Episode 23 | Roundtable Discussion | Empowering Innovation in Women's Health

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Podcast Guest Speakers

W. Kimryn Rathmell, M.D., Ph.D., M.M.H.C., began her work as the 17th director of the National Cancer Institute in December 2023. She previously led the Vanderbilt University Medical Center as physician-in-chief and chair of the Department of Medicine. 

With a specialty in the research and treatment of complex and hereditary kidney cancers, Dr. Rathmell also focuses on underlying drivers of kidney cancers using genetic, molecular, and cell biology to develop interventions to improve patients’ lives. Beyond her research interests, Dr. Rathmell is also a steadfast champion for mentorship and development of early career researchers.

Dr. Rathmell earned undergraduate degrees in biology and chemistry from the University of Northern Iowa and her Ph.D. in biophysics and M.D. from Stanford University. She completed an internal medicine internship at the University of Chicago and an internal medicine residency, medical oncology fellowship, and postdoctoral studies at the University of Pennsylvania. In 2022, she completed her Master of Management in Health Care from the Vanderbilt University Owen Graduate School of Management.

Dawn Mattoon, Ph.D., is the Chief Executive Officer at Mercy Bioanalytics. She brings nearly 20 years of experience in the biotechnology industry and has held leadership positions in R&D, strategy, and general management for leading companies including Invitrogen, Life Technologies, Thermo Fisher, and Cell Signaling Technology.

Most recently Dr. Mattoon served as the Senior Vice President for Clinical Diagnostics at Quanterix, where she led the development and commercialization of the company’s first two FDA authorized diagnostic tests for COVID-19, and received Breakthrough Device designations from the FDA for diagnostic tests in Alzheimer’s Disease and Multiple Sclerosis. She has developed and commercialized products across a range of proteomic and genomic technologies, and is thrilled by the opportunity to bring the highly innovative Mercy Halo diagnostic test portfolio to patients.

Dr. Mattoon earned her Ph.D. in Genetics with a focus in signal transduction from Yale University, where she also completed her postdoctoral fellowship.

Eve McDavid is the CEO and Co-Founder of Mission-Driven Tech, a new women's health venture transforming gynecologic cancer care with modern technology.

Ms. McDavid is a former Google executive and stage IIB cervical cancer survivor. For more than a decade at Google, Ms. McDavid specialized in strategic partnerships, product development, and commercialization spanning private industry and the public sector. She's built a track record of thought leadership by introducing industries to new technology and demonstrating how adoption unlocks unparalleled growth.

Forever transformed by cervical cancer, Ms. McDavid is a passionate advocate for women's healthcare access and equity. As a woman in tech who specializes in complex problem-solving, she's joined the World Health Organization's fight to eradicate Cervical Cancer by 2030.

Anu Parvatiyar is Co-Founder & CEO of Ananya Health — a medical device company building a platform technology to freeze cells in the cervix before they become malignant cervical cancer, without consumable cryogen.

Prior to Ananya Health, she led the team at eHealth Africa that worked with the Gates Foundation, WHO, the government of Nigeria, and other partners to reduce the number of polio cases from 122 (in 2012) to 0 (in 2015). Ms. Parvatiyar has also designed and launched several medical devices for critical care and cardiac markets in the US, Europe, and Asia.

She holds a bachelor of science in biomedical engineering and economics from the Georgia Institute of Technology.

Maria Luisa Pineda, Ph.D., started as a high school Intel International Science Fair winner.  For her undergraduate studies, Dr. Pineda was awarded an endowment of $2 million dollars from the Goizueta Foundation and an NIH fellowship with the Minority Access to Research Careers (MARC U*STAR) program. Dr. Pineda received her Ph.D. from the prestigious Cold Spring Harbor Laboratory School of Biological Sciences as an Arnold and Mabel Beckman graduate student and a William Randolph Hearst foundation scholar.
After graduating, she acquired investment experience in technology and life-sciences startup companies at Canrock Ventures and Golden Seeds, LLC. Under her leadership, Envisagenics has received non-dilutive SBIR grants from the National Institutes of Health, raised capital from investors, won several prestigious artificial intelligence competitions, and formed multiple research collaboration partnerships with Biopharma.

Shadi Saberi, Ph.D., has over 13 years of research and industry experience in the development of hardware systems, IC and PCB design, and system architecture.

Dr. Saberi has led iSono in the development of ultrasound system and hardware architecture which includes the transmitter and receiver analog front-end, interface with ultrasound transducer array, as well as digital signal processing in FPGA.

She has worked at Broadcom and Intel. She holds M.S. and Ph.D. degrees in Electrical and Computer Engineering both from Carnegie Mellon University.
 

Kristin Sherman, M.B.A., assumed the CEO role for Kovina Therapeutics in April 2021. Prior to joining Kovina, she served as the Chief Operating Officer for VMS BioMarketing, a healthcare marketing firm focused on improving patient outcomes for pharma and biotech clients.

Her prior experience includes serving as the Chief Financial Officer for private biotech companies such as Calibrium, LLC until its acquisition by Novo Nordisk in 2015 and Marcadia Biotech which was purchased by Roche in 2010. Ms. Sherman also worked as the Vice President and Treasurer for Guidant Corporation during the sale of Guidant to Abbott and Boston Scientific and previously served as Guidant’s first financial director for the emerging markets region located in Belgium.  In addition, Ms. Sherman worked as Guidant’s Assistant Treasurer during the company’s spin-off from Eli Lilly and Company. She began her career in finance and human resources with Eli Lilly and Company. Ms. Sherman is the chair for the Community Health Network Board of Directors, the current chair of the Compensation Committee and the prior chair of the Audit, Compliance, and Finance Committee. She also served as a board member and chair of the Audit Committee for Lacy Diversified Industries.

Ms. Sherman earned her B.A. in economics from DePauw University and an M.B.A. from The Tuck School of Business at Dartmouth.

Programs referenced in this episode

• Empowering Innovation in Women’s Health
• Cancer Drug Discovery & Development Accelerator at Indiana University Melvin and Bren Simon Comprehensive Cancer Center
• Y Combinator
• AOA DX

Transcript

BRITTANY CONNORS: 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 Brittany Connors, the Director of Investor Relations at NCI SBIR and today's host. 

