Afleveringen
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This episode concludes the three-part series on writing a strong commercialization plan. NCI SBIR Program Director William Bozza hosts a panel discussion gathering the five CEOs of the NCI SBIR-funded companies from the previous episodes to address questions regarding their experiences preparing to write their commercialization plan.
SBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In part two of the three-part series on writing a strong commercialization plan, NCI SBIR Program Director William Bozza is joined by NCI SBIR-funded, Beatrice Langton-Webster, director and CEO of Cancer Targeted Technology, Madelyn Herzfeld, co-Founder and vice chairman of Carevive Systems, and Carlos Castro-Gonzalez, co-founder and CEO of Leuko Labs, who share insights on this key Phase II SBIR/STTR application component.
SBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
Zijn er afleveringen die ontbreken?
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In part one of the three-part series on writing a strong commercialization plan, NCI SBIR Program Director William Bozza invites NCI SBIR-funded biotech innovators, Sid Selvaraj, co-founder and CEO of Arima Genomics, and Manijeh Goldberg, president, founder, and CEO of Privo Technologies, to share advice for aspiring phase II SBIR/STTR applicants:
https://sbir.cancer.gov/small-business-funding/grants/bridge-awardSBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Program Director William Bozza invites Director of Investor Relations Brittany Connors to dive into the NCI SBIR Investor Initiatives:
https://sbir.cancer.gov/commercialization/business/investor-initiativesLearn how this program supports SBIR/STTR companies in connecting with third-party investors and strategic partners through pitch opportunities at national showcases and more!
SBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Team Leader Monique Pond and Program Director Melissa Li continue their discussion on the FY25 NCI SBIR Contract Solicitation and describe the remaining topic areas.
https://sbir.cancer.gov/small-business-funding/contracts
Cancer technology innovators and submit funding proposals through this mechanism for a variety of focus areas, ranging from therapeutics to digital health tools.
SBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Team Leader Monique Pond invites NCI SBIR Program Director Melissa Li to provide an overview of the topics featured in the FY25 NCI SBIR Contract Solicitation:
https://sbir.cancer.gov/small-business-funding/contractsCancer technology innovators and submit funding proposals through this mechanism for a variety of focus areas, ranging from therapeutics to digital health tools.
SBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Director Michael Weingarten invites Matthew Gevaert, Ph.D., cofounder of Kiyatec to discuss the company’s journey. The NCI SBIR-funded cancer therapeutics company developed an innovative 3D cell culture platform that uses patients’ live tissue to assess and predict how tumor cells respond to therapies and inform more personalized treatment paths.
SBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Team Leader Monique Pond and Program Director William Bozza compare and discuss the two main funding mechanisms for biotech innovators, Grants and Contracts. Learn more about the mechanisms:
https://sbir.cancer.gov/small-business-fundingSBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Program Directors William Bozza and Saroj Regmi talk through the benefits of the Small Business Transition Grant for early-career academic scientists interested in transitioning their biotechnology from academic labs into a small business:
https://sbir.cancer.gov/small-business-funding/grants/small-business-transitionSBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, NCI SBIR Team Leader Monique Pond invites Program Director William Bozza to dive into the Innovative Concept Award, a funding opportunity that supports biotech innovations with the potential to develop new scientific paradigms focused on pediatric and rare cancers:
https://sbir.cancer.gov/small-business-funding/contracts/innovative-concept-awardSBIR DEVELOPMENT CENTER
SBIR Innovation Lab Podcast: https://sbir.cancer.gov/about/innovation-lab-podcast
SBIR Development Center: https://sbir.cancer.gov/LEARN MORE FROM THE NATIONAL CANCER INSTITUTE
Online: https://www.cancer.gov
By Phone: 1-800-4-CANCER (1-800-422-6237)U.S. Department of Health and Human Services
National Institutes of Health
National Cancer Institute -
In this episode, host and NCI SBIR Program Director William Bozza invites NCI SBIR Director of Investor Relations Brittany Connors to discuss how biotech innovators and investors can connect with NCI SBIR and other NIH institutes from June 3-6 at the 2024 BIO International Convention in San Diego.
Listen to this podcast to hear:
Overview of BIO International Convention and the networking opportunities for attendees to participate NCI SBIR's involvement at the annual conference; how and where to connect How the Investor Initiatives program supports SBIR-funded biotech startups NCI SBIR-funded biotech startups to lookout for at the event Podcast Guest Speakers:Name
Bios
William Bozza, PhD
Program Director
SBIR Development Center
National Cancer Institute
William Bozza, PhD 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 are targeting 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.
Brittany Connors, PMP
Director of Investor Relations
SBIR Development Center
National Cancer Institute
Brittany Connors serves as the Director of Investor Relations at NCI SBIR. She has worked at NCI SBIR in various roles since 2013, playing a major role in the center’s Investor Initiatives program. She has maintained a vast network and works with more than 70 industry-leading investors and strategics each year to review the NCI SBIR portfolio and to select companies to attend and pitch at events like BIO.
Programs referenced in this episode:
2024 BIO International Convention BIO One-on-One Partnering Match-making platform Investor InitiativesTRANSCRIPT
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. Today, we're excited to talk about the upcoming BIO International Convention in San Diego. I've invited the Director of Investor Relations at NCI SBIR, Brittany Connors, to discuss our program’s involvement at the event and how attendees can connect with our staff while we're there. Welcome, Brittany.
BRITTANY CONNORS: Thank you for having me, Billy. I cannot believe BIO is just around the corner and that we're talking about it already. I feel like the year just started. But let's talk about it, I'm excited.
BILLY BOZZA: Me too. So, before we discuss NCI SBIR's participation in the event, can you give our listeners who might be unfamiliar with BIO, a brief introduction to what the event is all about?
BRITTANY CONNORS: Yeah, definitely. So, BIO is perhaps the largest biotech focused event maybe in the world, probably in the world, bringing together upwards of 20,000 industry leaders from everywhere. You can really expect to see attendees from large pharma, I'd say that's a really good chunk of folks, the investment community, biotech startups, academia, nonprofit and government organizations like us.
It's really just four days packed full of educational sessions, company presentations, and I would say one of the biggest draws is the partnering meetings. A few of the educational sessions, I've already put on my calendar, include AI's Impact on Oncology Cancer Drug Development and Build your Product Pipeline with Non-Dilutive Federal Resources. Those will be super interesting, especially if you're looking to, you know, fund your company, if you're an early stage startup.
And then company presentations, BIO is really well-known for their Startup Stadium. So, this is something that small businesses can apply to ahead of BIO. So, then there's this competition and you get selected to be a part of the Startup Stadium. I think to apply, you have to be a company that has raised less than $10 million since inception and have fewer than 20 employees.
The great thing about Startup Stadium is that it's usually the first thing you see when you're walking into the conference and so it's great visibility. And if you win, I think you're fast tracked to certain incubator programs and you can also receive, I think, like, BIO membership and other perks from BIO.
In addition to Startup Stadium, there's tons of other company presentations going on throughout the conference, and these are kind of situated in breakout rooms, and they're 13 minute podium presentations. And really being noted as a presenting company, you know, within the Partnering app is a great way to increase your visibility for BIO, and to increase the number of your accepted partnering meeting requests, which is super important.
And then expanding on that point for partnering, BIO’s Partnering app and partnering meetings during the conference are really just top notch, Billy, like, I know we've both been there before. It's kind of mind blowing to see people rushing in and out, the bells dinging when time is almost up for your meeting, and then you're running to the next one on the other side of the conference center, and it's just mind blowing.
I think I saw on the website that more than 57,000 partnering meetings took place last year at the conference in Boston, and it's just hard to even imagine that number. But really, you use the Partnering app prior to the event. You schedule your meetings, or you hope to schedule your meetings, you send out requests to people that you've identified as the right folks to meet with, depending on your needs. The partnering system has amazing filters that you can use.
For example, representatives from our office, like Billy, since he's a Program Director, he's likely searching for oncology-focused small businesses that might be interested in applying for our funding. And then for me, I'm searching for oncology-focused pharma folks and investors that would potentially be interested in our portfolio.
BILLY BOZZA: Awesome. So, with that in mind, what type of involvement can attendees expect to see from NCI SBIR?
BRITTANY CONNORS: So, I finally figured out that we will be at Booth 825 this year. So, if you're interested in learning about the NIH small business programs in general, this will be the booth to go to. We will be participating at this booth, so Booth #825. In addition to us, there's, you know, 23 other institutes at NIH with SBIR programs. So, representatives from those other institutes will also be at this booth. So, if you have a technology that maybe, you know, is cardio focused rather than oncology, you can probably meet someone from NHLBI, the National Heart, Lung, and Blood Institute at that booth as well. And that's just one example.
So, we'll be at the booth throughout the event. You can go and if someone you're looking for isn't there, I'm sure you can find someone who can help you find them. During the event, we also meet with investors and strategic partners to let them know about, you know, what we're doing at NCI SBIR, and to let them know about all of our amazing portfolio companies that might be a good fit for them as well. You know, if not now, then down the line.
And then vice versa, really. A lot of investors have come to me with companies they're either, you know, vetting or, you know, companies that are really early stage in their portfolio and they're looking for additional funding. So, it's a good way for investors to really learn about us and, you know, what we can potentially offer the companies that they're working with.
And then we also sponsor our companies to attend and pitch at BIO. And this includes them being listed as NIH Innovation Zone companies and you can find that marker in the partnering system. Companies are sponsored for this opportunity after they've been selected for our annual Investor Initiatives Portfolio Showcase Program. So, they, you know, we open that program once a year, companies apply, and then I recruit a panel of around 70 third party investors and strategic partners to score and comment on all of the applications relevant to their interest.
Usually, we get around 100 applications and select 35 to 40 companies into the program, which includes matching them to technology and stage appropriate events like BIO. And then they have the opportunity to pitch and network and, you know, a lot of them haven't necessarily done much of that. So, it's a great way for them to really kickstart those kinds of those kinds of necessary business development activities.
And so, just to plug all of these companies, we've invited the following seven companies to take part in the Innovation Zone this year, most of them will also be pitching. So we have Acuraonics [phonetic]. Acuraonics develops novel therapies that selectively target cancer cells and deliver cytotoxic payloads, thereby increasing efficacy and reducing toxicity risk. Their lead candidate is a novel small molecule drug conjugant, in preclinical development for pancreatic adenocarcinoma, synovial sarcoma, and other rare tumors.
Indie Labs has developed hydro-pour, a simple, scalable, and efficient way to accelerate the discovery, development, and manufacturing of engineered cell therapies such as T Cell immunotherapies. This novel non-viral technology utilizes the power of microfluidic vortex shedding to rapidly deliver small molecules, nucleic acids, proteins, and gene editing complexes to immune cells, to immune cells, not sales, in a matter of seconds, yielding millions to billions of high-quality cells with negligible impact to cell viability and function. Billy, I think that's your company in our portfolio.
And then we have Luminary Therapeutics. They are a clinical stage company developing innovative allergenic cell therapies that utilize the companies unique Gamma 2.0 Plus platform to target solid tumors and B cell malignancies.
Reveal Pharmaceuticals aims to improve safety and deepen insight for magnetic resonance imaging. The company is developing a clinical stage, gadolinium free general purpose MRI contrast agent.
Stem Synergy Therapeutics is focused on discovery and development of small molecule drugs that target developmental pathways fundamental to cancer and cancer stem cells.
Stingray Therapeutics is a clinical stage company developing an innate immune checkpoint of the anti-cancer sting pathway in breast cancer and many other cold tumors.
Trans Code Therapeutics is a clinical stage RNA oncology company committed to defeating cancer through the intelligent design and effective delivery using a highly optimized iron oxide nanoparticle to target nucleic acids to tumors and metastases.
So those are our seven companies. They will all be in the Partnering System if you'd like to reach out to them. And then like I said, I don't think company presentation times and locations are published yet, but you can find that information in the partnering system and in all of the bio marketing materials.
BILLY BOZZA: Awesome. I'm really glad you mentioned investor initiatives. I think it's such a great program. In addition to sponsoring companies to attend events like BIO, how else does this program support SBIR-funded biotech startups?
BRITTANY CONNORS: Yeah, definitely. So, I mentioned the Showcase Portfolio Program. And, you know, this program, we send companies out to events like BIO, but in addition to that, every year we also create an investor book. And so, this book includes the executive summaries of all of those showcase companies. And so, you know, at -- throughout the next year as we're meeting new investors, new strategic partners, you know, even people we already have a relationship with, we're constantly, you know, sending them that book. It's also on our website. Send them the link to the website and we'll let them know, “Hey, if you're interested in any of these, we can either gather more information for you or just make a direct introduction to the company.” And then we step back from there.
So, we're always trying to make introductions. We also have an Excel document that's kind of like a filterable portfolio and it lists all of the projects we have funded as an office over the past few years. And so that's something that I always send out in addition to the Investor Book, you know, and we've gotten a lot of introductions from that document as well.
Ahead of these events like BIO, we also pitch coach our companies and that's either done in house at NCI SBIR or we work with entrepreneurs and residents at the NIH Seed Office, who are wonderful pitch coaches for, you know, our companies and companies across NIH.
We also will do one-off-pitch and mentoring events with some of our partners. We've done pitch before, pitch events before with pharma, like J&J, where we invite -- they look at our portfolio and invite certain companies, you know, that are interesting to them to come and pitch, this time it was in Boston. And then they invite the local investment and strategic community to come and watch those and give companies feedback. And then the companies have the opportunity to kind of pick people's brains and really network on a more intimate level.
And then we also have done kind of a similar thing, but it's more of a mentoring focus where, you know, companies come and present to a pharma company like Bayer and then they are, you know, really talking for a little bit with the folks in the room about what their next steps should be, you know, their biggest questions on their commercialization path and so on.
So, we're always, you know, looking to meet new people, and I think that's probably the biggest thing that we do is, you know, meeting new people all the time and making sure that they know about all of the wonderful companies that we're funding.
BILLY BOZZA: Awesome. If, if our listeners are attending BIO, how and where can they connect with the NCI SBIR team?
BRITTANY CONNORS: Yeah, you can find us in the Partnering app. So, you can find our office under NCI SBIR, parentheses NIH. Like I said before, you can also head to Booth 825 to meet with, you know, a program director and other NIH staff. I think last year we had other, you know, additional company presentations and NIH educational programming going on at Booth 825 throughout the day, so you can probably expect to see a lot of that as well. There's always going to be a lot of people around that booth and, you know, you're always welcome to come stop and say hi.
BILLY BOZZA: Great, sounds great. And, and what about -- Where can our listeners find out more about events like BIO where they can connect with NCI SBIR?
BRITTANY CONNORS: You can head to our website, that’s sbir.cancer.gov. And I think on the main page of our website, you scroll down to the bottom right, and you can sign up for our e-mail blasts, and those will keep you updated on, you know, relevant funding opportunities, events, and conferences we might be attending. And you can also follow us on LinkedIn, which is the NCI SBIR Development Center and then on X, we are NCI SBIR.
BILLY BOZZA: Brittany, thanks so much for speaking with us today.
BRITTANY CONNORS: Thanks for having me, Billy. I can't believe it's almost BIO. And I'll see you soon in San Diego.
BILLY BOZZA: Sounds great. 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 [email protected] or call us at 800-422-6237, and please be sure to mention Innovation Lab in your query. We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.
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In the second episode on writing a good specific aims page, Enzyme by Design Co-Founder and COO Amanda Schalk and JBS Science Co-Founder Ying-Hsiu Su provide insights into their experiences with reviewers’ first impression on an SBIR/STTR application, the specific aims page.
Listen to this podcast to hear:• Ways to address a competitive landscape
• Considerations for reapplying
• Application features for digital health and device startups
• Differences between an SBIR grant and traditional academic grants
• How to describe quantitative milestones
Podcast Guest Speakers:Name
Bios
William Bozza, PhD
Program Director
SBIR Development Center
National Cancer InstituteWilliam Bozza, PhD 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 are targeting 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.
Amanda Schalk, PhD
co-founder and COO
Enzyme by Design
Amanda Schalk, PhD is the co-founder and COO of Enzyme by Design. Amanda earned her undergrad degree in biochemistry on a full-ride scholarship from Eastern Michigan University and went abroad to Goettingen, Germany to earn her Master's and PhD degrees in Molecular Biology from the prestigious International Max Planck Research School for Molecular Biology and the Max Planck Institute for Biophysical Chemistry. She spent 5 years as a postdoc in the lab of Dr. Lavie at the University of Illinois at Chicago characterizing the structures and enzymatic activities of L-asparaginases, resulting in multiple first author peer-reviewed publications. She also has experience as the operations manager at a startup where she also has gained experience as a virtual lab manager.
Ying-Hsiu Su PhD
Cofounder,
JBS Science
Ying-Hsiu Su PhD is a co-founder of JBS Science Inc. and a member of the Board of Directors. Dr Su is a Professor of Translational Medical Sciences at The Baruch S. Blumberg Institute. She is one of few pioneers in the field of transrenal DNA for cancer detection. Dr. Su’s research team has developed the technology to preferentially isolate this circulation-derived urine DNA for detection of colon and liver cancers. In addition, a Standard Operating Protocol (SOP) for collection and storage of urine samples for biomarker studies in the EDRN of the NCI has been established by her group. Dr. Su has collaborated with JBS scientists in developing various approaches to bring the transrenal DNA technology to clinical applications in the fields of cancer detection and personalized cancer management. Dr. Su’s office and lab are located in The Baruch S Blumberg Institute. Dr. Su contributes her expertise in urine DNA technology. She serves as a member of the scientific advisory board.
Programs referenced in this episode:· PLAN series: specific aim page - - https://sbir.cancer.gov/commercialization/workshops-webinars/peer-learning/specific-aims
· NCI SBIR/STTR Grants - https://sbir.cancer.gov/small-business-funding/grants
· Phase IIB Bridge Award - https://sbir.cancer.gov/small-business-funding/grants/bridge-award
Transcript:[music]
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 this episode, you will hear advice on how to write a stronger Specific Aims page from a therapeutics company and a diagnostic company funded by the NCI SBIR program.
The first company, Enzyme by Design, will provide insights on addressing a competitive landscape, application features for therapeutic startups, and considerations for reapplying.
The second company, JBS Science, will highlight application features for diagnostic startups, differences between an SBIR grant and traditional academic grants, and describing quantitative milestones. Now, without any further ado, here's Amanda Schalk, co-founder and COO of Enzyme by Design.
AMANDA SCHALK: Hello I am Dr. Amanda Schalk, Co-Founder and COO of Enzyme by Design and I'm here to tell you how to write a good Specific Aims page. So to address the question, how long did it take to write your Specific Aims page?
I feel like this is a bit of a trick question because the writing of the page itself usually only takes an hour or two, but it involves a lot of homework and brainstorming on the entirety of the grant.
For us, it's definitely an iterative process. And a Specific Aims page really compiles every component of the grant, and as you flesh each part of it out, you have to make sure that the Specific Aims page really reflects that. So it's really working on a part, making changes, making sure the Specific Aims page is consistent with each section and updating it as necessary.
And what was really important for us is knowing that the first and last impressions count, so making sure that you really sum up your entire grant in the Specific Aims page. Among that is significance and impact. So really thinking about why? Why are we doing what we're doing? Why should people care? What problem or unmet need are we solving? And why is the problem significant? And really, what is the impact that will be had, if we're successful with our technology?
Another piece is innovation. Really explaining why our product is uniquely posed to solve this problem. And for the writing of the specific aims, remembering that the point of this is not to do science for science's own sake, but really using this as a way to test our commercialization potential of our product, and setting goals and milestones that clearly enable us to demonstrate feasibility.
So what highly compelling data do we need to demonstrate viability and reduce risk for investors?
Avoiding a mistake that I made of making really lofty specific aims and then going to the budget later and realizing that, “Oh, wait, I can't do that with this budget.” So understanding how much approximately it's going to cost and making sure that your specific aims fit within your budget, and thinking about it in terms of what successful product testing of our therapeutic looks like.
And really, we really stuck to having one to three quantitative milestones for each specific aim and having between one and three specific aims, so keeping it manageable.
So then there's a question of how did we address the competitive landscape as part of our innovation. And this part is really important. So regarding innovation, explaining why our product is uniquely poised to solve this problem, if we can't answer this question, then we have to go back to the drawing board and think, you know, does this make sense for us to even be doing this? How -- What can we do to show that our product is the one that's going to solve this problem more than anything else out there?
Part of this is knowing who else is out there, who are our competitors, which products are already on the market? They have the advantage of being known and understood. It also involves us having an awareness of competing products in development and understanding how our technology stacks up.
If there's something that's super similar, that's already further ahead, does it make sense for us to put our time and energy in developing this product or a different product or having a product that has features that's going to outcompete what's also coming up in the market?
