entrepreneurship at Stanford, and after which the I-Corps program was modeled, and finally The Business Model Canvas, which is a one page template that covers all of the different aspects that you need to work on for your commercialization plan. 

     Finally, the key resource that we used was also the SBIR instructions. Make sure to make the reviewer’s job easy and make sure that you address the information they're asking for in each section. 

     In terms of whether the commercialization plan for this SBIR can be leveraged for fundraising efforts, in our case it was the other way around. So first, we conducted our fundraising efforts. We went through series C then series A due diligence. Through that due diligence we had to provide a commercialization plan. So, this had the advantage that by the time we submitted SBIR, we had already embedded some of our investors. 

     And essentially, all the different sections of the SBIR plan were reflected or were different documents that we provided to investors as their data room for their due diligence. And these data room include aspects such as talking about your team and management structure, your product, your market size, your business model, the competitive landscape, what is the value proposition, your financials and fundraising plans, healthcare economics. So, these are really not duplicitous efforts, and they are all aligned. 

     In terms of specific considerations to highlight for medical device technologies, make sure to talk about your clinical development plan, which is a little bit different for medical devices than it is for drugs. For example, in our case, this is the way we thought about it. We started with a first in human for our Phase 1 SBIR, that was a proof-of-concept study where the goal was to establish whether the technology could fundamentally work. With that milestone in our Phase 2, we focus on feasibility. We conducted the usability clinical study to make sure that our end users and patients were able to use the device. And also, we received guidance from the FDA through a pre-submission where we got information about what evidence we needed to show in order to get the FDA approval. 

     So with that, we run a [unclear] or replica of the pivotal to make sure that the device was working as intended before we froze the design. So that put us in a really good position to execute our pivotal study, which is the goal for our current Phase 2 bridge. In parallel to all of this, it’s obviously very important to highlight your regulatory pathway and I will talk about that in a minute. Make sure to cover also your operations and manufacturing aspects like, what is your cost of goods and how that will compare to your respective pricing? 

     But even if you talk about your clinical development, how you will get FDA approval, how you will produce your device, there is always the question about commercial adoption, how your device will get paid for. So, in this area, we made sure to collect a lot of evidence from our key opinion leaders, facing advocacy groups, customers, and strategic partners. And we actually submitted some key letters of intent from some of these groups as part of our SBIR proposal. And I think that this was really a key aspect to make it even more compelling. 

     Finally, make sure that you talk about your total estimated time and cost to take your technology to market all the way, not only focusing on the next milestone, but also really think through all the different steps so that the financial and fundraising efforts realistically address this. 

     In the intellectual property section, we particularly talk about our patents. They are [unclear], whether they were provisional, filed, or already granted. Also, the geographical coverage. Make sure that the different geographics covered are also the main markets that you are planning to launch your technology on. And it was also very important for us to not talk only about our current patents, but also about the patents that we were planning would be generated as a result of the SBIR work that we were proposing. 

     We also talked about our trademarks, our trade secrets, and confidential information, but also how we were planning to protect it, how we are planning through nondisclosure agreements, encryption, etcetera. We talked about licensing agreements, which is particularly relevant if your technology originated in an academic institution. And we also talked about the IP attorneys we were working with as a way to showcase the experience we have in the team to pursue a reasonable, sensible IP strategy. 

     Regarding the regulatory and reimbursement considerations for regulatory, you need to talk about the classification. For this, we submitted A 515-G. There is a formal mechanism by which the FDA can confirm the class your device belongs to. We also conducted a pre-submission meeting with FDA. Make sure that you reflect the guidance you are receiving with FDA, and this is a way to reassure reviewers that if you conduct the work you are producing at SBIR, that will lead to FDA approval. 

     We also talked about the regulatory consultant that we were using as a way to showcase that we had that expertise. For the reimbursement section, we talked about existing codes that we had researched that we could potentially access. We talked about predicate products and how they were being paid for. We talked about the pricing that could be supported by these codes and how that compared to our codes. Make sure that you talk about the timeline and the clinical evidence that you will be required to access these reimbursement codes and make sure that your SBIR work reflects that as well. 