In this episode, you'll hear a roundtable moderated by NCI Director Kimryn Rathmell during the Empowering Innovation in Women's Health event which features female c-level biotech leaders who have been funded and supported by NCI SBIR, the American Cancer Society or both. These leaders will share stories about the impact their technologies are having on women's health, how SBIR and ACS have played a key role in the growth of their companies, key lessons learned as leaders and their advice for emerging entrepreneurs. 

Please note that there were technical issues when this was initially recorded, so we apologize if you hear intermittent disruptions. Without any further ado, let's introduce our panel. 

BRITTANY CONNORS: These are all incredible women, incredible stories, they're doing incredible things with their technologies, and I'm just really excited for you all to hear what they're doing, and thank you Dr. Rathmell for moderating. 

KIMRYN RATHMELL: All right, well, it's a pleasure to be back. And you all know me, so I'm excited for you guys to get to know all of these amazing women. They have a range of stories to tell. I won't get in the way. How about if we just start, we'll just run down the line, tell us who you are, tell us what you're doing, a little bit about your career journey and because this is a women's health focused event, how what you're doing works in the women's health arena. 

EVE MCDAVID: Great. Thank you so much. OK. Hi, everyone. My name is Eve McDavid and I'm the CEO and co-founder of a cervical cancer innovation company called Mission-Driven Tech. It is myself and my incredible partner and co-founder, Dr. Onyinye Balogun, who is a radiation oncologist with Weill Cornell Medicine. And we work with an awesome team of collaborators to bring a new medical device to market. The type of tool that we're developing is used in what's called brachytherapy. You might be familiar with it, it refers to internal radiation procedures, they're incredibly powerful and they offer curative treatment for cervical and uterine cancers. And it's actually used in a variety of other malignancies as well. 

The greatest challenge that we're solving in the field is that in cervical cancer, the five year survival rate outcomes have been stagnant for 50 years, so the survival rate for five years is just below 70% and it really has not budged and we believe that, you know, our hypothesis is part of the reason that the survival rates are stagnant is because in this part of treatment, up to 40% of women actually drop out from the procedures and their tumors will recur, and unfortunately, they will die instead of being cured from their disease. 

And it's a result of the medical device equipment that's used in care being designed in the 1970s. And so the tools don't properly fit the female anatomy. The pain isn't properly addressed and so you have this tremendous dropout in care. So, we're laser focused on solving for that with a device that is female fitted, has safer features, and ultimately can improve the safety of the procedure and then improve the outcome of the woman who goes through treatment and ideally ultimately survives it. 

And I came to this field actually from industry. I worked in technology, business, and media for many years. I was at Google for 11 of those 15. And then in 2020, I had myself a cervical cancer diagnosis and I went through these procedures. And I thought, well, gee, this is really strange. At Google I'm used to working in industry and sitting with industry leaders and talking to them about the problems that they have in their businesses and the things that keep them up at night, and we help build the technology and experiment with it, and deploy it, and solve those problems, and scale it to industry and then watch industry advance. 

So I thought you know here's a great use case of that model in women's health and this is where I want to work. So, I left industry two years ago and left to launch Mission-Drive Tech, and it's been a fantastic and incredibly difficult ride, but I'm really happy we're having the conversation here today about the challenges and the opportunities and growth in the field. Thank you. 

ANU PARVATIYAR: Hi, I'm Anu Parvatiyar. I'm the co-founder and CEO of the Ananya Health. We are a medical device company as well in the cervical cancer space. We prevent cervical cancer by freezing abnormal lesions after they've been identified. So, after a positive pap smear and HPV test, what we are looking for in the ship trial, we have a point of care tool that can be used to freeze abnormal lesions by a nurse, you know, a PA at the lowest levels of care, so, providing that effective therapy, the effective therapy to remove those lesions without having to refer women to a hospital. 

Our goal is to expand access to that procedure as we start to see more screening tools hit the market. You know, we need to meet that moment. We need to make sure that those women have a follow on pathway that can be accessed, that there aren't undue barriers to receiving that care. 

I am a biomedical engineer by training. I started my career in medical device and spent five years at a big med device company. All over the map, everything from cardiac, cardiac access ports to urinary diagnostic tools for core body temp monitoring. And about five years into that I got a phone call friend, as all good stories start, and I ended up moving to West Africa to work in public health. 

It was only supposed to be 3 months in West Africa and wouldn't you know that was 2014 and 2 1/2 months in Ebola hit Nigeria. We were working with WHO and the Gates Foundation in Nigeria. Long story short, I ended up staying there for 3 1/2 years. And part of my job was to be in clinics, you know, working with our clinical partners, deploying technology. And every single clinic I went into there was always, you know, the equipment graveyard, as we affectionately call it, all this technology that had been designed and sourced and bought, you know, in lots of places, you spend a lot of time and money bringing something to a local clinic in a part of the world that is traditionally underserved, and then you plug it in and it doesn't work, and you don't have anyone who can service it and you don't have the consumables that you need. 

And so, when I moved back to the US, a lot of what we started looking at is how do we create technologies that expand access and what does access mean, right? Not just the most remote regions of the world, we see some of those access issues in rural Alabama, we see them in Montana, we see them all over, and what we do is try to expand access to care at all levels. 

MARIA LUISA PINEDA: For everybody. My name is Maria Luisa Pineda. I'm the co-founder and the CEO of Envisagenics. We are an AI drug discovery company. We use RNA sequencing to identify novel therapeutics. We've been building this company. My co-founder and I spin it out of Cold Spring Harbor lab. We celebrated our 10 year anniversary in June. We've been awarded several SBIR awards, and I see all you know, all the folks here. So, thank you for the invitation. 

If it wasn't for SBIR, I think I wouldn't be able to be here because it was the first grant and that's how I got my first employee into the company. And I'm a PhD by training, I was a fellow at Cold Spring Harbor, then went to investment, I was an investor afterwards, and then been running the company ever since. So yeah, exciting times, building something that was -- it's now overhyped, but I'm excited about it. So, thanks for having me here. 

DAWN MATTOON: My name is Dawn Mattoon. I'm the CEO of a company called Mercy Bioanalytics. We focus on developing blood-based cancer screening tests. We sort of have a view that while all the dimensions of cancer care from detection to treatment are important, we've got the biggest opportunity that we see to really have an impact on the public health challenge of cancer is in that early detection space, finding it at the earliest stages. 

