Episode 125: How to Talk to Policymakers About Biotech, Innovation, and Healthcare Outcomes

Politics got you down? In this episode, we talk about how to engage with your lawmakers and move innovation forward. You're listening to BIO from the Bayou, empowering biotech leaders with the tools, assets, and expertise to improve healthcare outcomes.

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Serving the entire Gulf South, but recorded in the heart of New Orleans. Welcome back to BIO from the Bayou. I'm your host, Dr. Elaine Hamm, the Executive in Residence at Tulane School of Medicine. And today's guest is Srinu Sonti. He's a principal at Lewis Burke Associates, and he is a seasoned health policy and communications professional with years of experience both on Capitol Hill and the private sector. Welcome to the show.

Thank you for having me.

Okay, so how did you get into policy? Give me the journey here.

The journey was definitely circuitous. I came into it after law school thinking I was just going to work on campaigns. And thought that that was the culture and life for me. And then didn't really take to practicing law, didn't, but enjoyed the life of being in a campaign. And then I got very lucky. I got a chance to work for Senator Harry Reid in his leadership office. And this was in 2007.

Yeah.

And at the time, We were working on a reauthorization of the Children's Health Insurance Program. And I only had a notional understanding of Medicare, but the people there took me under their wing. And like anything else, if you show enough interest and you want to do it, they'll keep asking you to do work for them. So I did it.

Good advice.

Yeah. And that led into me working on the Affordable Care Act. And that led to me working on various other health policy bills and then defending the Affordable Care Act. I left and went to work at a think tank here in DC called the Center for American Progress, and then came back to work for Senator Durbin from Illinois. And there I focused primarily on Medicare and Medicaid and Social Security policy. And it was fulfilling. It was enriching. And Seeing how the work comes together, not only from the bench, which you're trying to fund through NIH, but also the regulatory process at the FDA and CMS. It's like riding a bike. The pieces started to fit together. And then when I started to work at hospitals, I got to learn about trials. And then here we primarily work with academic medical centers and universities. So it really is a full circle. Of like my career.

You didn't exactly grow up as a little boy dreaming of working on Medicaid and Medicare and hoping that one day you'll be able to do that.

No, not even remotely. In fact, even in college, there was no chance I was going to law school. I got pushed into it. So it came about because of an interest in, honestly, in civil rights.

Yeah.

In equity, in just equal opportunity. Those are the things that I thought I was going to do with my law degree. And this seemed to hit the mark, but I also worked for members of the Senate that believed in those values too. So, they gave me a lot of room to run, which is great.

Well, and even when I was at the end of getting my PhD, I had contemplated going into policy. There was a AAAS policy fellowship, I believe. Um, I did not get it. I think that worked out. I think that I'm, uh, I don't know if I have the patience or the mouth to go into politics. I don't think I do either. How do you find your zen in that? Honestly, like, that seems like a really big challenge. I have a lot of opinions and the inability to keep my mouth shut. So.

So do a lot of people up there. We'll definitely talk offline about that.

I love it. Oh, we're definitely not recording right now, I promise. Now tell me everything. Well, and so you actually do work for Tulane, and you guys prepare a report for us, and it's been incredibly helpful, especially, you know, when we're— there was challenges. Well, there's always challenges with any new administration, but just understanding and trying to navigate, you know, the NIH changes, the government shutdown, it's been really great to have that, you boots-on-the-ground perspective, but every university has this type of policy piece, right?

For the most part, they do have people who are advising them on what to expect when a new administration comes in. That's for sure. Yeah.

Yeah.

I would say how a university or any institution that takes a hard look at themselves internally, how reliant they are on government funding and what their relationships really look like and where that needs to get Either worked on or sustained is something that we do a lot of, and it's a constant process. You never want to make the assumption that you're in stasis.

Yeah.

You are always going to be faced with these challenges no matter what. Tulane's no exception, but I would say Tulane has a remarkable ability to adapt, and they do a great job of getting to know their local policymakers. I think it's the culture of Louisiana too helps.