And understanding the trends for how treatment landscapes might shift in the future. Yes, our product could be significant if it were coming out now, but if the treatment landscape is going to greatly shift, how will our product compare to products in five years, in ten years? And does it make sense to develop what we're trying to develop now and really thinking about it holistically like this?
Thinking about what features make our technology significantly superior, so having just a slightly different version isn't necessarily going to be enough to get adoption in the clinic.
So for us, we're going for non-inferior efficacy of our therapeutic and really the, the highlight is a superior safety profile, and it's a superior safety profile that's going to enable more patients to complete their treatments, and for us to be able to treat more patients that normally wouldn't be able to take this kind of therapeutic because of toxicity.
Thinking about why is my product going to succeed where others have failed? So understanding what's kept other technologies back. In our case, it's toxicity. So we really focus on proving superior safety profile while not having inferior efficacy, that's really important.
Another question that is important to ask is whether the technology is protectable by IP and what rights does our small business have on that IP? If you can't protect it, it's going to be really difficult to get a share in the market for this.
And another thing that I've learned is really trying to understand, does my product have a clear path to market? Does it have a way to be easily adopted by physicians, who are our patients going to be that are first trying it?
You normally don't get first line patients and how is this going to affect what we're bringing to market? And we've actually had to make changes based on knowledge that we've accumulated for hurdles to our path to market.
So what milestones specific for therapeutic technologies are essential to be included in a Phase 1 application? So efficacy is definitely one. How effective is our therapeutic against our target disease?
We used our specific aims to demonstrate proof of concept efficacy in vivo and multiple models of the disease using quantitative methods. We've used both well-established models, different CDX models, and PDX models to more closely mimic patient conditions.
And understanding that the efficacy that we demonstrate is going to support our path to market, so which subset of patients are we planning on doing trials in first and does our drug work for those types of patients that may have been pretreated with other therapeutics or have a certain genetic profile?
Setting specific milestones and aims for how safe or tolerable is our product. So doing toxicity studies, acute and repeat dose, and for PKPD, understanding how and how often will our therapeutic be dosed? So what is our route of administration? How long has our therapeutic stable in vivo? And how does this compare to competitors? Because it all comes into play in how effective we think our product is going to be adopted into the market and how it compares.
We made our aims quantitative by using meaningful benchmark metrics to compare our product with our competitors. Understanding how our product will literally measure up in the current and future market and setting up these milestones as feasibility go, no go points.
What will it take for our technology to demonstrate efficacy, safety, stability that is competitive in the market? Using purity thresholds like 95% as determined by SDS page and schematic thresholds that will give us a clinically effective therapeutic, having certain stability measures, a T1 1/2 of a certain number of hours or days, tumor burden reduction by a certain percentage, overall survival increase by a certain percentage compared to the first line drug, scoring clinical signs of toxicity percent body weight changes, organ changes, percent differences in clinical chemistry compared to first line drug.
For us to hire a biostatistician in order to make sure we have statistical power, sufficient statistical power for vertebrate animal studies, and understanding what are clear cut-offs our product needs to achieve to make the cut to be successful in the market.
A critical and unique aspect of our Specific Aims page really has to do with understanding how our therapeutic measures up in the market, and we did this by leveraging head-to-head testing with the current standard of care, first-line asparaginase, to really demonstrate that our technology is going to be able to compete and eventually replace in the market.
So doing this testing side-by-side is extremely important because that's really what investors have been asking us about and that's what they want to see.
And we used the Specific Aims page to incorporate suggestions from peer review on a resubmission application. One, by clarifying the path to market challenges that made using a half-life extension other than peculation necessary for a new product to be successfully adopted.
So there, there were certain path to market hurdles, that were not obvious, that we had to really make clear of why we're doing what we're doing, why we're taking this path, clarifying why our product would have reduced immunogenicity compared to currently available asparaginase drugs. This was something that reviewers really wanted us to demonstrate.
We also, in our resubmission, showed additional preliminary data and multiple xenograft models of the disease and additional PK data, and had basically achieved our previous Specific Aims 1 and 2 to demonstrate strong proof of concept for further development.
We also added PDX models, at the suggestion of reviewers. And to address toxicity-related concerns, we incorporated both acute and repeat dose toxicity, and really both the efficacy and the toxicity, we were comparing against the first line drug which was extremely important.
So thank you so much for listening and I hope this was helpful. Bye.
BILLY BOZZA: Thanks for the insights, Amanda. Now let's hear from Ying-Hsiu Su, co-founder of JBS Science.
YING-HSIU SU: Thank you for the opportunity to share with you my experience in writing Specific Aim pages for SBIR application, more specifically, a Phase 1 application for developing a product in the individual diagnostic space.
Just a little bit about myself. I've been working as a PI in a few R01s [unclear] and later co-founded a company, JBS science, writing SBIR for product develop.
The project I was referred to is developing a urine test for early detection of liver cancer. This project is awarded by NCI for one year Phase 1 study, three years Phase 2 study, and another three years Phase 2 Bridge Award. All three awards were founded by first submission, with the score ranging from 22 to 26.
I will use our Specific Aim page as an example to share with you our experience.
Since I was asked by a few colleagues who are quite successful getting R01, but happen, have not much luck for SBIR, for, why? So what I'd like to do first is to highlight the unique feature of SBIR that are different from a more traditional academic grants.
SBIR is a Small Business Innovation Grant, therefore, the application is product development and business-centered. So what is your product for business and is there a good market for it?
If there is no product, there is really no SBIR. So what is your product? It's really the most important question when you start to think about an SBIR application.
So this brings us to a significant section. So can your product change medical practice and if it is competitive enough in the market? As we all know, the purpose for Phase 1 is to have the Phase 2 for product development. Therefore, the milestone in Phase 1 is to be used to determine if the project is ready for moving forward to a Phase 2. Therefore, the milestone in the Phase 1 is really need to have quantitative and measurable.
So with a product in mind, what should be in the Specific Aim page? This is really the most important page of the application, so use the full page, at least 90% of the page. And I see it as the beginning and the end of the entire application preparation.
We start with the end and we develop the strategy, and end that mature, and we finalize the end. Since this is a page that reviewers get prepared for what to anticipate from the application, so it should have at least the product, and the significance, and the product, if it can change the practice and how is the market competition? And also the backgrounds and importance, also, how we de-risk of the application.
Of course, there are ends with the timeline, again, with the quantitative milestones. Phase 1 is really to get to Phase 2, so you want to have the Phase 2 in mind. And so I always put a projected ends for Phase 2 in the Phase 1 Specific Aims. And of course, the concluding remarks for what really the impact of the product.
This is example showing the structure of our Specific Aim page. Of course, a product, significance with some market information, and the background, and also what is the technique and innovation, also how we de-risk the application.
And of course, we have a Specific Aims timeline and milestone. And what I think is quite important, again, is to have what is projected aims for, for Phase 2, since this is Phase 1 and is trying to move forward to the Phase 2. So it's good to have this or to show reviewer you know what you want to do in Phase 2.
And the concluding remark, and full page, of course, it's almost full page here. So in the next couple slides, I would like to use this specific aim here to further illustrate how we de-risk the application and also how we work to get the milestone to be quantitative and measurable.
This is a section for background, including company information, technical innovation, and the risk mitigation, and how they related to the proposed ends.
I like to highlight the risk mitigation within in this section, such as the preliminary data such -- Our success in developing messaline [phonetic] assays and also successful mapping the HVCC [?] specific CPG methylation signatures for, to propose stream for assay development, and the already completed tests for detection of HVCC [?] specific TP-50 [unclear] mutation.
One of the three marker assays, that Phase 1 proposed to do, to develop and to evaluate for performance. And finally, availability of the study materials with the sample size.
All these were provided for risk mitigation in order to increase likelihood of success of the proposed Phase 1 study. So we can increase the likelihood to move forward in the Phase 2 application.
So what specific milestones for diagnostic technology are essential to be included in Phase 1 application? And myself, I think you want to propose the milestone that is achievable, not the ideal, perfect one, it’s achievable and is measurable, and of course, it has to be justifiable, a better performance.
So you need to know what are current test performance and how much better the threshold is needed to change the medical, current medical practice or improve the outcome of the disease.
Ideally, for the diagnostic, you want to have 100% sensitivity and 100% specificity, but this is probably not real. Versus the reality, what are the current test performance? In the HVCC [?] screening, the biomarker, the most used biomarker are serum AP tests, which only has a 50% sensitivity with very high percent of specificity, 95%.
So if you look at this number, you know you're not going to improve much in specificity, but there is room for sensitivity. So what we did is we propose, we believe it’s achievable, and indeed, it was achieved to detect 20 to 30% more HVCC [?] and earlier HVCC [?] to improve the survival, and that's. pretty significant.
I mean, you detect 30% more than what can be detected, so this can be a justifiable. And we also emphasize the non-invasive, convenient urine test.
So again, the really important is the measurable. So we have 20 to 30% more than serum AP and it's achievable, it's not 100%, and it's justifiable because it's significant to detect 30% more HVCC [?] to improve the prognosis of the patient.
So how to make a milestone quantitatively? The answer is use the numbers, because the number you can measure for the success. As an example here, the M1 in our study is to develop three assays. How good does the assay need to be?
So we say, well, five copies in here. So five is the number and if that's a justifiable, we say it's sufficient because we use five and we detect the markers previously. So basically, numbers and is it justifiable?
So in M2, the same, we put the sensitivity and specificity, again, achievable and justifiable numbers for the quantitative milestone.
So in conclusion, Specific Aim page is the one page for reviewer to learn the entire applications. There should be a product and how to de-risk the application and with a quantitative achievable milestone to justify for Phase 2 study. And finally, good luck on your applications.
[music]
BILLY BOZZA: There you have it. Special thanks to Enzyme by Design and JBS Science 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 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 [email protected] or call us at 800-422-6237, and please be sure to mention Innovation Lab in your query.
We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.
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In this episode, you will get advice from two NCI SBIR-funded startups on how to write a good specific aims page on your application. Senior Vice President of Radiant Digital Jeffery McLaughlin and Co-Founder and CEO of DoseOptics William Ware will share how they successfully put together this key application component.
Listen to this podcast to hear:· Highlighting significance and clinical impact in your specific aims page
· How to provide sufficient detail and quantitative milestones
· Specific features for devices and digital health
· Considerations for Fast-Track and Phase II SBIR/STTR applications
Podcast Guest Speakers:Name
Bios
William Bozza, PhD
Program Director
SBIR Development Center
National Cancer InstituteWilliam Bozza, PhD 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 are targeting 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.
Jeffrey McLaughlin
Senior Vice President
Radiant Digital
Jeffery McLaughlin is a highly accomplished professional with over 25 years of experience encompassing organizational leadership, customer and user experience, digital media, human-centered design, and software development.
Mr. McLaughlin is recognized for his ability to drive innovation through human-centered design thinking, customer discovery, and rigorous engineering. His research endeavors have yielded impactful projects in domains such as worker safety, trauma recovery, cancer survivorship, medication adherence, chronic disease management and more. These endeavors reflect his commitment to improving the lives of individuals through outcome-focused technology solutions.
In his role as Senior Vice President of Services and Solutions at Radiant Digital, Mr. McLaughlin provides strategic leadership across every facet of the company’s business, including service line definition, technology development, delivery, and business growth. Under his guidance, Radiant Digital has consistently produced award-winning digital experience initiatives for Federal, State, and commercial clients.
William Ware,MS
co-founder and CEO
DoseOptics
William Ware is the co-founder and CEO of DoseOptics, LLC. The company is developing an imaging technology that will allow, for the first time, radiation therapy to be visualized. Treatments will be easily and routinely verifiable directly on patients thereby minimizing delivery errors and improving outcomes. William graduated with a Master of Science in Chemical Engineering from Darthmouth Thayer School of Engineering, from where he spun out the company’s technology based on the work of President and Co-founder Prof. Brian Pogue.
Transcript:[music]
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 therapeutics company and a diagnostics company on tips to write a good Specific Aims page for your application. Today you will hear advice from a digital health company and a device company.
Up first, we have a digital health technology developer Radiant Digital. Senior Vice President Jeffrey McLaughlin will share considerations for fast track applications and digital health startups.
JEFFREY MCLAUGHLIN: Hi there, I'm Jeffrey McLaughlin. I'm the Vice President of Services and Solutions at Radiant Digital, also known as Radiant Creative Group. And we've competed in the SBIR and STTR program for around 15 years. We've funded multiple Phase 1, Phase 2, and Fast Track projects, and we've done so in collaboration with some top tier institutions like MD Anderson Cancer Center, the University of Texas, and Children's Hospital of Philadelphia.
So today, I'm going to be talking to you about how to write a good Specific Aims page. Throughout the discussion today, I'll be referring to one particular project in our portfolio, a program called Stem-Powerment [phonetic].
This is an online, gamified social intervention for adolescents and young adults that have undergone stem cell transplant therapy and are facing a protracted and challenging recovery period. So this program was developed in collaboration with MD Anderson Cancer Center and UMBC, and it was funded by NCI.
Is it important to highlight significance in clinical impact and how did you define your problem statement?
So let me first say that emphatically yes, significance is often the first thing you'll see on a good Specific Aims page. If you look at this like storytelling, significance functions as the core conflict that drives your narrative throughout your research proposal. And impact is the hero that you hope emerges from the narrative.
So I think impact is particularly interesting in the SBIR world, the commercialization drivers in SBIR make it well suited to diffusion of innovation models, for instance, which force you to think at a systems level and consider community and organizational and individual factors that might influence impact.
So in our Stem-Powerment project, we defined our problem statement from the top down. So, again, this is a digital intervention for AYAs who have undergone stem cell transplant therapy.
So we first start with the risks and the impact of stem cell transplant therapy on patients. And then we identified the specific behavioral gaps that we know exists today, and these are things like poor medication adherence and poor hydration management.
Linked those gaps to long-term outcomes that those patients may experience, if those risks aren't managed effectively, and then finally identified the critical factors specific to our population, AYAs that make this protracted recovery period especially challenging.
And those are things like social isolation, maybe returning to parent care after being independent, managing a very complex medication regimen, those sorts of things.
Next question, what milestones specific for digital health technologies are essential for a Phase 1 application?
So I look at a Phase 1 as a de-risking project. You want to look at both the technical and non-technical aspects of the work that you're doing and establish feasibility, that's the spirit of a Phase 1.
So from a non-technical perspective, I would argue that digital health is always going to be user-facing in some way. In many ways it can be highly personal for the users that are impacted by the work, so, some measure of user acceptance, some measure of the impact of the technology or the solution on, on the users that are actually going to be adopting it.
There are a number of different frameworks for examining this, and you can look at constructs like usability, subjective appeal, engagement, those sorts of things. But fundamentally you want to make sure that by the end of your Phase 1, you can demonstrate that your users will actually adopt the technology that you're proposing.
The other layer to the non-technical feasibility is really understanding how your solution fits in with the broader ecosystem of digital health solutions. So that's better quantifying or qualifying the need, understanding your stakeholder groups and your beneficiaries, buyers and partners, those sorts of things, and further refining your unique value propositions.
This may not translate to specific milestones, but if it does, it would look something like milestones that you would try to achieve using Steve Blank's Startup Method, for instance, where you want to conduct a certain number of user interviews with key stakeholders and integrate those findings into your approach.
From a technical perspective, you want to demonstrate basic feasibility of the supporting technology or the method that you're implementing, and you want to eliminate the known unknowns related to dependencies or upstream integration, or what have you.
Now, this can mean developing a prototype, it can mean having conversations or building support at an institution, what it translates into -- in terms of milestones, again, is going to be dependent on your, your project, but de-risking the project, that's what it's all about.
On to our next question, how did you make your aims quantitative? In Stem-Powerment Phase 1, we wanted to move beyond measuring basic usability as an endpoint. We were working with an AYA population that was technologically savvy and we felt like usability was table stakes, maybe too low of a bar.
So what we did was adopt a popular technology acceptance model that's typically used in enterprise IT, the TAM, this was developed by Venkatesh and Davis and others. It incorporates a number of useful constructs, perceived usefulness, ease of use, subjective norms, those sorts of things, it also lends itself well to adaptation.
So practically, what the TAM gave us was a collection of scorable measures that allowed us to set an overall cutoff score as our primary benchmark for demonstrating user acceptance and feasibility. We also layered in some intrinsic system measures, system performance, reliability, those sorts of things.
And then within the project we iterated through several approaches to the intervention, integrating feedback from our users and incorporating it, so as to increase the likelihood of achieving that benchmark that we had established.
Next question, can you highlight a critical and unique aspect of your Specific Aims page?
So first of all, I have to give credit to my collaborators. This was not my Specific Aims page, it was our Specific Aims. So credit goes to Doctor Susan Peterson and Doctor Martha Atkins at MD Anderson in particular.
One thing about the Stem-Powerment specific aims is that it was a breakthrough for me in terms of understanding grantsmanship, and it's essentially a narrative structure that looks a bit like an hourglass.
So you start from a broad problem, you narrow that down to a specific population, and a specific solution that you're proposing for that population, you relate that solution to a set of expected outcomes, and then you describe how you're going to scale beyond this single project.
So the solution has to be broader than just what I'm going to do in this Phase 1. And then you close with the aims themselves, which are succinct description of the activities that you're proposing to complete during the project.
Seems simple, but it is one of the most challenging documents to produce in a grant application. Often times producing specific aims is a highly iterative process. You start out with an initial draft, then you write your research strategy, and you go back to your specific aims at multiple times throughout the project, but it's hugely important. It's one of the first things that a reviewer is going to typically look at and it should be a clean, crisp, clear encapsulation of your project.
And the final question, how did you organize your Specific Aims for a Fast Track application? The program I've been describing thus far, Stem-Powerment, was not in fact a Fast Track, it was a Phase 1 to Phase 2, but I'll share my experience with other Fast Tracks that I've worked on.
It's a challenging application. You have to be able to make some pretty confident and bold claims about what you expect to find in your Phase 1, to justify that immediate transition to Phase 2 without a follow on applications. What that means is that that connection between your Phase 1 and your Phase 2 is always going to be the weakest point in the application.
There are several tactics you can use to mitigate that Phase 1 to Phase 2 transition risk. One is to introduce the background research early and often. So in your Specific Aims page, you want to describe the work that's been done today and why you believe that work justifies a fast track approach, and then the second tactic is to very clearly link the two phases.
So have an output from Phase 1 feeding into an input in Phase 2 in your aims. That means being able to describe an aim that accommodates unexpected findings from your Phase 1 immediately in your Phase 2.
[music]
BILLY BOZZA: Presenting next is William Ware, co-founder and CEO of DoseOptics, an NCI SBIR-funded device company.
WILLIAM WARE: Hi, my name is Bill Ware. I am the co-founder and CEO of DoseOptics. And I'm going to talk to you about how to write a good Specific Aims page.
Just a little context about who we are and what we do. We make imaging systems, cameras that image radiation therapy. We are a company that was founded with a successful Phase 1 application and we've had multiple Phase 2s, both through Fast Track and direct to Phase 2 and, and, and in a more, more recent phase, a new Phase 1.
So, the first question to answer is, what steps did we take to start organizing and drafting your Specific Aims page? And this, uh, there are really four key things that you need to address here.
You know, obviously you found something that has some sort of commercial relevance that needs to be described: why this is important? What's the unmet need that this technology addresses? Why you, why you'll be successful? What, what, what kind of team do you have or what kind of advantages do you have that you should be the one to be doing this work? And then what does the plan look like? Which really is, you know, the aims of, of the, of the page.
Additionally, once you've, once you sort of drafted this and get an idea, find the government agency that's looking to fund this, this sort of research. Obviously this is a NCI webinar here, so you've obviously made it to, to this part, but reach out and find the project manager and they can help with that and, and, and be -- They're really helpful to review your, your aims and, and what you're trying to do.
How were we able to sufficiently detail our Specific Aims page and still meet the, the one page limit? And this is, this is important, it's -- you really need to be concise, you've got one page and you need to address these questions.
So I'm going to use an example of, of our -- what we did on our latest Phase 1, the commercial relevance. This is -- We're developing a camera for a new paradigm in radiation therapy called Flash. And so that's the, that's the commercial relevance.
The second piece is the unmet need and that's verbatim, there is a, however, a lack of devices capable of monitoring the beam output and location on a pulse to pulse basis. So there's our, there's our unmet need.
Then we talked about in the third sentence, following the success of our imaging cameras, conventional radiotherapy currently deployed in beta sites. So we, we sort of toot our own horn and say, “Hey, we've done this before and we've done, we've built cameras before, so we can do this.”
And then, and then we hint at our plan. You know, we want to extend the capabilities of our camera systems for, for flash imaging in patients and for beam quality assurance.
And that's our first paragraph and we've ticked off all the boxes. So that takes up about, you know, an eighth of the page or so, in our case, we've got another half page or so to, to, to, to flush those out in a little more detail. And then at the bottom, you know, third of the page, we go through the three aims of the proposal.