And we have focused our efforts initially on the early detection of ovarian cancer. So, we're developing a blood-based test for ovarian cancer. And it’s actually a lot of investment, but not a lot of innovation. The markers that we use in ovarian cancer detection really are 40 years old, C125, these canonical markers. So, we've developed a really novel approach to this. It's built around by design of a low cost platform. Our goal is really global impact and we were delighted to be included as a BrightEdge portfolio companies. 

So, BrightEdge made an investment in a $41 million series A that we were lucky enough to close last year. I'm not even making this up, while I was sitting there during the fireside chat, we got a term sheet from our lead investor for a series B, so it's really hard. [applause and cheers] But there is money out there if you're willing to do the hand to hand combat, and if you are addressing an important clinical unmet need. I'll be around, happy to chat with others. 

We got breakthrough device designation from the FDA earlier this year and are now working with the agency to take the test through all of the steps that are required for regulatory approval. So it's been an amazing journey. I'm a first time CEO. I'm 100% learning every day. And a lot of times feel like I'm sort of making it up as I go along and had amazing mentors along the way, including on my board, other people that that, the American Society, the BrightEdge team have been phenomenal partners for us. Just super, super lucky. 

I'm also a scientist by training PhD in molecular biology, many, many, many moons ago. And so, you know, I think part of the message here is it is 100% possible to come out of academic training, scientific training, medical training and start a successful company. Many of us on the panel are great examples of that.

SHADI SABERI: Hi everyone, I'm Shadi Saberi. We are an AI powered platform for more accessible and personalized breast imaging. Our technology is a portable automated breast ultrasound scanner that gets attached to a variable accessory resembling a bra. It can scan the whole breast in 2 minutes without the need for a stenographer. Our goal is to make sure that breast imaging is accessible at point of care and it can be operated by anyone, a medical assistant, a nurse. We decouple image acquisition from interpretation and developing AI to help with early detection and diagnosis. 

I'm an electrical engineer by training, and my research and focus was not at all in medical or life sciences, but I lost a loved one to breast cancer. And radiologist, I understood that. Mammogram is not sufficient for half of women who have dense breasts and ultrasound is a great alternate. It was a question for me too, why is ultrasound not as accessible to do screening, to do whole breast imaging? 

I'm putting my engineering hat on to find out what are the challenges. It's very operator dependent. It requires a skilled stenographer. As a modality, it's very sensitive. It sees a lot of things, but it's not as specific so it can cause more false positive. And there's a huge shortage of stenographers. And also it's very time consuming, so it takes like 30 to 40 minutes to do. So, trying to solve that with engineering and it has been a great journey. 

But I would say not knowing how difficult it is, I always joke that it was a blessing in disguise to start this company. And as everyone said, there was a lot of learning on the job not coming from medical industry, learning about regulatory reimbursement, clinical study design, all of that requires great mentors and advisors. And also, like other founders who have been a few steps ahead of you, those are amazing resources that have helped us so far to get to this point. 

KRISTIN SHERMAN: So I'm Kristin Sherman. I'm the CEO of Kovina Therapeutics and we are developing treatments for HPV infections and cancers. So, think head and neck cancer, think cervical cancer. Yes, there's a trend that you're hearing for cervical cancer, but also cervical premalignant infections. So, the end of the day, it's great to be able to diagnose, it’s only one step. We need to be able to treat. And the question that I get a lot is well, really, haven't we solved this problem, right? 

We've got an HPV vaccine, it's highly effective, but it's not universally adopted to the millions that are already infected. This is a condition that sits dormant for decades and then rears its ugly head. So, there is still a tremendous need for a therapeutic and that's what we are focused on. 

So, I am not a scientist. I come out of the business world. So, my background is Eli Lilly, drug development and then a medical device company. And then I jumped into the crazy train of biotech. So, I've learned, had to learn the science, mentoring is key in that science world, that's for sure. But it certainly can be done and we're excited to tackle the challenge of developing treatments for HPV infections and cancers. 

KIMRYN RATHMELL: All right. Well, so that's round one. So, now you know why I was really excited to talk to all of these incredible women. So I mean, I love the themes of the things you're taking on are common sense and seeing a real gap and knowing that there was an option to move forward, so that's a big thing that I heard. But I also heard a lot about partners and mentorship and, you know, other tools that got you along the way. So, I wonder if each of you could expand on what resources you drew on as you made the decision or that got you to the big, the big good e-mail, so. 

EVE MCDAVID: Great. OK, wonderful. So, yes, you can't go at this alone. I would start, number one, in the encouragement to pursue this journey. So, this was not necessarily something that I thought, OK, you know, I'd been working in industry, I'd never really thought about starting a company, but I did earn an entrepreneurial mindset and an ability to solve complex problems. And when you start putting those things together outside of your day job, you're like, OK, those are those are some of the pretty big skills that you need along the way. 

I also had, my incredible husband is here, and I have said I always do better in the room when Matt joins us. I had incredible support at home to start taking big leaps. I had survived a really deadly cancer diagnosis, and what we learned in the data was that the factors in the column that, you know, made the difference for me we're effectively privilege, right? Being a wealthy White woman on a Google healthcare policy gave me world-class care providers that is inaccessible to most folks. 

And in conversations with my doctor, Dr. Balogun, and then her perspective as a Black female physician scientist, that the inequity in this field was so grave and so preventable, and, you know, seeing the want for better tools and the willingness to work on something together and, you know, to be ready to build. I took those signals as, OK, this is, you know, this is how you get started, this is how you take leaps, and this is really what it means to bet on yourself. You know, nothing is a guarantee. So, while we're here, let's do something really big. 

I think like everyone has talked about, you know, the journey is hard, mentors are incredibly important. I want to make a very specific call out though to funders and investors who understand what you're doing and are value aligned. Until ACS BrightEdge, we had not met an organization who said, you know what? It takes time and research and it's very capital intensive to make headway in oncology and we believe that's valuable and we're in it for the long haul. 