     And finally, we talked about the market access consultant we were working with as a way to show that we had that expertise in the team as well. 

     Finally, as a conclusion, this applies to the regulatory pathway and reimbursement considerations, but also to the whole commercialization plan, make sure to provide measurable evidence and justifiable numbers. Just to give an example, we justified our pricing using four different approaches. We used comparable products that we were already being paid for. We use our codes and we added a margin. We actually researched the average margin in the metric industry to make sure that would make sense. 

     We compared our pricing to our value proposition and estimated cost savings that we would generate to make sure that also checked out. And we finally back it all up by customer interview testimonials, in particularly, we talked to several medical directors from private payers to make sure that our pricing made sense for them. So again, this doesn't apply for pricing, this makes sense to your whole commercialization plan. So, the more you do this, the more competitive it will be to reviewers. 

     So, with this comment, I will finish here and I wish you good luck for your future applications. Thank you. 

BILLY BOZZA:    Lastly, CEO of Cancer Targeted Technology, Beatrice Langton-Webster will provide additional commercialization plan insights and considerations for imaging agents and radiotherapeutic technologies. Beatrice will also discuss what type of finance plan information should be included in the commercialization plan. 

BEATRICE LANGTON-WEBSTER:    Hi, I'm Beatrice Langton-Webster and I'm CEO of Cancer Targeted Technology. We've been around for about 15 years and we develop small molecules to prostate specific membrane antigen for prostate cancer. We developed imaging agents, radiotherapeutics, and chemotherapeutics. We have a long-standing relationship with the SBIR program and have used Phase 1, Phase 1-2, direct to Phase 2, Phase 1-2 Fast Tracks, and Phase 2B's to move our products forward. 

     So, I'd like to give you some of my thoughts today on how to write and some tips for developing a good commercialization plan. So, what are some of those tips? First and foremost, consider becoming an SBIR grant reviewer, that helped me enormously. I've been doing it for about 8 years. And when a good, good grant crosses your desk from a scientific perspective, you know it, but the same is true for a commercialization plan from a business perspective. 

     One commercialization plan does not fit all. So long ago, I started writing commercialization plans and I figured, oh, I could just tweak it for the next product or technology, that doesn't really work. It really needs to be very product specific. It's not an overall business plan, but rather a plan specific to your grant, product, technology or device. 

     You've got 12 pages, the same as the grant, so again, this is your best chance to make a business argument for your product and why it really should be considered for commercialization. Your value statement is your two-to-three-minute elevator pitch and it is your best chance to grab your audience, in this case, reviewers, and is your best likelihood that they will really read the rest of your commercialization plan and consider it. So, make sure that you really grab them in that one-page value statement. 

     And then consider each section carefully. There are lots of requirements and guidelines for each section, address two to three specifics for each one. So, for example, for company overview, I like to highlight key individuals that can contribute to product success here. From market, customer, and competition, I like really to consider a lot of the aspects of the competition. And so often people just say, well, this one or two product is my competition, but really you want to consider it from a biomarker perspective, you want to consider it from a disease and disease stage perspective, and you want to consider it from the type of product or technology that you're developing. 

     Intellectual property, again, be very, very specific here. Don't simply cite that when you have it, you will write the provisional. Be specific about what provisionals you have, what patents you have, where and when they were filed or issued. 

     Your finance plan, I'll talk a little bit more about that in a few slides, but again, you want to be specific about what you've done to date and what you're going to do post-grant. 

     Your production and marketing plan is very, very important. Production plan is vital to all products, but marketing you want to be a little bit careful here that you don't go out on a limb when you don't have to. Very, very small companies don't need to have a very extensive marketing plan because in all likelihood they're looking for development or licensing or even acquisition partners down the road. 

     And finally, your revenue stream. Here, again, you need to be specific on what your revenue stream will look like. So, you want to try to compare to commercialized products. So, don't simply say you're going to have the next billion-dollar blockbuster and give me a hockey stick type of scenario, but you want to really use known competitors and compare those to what your revenue stream will look like, and that will really lend some credibility to your market penetration scenarios. 

