Robbie Barbero: Keeping Up with Biotech

On this episode of The Inc. Tank, host Christina Elson talks with Robbie Barbero about the future of biotechnology and the startup industry. With the impressive biotech innovations likely to occur in the next decade, how will policy keep up with the scale of discovery?

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Full Transcript:

Christina: Hello, I’m Christina Elson, and on this edition of “The Inc. Tank,” we’ll discuss the future of biotechnology and the startup industry. We’re likely to see impressive biotech innovations in the next decade. How will policy keep up with the scale of discovery?

Our guest today, Robbie Barbero is the Chief Business Officer at Ceres Nanosciences. Prior to joining Ceres, Robbie was the assistant director of biological innovation in the White House Office of Science and Technology Policy. Robbie, it’s great to have you here with me today in “The Inc. Tank.” Thanks so much for taking the time to come and talk to us about biotech. So, there’s a couple areas that I wanted to talk with you about today because of your expertise, both working in policy but also being deeply involved in a startup company. So, there’s sort of three things. One is helping us understand like what biotech is and how fast it’s growing and what we can expect in the next 10 to 15 years. Another area is like what is this regulatory landscape that biotech companies are dealing with and how is that helping innovation or what are the challenges to innovation? And then third really, like what is your experience as someone who is running this really interesting company, which we’ll talk a lot about in a bit?

So let’s just jump into the first one. So, how do you define biotech? Because this is one of the scariest things that we talk about in “The Inc. Tank” is biotech, you know, space is not that scary, but biotech is really scary. So, how do you define it and what are some of the fears or concerns that you get from people when you talk to them about biotech?

Robbie: Yeah. Well, first of all, thanks for having me. And I would just say I don’t think biotech is it all scary. It’s exciting and that is why I’m in it. I think a lot of the fears or concerns that people have about biotech is that it’s a big, complicated area and it’s a little bit harder to understand than some other areas and frankly, it’s one of the only areas of science or in industry we’re making products that are alive or came from something that’s alive. So, for me, biotech is the use of biology to make products. Okay? So, maybe we’re manipulating biology, maybe we’re just taking something that we grow and then we’re turning it into a product like food. All right? It’s a pretty big space. It can include things like medical devices where you’re going in and putting something into a person in order to help their body be healthier, fix some problem with their body. It can go all the way through agriculture and chemicals that help treat pests and obviously, drugs are a big part of it as well.

Christina: So, digging a little deeper into this definition of biotech, what are some things that you see in the next say, 10 to 15 years that we can look forward to, you know, exciting, not scary, exciting that we can see and look forward to in biotech?

Robbie: Well, to answer that question, I think it’s good to look back and kind of remember where we are in the history of biotech. So, biotech really is only 70 years old. The discovery of DNA, the structure of DNA goes back to the middle of the 20th century. It took us another 20 years or so, 25 years to figure out how to manipulate DNA and then really biotech took off at that point. So, we’re just at the 25, 30-year point of the start of this industry. It’s already a well over $100 billion industry. And we’re in a really interesting time right now because there have been so many new discoveries as far as ways to manipulate biology and understand biology and you add on top of that the ability to take the information about biology and put it into our very powerful computers and do a lot of interesting analysis on these data.

I think that what we’re gonna see in the next decade is just an increasing number of new products coming across the whole spectrum, so crops, foods, organisms that are gonna be making things like chemicals for us that we used to get from oil. We do, you know, still get from oil, but we’re gonna be able to make them from biology, from sunlight and carbon and I think a lot of stuff in the therapeutic space. One of the most exciting things is everything that we’re doing around immunotherapy. So, unless you’ve been living under a rock, you know now that you can take immune cells from people and grow them up and engineer them to go back and kill cancers. We also now have drugs that we can give people to go in and very specifically target cancers by activating the immune system. We’re gonna see a lot more stuff along those areas.