What milestones specific for device technologies are essential to be included in a Phase 1 application? So in the Phase 1, you're really trying to show feasibility and show that you can meet, address an unmet need.
You know, these Phase Ones are really, you can think of it as an alpha, alpha prototype. And in all, you know, in sort of -- in all sort of product development, especially devices, it's really about prototype, test, and iterate: wash, rinse and repeat.
And, and so this -- For our Phase 1, we consider it, it's our -- sort of an alpha prototype of, of this device, what do we need to get done and how are we going to test it?
And so ours is, our three aims are broken down into a hardware aim. Our first aim is all about hardware and getting the hardware right. Aim two is about the software, to integrate and do image processing for us. And then aim three is how we're going to test it.
The next question is how, how do we make our aims quantitative? So, you know, our aims are, uh, pretty straightforward in terms of hardware, software, and how we're going to test it, but the, the quantitative aims need to address sort of the unmet need.
And so it's either for, for some cases, some people, it's, you know, you're developing something better than existing, so you've got a benchmark that you need to meet, and, and you really want to make these aims quantitative.
In our case, we are -- we need to develop a camera for a new type of radio, radiotherapy, and so that dictates sort of a lot of the metrics that we need to meet. We need to -- We have a speed of camera, imaging, in terms of frames per second, and signal to noise ratio, and it's got to be -- the resolution requirements are there as well.
And then from a software perspective, we need to be able to process, an image process within a certain amount of time because it's, it's really a high speed process that we're trying to capture here. And then we're going to test it using, using phantoms.
This is a Phase 1, you know, it's a limited budget. We're, we're not going to put patients in on this particular phase, once you get started getting into patients, it becomes very expensive.
What are some unique considerations for a Phase 2 Specific Aims page?
So, this, this focus is really around a Phase 1 application, but it's important to consider what the Phase 2 might look like. You want to plan for, for success, you wouldn't be doing this if you didn't think you would be successful. So in part of that planning, you should consider what's the, what's the next prototype look like? What's the next beta version look like?
And, and, you know, this should lead into that, the Phase 2 should lead into that, too. So the Phase 1 is really about feasibility, proving that it works, your image on phantoms, or, or a very small number of patients, and you just, you're just showing that it, that it's work, it works.
In Phase 2, it's more of a refined prototype, it's a more of a beta prototype. It's a net, you're making it smaller, faster, cheaper, closer to a commercially viable device. And then you test on it, on like, an order of magnitude more patients. If we did, if you did one in the, in the alpha, you probably want to do 10. If you did 10 in the alpha, in Phase 1, you want to do a 100 or so in, in the Phase 2.
But that all depends on the project and of course the budget.
Can we highlight a critical and unique aspect of your Specific Aims page? So our, our -- We're, we're starting from an already designed and built camera. So we've got a platform that we're building upon to, to do sort of this next generation type development.
And, so that's kind of unique for this, but, but we did start with a, with a, you know, a Greenfield sort of Phase 1 that was built upon some university research proof of concept type studies and, you know, you need -- In my opinion, you've got to have something to, to, to show credibility, to show that you've done at least the -- some basic amount of work that provides credence to the, the -- what you're proposing that you think you, that you'll be able to do what you think you can do, what you're going to propose to do?
And with that, that's it. Thank you very much. Good luck.
BILLY BOZZA: Thanks so much, Jeffrey and William 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 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 [email protected] or call us at 800-422-6237, and please be sure to mention Innovation Lab in your query.
We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.
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NCI SBIR Team Leaders Monique Pond and Jonathan Franca-Koh cover the basics of registering a small business for an SBIR/STTR application and the anticipated timeline to expect from submitting an application to receiving an award.
Listen to this podcast to hear:• Guidance on the four registrations that should be completed before applying for SBIR/STTR funding
• Managing eRA Commons accounts
• Addressing registration errors and warnings
• Reviewing the SBIR/STTR grants application summary statement
• Typical timeline from applying to receiving an award
Podcast Guest Speakers:Name
Bios
Monique Pond, PhD
Program Director and Team Leader
SBIR Development Center
National Cancer Institute
Monique Pond, PhD is a Program Director in the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI). She manages a portfolio of grants and contracts to small businesses developing novel cancer therapies, digital health technologies, and therapeutic devices. Pond leads the CARE program, Connecting Awardees with Regulatory Experts, and other collaborative initiatives with FDA to assist small businesses in navigating the regulatory pathway for their technology. She initially joined the NCI SBIR Development Center in 2018 as a Science & Technology Policy Fellow with the American Association for the Advancement of Science.
Jonathan Franca-Koh, PhD, MBA
Program Director & Team Leader
SBIR Development Center
National Cancer Institute
Dr. Jonathan Franca-Koh is a Program Director at the National Cancer Institute's Small Business Innovation Research (SBIR) Development Center. Jonathan manages SBIR & STTR grants and contracts with a focus on cancer therapeutics and novel tools for research and drug discovery. He provides oversight throughout the award period and mentors applicants and awardees in developing their technology goals and commercialization strategy. Additionally, he plays an active role in several center initiatives, including recent investor forums, workshops, targeted funding opportunities, and represents the NCI on the trans-NIH REACH program. Prior to joining the SBIR Development Center, Jonathan was a Program Director at the NCI Division of Cancer Biology and Center for Strategic Scientific Initiatives, overseeing the Physical Sciences-Oncology Centers (PS-OC) program, a network of interdisciplinary centers that brought together physical scientists and cancer biologists. Jonathan received his PhD in Cell and Molecular Biology from the University of London’s Institute of Cancer Research in 2003, and completed post-doctoral research at Johns Hopkins University and the J. Craig Venter Institute. In 2014 he completed his MBA from Johns Hopkins University, focusing on finance and health care innovation.
Programs referenced in this episode: SAM (System for Award Management) - https://sam.gov/content/home eRA Commons - https://www.era.nih.gov/register-accounts/register-in-era-commons.htm Grants.gov - https://www.grants.gov/applicants/applicant-registration SBA (Small Business Administration) - https://www.sbir.gov/registration NIH SEED Small Business Funding - https://seed.nih.gov/small-business-funding/how-to-apply/before-you-apply Transcript:MONIQUE POND: Hello everyone 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 or 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 Dr. Monique Pond, a Program Director and team lead here at NCI SBIR and I'll be today's host.
Today, we'll discuss a typical timeline for applicants from submitting their SBIR/STTR application to hopefully successfully receiving an award. Once again, we're joined by my fellow program Director and Team Leader at the NCIS SBR Development Center, Dr. Jonathan Franca-Koh. Welcome back, Johnny.
JONATHAN FRANCA-KOH: Thanks, Monique, happy to be here.
MONIQUE POND: So for people listening in today, before applying for SBIR/STTR funding, what does an applicant need to do?
JONATHAN FRANCA-KOH: As we discussed in the previous podcast episode, one of the first things you should do is contact a program director in our office and we'd be happy to walk through the process with you.
One of the first things you need to do is complete your company registrations. Here, there are four registrations that need to be completed. These are the SAM or System for Award Management, this is the electronic platform that is required for a company to do business with the US government.
Second is ERA Commons, this is the electronic system required to do business with the NIH. And then the other two are Grants.gov, which is a platform you will use to submit grant applications. And then finally, register with the SBA, Small Business Administration, and this is required for companies to participate in SBIR and STTR funding programs.
So while the number of applications has gone down, it still needs to be taken care of well in advance of submitting your application, because it can take six weeks or more to complete these registration steps. And there's also the order in which you do so is important.
First up is System for Award Management, SAM, you need to complete your SAM registration in order to then go on and complete the other registrations. This can take three weeks or sometimes longer to do an initial registration, and this is one that requires yearly renewal as well.
So even if you've received a SAM registration in the past, make sure it's current, if you are thinking of submitting an application in the near future.
MONIQUE POND: That's a good point, Johnny. And I would say for those who have happily been awarded, that's something to keep in mind, too, for the future that if you have a multi-year award, you want to make sure that you're keeping up with that SAM registration so you can progress to the next year of funding. So that's where companies and entrepreneurs should start, SAM registration, OK.
JONATHAN FRANCA-KOH: Yeah. And then you complete your SAM registration and you receive what's called a Unique Entity Identifier or UEI. Now, once your SAM registration is approved and active, next step is to register with Grants.gov.
Grants.gov is the platform you will use to submit your application. Once you have your SAM registration, you can then go ahead and register for that, and this takes about one business day or more, it can depend a little bit, but not, not as long as SAM.
MONIQUE POND: So is this the same Grants.gov where people can go if they're interested in just kind of doing a federal-wide search for different grant funding opportunities?
JONATHAN FRANCA-KOH: Yes. So the Grants.gov is not an NIH specific platform, it's a federal-wide portal which you can use to look for funding opportunities as well as apply for federal grant funding.
Next up, once you've received your unique identifier, UEI number from SAM, you may then go ahead and apply for your ERA Commons. You, as an individual, may already have an ERA ID and account, but your company needs its own account to do business with the NIH.
And registering for a new company in ERA Commons can take about two weeks or more, so make sure you do that ahead of time.
The ERA Commons system allows you to submit and receive information regarding your application, and your ERA Commons credentials are also used to access what's called the Assist System, which is NIH’s online system that can help streamline your grant submission.
MONIQUE POND: So with an ERA Commons account, is there just one person for each company that's associated with the account? Or could there be multiple people that have different roles and still have the same ERA Commons ID?
JONATHAN FRANCA-KOH: Excellent question. So with the new company registration, you need to identify a company signing official and this will be the person that has the authority to represent the company, the institution in grants administration matters.
It's also important to remember that you may have your unique ERA Commons ID, but that same ID can be used to access different roles and also different affiliations, so you shouldn't have to create different ERA Commons IDs for yourself, as an individual, over the course of your career, you stick with the same one, but you manage that account by adding either different roles for that account and different affiliations.
So perhaps you have both a university and an affiliation with the company, you can make sure to add both of those roles to your account. You need to be affiliated with the institution that you're representing to be on their application.
MONIQUE POND: And you know, I just want to add too, as sometimes, depending on the company structure and, and how busy, you know, the PI is, sometimes the PI is the signing official, but you could also have for an example an optional account administrator that is -- has access and is a, a signing official for that ERA Commons and company account.
JONATHAN FRANCA-KOH: Yes. And then last but not least, the final registration is with the Small Business Administration, SBA Company Registry. Once you complete the SAM registration, you can go ahead and do this, and this takes one to two business days to complete. And this registration is required in order for a company to participate in SBIR and STTR funding programs.
MONIQUE POND: So it sounds like for a company interested in applying to an upcoming due date, starting the earlier the better, right, with these registrations, since they can take several, sounds like several weeks, maybe even a couple months, to get through all four.
JONATHAN FRANCA-KOH:Absolutely. And they need to be completed to submit the application.
MONIQUE POND: Thanks, Johnny. That's been a great summary of the four registrations that are required for companies. And for those who want more details or, or want some links to go ahead and get those started, you can go to seed.nih.gov and find links to all four of the registrations that, that Johnny just mentioned.
So now, the company has completed the registrations, they've talked to a program director, developed a great specific aims page, submitted their grant application. So what happens next, Johnny?
JONATHAN FRANCA-KOH: Once you've submitted your application, hopefully it all went smoothly and you didn't receive any messages indicating a problem with the application, in which case you can sit tight and wait for the review to take place.
However, it's quite common that you will receive an e-mail indicating that there either are errors or warnings associated with your application. In the case of a warning, that is something the system has identified that it wants you to double-check or take a look at.
If you receive an error warning on your application, the application will still be processed, however, you should take steps to identify what these warnings are and make sure that everything's fine. If you receive an error message, this is an indication that your application will not be processed as submitted and so you will need to take steps to correct that error.
Now, as program directors, we're not able to help you correct most of these errors. You need to contact either the ERA or Grants.gov Help Desk, which you can find on the websites, and here, they're excellent technical support to help you both understand what the problem is and correct the issue.
MONIQUE POND: Yes, I think you know within the, the two or three days right before due date, those help desk, as you can imagine, are quite, quite busy, but, you know, if you're able to start the application say a week before the deadline, you know, and you encounter some of these errors that Johnny mentioned, I think, you know, that can, that can be a great time to reach out to the help desk and someone will be able to walk you through the, the solutions to them.
JONATHAN FRANCA-KOH: Yes, that's another reason we always recommend applying early, because you never know what, what to expect.
MONIQUE POND: All right, so let's say a company now has their application error-free through the system, and about how long should they expect timeline wise before the review will take place?
JONATHAN FRANCA-KOH: Once you've applied and the application has been accepted, it will next be sent for review, and the review will take place about two months after the application is submitted. Following review, you'll receive a score. This will either be a number indicating how well the application is scored, or potentially it could receive what's called a non-discussed score. That means unfortunately your application in this case was considered to be in the lower half of applications.
However, this is just your initial, um, idea of how well the application did. You really want to know the details, what reviewers thought, what their comments were, what they thought the strengths and weaknesses of the application were, and you'll get this in a document called the Summary Statement, which is released a couple of weeks after review has taken place, and this will be a summary of the reviewer comments, as well as a synopsis of the discussion that occurred at review.
And once you receive the Summary Statement, this is actually the best time to then follow up with your assigned program director to discuss what the chances of success are for funding the application and if, if not, what are the next steps in terms of potential resubmitting? What -- How would you go about addressing the, the weaknesses that have been identified?
MONIQUE POND: And I just want to add that, as far as the full Summary Statement with the comments that Johnny mentioned, that can be up to 30 days after that review meeting before that full Summary Statement is available.
But, you know, once a company or an applicant can see that in their ERA Commons account and has access to that full Summary Statement, then that assigned program director, on the first page in the upper left hand corner, you'll have that contact information and that program director will have access to those same comments. So a great time to reach out, we're always happy to set up a meeting and, and talk about your Summary Statement.
So I think we've gone through, you know, getting started with the company registrations, you know, first steps to applying for the, the grant, and kind of a general timeline for review and then follow up, hopefully, you know, with the successful score and discussing with the program director, either potential funding opportunity or, you know, as you mentioned resubmission.
Thanks again, Johnny, for speaking with us today, always, always a pleasure.
JONATHAN FRANCA-KOH: Thanks for having me, Monique. Glad to be back.
MONIQUE POND: As always, don't forget to check out our website, sbir.cancer.gov, for the latest funding opportunities and commercialization resources to support your journey from lab to market.
This was Monique Pond 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, you can e-mail us at [email protected] or call at 800-422-6237, and please be sure to mention Innovation Lab in your query.
We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.
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Podcast Summary
NCI SBIR Team Leaders Monique Pond and Jonathan Franca-Koh break down the importance of speaking with a program director before applying and share advice on how to go about doing so.
Listen to this podcast to hear:• When to reach out to program directors
• Tips for matching with the right program director
• The type of guidance program directors offer (grants, programs, steps based on innovation or company stage, SBIR/STTR application)
• Steps to take if your technology fits under multiple NIH institutes
• Actions to take after you receive your application summary statement
Podcast Guest Speakers:Name
Bios
Monique Pond, PhD
Program Director and Team Leader
SBIR Development Center
National Cancer Institute
Monique Pond, PhD is a Program Director in the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI). She manages a portfolio of grants and contracts to small businesses developing novel cancer therapies, digital health technologies, and therapeutic devices. Pond leads the CARE program, Connecting Awardees with Regulatory Experts, and other collaborative initiatives with FDA to assist small businesses in navigating the regulatory pathway for their technology. She initially joined the NCI SBIR Development Center in 2018 as a Science & Technology Policy Fellow with the American Association for the Advancement of Science.
Jonathan Franca-Koh, PhD, MBA
Program Director & Team Leader
SBIR Development Center
National Cancer Institute
Dr. Jonathan Franca-Koh is a Program Director at the National Cancer Institute's Small Business Innovation Research (SBIR) Development Center. Jonathan manages SBIR & STTR grants and contracts with a focus on cancer therapeutics and novel tools for research and drug discovery. He provides oversight throughout the award period and mentors applicants and awardees in developing their technology goals and commercialization strategy. Additionally, he plays an active role in several center initiatives, including recent investor forums, workshops, targeted funding opportunities, and represents the NCI on the trans-NIH REACH program. Prior to joining the SBIR Development Center, Jonathan was a Program Director at the NCI Division of Cancer Biology and Center for Strategic Scientific Initiatives, overseeing the Physical Sciences-Oncology Centers (PS-OC) program, a network of interdisciplinary centers that brought together physical scientists and cancer biologists. Jonathan received his PhD in Cell and Molecular Biology from the University of London’s Institute of Cancer Research in 2003, and completed post-doctoral research at Johns Hopkins University and the J. Craig Venter Institute. In 2014 he completed his MBA from Johns Hopkins University, focusing on finance and health care innovation.
Programs referenced in this episode: Program director contacts - https://sbir.cancer.gov/about/contact-staff SF424 SBIR/STTR Application Guide - https://sbir.cancer.gov/commercialization/business/icorps/sf424-sbirsttr-application-guide.pdf PLAN series: first steps to a business - https://sbir.cancer.gov/commercialization/workshops-webinars/peer-learning/first-steps-starting-small-business PLAN series: specific aim page - https://sbir.cancer.gov/commercialization/workshops-webinars/peer-learning/specific-aims Transcript:[music intro]
MONIQUE POND: 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 Monique Pond, a Program Director and Team Leader at NCI SBIR, and I’ll be today’s host.
In this episode, we’re going to discuss the importance of talking to NCI SBIR program director before applying and how you can make the most of your conversations with our staff.
Today, I’ve invited my fellow Program Director and Team Leader at NCI SBIR Development Center Jonathan Franca-Koh. Welcome Johnny!
JONATHAN FRANCA-KOH: Thank you, Monique, looking forward to our conversation today.
MONIQUE POND: Yeah, thanks for joining. So to get us started today, I wanted to talk about, who should be reaching to a program director?
JONATHAN FRANCA-KOH: That’s a question many people have, so I’m glad we’re starting with that. Chances are if you’re listening to this podcast, you probably should get in-touch, but more broadly, we are happy to talk to anyone who is thinking about an SBIR or STTR application, anyone curious about commercializing their technology, whether you’re ready for an application or not, even if that is something you think will be more down the road, a couple of months from now, we’re still happy to talk and give you whatever advice and guidance that we can.
MONIQUE POND: Yeah, I agree. I think you don’t have to have already started your small business to reach out to us, we’re happy to talk to you, if you have an idea about a technology and are curious if it would fit within our mission or potentially, you know, be right for an SBIR-STTR application.
So let’s talk about timing. When should somebody reach out to a program director in our office?
JONATHAN FRANCA-KOH: We’re here to help out at whatever stage you’re at, but my advice is to reach out as early as possible. It’s helpful if you know the application due dates and the timing of the cycle so that you can try and avoid the busiest periods, which are obviously going to be right before the due date.
So if you contact us early, you’ll have more of our attention and we’ll have more time to dedicate to answering your questions.
MONIQUE POND: That’s great advice. I often find that, you know, a month before a due date, you know, I have a lot more availability to meet with people and answer their questions versus the week before a due date.
So what are omnibus applications dates for those who might be new to SBIR?
JONATHAN FRANCA-KOH: Yeah, well, the magic dates are January 5th, April 5th, and September 5th. If those dates happen to fall on a weekend or a public holiday, then it will be the following business day.
MONIQUE POND: Great, thanks Johnny. So Johnny, can you explain to people listening in today how they go about reaching us or talking to us?
JONATHAN FRANCA-KOH: Sure, a great first point will be to look at our website, which has all our contact information. There you can see a list of our program directors in our office and our email addresses. We also have a general office email, which is [email protected] and that goes to a central mailbox which match you with the most appropriate program director and get you started that way.
MONIQUE POND: OK, great. So in that email, what do you recommend people include in there for information to make sure they get matched with an appropriate program director?
JONATHAN FRANCA-KOH: The more information you can give us ahead of time, the better we’ll be able to help you. How I like to go about handling these calls is to request that perspective applicants send a one pager or ideally a specific aims page that you’re thinking about in terms of a project, and that gives us a great starting point to initiate the conversation.
We’re happy to review those aims, I think that’s probably one of the things we do that provides most value to applicants. We will be able to tell you whether or not your ideas are coming across clearly, we can help you adjust and refine those aims so that they’re a close match for the project scope that’s appropriate for phase 1 or phase 2 SBIR.
A common question that we work with applicants is trying to help them figure out what is the best funding mechanism, whether they’re ready or not for some of the larger funding opportunities like a direct phase 2 or fast track application, or whether perhaps in their case a phase 1, which is our introductory grant would be the most appropriate.
MONIQUE POND: And that’s a good point Johnny, that’s a question I hear a lot from people. [brief crosstalk] Are there other resources or instructions that they can talk a look at perhaps or that you recommend before they jump on a call with you?
