The following interview is a conversation we had with Hala Borno, Founder and CEO of Trial Library, on our podcast Category Visionaries. You can view the full episode here: Improving Patient Recruitment and Diversity in Oncology Clinical Trials
Hala Borno
Thanks for the invitation.
Brett
Yeah, no problem. So before we can talk about what you’re building there, could we just start with a quick summary of who you are and a bit more about your background?
Hala Borno
Yeah, sure. Brat so I’m a practicing medical oncologist. I actually continue to see patients at the University of California, San Francisco, and I’m also a health equity researcher. And so that’s the background and the lens in which I have approached the development of a public benefit company, which is Trial Library.
Brett
What is health equity? Could you define that for us?
Hala Borno
Yeah, so health equity is really this idea of understanding factors that are driving differences and addressing those factors in order to make sure that individuals or circumstances that lead to disadvantage are addressed so that people have an equal playing field and opportunities to advance towards opportunities that make sense for them.
Brett
And can you take us back to the early years when you were growing up? Did you always know that you wanted to be a doctor, or did that come up later in life?
Hala Borno
I actually remember the precise moment where I decided to become a doctor. I was 16 years old. I was watching my mother consider treatment options for my grandfather. He was just diagnosed with colon cancer. And I realized, in the context of being an immigrant and navigating health in a new land, that there are a variety of barriers that she was trying to address in order to make sure that he had appropriate care. I also realized that a lack of knowledge and not feeling like she understood his health and the potential outcomes he could have was a big driver of fear, and I didn’t want to feel that. So when I was 16, I told my mom, I’m going to become a physician because if you ever get sick, I want to be able to understand and navigate care for you. And that’s really been that underlying motivation, is to help support her.
Hala Borno
But what has actually ended up happening is that I’ve translated that empathy in that sort of North Star to others, where I find myself practicing medicine and also building a company to help navigate and improve outcomes for anyone who may be in a circumstance of disadvantage.
Brett
And I know you’re still practicing medicine there, it sounds like. But talk to me about that transition when you decided to also add on to your schedule being a Founder and CEO of a venture backed startup. Because I’m sure that does consume a lot of your time and just mental bandwidth. So was that hard for you to make that transition and to give up part of your life and time of being a physician to be a startup Founder?
Hala Borno
It’s a great question. So my life prior to becoming a Founder was that I was an academic physician. So I spent part of my time doing research and part of my time seeing patients. And my research was, as we have already discussed, health equity based and working as a practicing physician in an academic medical center. I found that a lot of my patients were being afforded clinical research opportunities. And I knew that these opportunities were fantastic, that perhaps they would be able to access new diagnostics, they would be able to access new drugs. But I also recognized that these types of opportunities weren’t available to all. And so I shifted my research program to really being focused entirely on inequities and access to clinical trials. And I defined a lot of barriers that were driving these inequities and then started building solutions to address those barriers.
Hala Borno
And as I started generating this evidence base around how do we advance equity and access to clinical trials, UCSF noticed I was mentored through UCSF Innovation Ventures and they recognized that there was an opportunity to build a company around this in order to make a larger impact in a smaller amount of time. And so really it was UCSF that first encouraged me to consider an entrepreneurial path. And I realized that I could bring that same conviction that I was bringing to my research in the context of building a company and could make a big impact quickly. And so that was an exciting transition as you already brought up. Seeing patients was something that I did not want to give up. It was a really big part of what drives me. And so I continue to do that in a small way one day a week, but then spend the rest of my time focusing on the company.
Brett
And did you have any friends or family, loved ones and coworkers who maybe just thought you were kind of losing your mind going out and trying to do a startup, or did everyone just get it and were they fully supportive of the idea?
Hala Borno
This was different within my peer group at UCSF. It was unique for someone to transition, to become an entrepreneur while also remaining on faculty. But I had the luxury of a lot of support. Every person who even though they thought this was different, they thought there were risks involved with it. And it’s certainly a riskier path than remaining full time faculty and continuing my research program. They recognized that this is what was motivating for me, that this was so exciting and that I could bring the energy and enthusiasm to do something potentially transformational. And so it was worth the risk, and it was worth the chance. And so as a result of that, I’ve been really blessed with a lot of encouragement.
Brett
Wow, that’s amazing to hear. And a couple of other quick questions for you just to better understand what makes you tick. Is there a CEO that you really admire? And if so, who isn’t? What do you admire about that?