     The SBIR asked me to talk to you a little bit about what special considerations we might have given in our commercialization plan to the specific imaging agents and radiotherapeutic technologies that we were developing at Cancer Targeted Technology. So, there were four main ones here that we consider: production, customer, competition, marketing, and revenue stream. With respect to production and customer, we had to consider the isotopes, the half-life of those isotopes, whether the products were going to be made on machines or not, and then the distance to the clinic or the site of production for these different products, and that brings into play also stability considerations and things like what modalities that are available to make the isotopes or whether the isotopes are on site or need to be sourced from a foreign or domestic source. 

     With respect to competition, these are fairly new agents to the FDA and so we really have to look at conventional imaging modalities in terms of competition, but for radiotherapeutics we had to really look at chemotherapeutics as comparators here. But with respect to biomarker, again, you want to really highlight, for us, PSMA specific agents. So, that brought into play both the conventional as well as the specific types of competition. 

     Marketing, do CPT codes exist? Has Medicare really planned for these types of agents or not? In the case of imaging agents, it’s very interesting because the technology has a separate CPT code from the product, that is now changing, so that now they're actually combining the particular product with, for example, PET imaging and the actual technology, so there will be one CPT code. 

     And in terms of revenue stream, again, here be very specific. Are there comparators out there? So, use the competitors available, for us it was Polarify for imaging agent and for the radiotherapeutic obviously, Plu-Victor [phonetic] is a great one there to use as a comparator and to really understand market revenue stream and market penetration. 

     So, I mentioned that the value statement is really your two-to-three-minute elevator pitch. Here you want to define your product very carefully and from a unique standpoint, and the whole of this should be targeted to competitive advantage and uniqueness of your product. So, what are your expected outcomes? That is what differentiates you from current marketed products and what are the shortcomings of those products, and then really, how can you address those shortcomings? 

     Impact, really consider the disease stage. For us in cancer, obviously we have to start in late-stage cancer, but if we can move towards earlier and earlier stage cancers, that's really going to make an impact. Consider what the drug will look like. Is it a niche product or blockbuster, a me too, a first in class? Really, the development needs and the finance strategies look very different for those types of compounds. 

     Then really, again, highlight how your company in particular will lend credibility to the success to the future of commercialization success. And then, have you done it before? Have you done it either with a similar product before, that shows success? Have you done patent success before? Have you had licensing success? Or have you had finance success? All of those really contribute to that value statement. 

     The finance plan is really critical to the commercialization plan. It's really how you're going to bring this product forward, both from where you are now as well as going forward for the future to really commercialize the product. So, it's different based on the size of the company and what your strategy is for the company and your company expertise. Obviously, I've listed here the strategies for financing. 

     Has your company in the past had success and how can you use that success for the current grant? So, I'll give you an example from Cancer Targeted Technology. We used SBIR Phase 1-2 funding to develop our F-18 imaging agent, and we conducted a successful Phase 1 clinical trial using those funds. And on the basis of that clinical trial, we're able to license our product to Novartis. Novartis pays up front milestones and in 2026, they'll commercialize it and we'll start getting licensing revenues. Our mode and our strategy and our business model has always been to develop one or two drugs. Based on this, we're not going to become a fully integrated pharmaceutical company. We're really going to use the best development and licensing partners that we can out there. And in future, we'll be a good target for acquisition. So, we use those licensing funds then to develop our subsequent products and we're doing that now with both our radiotherapeutic and our chemotherapeutic agent. So again, it's a cycle and it repeats itself. 

     So, I was asked to consider who should have ownership in a commercialization plan. And obviously, the people that write the sections should be considered in this, as well as the PI's expertise and his background. You want to consider the people that are responsible for commercializing the technology or responsible for revenue plans and money raising. Ultimately, I believe a business role is important in ownership of the commercialization plan because that person will really be the person that has developed the company business, scientific, financial, and IP strategy. So, for me, the ultimate responsibility and ownership of a CP should reside with the CEO. 

     So, with that, I thank you very, very much for your attention and wish you good luck in developing your commercialization plans for all of your subsequent Phase 2 SBIR grants. 

BILLY BOZZA:    Thank you, Madelyn, Carlos and Beatrice, for speaking with us today. 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 Boza 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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