JONATHAN FRANCA-KOH: We have a lot of general information on our website, which is SBIR.cancer.gov. Another great resource is the Application Instructions, a document called the SF-424, that provides a lot of guidance and detailed help there.
But I think when you’re setting up a conversation with the program director, we’re really there to provide as much as possible answers to your specific, unique questions that are specific to your project. Each project is unique and we’re there to kind of provide you with our expertise and background to help you find the answers you need.
MONIQUE POND: Yep. Navigating the SBIR-STTR application, if you’re new to it, that can be a bit of a learning curve, so definitely reach out and we’re happy to try and help. I’ll add, the SF-424 instructions are helpful for things like, you know, how many pages for each section, what sections are required, and so if you do take a look at that beforehand, you can have those answers to your questions and then we can focus, as Johnny said, maybe more specific questions to your unique project.
So a question I know I get asked a lot and I’m sure you do too, Johnny, what if someone listening in right now has a platform technology or some type of technology that could potentially fit within multiple NIH institutes or center’s mission and they don’t know who to reach out to, whether it be NCI or a different institute or center, what should they do?
JONATHAN FRANCA-KOH: That is another thing that comes up quite frequently. As many applicants know, there is some overlap between the mission focus of the different institutes at the NIH and figuring out which is the best one for you is sometimes not so easy from the outside, so that’s another great topic of conversation with the program director to navigate those nuances and find which institute has the best fit.
Our portfolio at the NCI is pretty broad and spans technologies that are related to, obviously, therapeutics and diagnostics and novel imaging technology, but we also do fund significant projects in development of new research tools that do cut-across different disease areas.
So often, a follow-up question then is, I have a broad platform, but how do I tailor it towards something that the NCI might be interested in? So there my advice is make sure you are addressing a question that is of clear interest and importance to the cancer research community.
Make sure that you’re using appropriate samples, that you have recruited a team with expertise in cancer biology to work on the project, and it’s also a valid strategy to think about how you can secure funding from different ICs. So by focusing on cancer, you may then also have opportunity later on to explore other disease areas and potentially secure funding from other institutes.
MONIQUE POND: That’s a good point. Yes, I know I have several companies in my portfolio that have funding from not just NCI, but as you said, they’ve applied to other institutes for different indications and developed their technology in a way that fits that institute’s mission, and that’s a good thing!
So another topic I’d like to cover today is what if people are listening in and they’ve already applied either to another institute or the National Cancer Institute and they’ve received their Summary Statement, what do you recommend they do next, Johnny?
JONATHAN FRANCA-KOH: Yes, the dreaded Summary Statement. So this will be the feedback you received from reviewers on your application. Ideally, you’ll get a good score, in which case our discussion will probably be very upbeat and happy, and of course we love those conversations.
But in the case where you’re score may not be as compelling as hoped, one of the things we can do is help you to interpret the comments clearly and give advice on how best to go about addressing some of the concerns and critiques that reviewers have raised.
MONIQUE POND: For those interested in learning more, what are a couple of resources you would recommend for them to go to next, Johnny?
JONATHAN FRANCA-KOH: There’s one I’d like to highlight on our website, it’s called the Peer Learning and Networking Webinar Series. And especially for first-time applicants or people who are not as experienced with our program, there’s a great topic on first steps for starting a small business.
Here we have interviews and presentations from four entrepreneurs who tell their story of how they developed and started their own small business to commercialize their technology. It covers topics such as: what are some of the roadblocks they had to overcome, how do you navigate that transition from academia to industry, what are some of the financial tools and entrepreneurial resources you can access to help you on that journey, and how about getting help from universities and other organizations?
And we also have a topic on how to write a good specific aims page. Here we have presentations on how to write one for a therapeutic project, a diagnostic project, digital health project, and also a medical device project, and they go over the basics on how to get your message across clearly and make sure you stand out from the first page of the application.
MONIQUE POND: That’s great. So instead of, you know, just taking kind of a program director’s perspective and points, you can also hear from people who have done it and not just been applicants, but been successfully awarded, so hopefully that’s helpful to people listening in, if you are working on your first award yourself.
Well, Johnny, thanks for your time today and thanks for talking with us and helping our listeners out, if they’re new to SBIR-STTR, figure out how to reach you, how to get started, and hopefully people listening in, we will hear from you soon.
JONATHAN FRANCA-KOH: Thank you, Monique.
[music]
MONIQUE POND: As always, don’t forget to check out our website sbir.cancer.gov for the latest funding opportunities and commercialization resources to support your journey from lab to market.
I’m Monique Pond 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, you can email us at [email protected] or call us at 800-422-6237. And please be sure to mention Innovation Lab in your query.
We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening.
[music]
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NCI SBIR Director Michael Weingarten and Rukiyah Van Dross-Anderson, Founder and CEO of SBIR-funded Claradele Pharmaceuticals discuss the journey from postdoc to biotech startup and how women and underrepresented entrepreneurs with innovative cancer solutions can also leverage SBIR support to move their ideas forward. Listen to this podcast to hear:
• Stages of product development (fundraising rounds, company collaborations, team culture development, and more)
• Lessons Learned when transitioning from academia to the early stages of product commercialization
• Benefits of contacting program directors when applying for SBIR/STTR opportunities
• Coaching received through the Applicant Assistance Program
• Utilizing state biotech professional organizations
• Programs early-stage businesses can use
Podcast Guest Speakers:Name
Bios
Michael Weingarten, MA
Director
SBIR Development Center
National Cancer Institute
In this role, Michael Weingarten leads a team of nine Program Directors who manage all aspects of the NCI SBIR & STTR Programs including a portfolio of $182M in grants and contracts annually. The SBIR & STTR programs are NCI's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. Weingarten has implemented a set of key initiatives for optimizing the performance of the NCI SBIR Program at the NIH. These include the establishment of a new model at the NCI for managing the program - the SBIR Development Center.
Rukiyah Van Dross-Anderson, PhD
Founder and CEO
Claradele Pharmaceuticals
Rukiyah T. Van Dross-Anderson, PhD is the CEO and founder of NCI SBIR-funded therapeutics company, Claradele Pharmaceuticals. Her work began at East Carolina University, where she is an associate professor and the director of Graduate Programs, Pharmacology & Toxicology Concentration. Dr. Van Dross-Anderson is working to develop an effective and non-toxic drug as an alternative therapeutic regimen for melanoma patients who aren’t responsive to traditional treatments. To attract third-party investors that would help get her innovation to get to the patients that need them, Dr. Van Dross-Anderson is working through proof-of-concept studies to demonstrate her innovation’s commercial viability. Through her participation in the NCI SBIR program, she used funding to scale up production and received entrepreneurial mentorship to navigate the complex business world. Dr. Van Dross-Anderson graduated from Rutgers University, UMDNJ-RWJMS with a doctoral degree in Molecular and Cellular Pharmacology.
Programs referenced in this episode:• Minority Biomedical Research Symposium (MBRS) program - http://mbrs.newark.rutgers.edu/
• Minority Access to Research Careers - https://www.nigms.nih.gov/training/MARC/Pages/USTARAwards.aspx
• Applicant Assistance Program - https://sbir.cancer.gov/small-business-funding/application-process/applicant-assistance
• I-Corps at NIH program - https://sbir.cancer.gov/commercialization/business/icorps
• NCI SBIR Women’s Innovation Network
• Office of technology transfer (offered at most school)
• NCI SBIR Investor Initiative - https://sbir.cancer.gov/commercialization/business/investor-initiatives
• Small Business Transition Grant - https://sbir.cancer.gov/small-business-funding/grants/small-business-transition
Transcript:KEY: MICHAEL = Michael Weingarten, RUKIYAH = Dr. Rukiyah Van Dross-Anderson
[music]
MICHAEL: 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 Michael Weingarten, the director of NCI SBIR and today's host. Today, in celebration of the Women's History Month, I'm excited to introduce our listeners to one of our women awardees, Dr. Rukiyah Van Dross-Anderson. Rukiyah is the CEO and founder of an NCI SBIR funded therapeutics company Claradele Pharmaceuticals. Her work began at East Carolina University where she is an associate professor and the Director of Graduate Programs, Pharmacology and Toxicology Concentration.
Dr. Van Dross-Anderson is working to develop an effective and non-toxic drug as an alternative therapeutic regimen for melanoma patients who aren't responsive to traditional treatments. We will discuss her journey from post-doc to biotech startup, and share how women and underrepresented entrepreneurs with innovative cancer solutions can also leverage SBIR support to move their ideas forward. Welcome, Rukiyah.
RUKIYAH: Thank you. Thank you for having me.
MICHAEL: Can you kind of walk us through the arc of your career and how your company Claradele was formed?
RUKIYAH: Oh, sure. So my research career began at Alabama State University, where I was a chemistry major, and through the university, I participated in some really important programs that helped me to understand that I really love research.
So as an undergraduate, I was in the MBRS program, which stands for a Minority Biomedical Research Symposium. I was also a MARC student, Minority Access to Research Careers, and these two programs were NIH-funded programs that gave undergraduate students an opportunity to experience research.
And it's through that experience that I found my true love, which is research. So after graduation from my undergraduate institution, I did two post-docs, one at Vanderbilt University and the other at the University of Kansas Medical Center. It was there that I honed my skills and really learned how to become a cancer researcher.
From there I became part of the faculty at East Carolina University as an assistant professor, and I'm now an associate professor. And so throughout these years, I was really focused on developing novel agents that were effective against cancer. And so through this process, we discovered a novel molecule which we obtained a patent for to use as a therapeutic for melanoma and other types of cancer.
And so thereafter the question was, what do we do next? What do we do with this molecule that we've patented and how do we get it to the stage where the public has access to it or the public can use this therapeutic? And so to kind of answer that question, I started attending different workshops that discuss the different options or the different ways in which drugs can be commercialized.
And through this experience, I chose to form my biotech company, which is called Claradele Pharmaceuticals, and this company was founded in 2020.
MICHAEL: Got it. So you've really had an interesting journey. You know, based on the research and then deciding to start Claradele. Can you maybe tell us a little bit more about the product and the technology that you've been working on, with funding that we've been providing from NCI SBIR?
RUKIYAH: Sure. Yeah. So what we're working on is developing a small molecule therapeutic. And this agent has the ability to kill melanoma cancer cells and also stimulate the immune system. So the action of cancer killing and stimulating the immune system are really critical for effective tumor eradication.
And our data, thus far, indicates that we have an agent with unique and promising properties that has the ability to eliminate cancer cells.
MICHAEL: And can you maybe talk a little bit about how your approach and your solution are a little bit different from maybe what others are pursuing or what's currently available to patients?
RUKIYAH: So current therapeutic agents are incredible. They're much more effective than agents that were available in the past. And so these remarkable agents have the ability to cure cancers in some settings. But the problem is, is that these amazing drugs are not effective in every patient.
So what we want to do is to develop an agent that is effective against those resistant tumors, and so provide alternative therapies for people who are not responding to the current agents that are available.
MICHAEL: Oh, that's really interesting. So are there specific types of melanoma that your research shows your drug is more effective against, whereas the current treatments aren't effective?
RUKIYAH: Yes, our research thus far is showing that when we use a model, that is resistant to the current therapies, our drug can work in that resistant model. In addition, we're also finding that we can help the drugs that are already available to be even more effective.
So we're looking at our drug as a single agent and also combined with other agents to see where is our niche, where does our drug work best?
In addition, in our future studies, we plan to test other types of melanoma, those rare melanomas to which therapeutics that are currently available are not effective, so we can foresee using this agent in the treatment of different types of melanoma.
MICHAEL: So that's really interesting. You're kind of pursuing both the single agent approach, where you would be the primary treatment for the melanoma, but you're also looking at combination therapies. I'm curious, are you collaborating with any other companies that are also in the same space? And does it look like your drug is complimentary to their drug?
RUKIYAH: Yes, so that's one of our next steps. We're working to identify companies that we can work with in order to do that testing. And we plan to try to use both of those agents together, yes.
MICHAEL: And so what stage are you, are you at now? Have you optimized your leads or are you into IND enabling studies?
RUKIYAH: So right now we're in the stage, we're in the middle of doing our proof of concept studies. And our goal here is to find out the best way to administer the drug, under which circumstances. And we also want to identify the types of tumors to which our drug responds the most effectively.
And so, we are now approaching the stage where we're going to begin a fundraising round. And with that fundraising, what we plan to do is to use those dollars in order to fund the regulatory studies that we need to prepare for that IND meeting.
MICHAEL: Can you maybe talk a little bit about how you think your team is uniquely positioned to succeed in terms of developing the drug? And you know, it's a long path to get a drug from the very earliest stages, where you are, all the way into the clinic, treating patients, and then ultimately out to patients and getting FDA approval. How is your team uniquely positioned to succeed, do you feel?
RUKIYAH: You know, our team is composed of individuals who are experts in their field. We are constantly evaluating and modifying our team to make sure that we have the expertise on board when we need it.
And so I believe, though, that our special formula is that several members on our team have a personal cancer story, and that personal cancer story helps us to stay motivated, and it helps us to use that experience, plus our talents, to keep driving this process forward.
And you know, most people have a cancer story. And you know, to be able to use that as your passion and your motivation, to make sure that you do your best to move it forward, is the unique part of our team because most of us do have that experience.
MICHAEL: Yeah. No, I think you guys bring a really unique perspective with that. And I agree with you, as a cancer survivor, that does provide a very special motivation and a connection with cancer patients too. Rukiyah, maybe you could also talk a little bit about your, you know, your process for applying for your NCI SBIR award. You know, did you interact with an SBIR program director before you applied? And if you did, how did that help, help you out?
RUKIYAH: So I submitted an application for the SBIR STTR several times before it was actually funded. And I will say that in the beginning, for my first couple of submissions, I did not interact with the program director. However, on the later stages, I began interacting with the program director.
And one of the reasons that I didn't interact with the program director initially was that I kind of felt like it might be wasting their time. I didn't want to bother them, and I was concerned that if I asked the wrong question, it might appear that I was not ready for this opportunity.
So I chose not to do it, but that was not really the best way to go, because as I mentioned in my later submissions, I started interacting with the program officers and I can tell you it made all of the difference in the world.
The program directors, you are not wasting their time when you call them, set up an appointment, you're not wasting their time at all. And they're very friendly, they're very helpful, and I can tell you, I learned so much from interacting with them that it really made the difference in getting that application funded.
And so, you know, in interacting with the program directors, they gave you, they'll give you lots of helpful information. You may ask a question and you may think that you know the answer to it, but there may be more to it, and they can give you more insight into, you know, why a particular situation may be important. They may open up some other opportunities that you were not aware of, so very, very helpful to interact with your program officers.
And I can say, in my experience, I've had wonderful program officers, like Billy Bozza, who is wonderful. And I can tell you that the most important interaction that I had, as I mentioned, I submitted my application several times, and I was at the stage where I was going to give up and I wasn't going to resubmit again. And I can tell you that he told me “Don't give up. Let's try again, you’re this close. Let's try it again and see what happens.”
And he gave me advice that I needed to, to really focus on those issues that the reviewers thought needed to be bolstered, and again, it made all of the difference in the world.
So interacting with your program officers can make the difference between getting the application funded and not getting it funded, part of what they do is to help you to get your proposal funded.
MICHAEL: Yeah. No, that's really valuable feedback. And we, we actually spend probably at least a third of our time interacting with, with applicants like yourself, because it can be a really, if you haven't applied for an SBIR grant at the NIH, you know, it can seem like a tall hill to climb sometimes, but our programs there, our program directors are there to help kind of smooth things over, explain the process, explain the different parts of the application, and really advise overall on what the NIH peer reviewers tend to look for in a strong proposal.
So we actually think that's one of the most important parts of our jobs is interacting with applicants like yourself and others, and really trying to demystify the process and making it easier too. So it's really helpful to hear that back.
Now, did you also participate in the Applicant Assistance Program and, and if so, how did that kind of change the way you approached the application process?
RUKIYAH: Yes, I did participate in the Applicant Assistant Program and again, it was a great program. It really helped me to compose an application that was fundable.
So I'll start by saying that both me and my institution have limited experience with the SBIR/STTR Grant. So because of this, I had no mentorship. I didn't really know how to put this grant together because it's very different from a traditional R grant.
And so, without that mentorship, you know, I would compose it, submit it, and you know, that's how I would get my feedback as to how to put this together. So then by participating in the AAP, the people who are administering that program have extensive experience putting these types of grants together, and so they really helped me, provided me with the guidance that I need to put a fundable application together.
So for example, they helped me to understand what was allowable in terms of a company budget. We know as academics what's allowable as, on the budget, but on the company side it's a little bit different, so they help me to bridge my understanding of the company and the academic setting so that the budget would be set up properly.
Another example, they helped me with other aspects of the sheets of the different forms that needed to be filled out dealing with the company side of this whole process. And they also helped me to understand what are the expectations or the most likely expectations of the reviewers.
Again, the reviewer board is composed not only of scientists, but people who are business people, and I have no formal business training, so that helped me a lot to really refocus and think about what is expected in that grant, and the people in the AAP program helped me to understand that.
And so also another really important thing, as we were going through this process, the program will put you on a schedule. And so with that schedule, you have deadlines and milestones, and you complete these things on time so that the package is ready well in advance of the deadline, and this is really important because we all know when you wait till the last minute, it’s really difficult to put in a good package.
And so by setting up those deadlines, it really helped me to be able to compose it and then to be able to come back and look at it later, with a fresh mind and fresh thoughts. And so the AAP program was really, really helpful and I highly recommend it.
MICHAEL: That's -- I think that's really valuable feedback to our listeners today. We set up the AAP program about five years ago and it really is -- it was set up to do the exactly the things that you described, which is taking applicants, as they're putting together their, their applications, and really kind of coaching them, providing a coach who can kind of guide them through the whole application process.
I've heard from a number of companies who have gone through AAP, like yourself, that it really did help them prepare to get an award. Sometimes they had applied in the past, like, like you had, and had not been successful. But then when they went through AAP and then they, they resubmitted their proposals and they learned, you know, from the coach who was kind of guiding them, they got stronger scores when they reapplied like you did, and then we were able to give them an award, because they had strengthened their application.
So that that's the whole goal of the Applicant Assistance Program, and for those who are interested, we're actually going to be putting on a webinar on April the 25th, talking about the Applicant Assistance Program. And you can sign up and apply to participate in, in the AAP program. So April 25th is the next date for the webinar, I encourage folks to attend that. And you can also go to our website at sbir.cancer.gov and get more information about the Applicant Assistance Program there.
OK, moving on just a little bit, you have a background that is very similar to what our, a lot of our applicants are experiencing when they're first getting involved in SBIR, and that you come from an academic background and you were working to start up your company, I'm sure there are a lot of challenges involved in that, because, you know, you're, you're an academic by training, you were not an entrepreneur.
So you've had to kind of learn that along the way. So maybe it would, it would be really useful to our listeners, could you maybe talk a little bit about some of the key lessons learned as you've gone through your commercialization journey? And were there -- Was there any, any coursework, like, for example, the I-Corps program that you were able to tap into in order to give you the kind of information you needed to help as you were building your company?
RUKIYAH: So yes, key lessons learned. I learned a lot of lessons in developing a company. As I mentioned, I have no formal business training, but what I did to kind of understand the basics of business is to attend lots of different workshops. Those workshops provided me with some information about business, about drug development.
And then, what I started doing is to partner with people who are experts, so I don't have to be the business professional. But what my goal is, is to learn enough about business to understand with the business partners are talking about, and also to be able to contribute to the decision making process.
And so that's my goal with learning about business, and I use the skills that we use as academics all the time and collaborate. Collaborate, bring people in who have the expertise that you need, rather than trying to be a professional or to be in a position that you really don't have the qualifications for. And so that's been my approach for making this happen.
And so another thing that I've learned about business is that business is quite different from academia. In academia, we plan, we, we aim for perfection, and we have a route, and we try to stay with it and pivot when the science takes us there.
In the business world, it’s a lot different. And I think the general mentality is that you are going to make mistakes. And so as, as was mentioned, you know business is new for me. So I've made mistakes and the idea is mistakes are expected. And when you make those mistakes, you just pick up and keep moving forward.
The key is to have people around you who understand the business and know how to mitigate those mistakes and keep moving forward.
MICHAEL: Yeah, I think those are, those are excellent lessons. There, there is a program, in addition to the valuable training that you were able to seek out in the -- and the mentors you were able to seek out on your own, NIH also offers a program called Innovation Corps or I-Corps, and it's open right now to companies that have an SBIR at the NIH, whether it's at NCI or a different institute.
And it's really kind of like a boot camp to help companies learn how to put together a business strategy around the technology that they're developing.
So it's a 10 week program we bring in instructors who are experts in areas like therapeutics, devices, diagnostics, and they are there to help guide the participants in going through that program. We have found that I-Corps has really helped launch a lot of our companies and really advanced through the development process. And it really does that through companies learning what the value proposition, and where their, where their technology can really make an impact and solve an unmet need. So I encourage folks to go up on our website and look for information about I-Corps program, I-C-O-R-P-S.