I will just throw one out there because it’s the kind of thing that when I mention it to people, they say, “Wow, is that really possible?” So, there is real money and real science going into the space of being able to fight the process of aging, not just the symptoms of aging. And it goes under this bucket of increasing our health span or our lifespan. So, I don’t mean we’re gonna live for a thousand years, although some people think that might be possible, but it’s more like why do we have to go through this long, slow decline at the end of our life? Sometimes it’s five years, sometimes it’s 15 or 20 years where we’re accumulating these symptoms of aging. There’s now a real possibility that in the next 20 years or so, you can live a full healthy life right up until the very end.

Christina: That’s really fascinating. I mean, you do see that there’s a lot of chronic pain associated. I mean, the doctor told me the other day I can’t wear high three-inch heels anymore. You know, like I mean…

Robbie: I pulled my calf running yesterday.

Christina: Right? So that’s not…

Robbie: So, the last time it happened to me was…

Christina: It’s like…it’s a laugh. Anyways, so yeah, I would love it if we could fix a lot of things. But, yeah, I mean, there’s a lot associated with aging that, you know, slows down people’s desire to be productive. It slows down their ability to engage with their family, you know, and be part of the community. So, we’d like to more fully embrace older people as part of productive society. And that’s a really…

Robbie: Yeah. And we spend 60 years working. Why shouldn’t we really get to enjoy those last 20 years? Getting back to your question about scary, right? I’m not gonna use the word scary, but I think now you have to run the thought exercise on what would it mean if you could live until you were 90 years old and still be fully productive and do everything that a 40 or 50-year-old could do? What does that mean for society? What does it mean for the entitlement programs that we have? What does it mean for keeping people employed? What does it mean for productivity? What does it mean for the use of resources? A lot of interesting questions at a societal and global level that very few people are thinking about. So, if we build these things, which we’re building them, people are investing hundreds of millions of dollars into these areas, what are the implications for society down the road? I mean, as a former policy person, those are the kinds of questions that are interesting when you think about the intersection of science, technology, and policy.

Christina: Yeah, it really is. And it’s something that we want to, you know, being in higher education, we really wanna encourage students going into any of these areas to think about as we have these converging technologies. But let’s talk about your policy experience because you spent quite a bit of time in the Obama administration in a really interesting time spearheading some interesting work on trying to think through how the regulatory structures that we have involving biotech could work well with all the changes in that area. So, tell us a little bit about what that was like. What was a recognition and what were some of the issues that you were thinking to address, trying to maintain this balance between, you know, encouraging innovation and free trade, but also trying to make sure that we’re preparing?

Robbie: Let me tell you a little bit about what my role was in the White House and then you can understand why I took the approach that I did and why this is one of the areas that I worked on. So, I arrived in the White House Office of Science and Technology Policy, which is one of about a dozen policy councils in the White House, which is run by the president’s science advisor. I arrived there in September of 2012, just coming straight out of my Ph.D. from MIT. And this was before CRISPR had even been widely, you know, published or discussed. But there were a lot of interesting things happening, much easier to synthesize DNA, to sequence DNA, even to genetically engineer with other approaches. And they brought me in and said, “Biotechnology and life sciences are gonna be a portfolio that you’re gonna cover. There were other life scientists in the office, but it’s a big space so you need a kind of overlapping pieces of expertise.”

I’d started just talking to as many smart, thoughtful people as I could, saying, “What are the things that aren’t happening that should be happening? Where are areas where we need the White House to spend a little time thinking about trying to tune up the system or improve the system or fix it or build new stuff?” And it became pretty clear that our federal regulatory system for ensuring the safety of biotech products was going to need a tune-up. It was created in the 1980s by the Reagan administration when genetic engineering first became possible and it was tuned up by the first Bush administration, but it hadn’t been touched since then. And a lot of things changed…

Christina: Sure.

Robbie: …in biology between 1992 and 2012. The Clinton administration briefly tried to do something on it, but they just started too late and then had to leave before they got anything done. And so, I started looking at it and I just… I took a classic engineer’s approach, which is let’s assess the landscape, let’s look at what the future might hold for us and then let’s see how well those two match up against each other, and if they don’t, then let’s figure out some things to do. And one of the interesting things about the White House is that you don’t actually have that much ability to make things happen. You can say a lot of things. You can nudge a lot of people. You can make a lot of noise, but…

Christina: Make a lot of tweets.