Hala Borno
So I’m married to a CEO. My husband, Dr. Jay Batniji, is the CEO and Co-Founder, Weymark, and he’s a serial entrepreneur. He built a business about nine years ago. His first business was called Collective help. And I have learned so much by watching him through his entrepreneurial journey. He also is a physician and made a shift to building companies. And I admire him because while he is, of course, my life partner, he also is my biggest advocate. And so we’re together on this journey understanding the risks and the courage and the grit that it takes to build companies. But we continue to support each other as we move forward in this journey. And I fully admire the fact that he’s been such an important partner for me as I take this new journey and opportunity on.
Brett
Wow. That’s amazing. So you’re both positions turn founders.
Hala Borno
That’s right.
Brett
So you probably have a lot to talk about then, I guess, between those two.
Hala Borno
Absolutely.
Brett
Wow. Very cool. Now, what about books? Is there a specific book that’s had a major impact on you as a Founder? And this can be a business book or a personal book that’s really just influenced how you view the world?
Hala Borno
Well, my favorite genre has always been fiction. However, a book that has influenced me a lot as an oncologist, actually a piece of nonfiction called The Emperor of All Maladies. It’s written by a physician, an oncologist, and a scientist. Sadhartha moklerji. And it’s really the sort of history of cancer. And I think the reason that book resonates with me is because so much of today’s therapy is driven by this. Iterative science moving the standard of care forward one clinical trial at a time. And to me, it really sort of is emboldened me to really understand the role of science and research to improve outcomes for everyone and why it is so critically important that we have inclusive research today.
Brett
Amazing. I can’t say I’ve read that. So I’ll add that to my list to consider.
Hala Borno
Absolutely should.
Brett
Awesome. All right, well, I know this has been a lot of talking about you, and we touched on the company a little bit, but now let’s really go deep. So can you just take me to, let’s say, day one? What is that origin story or day zero? What was happening in the days leading up to launching the company?
Hala Borno
Yeah, absolutely. So I raised as a solo Founder in March of 2022. I raised a seed round led by Lux Capital, with participation by Next Ventures and other notable investors to build a company that would change the way that patients access oncology clinical trials. And this company is a public benefit company, so I have a commitment to really advancing the public good. I see clinical trials as a social good, and that means that it’s only through inclusivity that we can really obtain maximal value of clinical trials. And after raising my seed round, I started building a team. I was joined by my Co-Founder, chief Product Officer Steve Buck, and then others. And we really are a team committed to this underlying mission of advancing cancer precision medicine by driving equitable recruitment clinical trials. So we’re building a product that is a provider facing software that helps providers identify clinical trials that may beneficial to their patients.
Hala Borno
And we also have services, we have technology enabled services, which we call the Ally Navigation Team. And our services are unique because we use something called a social determinants of health framework. So if you don’t know what social determinants of health are, they are the conditions in which a person lives that influences their health outcome. So our navigators evaluate these conditions and then identify factors that may be driving inequity in access to clinical trials. And they intervene on three specific things food and security, travel and lodging. And so if they find that there are key barriers related to those three things, they can provide counseling and support to navigate the patient to the clinical trial site. And we think that is critically important to help improve equity in whom clinical trials are serving.
Brett
And if we just zoom in on the root cause, what do you think is the root cause of this diversity issue in clinical trials?
Hala Borno
A very important question, and with most major problems, there isn’t a single answer, right? But there are major factors. And our understanding is really driven by what the data shows. 77% of patients that enroll in a clinical trial do so because their provider recommended it. So what does that mean? It means that providers are the gatekeepers to clinical trials, that a patient’s probability of being an oncology clinical trial participant is really driven by whether or not the provider brought it up. Unlike other clinical conditions where patients may have more autonomy in clinical decision making, they might be willing to try things or take chances. By and large, in oncology patients really want their provider to help them devise a plan that will take them through their cancer journey in a way that will improve their outcomes. So that’s why our approach is really focused on the provider.
Hala Borno
So our software is providing the provider information to identify clinical trials that are beneficial for their patients. And then once they see those clinical trials, they can identify patients from their panels that are well suited for that trial opportunity. The other piece is that of course, that navigation support. So once they’ve identified those patients, we support their patients by navigating them to the clinical trial.