 And so, until we found ACS, you know, we swam for quite a bit. But once you find those folks who, you know, around you and, you know, back at behind you, believe in what you're doing, and want to see you keep going, it gives you the confidence, particularly in those hard moments, in those moments where you're not sure if you can keep going, to realize that you have the support behind you and that gets us through some difficult times. 

ANY PARVATIYAR: Yeah, I'm going to -- I always hate -- Eve is a really good friend of mine. I always hate speaking after she tells her story because it gets me teary every time. One thing [crosstalk] I want to add on to Eve’s story or Eve’s answer here. One thing, you know, we have really great support. We're very lucky to be funded by the SBIR program, which I think adds a layer of credibility as well as funding, you know, like it's something to -- when you talk to potential investors and you say, you know, we've been vetted, we've gotten a phase one and a phase two and that part of it is, I think a given. 

Something that has also been useful for me, there was a lot of talk in the fireside chat about collaboration, particularly in the women's health space. The reason that Eve is a good friend of mine, we both work in cervical cancer and we both understand that a rising tide lifts all boats, right? We are -- I'm happy to be a champion for what they're doing because we don't want, A, we don't want patients to get to the point where they need her technology and vice versa. But the more eyes we can put on the problem, the more we start talking about this in consciousness, the better it gets for everybody. 

So, I have been very lucky in my, you know, I'm a first time founder, a first time CEO. I've been lucky to be part of communities that really support female founders. And when I first joined YC (Y Combinator), in my head, I was like, they don't care about women's health, they just care about enterprise staff, you know? And I was happy to be proven wrong in that. Oriana runs AOA DX and they were part of our cohort. 

So, all of these women come and they support the things that you are building. I think there is a lot of collaboration that has been a huge resource for me. 

MARIA LUISA PINEDA: OK, so for us, I'm in New York City. So, when I started my company, we started it because, you know, we were the post-docs that were working on the now FDA approved drug SPINRAZA which is for spinal muscular atrophy in children that couldn't move a single muscle out of Adrian Krainer’s lab. I end up becoming a VC. And then my co-founder and Adrian called me, he's like, “Hey, remember the RNA drug that we're working on with children are sending us thank you notes done by hand.” Right? 

So I was like, OK. Let's go. Show me show -- Don't show me the data yet. Show me the pictures of the children, one of them. And now, you know, I'm a second time mom. I use them in my pitch to this day because one of them is from a little kid from Chile, five years old, and I have a 6 year old. He drew Adrian like an Iron Man with a little mouse on his hand and says, “Not all capes.” OK, so, I sat with him and I told him what to do in every single slide because I was looking at 30 biotech life science companies a week. And then I brought him to my bosses, OK? 

And then his twins were born the day before. And when his wife’s water broke, she goes like, “Your pitch!” And he still came, pitched, he looked like ***. Let me tell you something. But he still did it. OK. And then the most important part is, you know, he tried doing it, he didn't pass slide 3 because he started writing all this, the algorithms in the blackboard and then he left. They turn around, they go, “What was he talking about?” And I said, “It's amazing. We used bio-informatics, machine learning. We were able to identify the Type 1 SMA children. We put them in a phase one. Now they're being treated. Now they're cured.” 

And they go, “Why didn't he say that?” I said, “Well, he's a scientist. He's a bioinformatician.” They're like, “What?” So, what we wanted to build was, you know, a platform, a tool that is not existent. Instead of having, you know, one bioinformatician that you collaborate with, build the platform. That now, after 10 years, only took me 10 years to build it, but it really can in a year now from RNA sequencing all the way to an antibody, a binder, be able to analyze over, you know, I think for triple-negative breast cancer and breast cancer alone, we had 12,000 women's data set, 10,000 normal tissues, and we can identify targets that are prevalent in at least one of our targets that we just published. 

It's super difficult to drug, but we identified it, made a drug about it, and kind of like, in a year, be able to validate it. So, for us like tools, there is not there, build it, make it, get an SBIR grant, you know, find a mentor, find an investor, and very, very difficult to do early. You're supposed to kiss 200 frogs to find a prince. Really, in reality, at the end, the one that gave me the lead term sheet that was somebody that looked like some Colombian American, and the four or five investors we got for Iran were women and Jewish. 

B round our partner, Bristol-Myers Squibb, again came in, participated in strategic, Multiple Myeloma Research Foundation also participated in my current ones. So again, tools, if it doesn't exist, find it, build it. New York City, very difficult. Yeah.

DAWN MATTOON: I would say for us a big part of it, this is going to maybe sound a little counterintuitive, but we've been very intentional, I have been very intentional about seeking out critics, people who are going to not tell us what we want to hear, but who are there to poke holes in what we're doing. And a great example of that, actually, because he's become a really important mentor of mine, is the Chairman of our board, who's a guy named Stan Lapidus and some of you may know him by name, all of you will know him by his work. He revolutionized cervical cancer screening. Actually, he invented thin prep and founded a company called Cytech that sold to Hologic. He also invented a technology called Cologuard, and so a lot of people are familiar with him. 

And when we first approached Stan, it wasn't to asking for money, it wasn't to ask him to be on the board, it was to ask him to poke holes in our story, to make us better. And we, at that time, it was early days in the company. We shared the data that we had with him in ovarian cancer. I think at that point we had 17% stage 1 sensitivity, just to tell you, now it's 85% stage 1 sensitivity, but at the time it was not great. And Stan looked at the data and said, “This is so bad that I believe that you are representing it accurately and I'm going to join your board.” [laughter] 

And so, the lesson I think for me was we can't, not only should we not be afraid to expose our warts and all the flaws in our studies, in our data, we should lean into that because it's, in our experience, it's really drawn some pretty amazing people, Stan is one example. But this is more personal, as a first time CEO for me has been, I have a really trusted longtime adviser. She's also a CEO. She's been a serial CEO, very seasoned, very smart. And there's just a whole new language that you have to learn as a CEO. 

As a scientist, I know that language, I don't know the language of deal documents and voting rights agreements and all these things that you have to navigate when you're putting financing together, and having someone that you can call is really, really important for me. So, my encouragement always, especially for new founders, new CEO's is you want to have that diversity in your mentoring network. For me, Stan serves a really specific purpose as our chairman, Sarah, my phone a friend mentor serves a different purpose, but both super vital. 