Robbie: You can… Yeah. I mean, the current occupant I think is learning this, that it’s really about influencing people, not about just saying, “Go do it.” And so, that was what I had to figure out how to do, find out who the people in the government are that actually regulate biotech products and get them to understand the way that I was thinking about this. Many of them already agreed, they were just waiting for someone to say, “Yeah, let’s go do this.”

So, there are three agencies that are responsible for regulating biotech products: the Food and Drug Administration, the Environmental Protection Agency, and the U.S. Department of Agriculture. And so, we needed to bring all of them together and say, “Twenty-five years ago, you guys agreed to do these things. Some of those approaches don’t seem to be working anymore or have changed without you clearly articulating that they’ve changed and it’s just good government if we go out and retell everyone how we’re doing, what we’re doing and then ask for feedback from the experts on what changes we can make.” So, that’s basically what we did. And we didn’t create any new parts of government, we didn’t write new laws. We wrote down on a piece of paper for the first time in 25 years, here’s how this system is currently functioning. And then we put in place a strategy for them to keep doing that sort of assessment and making improvements on it over the next five years.

Christina: So, that’s important because, you know, creating the transparency for how something could move through a system, who’s gonna look at it? And, you know, as you’re saying, just laying out the process also can help you identify if there’s any gaps or areas that, you know, maybe no one’s paying attention to. So, there’s so much going on in these spaces where some of what’s happening is even outside, you know, so you have high school science classes and, you know, biotech hackers and like who’s regulating them? You know, so nobody, maybe, I don’t know. But, I mean, were there areas that you just thought, “Oh wow, you know, we need to put some eyes on that or…”?

Robbie: In this country, it is actually very hard to freelance and do things that are really dangerous to the broader public.

Christina: Oh, that’s good to know. Yeah.

Robbie: Yeah. So, just to be clear. I mean, we hear a lot. The do it yourself biology community is actually doing a really nice job of interacting with the appropriate authorities and they know how to call and how to be in touch with that and teaching their constituents, right, the people show up there. “Here’s the appropriate and safe way to do the things that you want to do.” Okay? It’s also important to remember that we don’t live inside of an authoritarian system, so our government doesn’t monitor everything that we do every day as far as I know.

Christina: Yeah. Let’s keep hoping.

Robbie: And that’s an important principle, right? We create these rules, create these frameworks, and we trust our citizens to do the appropriate thing. And with that framework in mind, what I thought was the most important thing to do was just to write down on a piece of paper. If you’re working on this type of product, here’s the agency you need to go talk to, and we did that. We wrote it down. It was that simple. If you have this kind of product, here is who you need to go talk to. And that’s the way that our regulatory system is really supposed to work. If you’re building something that you’re going to try to commercialize, go talk to the government and say, “What things do I need to do?” And those agencies and the people who work there, many of whom have been there since the system was created will tell you what approach you need to take.

Christina: So, that’s very helpful in the business community trying to understand how to build something in this highly-regulated space in the sense that it’s a hard space to operate in as a business and that’s something that, you know, I’d like to hear more about your own experiences. I mean, talent’s very expensive, equipment’s very expensive. So, how do you, switching over to your role as a business person now, being on that side, how do you operate in this biotech space as a startup?

Robbie: It’s complicated just like every… That’s the word I’ll keeping coming back to in this space.

Christina: Complicated. Okay.

Robbie: Yeah. It’s complex, right? I mean, I think when you’re trying to work in the area that sits at the intersection of health, and data, and things that are living and changing on a daily basis and trying to fix a problem, you have to be able to keep in your mind that sort of balance between a lot of these things that are changing. You can run the same experiment on a set of cells 10 times in a row and you might get a different answer because of things that are beyond your control and so you really have to figure out how to do good solid science. The most important thing in this industry is doing good science. You have to have good science. You have to have good data because that’s what everybody cares about. And you need to prove to your customers, and to the regulators, and to your partners the things that you say you’re doing, you’re actually doing. And that’s actually something that I find really refreshing. There are a lot of places in this world where you can get away without data and facts for a long time.