Brett
Wow, super fascinating. And can you talk to me about the business model if we just ask that simply how do you make money as a business in this entire operation?
Hala Borno
So we partner with study sponsors, so biopharmaceutical companies, we help them achieve the recruitment goals and that’s key. So the study sponsors are financing the research, they are financing the research protocol, the implementation of the research. And so we are a recruitment solution that can help them identify patients and also help them with their diversity goals. So something that’s really important and is talked about a lot right now is the new FDA draft guidances around diversity and inclusion in clinical trials. So there are draft guidances that are requiring study sponsors to be thinking about a diversity plan, to develop a diversity plan, and to determine how are they going to help make sure that their trial is actually appropriately recruiting diverse populations. And this is really important because when you look at the participants in oncology clinical trials today, they do not match the patients who are affected with these conditions.
Hala Borno
And when you have that type of mismatch, there are some serious problems. Well, for one, you might be missing signals of safety across certain populations, you might also be missing signals of efficacy. And those are important as well. You want to know if drugs work in certain populations and don’t work in others. And so this has become an area of a lot more regulatory scrutiny. And so study sponsors are responding to this by trying to tighten up their diversity plans and coming up with an approach to make sure that their trials are inclusive. One thing I want to add though is that this call around diversity is not new. And actually three decades ago in 1993, there was a public mandate called the NIH Revitalization Act that mandated the inclusion of women and racial ethnic minorities in publicly funded clinical trials. So there has been legislation around this, however, there hasn’t been a path around accountability.
Hala Borno
And as a result, we continue three decades later to have the same problems around inequities in home clinical trials serve. One thing that is really interesting, Brett though, that happened after the 1993 NIH Revitalization Act is that it spurred a body of literature, a science called recruitment science. And this is a term that was coined by a social scientist, Stephen Epstein, which really is this idea, this study of why people, especially from hard to recruit populations, decide to become human subjects in clinical research. And so recruitment science is a science that I was engaged in very heavily as an academic and through my recruitment science research program was able to develop a lot of the solution base that we use in Trial Library to partner with study sponsors and help them achieve recruitment.
Brett
Wow. Super fascinating. So it sounds like that’s the why now then, for this platform and for what you’re building right there’s? Pressure, it sounds like, from the regulatory side. And then I think just in the public. Right. I’ve seen a lot of media articles really hammering this problem and talking about this problem. So for study sponsors, I’m guessing this has been elevated to something that’s a very high priority at this point.
Hala Borno
Absolutely, it’s a high priority, and the regulatory pressure has really catalyzed this. But it’s always been the right thing to do. It’s always been the right thing to do, and now there’s more accountability around doing the right fit.
Brett
What does that accountability look like? If they’re non compliant with making this a priority, what’s at stake for them and what’s forcing them to ensure that they are doing the right thing?
Hala Borno
Well, study sponsors are trying to bring new diagnostics, new therapeutics to market, and they have to be compliant and adherent to regulatory guidances to make sure that they’re able to generate the evidence that will bring their asset, whether it be a diagnostic or therapeutic, to market.
Brett
Got it. Okay, that makes a lot of sense. And are there any numbers that you can share with us just in terms of the number of study sponsors that you’ve partnered with or if there’s a specific North Star metric that you really focus on to track and monitor growth?
Hala Borno
Yeah, absolutely. So we’re partnering with large global biopharmaceutical companies this quarter. Again, as I shared, I just raised the seed round in March, built a team, built a product, launching with our earliest customers this quarter. So there’s been a lot of fast movement and it’s been incredible to see this pace of iteration and working with a team that’s incredibly motivated. So we’re launching with our earliest customers, and we have been delighted that there have been a lot of study sponsors approaching us because they recognize that our model is quite differentiated, it’s guided by evidence, and it is really going to help meet some of the diversity plan requirements that are now really at the forefront of their minds.
Brett
And can you talk to us about the competitive landscape? So when the study sponsors are acknowledging this problem, making it a priority, when they’re going to evaluate their options to solve this problem, what does that landscape look like?
Hala Borno
Yeah, there are a variety of solutions that are trying to advance diversity in clinical trials. Some of these solutions are on the operating side. So this is on clinical trial operations. How do you quote decentralize a trial? Make sure that a lot of activities that are required for a trial can actually happen closer to a person’s home, so they’re not going to a central facility and bearing more of the burdens and logistics associated with that recruitment solutions. So solutions that are focused on recruitment alone rather than the operations sometimes are integrated in the electronic medical record. So able to generate lists of potential trials. Those have had some limited traction in the context of Oncology. Oncology has a variety of complex criteria that can make that difficult. For example, criteria may include requiring that a patient has something called measurable disease, meaning that you can see their disease on a scan and you can measure it with a caliper and it meets a certain threshold.