RUKIYAH: So you're absolutely correct. The I-Corps is a wonderful program. I also participated in this program as well and it helped me to identify the specific niche of my product. So where does your product fit in this vast market of products that offer to do similar things?
So I-Corps is really important to help you really fine tune your commercialization plan. And you know, I've also participated in other programs that I think are really, really important. For example, the SBIR-STTR workshops and road shows, man, those are some great programs.
And I'll say that I've attended these programs over and over again because each time that I go or I participate, I learn something new. And it reminds you of all of the options that are available to really push your product forward. So it's a great idea to really attend these workshops and pick up as much knowledge as you can in order to push, push your technology forward.
Also, once your grant is funded, I would like to recommend the Women's Innovation Network or WIN. That's a great program. It provides a supportive community of female SBIR-STTR recipients. It provides mentoring. We have speakers who talk about different aspects of commercialization, and it provides an opportunity for female investigators to network with each other, and to be a little vulnerable. And by being vulnerable, we can help each other, and so I recommend that as well.
I'd also like to recommend, for those who are seeking to develop a business, a biotechnology business for their laboratory discoveries, you may have some local resources that you can tap into. Many states have different biotechnology professional organizations that put on workshops and they -- some provide funding. And they provide different types of education about entrepreneurship.
So there may be some local organizations that you can also take part in, in order to learn, to build your business. And I would probably start to find out about if your state has a similar organization. Maybe start in your office of technology transfer, because that's the location where, in academia, that's kind of the line between academia and the commercial environment. So I would start there to find out if there are some local organizations that can also help you to get where you need to go.
MICHAEL: Yeah. And really thanks so much for bringing some of these programs up. Rukiyah. One of the things that I like to talk about, when I talk about our SBIR program is, I think people understand that SBIR provides funding, which is obviously the most critical element.
The way I like to think of it is it's necessary, obviously, but it's not sufficient. You know, you’re small business, you need funding obviously, but you need access to a whole range of different resources in addition to funding. So that's one of the things that separates the NCI SBIR program, I think, from others in that we really put a lot of time into thinking about and creating resource programs that our companies need.
So just as an example, you mentioned I-Corps, that was one program we created here at NCI SBIR for the NIH as a whole. But we also offer our Investor Initiatives Program, too, where we are able to connect companies that we're funding through our SBIR program with private investors.
So that, you know, as you're developing your drug, you're in the earlier stages now, you're obviously going to need to go out and raise additional capital. Because we're the NCI, we're able to develop relationships with some of the largest investors around the country, whether that's large pharmaceutical companies or some of the large venture capital funds around the country that invest in the cancer space.
So once a year, we invite all the companies that we are funding in our portfolio to go through our Investor Initiatives Program. And that's an opportunity for you to put together a short application, which will then be reviewed by a panel of investors.
And then those investors help us identify companies that are ready to go out and present and pitch their technology to, to other investors in order to help raise capital. And then we also do pitch coaching, to help, to help prepare our companies to, to go out and present.
RUKIYAH: I can say that that's really important because in this current climate, it's very difficult to raise funds. So having that edge, having those connections would be very helpful.
MICHAEL: I was wondering, maybe you could provide some advice. You mentioned the WIN Program as an example, you know, a program that we offer to women entrepreneurs in our program, and give them the opportunity to come together and really kind of share lessons learned.
In addition to that, do you have any other advice for women in academia who want to transfer their technology and really kind of start that journey towards a start up?
RUKIYAH: Sure. You know, the first thing that I would say is that this is very doable. It's doable because women have some ingrained properties that are really conducive to making this happen. For example, our ability to multitask is very important and very critical for getting this job done.
And so the job of transferring the technology into the commercial space takes a lot of multitasking. You can work with different people in order to get things done. Collaboration, that's also another property that we have as academics, and so we can collaborate with people in order to get things done.
And so for me personally, one of the things that I had to resist was the urge to be Superwoman. And so for me, what I usually try to do is do everything myself and, you know, try to achieve it all by myself, and that's really not the way to go.
What you - What is successful is to collaborate and delegate in order to achieve your goals. So that's one of the things that I would say that we really have to do as women, collaborate, don't try to do it all, find the experts and let the experts do what they know how to do.
And then finally, I would say in terms of advice for women, I would say ask for what you want. Sometimes we don't like to ask and -- ask people for help or ask for resources, but you have to ask, all, all that can be said is either yes or no. So just ask and if the answer is no, try another route and keep moving forward. Don't take it personally, just keep moving forward.
MICHAEL: I really think that's -- I think -- I really think that's excellent advice. There's, there's another program really focusing on academics doing the research, developing a technology who are interested in making that transition. There's another program that we offer called the Small Business Transition Grant.
It's a fairly new program, not a lot of folks are, are aware of it, but we're really trying to, to increase the awareness of that program and that, that program, we actually developed in response to conversations we were having with our cancer centers from across the country, where we were trying to figure out what can the NCI do to facilitate the translation of academic technologies and to get more technologies out of the lab and into small companies.
And one of the key funding gaps that they told us was existing, was that it was really hard for early career academics, like post-docs, to raise funds. You know, there was kind of a dearth of funding when, when you're really at the early stages in your career trying to raise funding.
So the Small Business Transition Grant actually is focused on, on post-docs and other early career academics, and it will provide funding to them while they're still at the university, both for their research as well as funding for both a technical mentor and a business mentor.
And the whole goal is to provide kind of the, the support that that early-career academic needs, you know, sounds -- and it sounds like you were kind of in that same situation, but the goal is to provide funding as well as mentorship support to that early-career academic to help them as they're looking to move their technology out of a university to a small business.
You can apply for either just a Phase 1 application or you can go for a combined Phase 1/Phase 2 application. And the funding will support the academic, first at the university, and then as they move their technology to a company, and they move -- and they advance that technology to a Phase 2, it'll continue that same support.
So, it's another program that we have tried to tailor to the needs of you and other academics that are out there looking to apply. And, again, we have information about the Small Business Transition Grant up on our website at sbir.cancer.gov.
We're actually going to be launching that program for the coming year sometime in, in March. So if you're interested in that, and I encourage everyone to, again, go up on our website to get more information and talk to a program director, reach out to us, send us an e-mail, and we're happy to give you more information about that program.
RUKIYAH: Sounds like a really interesting project. I think it's a great idea because young -- Generation Z, Young investigators, they want to own businesses, a very different mentality from previous generations. So this type of program sounds like it would be really great to help to launch their ideas and their businesses in the biotech space.
MICHAEL: Absolutely. And that's what we're trying to do with that, that program right now. It's, again, it's still a fairly young program, so we're, we're trying to, we're trying to talk about it a little bit more with folks like yourself to just kind of raise visibility that that's, that's a funding opportunity that an academic who's interested in moving to a small business, maybe creating their own small business, it's a funding opportunity that's, that's available to help to, to help support them on that.
Well, this has been great. I've really enjoyed our conversation. I wanted to ask you just one last question, and that's, is there one piece of advice that you'd like to leave folks with before we leave today regarding, you know, your journey or their journey as they're looking to start it?
RUKIYAH: Sure. I would say the best piece of advice that I can give is to use your skills that you have acquired as an academic researcher to start and grow your company. The skills that are necessary to make this work include: collaboration, persistence. You have to be persistent, networking. And so you can also use your passion, what is it that you really feel passionate about in order to keep the process moving forward?
And then I would also advise you to take advantage of the resources that are available to help you with commercialization of biotechnology products. I would also say, as you mentioned, this is a very long drawn out process. So I would advise you to know what the process is, but don't focus on the big picture, focus on your milestones, because if you get focused on how big this whole process is, it's discouraging, right, and it may prevent you from moving forward.
So just break your process up into milestones, achieve your next milestone, and, and view it from that perspective, rather than being focused on all that needs to be done. And I think that that has been really helpful to me to just kind of take this at small pieces.
MICHAEL: Excellent advice, break it down step-by-step and if you can work on it step-by-step, then it's not such an overwhelming kind of thing, you know, set your goals, achieve that one goal, and move to the next one.
Well, this has been wonderful. I've really enjoyed our conversation today. Thank you for taking the time. And I know it's going to be really valuable to a lot of the folks out in the community who are interested in coming back and applying for NCI SBIR. We look forward to working together with you in the future. And again, thank you.
RUKIYAH: Thank you so much for inviting me to talk. I hope that some of the information that I've shared will be helpful to someone. And it is great to be part of a community of people who are really devoted to developing cancer chemotherapeutics. And again, I just thank you for the invitation.
MICHAEL: Thank you. Thanks so much Rukiyah for speaking with us today. We really look forward to seeing Claradele’s continued growth and making positive patient impact. As always, don't forget to check out our website, sbir.cancer.gov, for the latest funding opportunities and commercialization resources to support your journey from lab to market.
This was Michael Weingarten 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 [email protected] or call us at 1-800-422-6237 and please be sure to mention Innovation Lab in your query.
We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks so much for listening.
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To conclude the three-part series on starting a small business, NCI SBIR Program Director William Bozza convenes the four panelists from the previous episodes to answer questions about their biotech entrepreneurship journeys.
TRANSCRIPT
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BILLY: Hello and welcome to Innovation lab, your go to resource for all things biotech startups brought to you by the National Cancer Institutes Small Business Innovation Research, or 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.
BILLY: I'm Billy Bozza, a program director at NCI SBIR and today's host. In the last two episodes, you heard from four of our companies about how they went about kick-starting their small businesses. Today, we are bringing the speakers together to answer some questions from researchers and to be entrepreneurs.
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BILLY: OK, so I don't want to take any more time. These are our panel speakers. I'm going to let each of you introduce yourselves, moving from left to right. If you could just mention your name, your company, role in the company, kind of, you know, quickly summarize how the company got started, and then I thought it would be fun to do like an icebreaker, talking about company culture and if you could each take about, you know, 2 to 3 minutes in time, so we have sufficient time for questions that'd be great.
MARGARET: Hi. I'm Dr. Margaret Jackson. I'm the founder and CEO of a company called Biomass. We are a preclinical stage company focused on the TGF beta super-family, developing therapeutics for cancer induced anorexic-cachexia. We have been successful in achieving a SBIR phase one and a phase one federal contract grant, which really helped get Biomass off its feet to generate proof of concept data to be able to seek further investment from investors.
So as per the icebreaker culture, you know, I have lived the world through academia. I have also had a fabulous 15 year career in large pharma for developing drugs and now I’m working in the smaller business biotech world. So the cultures are very, very different and being able to set up Biomass, we were able to set up our own culture.
In large pharma, while it's great to develop therapeutics, you're working with fabulous talent, a lot of resources and finance to move projects along. It's quite periodic, it also is slow in decision making. So in a smaller company, you're able to have a flatter structure, less bureaucracy. And you're able to make decision-making much more quicker and be more nimble.
And we're able to set up our own core values, which is on our web page, which is really to focus on scientific excellence, innovation, and people. And we also hold everyone accountable to get things done and at higher integrity. So thank you.
BILLY: Thanks, Margaret. Eric?
ERIC: Yeah. Hi, I'm Eric Broyles. I'm the CEO and founder of Nanocan Therapeutics Corporation. And Nanocan is a preclinical biotechnology company that is working to commercialize a patented immunotherapy delivery technology developed at Harvard's Dana Farber Cancer Institute. We’re the nanocancer global exclusive licensee for the technology.
As far as company culture, so I'm actually a lawyer by training, I practiced corporate law for 10 years before becoming an entrepreneur, and I've done healthcare deals for the past decade or so, and so definitely a big difference in culture from being a lawyer to being an entrepreneur and certainly being an entrepreneur in the healthcare and biotech space.
I would say our culture as a company is obviously innovation is very important to us and sort of patient centric. We always keep in mind who is the person that will benefit from our innovation? And that's the thing that drives us, each of us, every day as we roll out our technology.
BILLY: Great, Craig?
CRAIG: Hi, everyone. I'm Craig Ramirez. I'm one of the co-founders and the CEO of Tezcat Biosciences. We are developing a RAS cancer therapeutics platform with the lead asset identified. And this is all really based off of my work at NYU while I was getting my PhD, where I then created this company. We're still early stage. It's still myself and the other scientific co-founder with a lot of advisor advisors and consultants. So it's kind of hard to talk about company culture because it's really, you know, me and my scientific founder and our kids around us as work from home and you know, navigate the startup and early family life all at once.
But, you know, I think for us it's really just continual learning, I still feel like sometimes I'm that academic where I'm learning about accounting, I'm learning about the legal, you know, learning about how to scale the business. So it's been cool.
BILLY: Thanks, Craig. Joe?
JOE: Yeah, Billy, thanks for the invitation to speak today at the panel. I'm Joe Peterson. I'm one of the co-founders and Chief Technology Officer of Symbiosis. We're a med tech company based in Chicago, Illinois and developing precision medicine tools based on AI and biophysical simulations, primarily in early stage breast cancer, but across additional indications.
The company was founded five years ago, initially with support from an SBIR phase one grant. Since then, we've completed a second phase one and are working on a phase two grant from the NCI and have raised the Series A round of financing.
The company was founded on three principles. The first is scientific integrity, the second is honesty and innovation, and the third is to always keep the patient at heart. And so our goal in everything that we do here at the company is to push towards improving the lives of patients and that comes through our various different software medical devices that we're bringing to market.
BILLY: Great. Thanks Joe. Yeah, so I'm really happy with this panel. And we organized it in a way to have people that have started up companies from different places, right? Some spinning out directly from universities, other that have spent time in big pharma, and others that, you know, come from in Eric's case, a legal background, and was able to license the technology from a high-powered institution, so all different avenues. So feel free to go ahead and type your questions in.
I don't see any yet, I have a few banked ones to get us rolling. Now feel free to enter any questions at anytime. So I guess one way to get started is it's a daunting, it's a big commitment, right, starting with small business. So how do you know when is the right time to do this? And what were the key factors in your move and making that key move to starting up a small business? I'll leave that open to anyone who wants to jump in.
CRAIG: I guess I'll start. I just wanted a different type of challenge than what I was getting in academia. And after, you know, along with the other co-inventors at the university, you know, seeing the potential of what we've discovered, I wanted to see it through at least to a point that I could take it, and so that's when we started talking to the right people about starting a business and seeing, you know, how to get this done and just get into the driver's seat to move it forward.
JOE: Yeah, sure. So I think I think it there's a couple of things that have to come together. Part of it is the technology space needs to be ready. The technology needs to be ready. You need to have conviction both in your team and others, and I'm constantly reminded of the 2000 tech boom and ultimate bust. If you think about it, there were companies like Uber, there were companies like Go Puff.
There were companies, much like many of those that are successful today, that weren't successful just due to sort of the timing and the availability of technology. I think this is especially important from a med tech setting where there's a huge push in digitization of assets within hospitals and healthcare settings that wouldn't have been possible to create solutions around in the past.
So, you know, in terms of AI and other solutions like those that we're developing, the timing I think is super critical. The other is the conviction of the people that that you're working with, those willing to come together and work hard and fail and learn along the way.
WEIX: Yeah, I'll piggyback on that. In terms of I really want to stress the sort of the conviction part and the commitment. So I've been in my business for three years and I've not taken any salary in three years time, right? And so and there are a lot of hard days in starting a business and a lot of bumps and bruises. And so having that commitment and then also having a team around you that's also committed. But prior to getting into the business, I think it's important for you to understand what's your investment thesis before you decide to just take on anything and do as much due diligence as possible.
Now, I have a little unfair advantage because in one of my businesses is an expert network and I'm sure you've all have probably heard from them. These are these firms that call you to ask you to talk to Wall Street about something. I happen to own one of the largest ones in the US and so I had the ability to tap into all the top key opinion leaders about the innovation that I was exploring.
But more importantly, the innovation that Harvard licensed to me fit within an investment thesis. I had started making investments around the whole concept of innovative delivery systems, right? And that's my sort of narrow focus. I have a patch technology company in Europe that is solely focused on delivering actually vitamins through patches, but there will be regulatory approved patches.
Another company, again, in the delivery space. So this innovation, which is about making immunotherapy more accessible, right now, it's delivered systemically, our technology allows for a seed to be implanted and have micro doses over a three-week period from a slow release of this technology. And so that fit within my thesis of finding a better way to make medicines and things available to the body through delivery.
So I'd really ask you to press yourself on why am I doing this? How does this fit within, you know, sort of my thinking about where the world's going to go? And I think that will be very important to you as you move forward.
BILLY: One follow up question is how much time did you spend upfront in the beginning kind of understanding the market potential for your product and kind of identifying any potential barriers to market entry? Because I know those are some critical things that peer review looks at for phase one SBIR, so I'd imagine that's something that you all pay some attention to as well.
CRAIG: I mean, for me it was part of my whole PhD, you know, in the academic setting, working with the, you know, the cancer centers and the clinicians. So it wasn't one of those things that I actually, you know, had to go out and start from scratch, it was kind of just an accumulation of all that work and then it was just, “Oh, there's this part of the application. OK, let's actually sit down and just put it on paper.” But that's a unique situation, coming from academia.
BILLY: Got it. Thanks, Craig.
MARGARET: I just also want to add that anyone that is being successful in achieving like an SBIR award, there's a fabulous opportunity to also apply through the NIH I-Core program, which helps you with commercialization and plans around your company, I was part of that. I'm not sure of any other panelists were, but it was a really excellent resource, a very intensive program over 8 weeks where you get to do market research by speaking to stakeholders, patients, caregivers, et cetera, about 100 stakeholders in a period of eight weeks and collecting that feedback and relaying back and really fine tuning your commercialization plan and any issues around market access. So I would strongly recommend as soon as you receive an SBIR award to apply for the NIH I-Core program.
BILLY: Yeah. Great, thanks, Margaret. Great plug. That's one of our high-powered non funding resources. It's a tremendous opportunity to refine your business model canvas and understanding. A bunch of questions coming in now, so now we'll probably jump around a bit. This one, I think kind of fits into this early stages of starting up your company. What advice do you have for putting together an advisory board for your company?
ERIC: Yeah, advisor boards are critical to early stage companies, and for me it was especially critical because, you know, the capital markets, they look at me, they say “Well, you're a lawyer, right? You've had some successes in healthcare space, nothing this technical.”
So for me it was very important to surround myself with key opinion leaders and I've done that. I have the former head of Tricare on my board, I have the Chair of the Credentialing Committee for the American Board of Radiologist, so he actually certifies every radiation oncologist in the US, he's on my board. And so I really wanted to pick people from top institutions, but then you also have to make sure that they are available to you, that they're not just the name to show up, but that they actually add value to you.
And I've been fortunate enough to have, again, top doctors from Cleveland Clinic, Memorial Sloan [unclear], former head of Tricare, and they're also very accessible. They take my calls, they're very active, they show up for our advisory board meetings, and they're willing to open their networks to help push the project forward.
JOE: Following on that coming from an academic background as well, you may not have the business acumen or as necessarily the skills or expertise to come to market. So in addition to KOLs, I think personal mentors are absolutely critical and ideally those KOLs are personal mentors to you as well. Coming from a scientific background and not a healthcare space, it's been really important at Symbiosis to recruit those who have both business acumen and clinical experience.
We’ve brought in people from various different clinics around the company. That will help you understand not only where you're going with your business, sort of fill that market research side of things, but also to build a group of people who believe and can help you through those pivots. You will experience pivots in your business and it's important to have those people who are on the ride with you through those.
MARGARET: I would also just like to add that, you know, while sometimes it's good visibly to have an advisory board and that's important also when you're starting to interact with investors, but I do want to emphasize what Joe said, you really need to surround yourself by people who really cover a lot of your weaknesses that you don't have. And that doesn't need to be an official board, right? I'm here in the Massachusetts area. We are, we are –
We have loads of companies here and any number of members of the various companies in this area will happily take a call or a coffee break and have a conversation. Also, so those are sort of informal settings, the other is to really expand your network and get involved in various programs. I participated in a life science company accelerator or incubator program for women in life sciences.
And that was another excellent avenue to be able to learn a little bit more about how you present, etcetera to investors, but they were also giving you an advisory group of experts who had lived and breathed this previously, and who could be mentors for you. So they weren't officially on a board, but they were real great supporters through that program and continue to be after the program.
So you really just need to surround yourself with people and get involved with expanding your network and trying to really get involved in as many various programs where people have had experiences in areas where you've had weaknesses.
BILLY: I have a question here and this is tied to, I guess, marketing outside of the US, if any of you had experience developing solutions and hopefully commercializing products outside of the US and internationally, what are some of the associated upsides or challenges? And before you answer that, I'll just give a quick reminder, for SBIR funds, all dollar and work must be spent within the US, but of course, outside of that, you have opportunities to go in other markets. Eric, I feel like you mentioned this already a bit.