I think so, yeah. And it's important for universities to be involved, but it's also really important for scientists to be involved in policy. And that's something that— one of the reasons why I wanted to bring you on is because we polled a room full of scientists at how often they talk to their representatives, and we saw maybe 4 hands, you know, raised. And that's just so— I mean, not uncommon, to be fair.

Yeah.

But it's something that's incredibly important, not just for your own personal research and the things that you're working on, but in general for science and helping people understand and navigate what is a really complicated and hard topic.

I think it's always important to keep in mind that when you are engaging with your policymakers, they want to learn. The only way they can make their decisions, they can do their job, is to get input from the people that they represent. And I mean, broadly across the country, but who they get input from matters a lot. I also think members of Congress take an enormous amount of pride in being able to say, in my district, in my region, we are doing X.

Yeah.

And that involves having them come to the institution, which I myself, more than talking to them in DC, which is great, you should do that. Bring them down to the campus, talk to scientists. The scientists love it, which, and the policymakers love it because they just come from 2 different worlds. But at a bench, we all know you're, if you're working on something that involves oncology, we get that.

Yeah. It feels intimidating. Sometimes it feels a little, mm, that they're not gonna get it or that they, they don't wanna hear what you have to talk about. But I think that's really, I liked what you said about it really being that they take pride in that piece of it.

Yeah.

Especially as you bring federal dollars to your particular, you know, county or your district. You're bringing money into the place that they represent, and that's really important.

That's right. And the more you can do that, the more they get familiar and comfortable. And then you can start to see where, when they start to talk to people that invest money, or when they talk to government agencies, in the back of their mind, they're looking at you, the bench scientist, trying to make strides in, say, a disease area. And it goes a long way to, like, informing their questions.

I contact my representatives quite a bit. Usually it's reactive. On occasion it can be proactive, and we'll kind of talk about— I'll follow up with some questions around that. But the only time that I've had someone contact me back and wanted to have a conversation is when I talked about science and what I did. Because, You know, I'm in drug development and I talk about some of the things that we're working on and how it impacts our small business. And that's when I actually got a call back from a senator and one of my Congress representatives. And so I think that that was a really telling experience for me of just like, oh, you know, they actually really do want to understand this piece better and across the spectrum, not just, you know, working on a cure for cancer, but the small business piece of it too. And that's a big piece. How do you be more proactive? Versus reactive, which is how sometimes I think we feel right now.

I come from the perspective that most members of Congress actually want to be helpful to innovators. I take it out of the lens of you're here because I need money, and I need money to do this amorphous thing that will sit in a publication that could sit on a shelf. That's not the case. That happens. Sure. But I think for the most part, you want to be helpful to an innovator. And especially those who are developing therapeutics and medical devices. Those are exciting.

Right.

But I also think individuals in government want to be able to do a better job of demystifying the decisions that they're making. And so, like, if I am in talking to a scientist, I want to be demystified about what you're doing. I don't need to know about what's in the cell culture. I want to know why this is happening and If I was to ask, what are your plans about going to the FDA? Do you have any? Or are you getting some outside investment? Do you have a company? I think innovators are excited about that, especially scientific innovators. And then for me, I want to see more dialogue between policymakers and founders. So by and large, policymakers who make decisions, they can do a better job of being informed if we're doing more things That involve them being in a room talking to each other.

Right. And so, let's take it from the— you're, you're a scientist within academia. What are some ways that you can engage with DC beyond just sort of, you know, sending out an email to your representative?

Most universities have government relations and communications teams. I think those universities' communications teams are always looking for content. And those are great ways of saying, look, I just filed a patent, or I just worked with this. I presented this paper here in far-off place. There's often European conferences or Asian conferences. I think scientists often underestimate the power of the global reach of their work and the collaborators that they work with. And I think oftentimes policymakers will say, okay, well, this is just what's happening in this one little lab in New Orleans.

Often not. Yeah.

You're presenting it to a global audience. Take advantage of being able to use a broader megaphone available to you by being affiliated with an institution would be the first step. Sure.

So, reach out to your government relations. Are there other titles that they go by?

Yeah, government federal affairs.

Okay. Federal affairs.

Yeah. Yep. And then communications.