Christina: Or a product.

Robbie. Or a product. But in our industry that separates the successful companies from the non-successful companies. And then you build out from there. So, how do I find the people who not just know the science but know how to think about it, and understand it, and understand why we are doing that science? And then you decide what equipment you need, and what facilities you need, and what partners you need to get there. It is a longer horizon than a lot of other industries, but that’s because it takes a long time to assemble the right data sets and the right evidence and proof that you’re doing the things that you wanna do. The good news is it means that it’s gonna be almost as hard for anybody else to do that as well. So, I like being in an industry where if I go to sleep at night, I’m not worried that somebody’s gonna catch up with me overnight. There definitely industries where that’s true. If you take a week off, in some industries, a new company can form, take over half your market, do the exact same thing you’re doing, and now you’re a head-to-head competition. In my industry, you do need to run fast. You need to make sure you’re not making mistakes, but you can build off of your progress and you can really build a substantial lead that makes you valuable just based on the work that you’ve done.

Christina: Tell us a little bit about Ceres Nanosciences. What are you doing there? What is the goal?

Robbie: We make a product. It’s chemistry that can improve the performance of diagnostic tests. So, we have a little particle that can capture, concentrate, preserve very low abundance analytes, and by analytes, I mean anything, right? It can be chemicals, it can be proteins, it can be whole virus particles, or it can be DNA. Take that out of a real biological sample, so blood, or urine, or saliva and then put it into an assay downstream or a test downstream. So we don’t make any of those tests. We’re just in the business of improving the acquisition of the data from your body. And this is an important area to be in because as we move into an era of personalized medicine or precision medicine, the quality of the data about you, about your states of health and disease is the most important thing for your physicians, for you, for everybody to understand what kind of things we should be doing to help you. If you don’t have good data sets, just like in anything, garbage in, garbage out is true in biology, just like it is in software.

If you don’t have those good data sets, you can’t make the right decisions. And we realized that being able to turn those atoms, those things that are floating around in your body into the digital information was really important and that very few people were thinking about, “How am I gonna get that data out of the body and into the machine that’s gonna convert it?” So that’s where we focus, is on that upfront from the machine piece of it.

Christina: That converting atoms to bits. That’s cool. Like you’re actually the person that’s doing that.

Robbie: So, yeah. And we don’t actually make the machines that convert it. We just help you give get atoms into the machine.

Christina: Get it. You’re in the interface, right?

Robbie: Yeah.

Christina: That’s cool. So, once it gets into the machine, we were talking a little bit about, again, the quality of data sets and the power, now the computing power that’s available for some of this. So, what are some of the challenges that you all have in terms of getting the samples that you want to really hone the product that you’re doing?

Robbie: Well, this gets back to your previous question about cost. Getting real biological samples is expensive because you’re asking someone for what is essentially or just recently was a piece of their body. And they’re all a lot of rules around the appropriate way to do that to make sure that people understand what you’re gonna do with that sample that they gave you, especially in product development. And there are a whole set of rules for good reason that you’re not taking this information from people and doing something inappropriate with it.

On top of that, you have to make sure that the question you’re trying to answer about the biology can actually be answered by that sample and that’s a hard one to know. So, there’s a little bit of catch-22 here, right? If you’re trying to develop a new test for a disease that doesn’t have a test for it, here’s the thought exercise for you. If it’s not already easily diagnosable, how do you find people who have it, who can give you samples so that you can build the test?

Christina: Yeah, right. Some of these things really haven’t even been defined yet as a disease. Right? So, there’s a spectrum and there’s all this stuff and we’re trying to sort it out. Yeah.