ERIC: Yeah. So Nanocan, part of the agreement I had with the professor at Harvard Medical School, who invented this, he said, “Look, I want to make sure you get this technology to poor people around the world, right, because it makes immunotherapy accessible and really affordable.”
And so I made a commitment to him to do that, and I've taken it seriously. I've actually spent a month in Africa early last year meeting with various stakeholders from the regulatory authorities to universities that could be potential partners to extend our US based clinical trial, which we hope to start this year, and thankfully to NIH grant funding is very critical to that.
Our STTR funding is very critical to launching our phase one study in prostate cancer later this year. But with that said, I've spent again a fair amount of time in Africa and other countries in the Middle East, I'm talking to potential collaborators and there you just, again, your advisory board is helpful, your personal network, and then finding the right fit for your product in the market that you're approaching.
And I think you'll find openness, particularly in developing or low and moderate income countries, you'll find an openness to discuss. It takes some work and some effort and you probably, you know, I wouldn't get distracted with it. Meaning if your core focus is the US, do that. And so in our mind, our core focus is launching this in the US and then if the right opportunity opens, it presents itself, we'll extend the trial to a market in Africa and I think we have some opportunities to do that.
JOE: I can't speak directly to marketing overseas or expanding business overseas, but a few considerations that I am aware of are licensing technology from either governmental or academic institutions in the United States, there can often be some restrictions there in terms of manufacturing, as Billy mentioned, in terms of SBIR where those funds can be spent, so there are considerations there.
Additionally, just in the medical device space, there's significant changes in regulations around the world, especially in Europe and some of the other countries that are very quickly changing the way in vitro diagnostics and devices are considered by those regulatory bodies. So it's both an exciting and somewhat at an uncertain time in those areas. So be aware of some of those trends, book at some of those trends, and consider that in your overall business plan.
BILLY: So we have a couple of questions all related to funding, makes sense, it's a hot and important topic. One I think I can answer, it's about funding levels for stages of SBIR. For phase one, it's $400,000 and for phase two it's $2 million. Now, for the panelists there's a question on is there a strategy, is there a good timeline for applying to SBIRs looking at non diluted funding versus raising money through angels and venture firms? Do you do both in parallel? What's your experience and what's a good approach?
MARGARET: Maybe I'll chip in with this one, because, you know, I think you should all – the role of a CEO of a company is always to raise money, so you're doing everything in parallel. But I would strongly recommend, in setting up a small business, is to really go down the non dilutive funding route first. It's highly valuable for three reasons.
One, it's scientifically reviewed, so it gives you validity of the science, the work you're doing when you go out to an investor. So that speaks a lot, because many of the investors maybe don't have knowledge in the scientific area that you're working in. So that's a ticked box. Number two is it helps you create value in your company if you've received that grant, because you're moving your project along, hopefully to a value inflection point, which means you've created value in the company rather than just maybe an idea, which I think is good when you're going to speak with investors.
And then third, it doesn't take equity of your company as you're trying to develop that initial sort of proof of concept creating value in the company, early value, so really go down that route. And I personally started my -- applied for my SBIR and federal contract really with no real preliminary data, like a lot of what you require for a lot of like RO1 grants, if that's what you're used to, it was really going through with the idea. And that phase one was really to help you get that proof of concept, which –
So we really, I would say, go down the non diluted funding first, but in parallel, you always need to be bringing money into the company, so you do need to be speaking to angel investors and also see angel investors as well. I do want to put a plug in for my own learning experience, though is it's also important to understand the eligibility criteria of your company before going to speak to investors as well.
So if you have a single investor with over 50% of your company, you are no longer eligible as a company for SBIR grants. So make sure you use that in your negotiations with investors.
BILLY: Thanks Margaret. Others, I'm sure others have other situations or strategies, or is that pretty much aligned with your experience?
ERIC: I think Margaret hit the nail on the head. I mean it, the answer is D, all of the above, it's just D. First of all, it's very tough raising funds, right, for business. You gotta be -- you're going to hear a lot of no’s, you're going to have hear a lot more no’s than you will yes. And so you really have to -- the non dilutive approach is very important, as Margaret said, it's a great signaling and sort of validation point.
And then again, the lack of dilution, but you need to be out talking to every potential investment resource, whether it's angel networks or friends and family, private equity, venture capital, whoever you can talk, soft dollars from states and cities, sometimes there may be soft dollars available to help your innovation, that's also non dilutive funding. But you got to do all of the above.
JOE: To Eric’s point there, starting those relationships early, even if perhaps your technology is not ready or your business plan isn't ready, showing people where you're at and showing that progress, maybe if you do receive an SBIR and you're delivering towards that progress, that's something that you can you can take out and build that confidence, not just sort of the scientific validity, but say, “Hey, we're meeting our milestones as we go along through this process” and that builds that confidence and the credibility with those investors, who may not initially be interested but may come back around in the future, whether that's angel or venture capitalists.
BILLY: Thanks Joe. This question kind of relates to what we were just talking about, seeing as you progressed towards phase three. I'm not sure if that's, you know, clinical or SBIR phase, but I guess as you move down into later stage development is kind of funds that you raise, is that tethered to giving up equity? They mentioned here credit, I'm not entirely sure what that means, but maybe I guess they're asking options for raising funds and then giving a portion of the company versus giving you know dollars back. Eric, you mentioned soft dollars, someone can speak to that a bit.
ERIC: Yeah. I mean, you really have to be thoughtful as you build out your capital stack, right, and think about -- but as your -- Look, my goal was I want to take as little capital as possible and so having non dilutive capital is a good source of that, but I want to take as little capital as possible so I can hit a valuation inflection point, right?
And so for us, it's about launching our phase one trial, right? After you get phase one, and I'm talking in the clinic, now not clinical FDA, IND phase one clinical trials, that'll be a valuation inflection point. So we'll be able to go out and raise additional funds at a higher valuation, which generally means lower dilution, but you're going to –
You should just plan on taking dilution and the earlier you are, the more you're going to be diluted because you have less to really show. And by the way, you'll find in the biotech space, and this is actually a little source of frustration for me, there's kind of a set template. People want your company to be in it.
They want you to be between kind of $10 million and kind of $15 million. And they want to buy 15 to 20% of the company and almost doesn't -- I hate to say it -- it almost doesn't matter what your technology is or how, you know, that's just kind of the market, if you will, for early stage healthcare and biotech investing. They're going to look at evaluation, at that number. So if you have a $10 million valuation, somebody puts in $2 million, they're going to take 20% of your company.
And the question you should ask yourself is how far can this $2 million take me? Can this $2 million help me to drive the value of my company up to $40 million, $50 million, or more?
MARGARET: And I would just say that that first, for that early investment, that's probably the most expensive part of the investment in any company. So be very thoughtful. So try and get as much non dilutive first, if you can.
CRAIG: And there are non, you know, to Eric's point about kind of the template, there are also less traditional milestones that might be specific to your technology as well. And then this goes to, you know, reaching out to potential investors or potential partners kind of learning about, they're not necessarily the end user or customer, but they sort of are because they might be participating next round or in a partnership.
So figure out what their pain points are with your technology and then think, OK, with this grant or with this, you know, fund raised, can we address those pain points which will then allow us to either partner or, you know, raise the next round?
So I agree with Eric, there are these, you know, set, almost set templates, but then some sometimes there are these little -- there is some wiggle room depending on who you're talking to.
JOE: Beyond that, I think, as Eric mentioned there are sort of these templates. It's more important to find investors who are going to back you, who are going to be partners along the way, and the right fit for your company necessarily, compared to you know -- as Margaret mentioned, you know, it is expensive to get money early on.
So really important to find the people who are gonna work through it with you to understand the pivots that you're going to take to work with you on milestones and say, hey, you know, maybe, you know, maybe there isn't just one milestone for a company which is a regulatory milestone or a clinical milestone, but to build out a sort of a road map and work with you on that as you're thinking about your future funding strategy.
BILLY: Great, awesome discussion. So I see a bunch of SBIR related questions and if we have a chance, I'll answer those, but if not, when we wrap up, I'm going to share some slides with some program contact information and the best way to is just reach out to a program director myself or someone else on the team and we can answer that. I really want to spend the time mostly, you know, focusing on how to start a small business.
So now we have the question for understanding the need for commercial potential profitability, but how do you balance that if you want to develop an open source or open tools or accessibility for communities that are going to struggle with the price point for technology? I think some of you have some experience in this, so any advice there?
ERIC: Yeah, I mean, your investors -- ultimately look as a CEO of a for profit company your obligation is to give a return to your shareholders and investors, right? That's your number one, right, like obligation and focus. And it's important again to have values in the company, like all my investors know that I'd love to eradicate the words, “There's nothing we can do to cancer patients,” right, which I heard my doctors tell my dad when he got lung cancer right before he died. “There's nothing we can do.”
So, like, that's a focus, and they're like, that's great. Eric, we believe in that, but you got to be profitable, too. And if you're -- Actually, if you're profitable, you're probably eradicating those words. Right? So the profitability lines up with the values.
In terms of how you think about, there are certain legal things you need to be considered of in terms of, like there's certain programs you may involve that where you can't price your product differently, right, depending on -- or you have to give the lowest price point if you’re -- So you need to really be thoughtful about how you set up products in communities that may not have access, whether that's domestically or abroad, you need to be really thoughtful and see what limitations you might be putting on your main product.
But for me, it's about proving that our technology works, if it works, then it's going to be disruptive and it'll drive a lot of value to the company and it'll give us flexibility to do some of the things that are core to our vision of helping low and moderate income persons in those markets to access the technology.
BILLY: Thanks, Eric. So here's a good question. What advice and recommendations do you have for helping start a company as lean as possible? Craig, maybe you want to take a shot at this one, you mentioned [crosstalk] --
CRAIG: Yeah, just utilize any resources as much as possible. And I think I mentioned this in my little video is really don't be afraid to ask because if you don't ask, you'll never get, and that's what my dad has always, you know, told me. Yes, you will hear no’s, but then, hey, you're on to the next one and hopefully you'll learn from that no.
Yeah, you know, I don't want to necessarily say it because then, you know, luck will have it that I'll no longer benefit from this, but I usually play the mentee card. You know, I'm just still in my mind, a young kid coming from academia, right? Like, I have a lot to learn, so I always ask for help and people often times have just been so willing and gracious with their time and, you know, what they've learned over the years.
So, I mean, I've played into that and that's helped me a lot, I'm very grateful for it. Hopefully I can still so use that after saying it on this webinar. But yeah, I think the biggest thing is just you just need to be willing to put yourself out there and ask for help.
BILLY: Piggybacking off that, how helpful in your experience and others too, maybe Joe, has the university been in, you know, helping you make the next steps transitioning from academia to small business?
CRAIG: Depends who you talk to within the university. You know, some are more set in the academic way, some really want to see more of a, you know, tech transfer, right, like the Tech Transfer Office. Once again, you have to really put yourself out there and kind of ask for that help.
Unofficial mentors I think are really what helped me get to the even the point of SBIR award. Yeah, and once again, it was just utilizing the resources that were available and they're not always advertised. So that's really where asking comes in handy.
BILLY: Is it worthwhile tapping into, you know, say, like the business department, the business schools, and maybe entrepreneurial classes there? Have either of you found that helpful or anyone on the panel?
JOE: Yeah, absolutely. I think, you know, in terms of the business school, there are often entrepreneurial courses that you can take that can be short courses, they could be long form courses. There's no, there's no -- Nothing better than actually jumping in and doing it. But often universities have many different things that you can take advantage of: pitch competitions, meet ups, incubators, tech transfer offices, as Craig was talking about.
There's oftentimes an ecosystem around good universities because that's just what happens when you innovate. So as to Craig's point, they may not be well advertised, so getting out there and networking and learning about those resources is huge.
I'd also say don't forget the federal resources. You know, NCI beyond just the funding has a huge number of initiatives like plan, like the investor initiative, like I-Cores that you can rely on. The Small Business Association has many different courses. And then within large communities like Chicago there are accelerators or incubators that can be rather unique in the way they provide support.
The general approach tends to be taking some equity in the company, but there are different models out there for that type of support. So, you know, there's a lot of opportunities out there, there's a lot of options, there's a lot of resources, and you know part of it – The hardest part is oftentimes finding those.
BILLY: Great, thanks Joe.
MARGARET: I think one other thing, just to add, that one of the biggest sort of costs in a startup company is full-time employees. You know, we heard from George, like, sorry from Eric about, you know, not taking a salary, like having a full-time employee in your company requires having that salary and you have obligations to that individual or people in your company.
So as a startup company, I think be very -- to be capital efficient, be very thoughtful, do you really need to have a full-time employee for the activities that you require? Yes, you want the right talent at the right time, but that could be done through consultancy and done through, you know, CROs or various other groups that will charge per hour or through like a retainer, but that you're not really having to have the full obligation of a full-time employee and plus benefits etc, as you get the company up and going into a growth phase.
BILLY: Great. Thanks, Margaret. There's two questions here. I think they're getting at the same thing. It's kind of balancing SBIR funding versus investor funding and in this one specific example, investor funding happened first and I think that's OK, right? So maybe this looks like you've already established your proof of concept and now you can think about coming in with either a fast track or direct to phase two application and really driving commercialization of your technology forward.
You know, it's also a good thing, right, if you have buying power from investors that says that whatever technology you're trying to development, you've got some tracks and you've got some interest. That's the ultimate goal for this, for our program is for us to de-risk your technology, put you in a place where you can go out and raise external funds and really, you know, market your technology. So if you've already done some of this, you know, I don't think -- that's definitely not a deal killer at all.
MARGARET: I think if you're applying for, you know, non dilutive funding, if you had a potential investor maybe hasn't committed yet, it does help to have maybe a letter of support that, you know, if you were going forward for this non dilutive funding opportunity that you would down the line have a potential investor and I certainly -- I did that when I applied, I don’t think that hurts.
If you're going for non dilutive funding, investors love that because it's non diluted, it's non diluted to them too, so having the opportunity is a win-win for you as the founder and also for the investor. But I did stress, just be really careful, if you're taking an investor money to make -- and then applying for thinking about applying for SBIR, you do need to be eligible as a company to have -- make sure that you don't have a single investor with over 50% of the company.
BILLY: Yeah, great point. Thanks, Margaret.
JOE: And to add, there's the focus element that's incredibly important to, you know, one thing companies with technologies or technology platforms like to do is try to run after too many things, so making sure that that funding and what you're trying to do with it is aligned with that path to market, I think is something you should you should think critically about, especially in terms of SBIR contracts, you know, versus sort of the grant mechanisms where there may be more specificity in the former than the latter. Great opportunities, though.
BILLY: Joe, I think I have one for you, so since you're speaking, I'll go ahead and phrase it, for entities delivering IT technologies or leveraging them, do you recommend having software engineers in house or contracting or another approach for that?
JOE: Yeah, that's a great question. I think to Margaret's point earlier, you really need to think about the trade-offs between full-time employees, especially if maybe your runway is minimal. Where I draw the line there is in the distinction between, is this a skill set that is going to be necessary and critical for the regulatory approval process?
If you're developing med tech devices, that will be regulated, I think it's absolutely critical to build those skill sets in-house and have those skill sets in-house to be able to run the documentation play for regulatory clearance or approval. If you're thinking more of a digital health, or if you're thinking more ancillary product features outside of maybe a device function then think more about outsourcing.
All that said, initial prototype, I think it's very reasonable to try to outsource that. We did some of that very early on, use consultancies to sort of stand up our software architecture and then hire people to come in and sort of flesh it out. So I think all options are on the table, but think really, really hard about the decisions between the two.
BILLY: Thanks, Joe. This is piggybacking off of that and this is open for all panelists, and I think they mentioned collaborators, but I think we can distinguish collaborators versus maybe contractors CROs, CMOs. How important is developing face time, you know, with these collaborators or contractors and is there an estimate of how much face time in person versus virtual, now that we're in mostly a virtual setting? Any comments there?
It's a tough one. It's probably going to depend on, you know, specifically who the collaborator is, how much percentage of time they have in the project, or exactly what they're doing. But I think it makes sense to me and I'd like to hear from you all, if you need to have some of this one-on-one interaction, right? If you're leveraging a well established CRO or CMO, you know they have the ability to manufacture your therapeutic to perform, if we're talking therapeutics toxicology studies. But do you need to – How much do you need to keep on top of that to make sure things are operating in a correct manner?
ERIC: I would suggest you be very aggressive with that. So for us, so we have a CDMO that we work with and we have at a minimum a weekly meeting with them to review where they are with our product development and then over overseeing the CDMO, I hired a separate CMC expert, a guy who ran a division for Pfizer manufacturing.
I hired him separately just to be a consultant looking over their shoulder and we talk to him almost every day, right. And so we're very -- and so our engagement -- And physically he helped us to pick our CDMO, so he and I probably took five trips across the country to do like many FDA audits of CDMO sites or CMO sites. And so he's a trusted advisor that is very active with the company and is on multiple calls and emails with some of my full-time employees every week.
Now, for some of our CRO work. So we're doing, for example, our last IND enabling study in a large animal with our technology, that's a trusted CRO that even Johnson & Johnson, Merck uses, so I'm not looking over their shoulders, they've done a million. Of these type of studies, and so it's less interaction with the CRO for our last study.
But on the manufacturing, very, very hands on. But it will depend on where are you, what are you trying to accomplish, and you'll have to make the call on that. But for us, with this kind of innovative product that you know people are like, wow, will this thing work? We spend a lot of time on the actual manufacturing of it because it's only been made in an academic lab up at Dana Farber, transferring that to a GMP facility is a different, different ball game altogether.
BILLY: Yeah, great point, Craig, Eric, sorry. Craig, did you want to add something? Did I cut you off?
CRAIG: Oh no, I was just going to say thanks for the pat on the shoulder. No, I mean, we've been completely virtual this entire time and I think kind of to Eric's point is it depends on your technology as well and who you're using. You know, if they've created this, it's no problem to use them, right, have your check-ins, but really they are the experts in that.
And for us, when it comes to our collaborators, because whoever asked that question, you specifically asked about collaborators, once again, it depends where or who you're using. So for us, it's the lab that I came from. So, you know, my old thesis advisor, Doctor Barzaga [phonetic], probably doesn't want me in her lab anymore. Right? She's had enough of me.
But no, I mean we can plan experiments by text with the post-doc who's working on it. It's just a different age now that that we're working in. So I think it depends on technology, it depends on who's doing the work, and how comfortable you are with those people.
JOE: Something in the device space, when you're building something for a user, as we are, nothing beats on the ground observation. A user may tell you they have a desire or need for a particular feature, but they may not necessarily understand all the inefficiencies with their clinical workflow. There's nothing that beats being on the ground with them, observing how they work, and how that affects their day-to-day.
Not to say, not to trust them, but, you know, trust, trust, but verify. I think the other thing to that is there's something that you, you know, especially collaborators on the clinical side, that you aren't necessarily going to get from a purely virtual meeting. There's the relationship side of things that can be very, very beneficial to work out in person. So I think there is a lot of value to in person interaction.
BILLY: Thanks Joe. I have two questions. I really want to try to squeeze in here. So maybe Craig, if you can just answer this one and then I have a wrap up question. There was a comment that you licensed your tech from your university and then you filed new patents, maybe this is additional patents to extend your coverage, was this still related to the initial technology, once you set up your licensing agreement? Yeah, can you just comment on that kind of, how you license your technology from the university patents and any additional role the university played kind of there after that?
CRAIG: Yeah, it was unique, you know, or interesting, you know, to license back technology that you were the inventor on. But it was pretty straightforward for us with NYU. I have heard horror stories with some universities. So we were, you know -- It was a good experience for us. But then after that, we decided to file -- They were new patents to broaden protection that was out of the scope of the NYU license.
So we did that all on our own. We're basically taking what we learned from the patent process while at the university and then you know helping -- that helped us guide with our external counsel as Tezcat.
BILLY: OK, great. Now a wrap up question here and then I just have two quick slides to show after this is knowing all that you know now, if you can go back, what is one thing that you know now that you wish you knew when starting up your company that would make things maybe simpler or easier? There has to be items I'm sure.
MARGARET: I raised it a few times through this call is that really you want to make sure you leave the door open to be able to apply for a non dilutive funding. So you know, as you're in parallel trying to get investor funding, make sure that you are still going to be eligible for non dilutive funding because there are criteria that you need to be aware of. And the other is, I would say in addition to that, you need to be extremely organized.
We've talked a lot here about communication, it was the last question about going out to zeros or collaborators, but it's so important that the communication, it's two ways coming back, and when you're going to investors, they want to know what studies you've done, you don't want things sitting in your e-mail. You want to make sure that you are putting a little bit of extra money into getting those, you know, official study reports with your statistics and everything, getting them archived away, having electronic notebooks, so everything is being tracked real time and is it is accessible and well organized for an investor who wants to go into a potential data room. So I would just do a plug for there needs to be operational excellence as well.