SHADI SABERI: Yeah. If there's something that is missing or if there's something with the status quo that you are unhappy with, question it, and go build it and that's, I guess the story that we had. I had a full time job in industry. I was designing wireless chips and to me, not having ultrasound accessible, I was like if I can make it easy to use and low cost, why isn’t it more accessible? So, that was kind of like what consumed my mind every day at my job. And that's when I decided to start the company. 

And serendipity is also a big thing. When you network and meet people, big things can happen. So, my cofounder actually met Sam Altman at the networking event at the time. And it was 2015, YC was mostly funding SAS companies, like barely hardware, let alone life science. And through a conversation, he mentioned that his mom had breast cancer that was missed by mammogram and detected by ultrasound, we should apply to Vice. So that's the story of how we apply to Vice City. It was just an idea, we didn't have any prototype. 

So, everyone, their demo day goal is usually growth, like 200% week over week, that's the target for demo day for us. Build your first prototype. So, that's how we started. And we’re also open to like, hear people poke holes. When we try to raise our seed round, the original idea was to build something that everyone can use at home for self monitoring. So, it was like a consumer idea, but we received a lot of resistance from investors and, you know, one that was friendly and started poking holes at our idea, and we realized that burden for us to get the clinical evidence that is required to go to home, so we have to take like steps to get there. And also the SCIR and I-course program help us with the customer discovery to say now we go to clinic with our first customer. 

So, people, you know, customer discovery and learning what are the hurdles in front of you I think is a, you know, part of --

KRISTIN SHERMAN: So, my main tool is looking under every rock and what do I mean by that? We went the grant route and early on had great success. We had three different STTR SBIR grants. We have used TABA funding for some regulatory support. We've participated in the investor initiative program and that is all wonderful. Obviously, non-dilutive financing is great and that scientific validation, you know, you're going and talking to investors and you can say, hey, I've been through study section, I've been funded. That's all wonderful. I had some matching money from Indiana. Yes, there's biotech in Indiana. I know people find that hard to believe, but I'm from Indiana and that's where the science originated. 

So, that's the best part about all of the NIH funding. But then there are all of these other programs, the opportunity to pitch, the opportunity to apply for a competition, the opportunity to get feedback. And I'll make this real for you with what I call kind of this ripple effect. You cannot imagine how one interaction can lead to 10 other interactions and a total left field shift in direction. 

So, about a year ago, I met Lauren because I came here to Bayer and presented our program just to get feedback, which was wonderful. At that time, had a chance to meet Michael and his team, invited them to Indiana, they came and did a boot camp, which was wonderful for our ecosystem. But in that same event here in Boston, I learned about American Cancer Society and the BrightEdge program. I said, hey, why not? I'll apply, and then they hand you all these mentors and I was like a kid in a candy store. Not only did you have your mentor, the list of people you could talk to. So we just went down the mentor list and started having conversations, getting great feedback. 

But also getting warm intros to venture funds, so it helped with the 200, kind of cut that list down a little bit, and then one of our mentors happened to be the CEO of an oncology company focused on head and neck cancer, one of our indications, so tremendous wealth of knowledge, access to her advisors. So, this one interaction, coming up here and presenting to Bayer, rippled into about 10 to 15 different interactions. 

So, look under every single rock. Do not give up an opportunity because you have no idea where it might lead, who you might meet, what conversation might lead to a potential investor or a potential program or a potential pitch or a potential piece of information that you hadn't even thought about relative to your program. 

KIMRYN RATHMELL: All right. I love all of the different tools, resources, build your own, that you all have plus the drive and how much, it's clearer the, you know, personal investment that you all have in your products, in your companies. I would guess that there have been roadblocks along the way. We've heard a couple of them, but I bet there are some good interesting stories. So, maybe we'll come the other way this time and you've been around --

KRISTIN SHERMAN: Well, I'm going to continue my Indiana theme because it's a little bit of a roadblock. We do not have access obviously to the same kind of venture money that exists on the coasts, nor do we necessarily have access to the talent and so, we've solved that in a couple of ways. One, we've created a very collaborative ecosystem. And what that means is we all share resources. We call each other, we support each other. When we find out about a BrightEdge program, that goes out through our whole network. So, instead of creating a competitive environment or a competitive ecosystem, we've created a very collaborative ecosystem, a lot of different organizations that you need to be on the lookout for and, especially in some of these more remote – 

We have the Indiana University Simon Cancer Center in town. They've got a drug discovery accelerator. We asked, and now we're a part of that. So again, it's back to looking under all those rocks and don't be afraid to just pick up the phone and say, hey, will you help me? Will you support me? Here's what I'm doing. Can we partner? Can we work together and trying to create that collaborative ecosystem? 

SHADI SABERI: I guess roadblock is you always don't have control over timing of events. One story that I would say, when we were submitting our first five 510k clearance, we were -- it was during COVID and there was a lot of delay in getting our data. And one of the problems that we have was our biocompatibility lab, NAMSA, was short in supply chain, so their whole test was delayed and that delayed our submission. 

So, we tried to be creative, and recently FDA issued like a draft guidance that skin contact only devices can do a risk-based biocompatibility. FDA later asked for biocompatibility data. But you have to think outside the box when roadblocks come. There might be another solution and there might be a silver lining. 

DAWN MATTOON: Yeah, I would say for us, the roadblocks come in different sizes and we try really hard to use the little ones to build the muscle memory that we need to overcome the big ones which are inevitable. So, that's definitely one lesson. The other lesson that I think for me is when the big ones come, the response initially is an emotional response, and you got to just ride that one out because that's not where the solution lives at. 

So, I've learned that when we have a tough interaction with FDA or we have a tough data read out, something that's negative, that's unexpected occurs, the only person that I'm allowed to text is my husband. [laughter]

At least for an overnight, we sleep on it, and then always with a super creative team, super smart people who are really, really committed to the mission, there's a solution that eventually reveals itself, that path forward somehow always reveals itself, but it's never in the moment, it requires a little bit of reflection. So that is a tough earned battle scar sort of lesson, but it's been really valuable for us as we've gone along. 

And I can say with confidence that we haven't hit the hardest thing yet, I don't know what it's going to be or when it's coming, but it hasn't come yet. So, we need to use every opportunity to build the muscles and prepare for them. 