Robbie: Yeah. If 10% of the people who are suspected of having the disease actually have it and you need to assemble a data set of 300 true positives in order to prove that your test works, that means you have to ask 3000 people for their sample and their doctor, and then you have to store it and transport it and do all that stuff. So, it’s a complicated, challenging process.

Christina: So, let’s talk a little bit about what kind of funding is available to support this kind of work because there’s a lot of news about big biotech companies, you know, genetic determinations or, you know, whatever people are doing and lots of venture capital going in there in big rates. And then there’s drugs, right? Emerging drugs. But there’s a lot of other people that are doing things like what Ceres Nanosciences is doing. So, what is the venture capital landscape look like in that area?

Robbie: We sit in the diagnostics area, which is really having a reemergence in the last few years, so I’ll give you just a single data point. There’s a company called Grail. They have raised over $1 billion…

Christina: For that?

Robbie: …in funding. I mean, their vision is like they’re going to be able to diagnose every disease. They’re assembling a massive, massive set of real samples from people in order to be able to try to diagnose every or many diseases you have to collect lots and lots of samples so that you have statistically significant numbers at each time. So, that tells you that there is money in this space and we have a very clear value proposition. We have a really powerful technology and we’ve gotten a lot of receptivity from investors when we’ve gone out because we don’t build the machines. You don’t build the boxes and our product is chemistry and we’re less capital-intensive than a lot of other products and technologies in this space. It’s a great space to be in right now. Biotech broadly is doing great. It keeps breaking records every year for IPOs and for acquisitions and diagnostics are increasingly becoming important because as we, again, move into an era of precision medicine, the drug companies want to know that the drugs that they’re developing are going to the right people. So, the days of just like take an aspirin and your headache will go away. That’ll always be true, right? But as we get into more sophisticated therapies, we wanna make sure that we’re giving that therapies to the people who are most likely to respond to them, and the way that you do that is through more accurate diagnostics.

Christina: So, let’s talk a little bit about the employment landscape going forward. So, you know, you went to MIT, I mean, I’m sure that wasn’t like a cakewalk Ph.D. kind of situation. [Inaudible 00:22:33]

Robbie: It’s a very intense place.

Christina: And then you went into doing some policy for a while and, you know, now you’re in the business community. So, what was that path like, and what advice could you give to other students who are sort of looking at, “Where can I plug into biotech?” I mean, you know, some of them who are doing degrees in engineering-type field, but, you know, there’s other people out there that are just fascinated by all of this growth and innovation in this area. So, what advice do you have?

Robbie: So, we didn’t even touch on this yet, but I actually took five years off between undergraduate and graduate school. So, my first three jobs straight out of undergraduate were in small biotech companies. And it was a fantastic experience. I always tell people small companies are great for young people especially because if you are a hard worker and you are good at your job, you can get much more experience and responsibility in a small company than you can in a large company. Because let’s be honest, small companies don’t have enough people to do the things they wanna do, right?

Christina: Sure.

Robbie: So, if you’re excelling in your role in a small company, you will definitely get more responsibility. So, that’s my piece of advice is, especially if you’re young, go out and find that small company. It’s a little bit harder because those companies don’t have the resources to come to your career fair and really pursue you the way that a larger company would, but you can go find those companies and there are a variety of paths to doing that. And when you find them and you can get in and do that job, take the job. So, my first job was as a quality control associate, which is the least sexy role in biotechnology.

Christina: Right. Sure.

Robbie: Make sure that the thing that we just built works the way that we’d said it’s gonna work and then do it again tomorrow and the next day…

Christina: And the next day.

Robbie: …and the next day, and the next day. But I learned a lot about the way that the business runs because the product is the most important thing in biotech, just anywhere, right?

Christina: Sure.

Robbie: Everyone thinks R&D is the sexy thing, but R&D is just trying to figure out what new product to make. The product that you’re making and guaranteeing that it’s the same every time is the core, it’s the meat of the business. And to going in as a 22-year-old and even quality control and seeing this is how we prove that this thing works the same every time and here’s what we do and it doesn’t work. You know? That gave me a lot of visibility. I got to know the management team really quickly because I was the only quality control person.