BILLY: That's great. That actually ties into our last planned webinar series, “Implementing a Quality Management System.”
MARGARET: There you go.
BILLY: So if there's any interest in that, you can go on the planned web page and check some of our curated webinar topics and there's a lot of good info on that as well.
ERIC: And I would just say don't make assumptions. Please, please, please ask. I wish I would have asked more questions, particularly taking technology from an academic setting into a GMP, don't make assumptions. If they say, “Oh yeah, the technology does A, B, and C.” Even if you invented it, you need to get a perspective of somebody who has to commercialize that technology because they're gonna be a lot of gaps from an academic setting from a product inside of an academic setting to getting it FDA approved, and so don't make any assumptions, ask the questions.
BILLY: Thanks, Eric. Great advice. So I just wanted to spend some time, there was a lot of program questions that I just didn't have time to answer. These are questions that are easily answerable by myself and anyone else on the SBIR team. If you go on our web page, this is all of our PDs you can match your technology with, you know, specific technology expertise and set up a call, get some more information about the program, and the applicability of your technology.
Someone mentioned how will the audience be aware of future upcoming planned webinar topics? So there's a link on our plan web page that gets regularly updated with new information when new video content becomes available, so you can bookmark that. Also, we advertise LinkedIn, Twitter. Our e-mail blasts, our different sections within NIH, so chances are if you heard about this one, hopefully the same mechanism will happen for the next couple of sessions.
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BILLY: Thanks again to our panel of entrepreneurs for sharing their insights and inspiring stories. 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.
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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, email us at [email protected] 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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NCI SBIR-funded biotech innovators Joseph Peterson, CTO and Co-Founder of Nanocan Therapeutics, and Craig Ramirez, CEO and Co-Foudner of Tezcat Biosciences, share advice on the priority steps aspiring entrepreneurs should take when starting a small business.
TRANSCRIPT
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BILLY: Hello and welcome to Innovation lab, your go to resource for all things biotech startups brought to you by the National Cancer Institutes Small Business Innovation Research, SBIR Development Center.
Our podcast host interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting-edge cancer solutions from lab to market.
BILLY: I'm Billy Bozza, a program director at NCI SBIR and today's host.
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In the last episode, you heard from two SBIR-funded therapeutic companies about how they started their small business. Today, you will hear from a therapeutics company and a device company about their journey going from lab to market.
Up first, we have a medical device developer Symbiosis who will share their journey going from academia to business and the resources they utilize when kick starting that path. Here's Joseph Peterson, the co-founder and Chief Technology Officer of Symbiosis.
JOE: Hi, I'm Joe Peterson, co-founder and CTO of Symbiosis, a pre-market med tech company developing software medical devices for precision cancer care. We're working to bring a tool for breast cancer treatment planning to the clinic. We've completed two phase one SBIR contracts and are working on a phase two contract now. I'm honored that the program organizers invited me to speak to you about our journey and my learnings.
Why did you decide to start a small business? Well, Symbiosis was founded to change the way we understand and treat cancer. We have the belief that comprehensive mechanistic bottoms up technology that accounts for biology, chemistry, and physics of cancer, paired with top down AI approaches, will be necessary to revolutionize cancer care.
It was this belief that spurred us to work to translate research from the lab out into the world. We aim to revolutionize cancer treatment by one, providing physicians with personalized navigation tools to better understand their patients and their cancers. Two, help patients make more informed decisions about the risks and benefits of treatments, ultimately to allow them to find the right balance of toxicity and likelihood of successive treatment. And three, to aid in the development of new life changing drugs so that patients live better, longer lives.
Most importantly for us, it was about improving patient outcomes and ultimately to help more patients experience and cure. How did you manage the transition from academia to small business and what would be your advice to those thinking about a similar change?
The transition is a continual learning process, personally, professionally, and as a company. I love this quote from Steve Blank, who is one of the creators of the Lean Startup Process. He says, “The startup is an organization formed to search for repeatable and scalable business model.” What this means practically to a scientist like me is that you're constantly generating hypotheses and testing them with data: market data, customer data, scientific data, and technical data. And ultimately making some bets along the way about what could be a product and who your customer would be.
My advice to those thinking about a similar transition would be first to prepare to wear many hats and finding others who are similarly willing. The startup process is long, requires adaptation, and your company will be understaffed for a very long time. Second, to spend time identifying your strengths and weaknesses, identifying gaps and either self-educating or finding others to complement you is so important to your success.
Third, as a technical person, you may be inherently uncomfortable with networking. Spend the time doing it. When you find people you respect, ask them to be mentors or ask help. It's critical at your early stage in this process. And fourth and most importantly, talk to the customers and potential customers early and often. You may be building the coolest widget in the world, but if it doesn't fit a customer need, you won't have a business.
What are some helpful resources? Non-dilutive funding is a must. Pitch competitions are perhaps the best way to obtain non-dilutive funding. This might be a traditional pitch competition in a startup friendly ecosystem or a less traditional competition forum such as a startup weekend or a hackathon.
Grants and contracts, whether SBIR or other grant programs are great opportunities to prove out of technology prior to development and all the major federal agencies provide these, whether it be NIH, DOE, FDA, or the Department of Defense. Be cautious of the grant versus contract distinction early in the value proposition discovery phase however, as a contract will be attached to a relatively rigid set of milestones, while a grant may allow for more flexibility and the ability to pivot.
Translational research grants, such as those offered by NIH, are excellent options as well, and are generally open to both nonprofit and for profit institutions, however they come with some restrictions. They require a strong track record of research success. Requirements are high, but they can be overcome with great academic or clinical partners. And best of all, early customers could be a pharmaceutical company or a hospital that might pay for your services or other early stage companies.
There's no better way to validate your idea than to show that someone is willing to pay for it. In terms of entrepreneurial training, most large universities have some form of entrepreneurship course. As a tech focused academic, you might not be familiar with the courses offered by your business and engineering schools, but they almost certainly exist.
Most campuses these days also have startup communities that host networking events which are great opportunities to meet like-minded folks and share knowledge. Perhaps the best programs that I've seen are the innovation I-Cores, which is an immersive seven week experiential training program for scientists and engineers in the university focused on customer discovery.
These are also offered by most of the federal agencies and this program was a game changer for how Symbiosis thought about our own product. Finally, there are incubators and accelerators. Many large research institutions, research parks host startup incubators where free or cheap office space and entrepreneurial mentorship can be obtained.
There are also many independent and large tech sponsored technology accelerators. Some examples of the former in the biotech space are Alchemists in the San Francisco QB3 out of the University of California system, Start X out of Stanford, Alpha Labs out of Pittsburgh, or Matter in Chicago. Examples of large tech sponsored biotech accelerators include Johnson and Johnson's J Labs, Illumina Accelerator, and GE Healthcare's Edison Accelerator.
Are there any technology specific considerations when starting a med tech small business? When considering technology that will ultimately impact a patient, a risk-benefit framework is helpful, in fact, it is prescribed by regulatory agencies like the FDA. Similarly, when thinking about your company, there are risks and benefits besides financial benefits which benefits you value will have to be part of your company mission and vision.
The risks, on the other hand, are more predictable. One of our investors laid out their four part model for how they assess risks in potential biotech, health tech, and med tech investments. First, there is scientific risk, is the science sound? Often we can be tricked by confirmation bias or confounding factors. Second, there's technical risk. Can we actually build a technology based on the science? Scaling up what works in the academic lab is often harder than you might expect.
Third, there's regulatory risk. What is the potential impact of your technology compared with the potential harm of malfunction or misuse? Are these aligned and will the regulatory agency come to agreement in a reasonable amount of time to bring your product to market?
Fourth, there's market risk, is the customer actually willing to pay? Scientific processes should be applied to market research, but as with all human decision making, small and fickle preferences are uncertainties. Not to mention that if you land in the space that is worthwhile, there will be competition. Coming up with strategies to mitigate these risks will be an essential part of your journey as a med tech small business.
Finally, what are some of the key challenges you faced and how did you overcome them? Clinical partnerships are difficult to form without prior relationships in either academic or clinical research. Clinical data is king for health, med, and biotech companies, and is absolutely critical both for the pre-market feasibility and the marketing studies that you'll be doing.
Forming those clinical partnerships are more important, though, for the KOLs, who help define your product value proposition and who will ultimately evangelize your technology as they are early adopters. Forming these relationships early on was a huge hurdle. Getting data into the company was a huge hurdle early on, but you have to have persistence and you have to be deliberate in who you go after and how you approach them and bring them on board.
Ultimately, clinical collaborations are things that should last the lifetime of your solution. Where there's initial excitement and then you're burning a huge amount of money for a very long time until you develop that scalable revenue. This includes hurdles along the way, such as regulatory uncertainties, left hand, right hand turns, bumps and clinical and feasibility experiences, and ultimately in adoption.
As with any disruptive technology, the adoption will take some time. There need to be those true believers early on who will jump on board and frankly, we've had some success in this by bringing excellent people and talking to people who are leaders in the field willing to adopt new technologies. But ultimately, the place everybody wants to go and we haven't gotten to yet is reimbursement.
And it will take a huge amount of clinical data, clinical evidence and lots of use to support, but ultimately that's the Holy Grail, that's what's going to make your technology scalable.
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BILLY: Our second speaker is Craig Ramirez, co-founder and CEO of an NCI SBIR funded biopharmaceutical company, Tezcat Biosciences.
CRAIG: Thank you, NCI and the planned Webinar series for asking me to be part of this program today. So when I started on my journey, I truly felt lost and I'm glad there are programs that are helping facilitate this transition from academia to startups.
So my name is Craig Ramirez and I'm a scientific founder and CEO of Tezcat Biosciences. We are a preclinical stage company developing RAS Cancer Therapeutics platform out of NYU and we have been fortunate enough to be the recipient of two STTR awards through the NCI, and I've been asked to provide my take on the first steps for starting a small business out of academia.
Why did I decide to start a small business? Well, I felt like I was in the right place at the right time. I was trained by a world expert in RAS cancers during my PhD. And during this time I discovered a way to harness my observations for potential therapeutic gain. And my thinking was that if this idea is to be pushed forward and given a chance, I will need to spearhead the company as a subject matter expert.
And as I began to think about how this would be done, I grew to appreciate aspects of industry that were not part of my day-to-day in academia. So with my scientific co-founder, Dr. Andy Hauser, we founded Tezcat Biosciences. The transition we took has been gradual. We looked at where we were in the development of our technology and where we needed to take it.
And to reduce personal risk in an already very risky industry, we maintained our positions at NYU while we built out the company. So we started to build a foundation through networking, exploring business models, and really going down rabbit holes of where our technology could potentially be applicable. And when we decided we were ready to explore the next step, we found a university mentor to begin the process of applying for an STTR.
And once we finally received our first award, after many submissions, I took on a full time position at Tezcat. And for those of you contemplating the same transition, three pieces of advice as you start off.
One, be your worst critic about the opportunity your technology addresses and why it should be developed. Number two, set milestones that will fill those gaps or address those concerns you've identified. And three, make sure you really believe in your technology and have the personal ability to execute on your plans.
The first step we took to protect our IP was to disclose what we were working on to NYU's Tech Transfer Office and with their advice, we worked on further developing our data package to support claims that we want to make in our provisional patent application in the future. And importantly, as I say we, I mean the inventors of the technology as university employees.
And once these applications were filed with the USPTO, Tezcat negotiated and executed a license agreement with NYU for exclusive worldwide rights to the technology. And we were fortunate to have help from a law firm for negotiations, but I would be happy to discuss other resources that may be available.
And as Tezcat, we have continued to pursue additional patent applications to broaden the protection of our technology and approach. So two challenges that we have faced include building a robust development plan and understanding key experiments or milestones. So for the development plan, we're not necessarily taught about toxicology, manufacturing, regulatory, or clinical trial design during our academic training, you know, depending on what track you're on.
But thanks to our time in the Texas Medical Center Accelerator for Cancer Therapeutics, we have developed a development plan that will help us get to the next stages. The second obstacle was understanding the most value building experiments in the eyes of potential stakeholders. And so once again, coming from the academic training, we know how to carry out experiments in our field, however, those key experiments that we need to prioritize or address were not always obvious to us.
So thankfully, you know, we listened. We had to, you know, be humble and listen to others. And we always asked potential investors, pharma partners, or other stakeholders what data they wanted to see in order to feel more comfortable with our approach, and this has greatly helped with setting our development milestones, our story, and utilization of funds, which in the early stages can be limited.
And I'll just briefly highlight some resources that I have found helpful over the years, but I welcome any other suggestions or questions. So these resources include city networking events, which can be found through university groups or city and state life science resources. University classes and events have also been a useful place to meet other like-minded people and, you know, really explore ideas and resources that they have been utilizing.
And some universities even have venture groups which can be useful when testing your vision for the startup. Make sure to keep up to date with what is happening in industry through blogs, articles, or newsletters like Fierce Pharma or Fierce Biotech. Also cities, states, and even VCs have incubator or accelerator programs with various offerings.
We participated in Entrepreneurship Lab NYC very early on and then more recently we finished our time at the Texas Medical Center Accelerator for Cancer Therapeutics program. And I would say in terms of resources, just don't be afraid to ask for help. This may not be something you are used to from the academic culture sometimes, but if you don't ask, you will not receive. So I look forward to participating in the future panel discussion and really answering any questions you may have. So thank you.
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BILLY: 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.
[music]
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, email us at [email protected] 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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NCI-funded biotech innovators Eric Broyles, CEO and Founder of Nanocan Therapeutics, and Margaret Jackson, CEO and Foudner of BYOMass, share advice on the priority steps aspiring entrepreneurs should take when starting a small business.j
TRANSCRIPT
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BILLY: Hello and welcome to Innovation lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute Small Business Innovation Research, or SBIR Development Center.
BILLY: Our podcast host 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.
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In this episode, you will hear from two therapeutic companies funded by the NCI SBIR program about starting a business and how they kick started their journey going from lab to market. The first company, Nanocan will share their vision, licensing journey, and the various considerations that went into forming their cancer therapeutic startup.
Then we will hear from Biomass and how this company went about building a business team, established a corporate structure, and found resources for managing their business. Now, without any further ado, here's Eric Broyles, founder and CEO of Nanocan.
ERIC: Hello, my name is Eric Broyles, and I am the founder and CEO of Nanocan Therapeutics Corporation, which is a company that Harvard's Dana Farber Cancer Institute has spun out a patented technology that we believe will be revolutionary in cancer care.
Our company is at the preclinical stage, which means we have not done in human clinical trials yet, that is our next phase that we're going to move into over the next 6 to 9 months. We will use a proprietary nanoparticle drone delivery mechanism that actually can intratumorally deliver immunotherapy for certain solid cancers, cancer tumors. And then we have a formulation that works on brain and lung, that is a liquid formulation of this technology.
So I want to talk about why I started a company to undertake this endeavor. And one of the most important things to me is vision. What is the vision that you have? And I met a professor at Harvard Medical School who had invented this technology and just hearing his thoughts about how he developed the technology, what his hopes were for the technologies placed in the marketplace, really inspired me, and I was inspired by again his creativity, his genius, really with making this invention.
And so I really formulated my own vision for how I wanted to take -- where I wanted to take this product. And I was encouraged and inspired that that I would have an opportunity to lead and develop a commercialization of a technology that can save lives.
As an entrepreneur, you have the ability to be creative. You have the ability to make a positive impact on society, and you also have the ability to achieve financial rewards. I want to talk about the steps we took to secure the IP rights to the invention.
Initially I had to meet with Harvard University to share my vision and market approach for their intellectual property. And I'm trained as an attorney and so I understand intellectual property, but it's also very important in that step, after you share your vision and get buy in from them, you should engage good IP counsel, intellectual property counsel.
Following that, you will eventually get a term sheet for your technology, again, this assumes you have not invented the technology yourself. You'll get a term sheet. We got a term sheet and then you will get a draft license agreement. It's important for your license agreement, certain key terms, what's the scope of the license? What's the term? How long will you have the right? Is it exclusive or not? What's the geographical limitations? How much do you have to pay in royalties and are there other payments that you need? And then what are the milestones you have to achieve to maintain your rights to the IP?
Those are all key questions. Again, good IP counsel will be able to -- will know these things and be able to guide you through those topics. What are the right types of corporate structure that you should consider? Well, they're your usual suspects in which are going to be C corporations, limited liability corps, S corps. These all have their pros and cons. Most institutional investors of venture Capital fund or private equity fund, they're used to seeing a C corporation structure.
There's some investors that may want to see an LLC structure, an LLC provide you certain tax benefits. You could write off your losses, particularly during your pre-revenue stage, and you're just spending money. And then there's an S-Corp structure, you should seek good accounting advice and good legal advice to help you figure out which of these structures works best for your company.
And then you should also talk to other entrepreneurs about why they chose the structure that they did. It may depend on the industry, your timing of getting in and out of the business. Those are all important considerations that the right guidance will help you to figure out.
And then thinking about financial tools and funding sources, I would encourage you actually to be open to all types of funding source. Non-dilutive grant funding that like NIH provides or NCI is very important, it's a very good source of funding, but you should be aware that it does take a lot of time to prepare the applications. There may be a gap between when you submit the application and when you get notice of award funding. And it requires that you really pay attention to details and follow very specific instructions, and have very thoughtful responses because it's a competitive process, but it's definitely worthwhile, and I'd encourage you to consider it.
And then obviously there's raising private capital and the private capital, it could be venture capital, it could be a family office. Check your university and see if there's an angel network or check your local community to see if there's an angel investing group. There's several of these groups across the country that may be a good fit and you have what you call friends and family and you'll have to figure out which of these sources of capital works best for you.
And then there'll be key terms, again, you should get good legal counsel, they'll help you sort of work you through these issues. But you should also, again the importance of your vision is critical because you're going to get a lot of no’s and it can be discouraging to you at times, but keeping that vision in the why you decided to be an entrepreneur in front of you will help you to sort of work through those no’s and the challenges that you might encounter and will encounter.
How have I put my team together for Nanocan? So for me as the founder, the sort of two important considerations were number one, what am I doing? And then number two, who am I doing it with? I wanted to have a really a cohesive team and really pick people that I enjoyed working with. It doesn't mean we all have to be alike, in fact, you shouldn't all be alike, you need to be able to challenge each other.
But you should really share, have alignment on vision, which I think is important and share certain common values, particularly having visions about where the company is going and I was fortunate to be able to build a team that shares my vision and has -- And then look at the expertise that they bring in figuring out the gaps in your own expertise.
You should have a law firm prepare your employment agreements or consulting agreements. You'll have to figure out how you're going to compensate your team. If you have some seed funding, you may be able to pay them, but typically early stage companies, it's heavy on incentives and really light on cash compensation.
And then you also want to assemble a board of advisors who can help, you know, open doors, they have expertise, they have their networks, and that can just give you good guidance and direction, which would be very important. I have Dr. Nguyen who's actually a professor at Harvard and also, a researcher at Dana Farber and he's part-time with us but adds great value for our business.
We have another colleague who runs our clinical trial, we have another person on our team who's good at international projects, and that's important, that’s an important part of our vision, expanding our technology internationally. And then you need good financial advice and we actually have an in-house CFO with extensive experience, starting his career at Merrill Lynch and working on a number of high finance projects.
And then our advisory board, it actually includes the inventor, it includes oncologists from the top institutions in our country that were excited about our technology, and they make themselves available and you should really be respectful of their time, but really also leverage their expertise in the network. It can be very important and save you a lot of time and headache being a good steward of your relationship with your board of advisors.
So what were some of the key challenges we faced and how we overcame them? In any drug development project you're going to hit snags, so be prepared for that. Make sure you have access to the right expertise, which is why it's very important for you to have a good team and a good board of advisors. Our company had challenges securing a human grade immunotherapy for our inhuman trials, but through our network we were able to overcome that challenge.
We also had challenges finding the right CDMO partner and again leveraging our board of advisors, our team, we were able to find the right partner. I'd also encourage you to consider attending conferences like CPHI which has a broad range of players in the pharma and biotech industry who can be helpful to companies.
I thank you for your time. I wish you the best as you bring your technology to market and really appreciate this opportunity to share with you.
BILLY: What a great journey. Up next we have Margaret Jackson, founder and CEO of Biomass.
MARGARET: Welcome to NCI SBIR Peer Learning and Networking, first steps for starting small business. I am Dr. Margaret Jackson, founder and CEO of Biomass. We are a preclinical stage precision medicine company, focused on developing novel therapeutics for cancer anorexia-cachexia.
Biomass, as an early startup, was able to accelerate based on receiving both SBIR and federal contract phase one funding. So why did I decide to start a small business? I decided to start Biomass for three key reasons. First, passion, I'm incredibly passionate about finding a cure for cancer induced anorexia-cachexia.