MARIA LUISA PINEDA: So, I was thinking about that and I think one of the biggest roadblocks I've found in the past 10 years have been biases, conscious and unconscious. You know, when I come in, my cofounder is Latino and we go in and they tell us we love seeing or pitching a couple doing a biotech, so innovative. And my co-founder and I look at each other and is like, really? Because we're not together. [laughter] Yeah. I mean, we are, but not really, right? Like, we spend more time with each other than with our significant others. 

But in reality, we're not married, but we just wasted, what, 10 seconds of the pitch responding to that answer. Do you think a man gets that question when they go into pitch? Never! Right? So, you know, the biases in every single meeting, it doesn't really matter if it's scientific, business, investor, every single one. The head of the CIA, one of the only women, and I asked her that because it was impressive, she was the head of the CIA as a woman and I said, “How did you deal with that?” She says, “We called them, you know, like walls. And they're made of stone or brick. And at the CIA, we try never to get dirty like the pigs. So what do you have to do? You have to go around them.” 

And that's exactly what I'm trying to do, going around them. And that's just with perseverance and just figuring it out. With investors sometimes, we decided to generate more revenue as a biotech. So, we actually have everything, we're profitable. I have a platform company, we generate over $25,000,000 last year and because of that I could say, you know, I don't need you. Thank you for, you know, being mean and not nice and having that bias, but I don't care. If you're interested, give me a term sheet. You want to see my deck? Send me the term sheet. You want to do the diligence? Send me a term sheet. If not, you're not serious, I don't care, I don't have time for you. 

So, you know, if you have the upper hand, then you're able to say things like that, even if your tone changes, so, you know, and you're confident, and the women powerful is that, I've learned that when I did, the Pfizer women thing, but sometimes it helps, sometimes it doesn't. So, in reality, those biases and those things we encounter them. I mean, we’re the riskiest people that you can – innovators, women, you know, first time entrepreneur, I have an accent like, risk, risk, risk, risk, anywhere you can look at it, right? So, you have to go around it and persevere and you're the ones that are building the next generation of therapeutics of medicine of devices, of diagnostics. So, that's what we're here in the states for.

ANU PARVATIYAR: Yeah, I love that answer. I love the idea that, you know, we were talking about this on the prep call. I really think for a first time founder, it is a feature, not a bug that you do not know how hard it's going to be, because if you did, I don't know that you would start the first time. The second time, you're like, OK, I know what I'm getting myself into and I know how to get past some of these things. But I think grit is a really big part of the process. 

So, I'm going to jump on the obvious answer here, the roadblock being funding, really hard to learn to fundraise, period. And the way that you learn it is by doing it and it is painful and scary and full of rejection because that is just the way the process works. You don't -- It's kind of like dating, you don't need everyone to say yes, that would actually be bad. What you need is a few people who are really committed to what you are doing to say yes and to be on that journey with you. It’s probably not going to happen on your first time. It's like doing an experiment and getting it right the first time, right? That never happens. 

So, I think if you look at it in that same way like, I'm building the muscles, I'm learning how this process goes, it gets easier over time and it's only possible if you are committed to what you are building from a mission perspective. So, we love what we do and we're lucky to be able to do it even though it's hard. I think that is the way that we overcome that roadblock. 

I think there's a lot of, a lot of, you know, how do you get to controlling your own destiny and, you know, getting to revenue, making sure that you have the leverage when you get to that conversation. For us, we're an early stage company. We raised a seed round and looking at a series A with our FDA milestone next year. For now, the SBIR program really helps us do that. We run a women's health company. With cervical cancer, we think that is a big and important market, but it is not a traditional venture story that you hear a lot, right? 

And so we get a lot of pushback early on. We like to remind people; it's not only women in Africa that benefit, right? This is a big market. Preventing cervical cancer is something that affects every woman of childbearing age here in the United States. And if we learn something from that really big market because we prioritize access, that will come back and lower the cost of care in the US, it will help the outcomes and, you know, help expand access here. 

I think early on that story is really hard to tell. As you get more traction, as you get more funding, as you get more data, more people are willing to come to the table and listen to that because they see something that they like. But early on, I think you need to go around the walls and power through it and you know, use those learnings and future, you know the muscles that you built there. 

EVE MCDAVID: Everything this entire panel has said is oftentimes, it feels like an insurmountable barrier until you figure out how to, you know, get the key to the keyhole, underscore the points around investment being a huge barrier, and the gender bias, gender equity, and building solutions to address inequity into women's health. It's like, oh, my goodness, number one, not all of that is true, and number two, all the inequity that you've ever, you know, needed, wanted, or never wanted to see, and all the conditions that myself and my incredible friends and colleagues are addressing are, you know, areas of medicine that if men were impacted, these challenges would have been solved a long time ago. 

An illustration of one of the ways that we address these barriers, a lot of time at Mission-Driven Tech, I talk about our work as a break the dam effort. You know, we will try just about anything to get the folks on the other side of the meeting, whether from an investment standpoint or a partnership standpoint or visibility, to care about what we're doing. So, our team had a really, you know, like, creative idea of, OK, it's difficult to convince certain folks who are going to be decision makers, but what about the everyday woman who she herself, if we think about the screening statistics right, at least 25% of women who are screened for cervical cancer will have an abnormal pap test in there, an abnormal result in their lifetime. 

So, like, what if we just made the cervix a really identifiable icon? What if we got a cervix on the desk of every decision maker in America, right? What if we made the cervix something that you couldn't stop looking at and unforgettable? So, we did this little experiment with the local artists to create these, they're coasters, OK, they're not a biotech product. But we started using them as a community feature and a way to reach decision makers and do something creative. 

So, we created these as an experiment and we actually started selling them, again, also as an experiment just to see what would happen and we had a lot of purchase uptake. So, it's not the silver bullet here, but it's a demonstration of we will do just about anything to get our great work done to make our companies more resilient and less dependent on market factors for funding and to create megaphones and spotlights for this important work. There is a material problem here that affects half the world's population. 

And that recognition is the platform from which investment and then innovation flows. So, my approach to these barriers is they are real, they are everyday and in our face and, you know, as best as we can, for as much time as we have against this, we do everything we can to break that dam. 