Christina: Sure, yeah. And you could help them understand, like where to… Yeah.

Robbie: Yeah. Help them understand, and then they added more and more responsibility as I learned how to do that job better. So, go find that small company, take that first job even if you don’t think it’s the most exciting and sexy one because, trust me, if the company is on a growth path, which most of these companies are, and if they’re not they will shut down. You can find a new one. [Crosstalk 00:25:15] If they’re on that growth path, you will have the opportunity to do more interesting things moving forward.

Christina: There’s a pretty decent abundance of biotech startups in this Washington, DC area, so there are a lot of opportunities for young people around here, would you say?

Robbie: Definitely. Yes, for sure.

Christina: Okay. And it really is a two-way street. I mean, when you are coming out of college and you wanna find that first job, it should be about matching, you know, your goals and values with those of the company and making sure that there’s something there for both of you and not just that, “Well, they showed up on campus and…”

Robbie: “And I recognize the brand.”

Christina: “…then I recognize the name of the brand.” Yeah. I really do encourage as much as I can students to dig below the brand. Right? Dig below the brand. So, there’s a lot of opportunity in this area. What would you like to see happen in the next 10 to 15 years in terms of emerging science in biotech? Like what would be to you a great thing for this field?

Robbie: I’m gonna be really broad here because I’m gonna tell you what gets me excited about biotech every day and has been since I first started studying reading it in college. The ability to reliably predict how a living system will respond to some sort of manipulation, that’s the dream. I mean, that’s what we really want. We can do that for the most part with software, right? We can write a piece of code and then if we test it enough and get the bugs out, we know if you do this, it will give you this answer. If you do this, it’ll give you this answer. The machine learning AIs piece is a little different because we don’t actually know how those things are making the decision that they are kind of teaching themselves, right?

Christina: Sure.

Robbie: But in a lot of fields of engineering, we know what will happen to the system when we manipulate it. We’re not at that point with biology, and especially not at the level of complex biological systems like organisms or even tissues. So, that’s the dream. It would be amazing to just sit down and say, “If I changed this protein, here are all the things that at the level of the organism, they will happen.” I will put one kind of marker down as something a little more tangible and interesting that I think. I think that it would be amazing in the next 10 years if we could grow a human kidney in a lab. There are 90,000 people on the organ transplant waiting list waiting for kidneys. There are not enough people donating them and most of these people have 5 to 10-year maximum lifespans when you’re on that waiting list. It should be possible to solve that problem.

Christina: In the next 5 to 10 years, yeah.

Robbie: Not 5 but I think in 10 years. There are companies working on growing organs, and not just small companies but big companies, including United Therapeutics which is just right here in our neighborhood and they’re starting with lungs, but that’s what they’re doing.

Christina: Well, Robbie, thanks so much for coming in and helping clear up some of this landscape and sharing with us some of the information about what’s exciting in biotech and what Ceres Nanosciences is doing. I really appreciate the time and I look forward to having you come back and giving us an update. Maybe on…

Robbie: I’ll come back anytime.

Christina: Sounds good.

Robbie: Yeah. Thanks for having me. And I’ll just put it in one more plug for the field. So, to all the young students out there who are listening, don’t, you know, without thinking about it, jump into the web IT space, I think that the future and a lot of the most interesting and exciting things and the ability to have a positive impact on humanity are gonna be in the biosciences.

Christina: That’s wonderful. I fully concur on that. Yes. I would love to see, you know, our engineering and in business and computer science students really take a hard look at how they can contribute to this field.

Robbie: Yup.

Christina: Thank you, Robbie.

Robbie: Thank you.

Christina: All right. There’s no roadmap to follow when it comes to understanding biological systems. We’ll continue to explore the financial, legal, and ethical implications of this burgeoning field. Thanks to Robbie Barbero for talking with me today. Until next time, this is Christina Elson in “The Inc. Tank.”

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