I know the patient. My father passed away over 30 years ago with his debilitating disease, and yet fast forward 30 years, there is still no approved treatment. We can do so much more and we need to do it so much better. Second, expertise, I have over 20 years of drug discovery and drug development expertise in developing novel therapeutics and taking programs from early concept right through to early stage clinical trials. It's a wonderful thing when you can combine your passion and your career together to develop something truly important for patients.
And thirdly, culture. To develop a novel therapeutic, you can do it at large pharma or as a startup, both the pros and cons. At large pharma, there's fabulous resources, fabulous talent, but there's hierarchy, bureaucracy, slow decision-making. In a startup, you have a flatter structure, meaning being able to be more nimble, enable rapid decision making, build closer-knit teams, and faster execution of your programs.
At Biomass, we have developed our own culture. Scientific excellence, innovation, and people are at the core of our culture. We have a very high bar as we are developing drugs to survive and develop that first cure for cancer induced anorexia-cachexia. There is clear accountability to get things done with high integrity.
So guidance to anyone considering a startup. I would suggest don't be afraid to fail. Be afraid to not try. So how did we assemble our business team and what were some of the important considerations? As an early startup, it's really important to have the right people with the right talent at the right time to do the right job that helps you grow your business.
But as an early startup company, quite often you're cash constrained, often referred to as bootstrapping. And it's really important for you to consider how best to deploy your capital. Quite often for the business team, you do not need them in full time in the organization, but they are required at specific times for specific functions.
So the first question to ask is, do you need individuals as a full-time employee within the organization or can you use resources externally that can be more capital efficient? An example would be there isn't a need for chief finance officer for an early stage company, but it's essential to have an accountant, because you as a full-time employee can bring money into the organization, can receive the invoices, but you do need somebody externally who's able to pay those bills.
In addition, you need someone who's going to be able to do your monthly accounts and also your annual taxes, but that could be done as a monthly retainer or can be done at an hourly rate. Likewise, it's important to have business development expertise, but not required full-time. It's essential for thinking about in licensing or out licensing at certain periods of time, and also for setting up your templates for consultancy agreements, confidentiality agreements, and master service agreements.
Again, not required full time. IP is king for a company and therefore it's really essential to have an IP attorney which can be external to actually support your IP strategy, at times when needed. And finally, it's essential to have outside counsel. You don't need to have a chief legal officer internally in your organization, but you certainly do need an experienced life science outside counsel who can actually help you demystify term sheets from investors or any other additional contracts that may come from any other organization.
So the guidance at this stage of an early stage company when forming a business team is to consider resources outside your organization to support the organization, which can be done at a monthly rate or at an hourly rate.
What are the considerations for determining the right type of entity for starting your new company? There are essentially seven classes of business structures, and it can be overwhelming, but essentially the business structure you choose influences everything from day-to-day operations to taxes and how much of your personal assets are at risk.
In life sciences, limited liability companies, LLCS or corporations, C-Corp are the most common. LLCs can be a good choice for medium to high risk businesses, owners with significant personal assets they want to be protected, and owners who want to pay a lower tax rate than they would with a corporation.
Corporations offer the strongest protection to the owners from personal liability, but the cost to form a corporation is higher. Corporations also pay income tax on their profits and again when dividends are paid to shareholders on their personal tax returns. Corporations have a completely independent life separate from its shareholders, and if a shareholder leaves a company or sells his or her shares, the C-Corp can continue doing business relatively unstirred.
Corporations have an advantage when it comes to raising capital because they can raise funds through the sale of stock, which can also be a benefit and attract employees. Corporations can be a good choice for medium to high risk businesses, those who need to raise money, and businesses that plan to go public or eventually be sold. So guidance, really speak to outside counsel about what works best for your business vision.
Are there any technology specific considerations when starting a therapeutic small business? Yes, we live in a virtual world where technology is critical for communication, documentation, and archiving. It really is important to make sure that operations are in place. So for accounting, an example would be QuickBooks, which is great to be able to provide purchase orders to vendors for drug discovery, drug development work, helps you track your invoices against statements of work, helps you track expenses.
You're able to do a payroll and also provides reports such as your balance sheet and profit and loss. Payments can be also done both nationally and internationally using Bill.com. It is really important when working with external vendors or consultants or even with employees internally, that DISA and reporting is archived and easily accessible. Examples of being able to archive and share would be using Box or SharePoint.
In addition, it's important to have a dear room that's available for diligence with external investors. Examples would include dearrooms.com and also SharePoint. This means that you're able to give restricted access to individuals to confidential information that is clearly marked as confidential.
For data managed for high throughput screening data, regular screening data, biological data, chemical structures, antibodies, sequences, et cetera, it is important it's all in one central repository. And an example where this can be easily accessed, visualized, and interrogated is using software like CDD, Collaborative Drug Discovery, which also has the benefit of having access to an electronic lab notebook where your study protocols can also be uploaded.
And finally, as you're working with investors and trying to keep on top of the CAP table, it is important to make sure that you're able to access that and make sure there are no mistakes and a great software is Carta.
So the guidance for any startup company is to make sure that you have the proper operations software in place, do not store confidential important information fragmented and in people's inboxes. They need to be correctly archived and accessible and be able to visualize.
So what kind of financial tools and resources would I recommend to an early life science company? I cannot stress enough how important it is to go after non-dilutive funding. It is important for three reasons. One, it means that your research has been peer reviewed, it's scientifically validated, which is really important when talking to external investors.
Number two, it means you receive money, you get your company off the ground, you advance your research, and you create value in your company. And third, mid range you get money and not at the expense of taking equity of your company. There are multiple types of non-dilutive funding. There are the Small Business Innovation Research Awards, the National Science Foundation, Department of Defense, federal contracts, Bill and Melinda Gate Foundations, in addition to multiple grant opportunities that may be present on websites, all of areas that you're investing in.
There are multiple resources to help you apply for these grants, if this is your first time. There are books that are available online from Amazon which actually walk you through step-by-step how to apply and submit these grants. But most important to be aware of is you need to give yourself about eight weeks prior to submitting any grants to ensure that you actually have risk completed all your registrations.
You need an employer identification number. A Small Business Association registration, registration with ERA comments, SAM.gov, Grants.gov. And there are companies out there who have actually experienced writing grants and are now consultants to help the next generation apply for grants such as EGC and Free Mind.
The other opportunity to receive money is through dilute of funding. This is where you receive money from angel investors or from venture capitalists for seed funding or Series A investment. That'll be the first time you experience a term sheet which can be overwhelming, and there's a great resource called Venture Deals by Feld and Mendelson that you can purchase online, which actually take you through step by step the pros and the cons, all of each of the descriptions on the term sheet, of the economic terms, the controlling terms, the permissions, and the restrictions.
In addition, there are local networks to help you demystify term sheets. An example in Boston is the Capital Network. They also help you understand a cap table. There is also multiple incubators or accelerators that you could join that actually help you to understand how to get your first investment and how to meet investors. An example for women founders is Springboard Enterprises supporting life sciences and digital health.
And also really important to build your network of other CEOs or C-Suite executives who have lived and breathed this. So the guidance for applying for funding and the resources at your fingertips is to really build your network of individuals who have had the experience of doing this and have been successful in achieving funding.
What do I know now that I wish I had known first when setting up a small business? Well, setting up a startup company for the first time is a very steep learning curve, but a very rewarding experience. It is important to surround yourself with really great people, great talent that will help you as an individual grow, but also help the company grow.
It's very exciting to get your first non-dilutive funding and it's very exciting to get your first investor, but you should be very mindful of how the deals or the term sheets of an investor equity financing actually affects your eligibility to apply for an SBIR grant.
So if you have a single investor with over 50% of the company, you as a company are no longer eligible to apply for an SBIR grant until you have further investors who come to the table. So it's very important as part of the investor negotiations to ensure that you are still eligible to apply for non-diluted SBIR funding.
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BILLY: There you have it. Special thanks to Nanocan and Biomass 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 Bozza from NCIS 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, email us at [email protected] 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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RefleXion Co-Founder and Chief Technology Officer Samuel Mazin, PhD, shares his journey from postdoc to startup and the NCI SBIR support that helped develop a biology-guided radiotherapy that provides treatment for metastatic cancer patients with limited options.
TRANSCRIPT
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MICHAEL: Hello and welcome to Innovation Lab, your go to resource for all things biotech startups, brought 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. For more, check out our website at sbir.cancer.gov. I'm Michael Weingarten, the Director of NCIS SBIR and today's host.
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In this episode, you will hear from a medical imaging company, funded by the NCI SBIR program, about the journey from post-doc to biotech startup. RefleXion Medical Founder and Chief Technology Officer Sam Mason will share how the company leveraged SBIR support on their way to receiving FDA clearance for their technology that revolutionizes radiotherapy for tackling metastatic disease.
Now, without any further ado, here's Sam Mason, Founder and Chief Technology Officer of RefleXion Medical.
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MICHAEL: I thought maybe a first good question would be if you can kind of tell us how you started your journey as an entrepreneur.
SAM: Well, I was trained in computer engineering at the University of Waterloo in Canada, that's where I did my undergraduate, and then came to Stanford for graduate work in a field called medical imaging, so that's where I fell in love with medical imaging, by just taking a class and understanding how just with, you know, basic energy systems, we can see inside the body without touching the body, so I was just fascinated by that.
It was during a post-doc in the same program that I had this idea for RefleXion. I was pursuing an academic path, but I was struck by this idea because it was it was a natural marriage of the field I was in with a field that I was just recently exposed to, and that was radiation therapy. And so that's what kind of set me off on this entrepreneurial journey.
I was not planning to be an entrepreneur, but it was an idea that I guess wouldn't let go of me and so I just had to keep pursuing it and eventually I co-founded the company with a high school buddy of mine, Akchi Nanduri [phonetic], you know him as well of course, and the rest is history.
MICHAEL: I think it would be really interesting for the audience just to learn a little bit more about the technology that you're developing now and kind of maybe a little bit more about the original idea and how you guys developed it.
SAM: This is a technology that is really meant to tackle, for the first time, stage 4 cancer with a machine. The idea germinated while I was a post-doc and I knew a lot about how medical imaging worked, how CT scans, MRI scans, PET scans worked, and particularly PET, which involves the administration of a radiopharmaceutical in the body that literally has cancer light up, so that a PET scanner can kind of see where cancer is, it's one of the best ways of actually visualizing cancer in the body.
You know, to my knowledge that had not been used at all in conjunction with radiation therapy, which is using high energy X-rays to treat cancer, at least at the time of treatment. So I thought, you know, wouldn't it be great if the machine that's being used to treat the cancer could also see it and not only see it, but see it live in real time?
So my idea was actually a way to circumvent the slow PET imaging process and instead of using a PET image, which is what how naturally people would think of a PET scan, the innovation was to use the actual emissions, the stream of signals that are literally coming out of cancer cells to the PET scanner, use those same signals, but integrate a radiation therapy machine around it that will detect those signals in real time, and then shoot back or reflect the radiation back where it's coming from, hence the name of the company.
And so that was the germ of the idea that my co-founder and I started to really pursue in earnest. You know, we didn't realize how long of a pursuit that would be and how arduous, but -- and we're still on that journey, of course, as a company, but that's how it got started.
MICHAEL: The RefleXion technology, how is it an improvement over the current state-of-the-art in terms of what it will offer for patients going forward?
SAM: RefleXion, because it uses this pad signal or what we essentially call it a biological signal to direct the radiotherapy beam, it's the first time you have this real time direct targeting mechanism that's being mediated through a radiopharmaceutical, through an actual molecule that is taken up by the cancer itself.
So the reason why that's important and significant is because current radiation therapy technologies are all based on some form of anatomic imaging, as opposed to real time biological targeting, and so that really limits their ability for a variety of reasons to treat more than just one or two tumors in the body.
And if you really want to tackle stage 4 or metastatic cancer, where patients unfortunately have more than just one or two tumors in their body, they can have 5, 6, 7, 10, sometimes more, you need a technology that is going to be able to achieve that and so that's exactly what we call biology guided radiotherapy, which we've now dubbed as Syntex [phonetic] therapy, to be able to really add an option for the stage 4 or metastatic patient beyond the current standard of care.
And in addition to that current standard of care, which is predominantly drug therapy, and really do better in that field and in that that type of patient, you know, as we all appreciate you know when someone is diagnosed with cancer, one of the first questions you might ask that loved one or friend is, you know, did you catch it early or what stage is it?
And because stage is such an indicator of not only how advanced the disease is, of course, but the types of treatments that are even available and how effective they might be, and the later the stage, the narrower the suite of treatments that are available for that patient.
So that by stage 4, typically it's only drug therapies that are available, although there are many exciting drug therapies, a lot of innovation has happened on that front, if you look at outcomes data, it's still very poor compared to the efficacy that you see in earlier stage disease where local therapy like surgery or radiation are the predominant modes of care.
So what we're trying to do is add a new option and bring radiation, external beam radiation as a modality in the stage 4 setting alongside the drug therapy to try to really give the patient the best chance at beating back their cancer.
MICHAEL: This technology will actually enable the first time that you'll be able to effectively use radiation therapy for phase 4 cancer patients in an effective way, is that correct?
SAM: That's correct. I mean, there is, you know, a real push in the clinical community to use radiation in the stage 4 setting now, in metastatic patients now. However, it's really limited to what's called the LIGO metastatic disease, so these are patients with just a few, maybe one or two tumors. And it's really difficult for these technologies to scale, to treat more than just a few tumors in the body.
So this really does open up the door to more broadly treat metastatic disease in scale to larger patient populations. And we think, we believe, you know, anywhere around any clinic around the world because, you know, one of our goals is to really be able to improve the efficacy of treatments for stage 4 cancer and you can only do that if you are in the Community setting, not just in the academic center setting, and so you know, we've also designed this machine to be in the community clinic as well.
MICHAEL: Maybe you can talk a little bit more also about the role that SBIR played in helping you develop the technology and also in growing the company as a whole.
SAM: Of course, the NCI SBIR program has been such an important part of RefleXion’s development, especially on the earlier side when it was really hard to convince investors to put money in the company. So Akshay [phonetic] and I, we were knocking on the doors of the venture capitalists on Sand Hill Road saying, “Hey, you know, we need $10 million bucks to build a machine that we won't know it'll work until we build it.”
And you can imagine the type of reception we received right off the bat. And so, you know, we had to really look for ways to find capital, but also find validation for this technology. The NCI SBIR program was one obvious way to help solve two of those two issues. You know, a start up, I think many entrepreneurs will say, initially is really about runway. You know, how much time do you have to get to that next milestone? And time is money.
It's capital that you need to survive, to keep going, not just keep the lights on, but keep moving forward and developing your technology. So our first interactions with the NCI SBIR were through contacting a program director there at the time his name is David Balin [phonetic] and we, you know, pitched to him just like we're pitching to an investor, right?
We tried to basically convince David that this is a groundbreaking technology, because one of the challenges with any type of grant mechanism is you still have to go through a process where you have to show some preliminary data to show that your technology will work, right? You're gonna get scored through a scientific review process. And it's a bit of a chicken and egg problem because we didn't have this machine to generate the preliminary data. We needed money to build the machine.
So what was great though, is that, you know, as David came to understand, you know, part of this chicken and egg we were in, you know, it was important guidance we received from him on how to go through the process and be successful in being able to get those first grants from the NCI.
But those were our first interactions back, I think in around 2010 or so, when we received our first phase 1 grant, which was important, again, not just for the capital part, which again helps with the runway, but validation, you know, investors look at it as well, look, this did go through a rigorous scientific review process. This also went through a process that the NCI SBIR has in terms of getting other entrepreneurs to review these applications.
And so there's both a commercial and a scientific basis for passing that gate and so, you know, that's certainly recognized by the investment community. So I think there are a multitude of factors that, you know, why we wanted to try to get SBIR money, you know, as soon as we could.
Predominantly, those funds and those projects were aimed at mitigating the technical risk of the project and that was really the biggest risk. You know, we had to build a machine. In the radiation therapy field, these machines rotate at about 1 revolution per minute and we had to build a machine that for the first time would rotate these high energy, you know, linear accelerators at 1 revolution per second.
And so that was a really large technical risk we had to overcome. And, you know, as it turned out, one of the things I learned along the way in terms of how investors think about risk, that's the hardest one for an investor to get their minds wrapped around. It's the hardest one to predict and assess. You know the clinical risk, well, you can assess that by what does it take to kind of develop a clinical study and how long without trial to, you know, to read out and you can look at your outcome data to mitigate that.
Market risk, you can get your head around well, what does the adoption curve look like? How are customers adopting this technology? Technical risk is a really funny beast because you don't necessarily know what you don't know, and so because of that, investors really shy away and that's why we had a really tough time raising venture capital I think in the early years.
So that's I think where the NCI SBIR program helped us the most and where I would advise other entrepreneurs, you know, if technical risk is a big challenge for you, it is a great program to try to leverage.
MICHAEL: What has been the most meaningful part of this entire journey for you?
SAM: When you actually see your own idea touch a patient in a positive way, that's the most meaningful part right there, that makes it all completely worth it and more. You know, the other, I think, really inspiring part of it is to watch, you know, such talented people that, you know, we managed to recruit into the company, make this vision become a reality and it just gives you such a hopeful feeling for what humanity can do when you have kind of a shared mission and vision of what's achievable, what's possible.
I think we take it for granted, but concepts, like this one, which seems so much like science fiction, right? Literally you put a patient on the table, the machine senses where the cancer is and treats it without even touching the patient. You know, we take it for granted that those types of technologies are developed on a continuous basis and I think it just, you know, seeing it firsthand is such an inspiration to myself for what we, you know, as humans can achieve.
So, you know, there are multiple reasons why I'm so proud to be, you know, part of this company. The RefleXion X1 machine is now installed in four sites across the US, so specifically at Stanford, City of Hope in Southern California, University of Texas Southwestern in Dallas, and UPMC in Pittsburgh. And we have been treating patients for almost 2 years now and there have been I think over 4,500 patient treatments delivered by those machines I listed.
So we're very proud of the fact that we're already having an impact in cancer care and finally using our machine to try to beat the disease. Of course we are, as you mentioned, we're also waiting for FDA clearance for the biology guided part of the machine, which we're calling syntax therapy, and that's what engages the PET scanner to be used for, you know, basically using those emissions to guide the radiotherapy beam in real time and have the cancer literally talk to the machine and be able to open up applications like metastatic disease and others for cancer treatment.
FDA guided us to a de-novo pathway, de-novo literally meaning new. In fact, they also gave us breakthrough device designation status, particularly in cancers in the lung. Because of that newness, we had to also cross a clinical bar of evidence that was traditionally higher than previous for external beam radiotherapy systems. So we conducted a clinical study last year that was successful and now we are, we believe very, very close to, knock on wood, FDA de-novo approval for syntax therapy.
So that's something we're hoping to launch early next year, if all goes well with the approval, and we get syntax therapy along with the conventional image guided therapy that will continue into patients as soon as possible.
MICHAEL: What are just some of the key lessons learned along your commercialization journey that you can share with us?
SAM: The first one is it takes longer than you think. I mean, it's funny how – I don’t know arrogant or I know the right word is, but we were pretty optimistic, let's just say, and, you know, a cold dose of reality would hit us on a monthly, quarterly, yearly basis. You know, people would tell us it's going to take longer than you think and they were right, so plan for that.
I think, you know, if your science is sound, or at least your evidence for what your building is sound, unless that changes along the way, then there's no reason why you should stop pursuing it. And I think the other key lesson is, and this is something thankfully, we had ingrained in us from the beginning because neither Akshay [phonetic] or I were in the radiation therapy field to begin with. Not only that, we weren't and aren't MDs either.
So we were already in a space very outside where we were comfortable with, both from an industry and a clinical perspective. And so we knew right away we need to hire people that are more experienced and smarter than us in these areas. The smarter, the better, try to be the dumbest person in the room. It's hard to go wrong when you do that, but recognize that, recognize where you really do need to complement your team early on and throughout the company's life and be honest with yourself about that.
So those are probably the two most important lessons I'd say I learned. An entrepreneur is literally like by definition charting unexplored territory. And so that, you know, that means that no one knows what that next bend in the path is going to look like. It's always easy to look back and you see the entire path, you see all the windings that happen, you can also connect those dots really well, but not knowing the future is something you have to become comfortable with and realize that that also is a sign you are charting an unknown territory and so don't let that dissuade you, I would say.
I like to tell people that entrepreneurship requires three important traits: vision, persistence and ignorance, and we shouldn't underestimate the importance of ignorance sometimes, because it, I think it keeps us appropriately naive and it encourages us to be optimistic.
MICHAEL: Well, listen, Sam, I want to thank you for joining us today. I think this has been a wonderful experience. It's been great working with you and with others at RefleXion over the last 12 years now and we really look forward to your continued success as the company moves forward.
SAM: We really appreciate what you guys have helped us do.
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MICHAEL: What a great story. Special thanks to Sam Mason from RefleXion 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 Michael Weingarten 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, email us at [email protected] 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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