KIMRYN RATHMELL: All right, fantastic. In the last couple of minutes, I want to make sure we cover the funding; again, we've got others in the audience who would like to be you. We'll start here again and then I'm going to have one more question and we'll run back. Tell us your story of how you got your funding and any anecdotes along the way or sort of pearls in your ACS or NCI funding story. 

EVE MCDAVID: Wonderful. Thank you. Yes. So, as I mentioned, we are funded in, we're funded by the ACS BridgeEdge program. And we've also had a number of other groups and organizations invest, either directly into the company or award grants for us to be able to continue our development work. And at the beginning of our journey, myself and Dr. Balogun participated in a business plan competition at Weill Cornell Medicine and this was in 2022. So, the notice came across our desk to say like, you know, do you want to participate in this? Do you want to put together a plan and pitch for capital? 

And a lot of my time at Google was pitching. So, it's like, oh, I can do it over here, fantastic. So, we got started and what we saw in the room when we got to the pitch competition was what we've been betting on the whole time as we were building out our work and creating hypotheses around our work was that we just needed visibility. You know, we thought that we would do really well and we did. We placed in that competition. And it gave us our first pre-seed capital and with that it was the hope. Money for a start up is oxygen. It's what makes the entire enterprise possible. And so when you get a check, when someone bets on you, you get to go and your job is to go as, you know, as far as you can go until your next checkpoint. 

We have not scotched along the way. So, benefited from an NIH funded coaching program for an STTR that we just submitted last month. So, you know, it's maximizing every single opportunity and then when you get that win, knowing exactly what to do with it and building so that you can go get the next win that's going to follow with everything you've just produced. 

ANU PARVATIYAR: We started out with angel checks, you know, just friends and family pulling money and went through an accelerator in 2021. We got our first SBIR grant through a month, a solid month of three of us sitting in a room and writing this out. It was hard won, I mean, obviously. It's great to have that credibility. It's great to have that fundraising. It's also good for the morale of the team to see that pay off, I think to know that you did something hard and, you know, made that through. 

We recently, we wrote our own SBIR phase two. It just got funded in September. So, we sat down and wrote our 12 page commercialization plan all together and it forces you to think about where the direction, you know, how are you going to do the things you say you're going to do? The process of pulling partners in and getting letters of support made us have clarifying conversations with those partners and this is what we're really going to need to get these things done. 

So I think you know, we've been lucky enough to raise external capital from traditional investors, we've been lucky enough to raise grants, but both of those teach you something different about the process. One thing that I want to highlight about NCI funding, is we care a lot, you know, we're a mission driven company, we're a benefit corporation. We really care about the access issues because we think that is good business. We think it is better business to focus on the large market, you know, globally than just the US market that a lot of US-based pre-regulatory investors are hyper focused on. 

So, we are really allowed to do both things. We look at the US market as a big and important option for us, but the SBIR funding has allowed us to maintain some of that mission focus and look at that access in a way that we maybe wouldn't have the oxygen to pursue. 

MARIA LUISA PINEDA: OK, like, I'm very operational, so I'm going to be a little operational. So, first I'll say maybe two months I did the business side. Most importantly SBA have and NIH and NCI have this, like, $75 and sometimes free by the state that you can go and now I still send every single post-doc that comes in to go and take the class. It's a course, it's a 2 day course, and I'm forgetting what the name is. But it's, you know, you go in and they teach you what a business plan is, how is it written? 

I've used every single opportunity from SBA to get a free consultant to pay it, to even just look at it, that was the first thing, to look at it. Even just the writing programs. So, R-44’s, they're so different than the R-21’s. So, I've been writing grants since I was 15, that was my first grant, NSF, and I know I am a little overachiever, but I love writing grants. So I was like, well, it's just the same thing. No, it's not. 

So, even just the setup. So, just learning how you set it up and getting the feedback right away from SBA, from a consultant, from your PO, first thing, writing the customer, you know, and then getting their signatures and their logos because you're going to write those for them and then they're going to go get them approved. Most of them are pharmas or something like that, at least for us, are pharma. So, just every single thing, it takes so much work. 

I think every SBIR grant it's around 100 pages, 120 pages, including the letters of support. They're not small, right? So, they're tough. I mean, they're - And then the reviewer comments sometimes are tough on you, but it really makes you a better, you know, kind of like company. And just, we do the first one, the $400,000, $500,000, really useful, first employee we hired. So, it's like every little thing is useful and just there's so many programs between the NCI. 

We've used the FDA one, we've gotten paid to go to Bio, the investor one. I've used every single program, you can ask them. If there's one, I’m applying for it. Competitions, yeah, sometimes I don't even notice. We want the Microsoft AI World Competition, and when I met with the CBO for Microsoft in New York, she flew over, she sat down, and she looked up, she goes, “You're a female biotech CEO in New York. Nobody said that to me.” And I said, “Yeah, I purposely didn't put it in the application so I could win it.” [laughter] Right? 

So, you know, whatever gives you the edge, you do it because that oxygen is needed for you to persevere and take your science to the next level. So, just go to the stones, but SBIR has been essential in commercializing and every single step in the 10 years, I think we wouldn't be able to be here without it. 

DAWN MATTOON: So, we did probably the traditional route we had an angel investor early on. We did a friends and family round after that. And last year kind of outside independent market price round that the company had done and it was 100% kissing 200 frogs to find that the 10. What I what I learned I think it's two things, one is every interaction that you have with a serious investor, with someone who's really engaging with you thoughtfully makes you better, even if they ultimately say no, and it's kind of crushing. All of the questions that they asked helped us to refine the pitch and so each successive pitch got better and better and better. That was, that was really key for us to understand. 

And it took about a year to get the A done, finding new people to talk to. So, it's not a couple of weeks sort of exercise, it takes a long time. The other thing is not all money is created equal. And one of the most terrifying things that I did in our series A raise was say no to money. There wasn't an alignment of mission relative to what this particular investor had in mind. You know, that was a much more short term gain sort of perspective. This is hard when you're not there yet, to step back from the wrong money, it's really scary, but in retrospect, I’m so grateful for some of the people that are outside of that circle. 

SHADI SABERI: Yeah. For us, fundraising has always been challenging. Well, at the time, seeing this YC Investor, they will all get scared, and we go and pitch to healthcare investors and they will say, “What? You're going to consumer, you're crazy.” So, it took us a while and we raised angel money and SBIR and we were very scrappy. It was me and my co-founder for the first four years until we were able to raise our seed round. 