Hala Borno
A lot of Oncology trials are increasingly also genomically selected. What does that mean? It means that there are genomics or genetic alterations that are required to be present in that patient in order for them to be eligible for a trial. Again, these types of more complex criteria can make more automated identification of patients quite challenging. And so that’s why our process, which is really partnering with the provider to help identify patients, is unique and recognizes that oncology is really one of the most complex in our drug development ecosystem. The other piece that we think is important is that our model is focusing on partnering with providers working in our communities. So the vast majority of patients in the United States are diagnosed or treated for their cancer in community settings. A lot of the solutions that are trying to accelerate recruitment are being funneled or are in sites that are more urban academic sites.
Hala Borno
And so we are trying to shift the paradigm where we are partnering with the communities to help them offer their patients these opportunities and not just have the patients that are making it to these academic sites being offered the opportunities that may serve them. So this is really a unique approach and is absolutely necessary if we are going to make sure that we expand the potential participant pool for clinical trials.
Brett
And let’s say five years from now, if the industry as a whole is unsuccessful in improving diversity in clinical trials, what do you think will be the reason why it’s failed and why it has failed to be successful in improving diversity?
Hala Borno
Shortcuts. There are no shortcuts. And I believe that if you want to improve equity in whom clinical trials serve, you also need a component of touch. Okay, technology has a role, absolutely has a role, but you also need a component of touch. And so my research program showed that when you have navigation support integrated in cancer centers or in settings in which patients are receiving cancer care, navigation accelerates recruitment overall, but is primarily in service of more diverse patient populations. And so I realize a component of touch is required if you are to advance health equity. And if you take shortcuts and you lean on solutions that do not include this sort of services component, these shortcuts will continue to be biased and serving a subset of patients. And what do we get? We get biased outcomes. We know that in the era of precision medicine, where we are tailoring therapy for the unique biology of patients in the era of cancer precision medicine, the unique biology of their tumors.
Hala Borno
If we do not address the fact that the data and the science is biased in which we are leveraging to develop new therapeutics, we are going to continue to produce therapeutics that are beneficial for a subset of patients. And really, that means that we’re going to continue to have the haves and the have nots, because we’re taking shortcuts. So I believe it’s about taking a path that is thoughtful, not necessarily taking the shortest path, but being very rigorous in identifying and unpacking and addressing all of these drivers, some of which require human touch in order to advance equity.
Brett
And let’s end on a positive note here. Let’s talk about what this will look like when it is solved. And maybe like the three or five year vision for the company. What do you see it looking like? What lies ahead for you?
Hala Borno
So when you solve this problem of inequity, what do you get? You get more efficient clinical research that’s good for all of us, because it means that drugs and diagnostics that we could benefit from will come to market sooner. Brett let’s think about the COVID-19 vaccine development, where it was a race to develop the vaccine, right? And because of inclusivity, because of engaged research participants, were able to access vaccines faster. And vaccines are a public good, right? They were able to change the pandemic in a fundamental way. So that’s what we need to understand when we think about clinical trials, that if we have inclusivity, that accelerates recruitment, that helps bring new therapeutics and diagnostics that we can all benefit from, and that is what we are striving to achieve.
Brett
Wow. That’s so amazing and so exciting. I’d love to keep you on and ask you another 30 questions here. I have so many things that I want to explore and dive deeper on, but we’ll save that for a future interview before we wrap up here. If people want to follow along with your journey, where’s the best place for them to go?
Hala Borno
Please feel free to join the conversation by going to triallibrary.com. We also have a blog where we add in content to help you further understand our model and how we’re thinking about health, equity and clinical trials.
Brett
Awesome. Well, thank you so much for coming on, sharing your story and really sharing an example of technology being used for good. A lot of what we see out there today is just like a better version of Slack or a better version of email. But what you’re building is there important for society, and it’s just really fun and cool and exciting to hear. So thanks so much for taking the time to chat and talk about everything you’re building.
Hala Borno
Thank you, Brett.
Brett
All right, take care.
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