And with money that we raised, we were very efficient to get our first 510K and that was like a big milestone for us to go raise the big A round. And yeah, the market had crashed, exactly at the time we're going to raise our big A round. So yeah, you don't have control over timing. And again, we started like raising smaller pre-A, bridge, so that like, we can show more traction. So like, the expectations also, as I was telling you earlier, from investor is a little bit higher when you want to go to the A round. They want to see more traction specifically if you are clear, if they clear a device and commercialization, as I learned, is expensive and it requires a whole different kind of talent. So that's how we're shifting, it goes around. 

KRISTIN SHERMAN: So, I already shared my SBIR funding and American Cancer Society. We had also raised a bridge and we're able to do that with angels and local money and we're working on a series. A lot of these later rounds come from relationships that you start early. Investors want to follow your progress. They want to understand that you've set goals, you've achieved those goals, you've derisked your asset, you've derisked your science, whatever that means in your world. So, I'm having conversations now with folks that I've been having conversations with for two years and that's OK. They've given great feedback along the way. I know what they're looking for and I'm working towards that. 

And to your point, then I have a much better feel for how they're going to behave when they're around the table. Because like it or not, whoever you bring into your round usually gets a seat in governance. If they're the big, if they're, certainly if they're the lead. So, you're building these relationships. And you're making sure that if you have luxury of picking who you want, you understand how those relationships are going to play out in the table, when they sit at the table. 

So, start having those conversations now, know that they're going to want to follow what you're doing and it will take a long time, but it'll be worth it at the end. 

ONLINE MODERATOR: Monique, I'm going to come back to you. I want to give the folks on mine just one quick opportunity to really participate. 

MONIQUE POND: All right. Thank you. Yeah, we had a couple questions. So, the first was about building the team. How did you build your team, where did you find people? And then the second question that came in was about CEO's and kind of the business side of the experience. If you're a scientist by training, where do you start kind of building these skills?

KRISTIN SHERMAN: I'll take team because I like to build what I call the bits and pieces model, so, bits and pieces of really experienced people. There's a whole ecosystem out there of folks that are pharma retirees, biotech junkies who like to work for multiple clients. You don't need them full time. You need bits and pieces of them. Your burn rate can't sustain them full time. A lot in networking, but there are also a lot of fractional employment partners, I just launched one. There's one down in the Research Triangle. Companies are offering these part-time exec and part-time device models, but it also allows you to access really experienced folks. 

ANU PARVATIYAR: I’ll add to that really quickly. Make sure the people that you're bringing on full time, like the people that are going to be building that journey with you that are coming in at the earliest stages, you can teach many, many different skills, you cannot teach like the core mission and values. Make sure the people that you are bringing in early are aligned with you there. 

You will, you know, all of you will learn new things along the way. The things that you will be doing four years down the line are not what you thought. So, make sure that it is somebody that you want to walk into the office and see every day.

MARIA LUISA PINEDA: You know what? I think I will say the opposite. I will say, actually, whatever you're not good at, you go find because I think what's best is to know what you're not good at. OK, and what you're not going to be -- OK. It's fine, right? Just find that person to fill that gap. And then for the business question, that scientist CEO's, I don't know. I think I still Google half of the stuff. [laughter] I'm kidding. But mentors – 

KRISTIN SHERMAN: Tech transfer offices. Sometimes they --

MARIA LUISA PINEDA: Sometimes they have. Yeah, it's just, you know, you learn, I'm still learning every day. And I get really, really difficult criticism from my own investors, my own pharma partners. And you know, my head of it is here and, you know, every time we say no, I say it's not a no, it's a maybe later, and then we learn what we need to do and then we get the science there and then we come back to them, we say here it is. So, again, just learning as much as you can. 

DAWN MATTOON: The one thing I would add on the building the organization is that the people who are really good and really passionate about the earliest stages of a company are not always really good, and more importantly, really passionate about what happens in the latter stages. And sometimes those goodbyes are tough, but they sometimes are necessary and we've had to go through a little bit of that evolution at Mercy as we've kind of gone through our maturity arc, and there's a way to handle those that's incredibly respectful, but they're difficult and it's important to make decisions if you think they're necessary. 

EVE MCDAVID: And then one thing that I think is a little bit underrated and particularly folks who are in academia, we have been really scrappy from the start and where possible, have had a lot of student teams, anywhere from undergraduate, graduate, PhD level students who are looking for capstone projects with real world application. So, we're hearing for communications, for IP, I mean, like, the list goes on. So, if you have a great university affiliate to find Scrappy talent and staff what you can with that as official -- 

KIMRYN RATHMELL: All right, we are technically out of time, but one sentence of advice that you'd give to people. 

KRISTIN SHERMAN: For me it is mentoring and networking. You need to have as many conversations as you possibly can. 

SHADI SABERI: Believe in yourself and your mission and everything else becomes easy. 

DAWN MATTOON: It's come up already in this conversation, but I'll say the women's health sisterhood is a real thing that you should lean into, because this is a group that lifts each other up. 

MARIA LUISA PINEDA: Just persevere. Science will bring the money. Just believe in it, continue building it, and it will come to you. 

ANY PARVATIYAR: Spend time and understand your customers. Make sure you understand who you are building for. And it is really easy in the early days to think that is investors, it is not. Make sure you are talking to your customers at every step of the process. 

EVE MCDAVID: Keep going. 

KIMRYN RATHMELL: All right. Well, I want to thank this amazing panel. I would love if this was a table and we could have dinner together. These are incredible, incredible women and thank you very, very much. 

MARIA LUISA PINEDA: Thank you guys. 

[applause]

BRITTANY CONNORS: Thank you to Dr. Rathmell for moderating and all of our incredible panelists for sharing their unique perspectives. 

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 is Brittany Connors from NCI SBIR. Please join us again for the next installment of NCI SBIR Innovation Lab and subscribe today wherever you listen. If you have questions about cancer or comments about this podcast, e-mail us at nciinfo@nih.gov or call us at 800-422-6237, and please be sure to mention Innovation Lab in your query. 

We are a production of the US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Thanks for listening. 

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