Yeah. So, reaching out when you have a publication, when you get a grant, when you're speaking, you know, on a, especially internationally, letting them know that, This is happening.

Yeah. And because video is everywhere, and if the university can put their brand on video, they would love to showcase and highlight faculty that are doing more.

Yeah. Well, what about a startup company? Obviously some similar things, you know, reaching out when you don't have a government affairs person, although I do see some of the larger startups will have started to have more policy or government affair type positions within the companies, but If you're a company of, you know, 2 to 3 people, what's some ways that you can engage in a similar way?

Take advantage of associations that are similarly situated would be one way to think.

Oh yeah, sure.

And because you are a constituent, um, you can always find your member of Congress in your district. So like, if you are doing something, if you are a small business and you want to invite a member of Congress, believe me, when they're in district, they're looking for you and they want to talk to you and their staff would be happy to engage in a conversation with you. And I am a big fan of establishing greater cooperation between academic institutions, investors, and founders. So if you could do it together and team up—

Oh yeah.

And you start to think logically about like what sorts of things that a member of Congress could be asking back in Washington. You're informing them, and you say, okay, well, I talk to people who invest, I talk to people who hold patents, and I talk to people who work on— in science, and they can cooperate and get along. This is what we should be fostering. And it's just a small company of 3 people, but—

Right.

It feeds into a larger ecosystem of biomedical research.

So if you have a press release, or you hit a major milestone, or you get a Don't hesitate to sing it from the hilltops. Send it out to the staffers or send it up. Absolutely.

Yeah, because they want to hear and they want to know that it's happening. And it doesn't matter if your senator is also, like, the most important person in the Senate, happens to be the Speaker of the House. Believe me, the Speaker of the House was from San Francisco. Nancy Pelosi still heard from People in San Francisco inventing things constantly. So, and she talked about that. So this is the kind of thing where you just can't be shy and you can't be humble about it. Please brag.

Yeah. Well, and one of my first experiences in understanding that you can reach out to them around stuff around your business is when years ago I was at a startup company and we had applied for a CDMRP grant and, um, Congressionally Directed Medical Research Program. We love our—

Very good.

Don't we? And there was a government shutdown because right when they announced the CDMRP grant, you know, recipients there, the timing always is around October, November. So that's how it was at that time. And we reached out to our congressperson in our district and said, hey, we got a good score, we're set to, you know, get this, you know, and, and our business is struggling. And so that was a really sort of— It never occurred to me that we could reach out to our, our congressman to complain about a grant that hadn't, you know, come down into our, into our bank account. But the staffer reached out, the staffer came and visited with us and learned more about what our company did. And I, that was such an eye-opening experience of just like, not only did they help, and they also wanted to learn about us too and kept in touch with us. So that was really encouraging.

Yeah. Yeah, because you're definitely feeding into the larger community, and you are demystifying something that they could never— they don't have the academic or the time or the bandwidth or background to even process it. But you're giving them— you're part of their team. And if they see you as part of their team and giving them more information, they will stay in touch.

I like that. Well, and I like the piece that you talked about sort of like going as a team when you're bringing in all of the pieces so that they don't have to connect the dots. And one of the most powerful experiences I had was working with Pew Charitable Trusts. They were taking on the initiative around antibiotic resistance, and it was a program, I think it's called something different now. I didn't really like the name in the first place. It was like Super Mom Against Super Bugs. I was like, I'm not a mom. Uh, so, but the goal was to really impress upon the legislature at that. We had this huge crisis, and we still do have this huge crisis looming up around sort of antibiotic resistance and lack of drugs. And they, one, they gave us sort of a quick sort of dive on how to talk to your representatives, which was really nice and helpful, but they also paired us in the ecosystem in a lot of ways.

Hmm.

So, I was working on a drug. I was paired with someone that was working in a hospital, and then we also had someone that lost a child to the disease that we were working on. And so, the 3 of us They trotted us around to all of these different offices, and we got to share our story and connect all of the dots of the patient journey, the clinician journey, and then the drug development journey. And by the end, we'd had our routine down really, really well. But like, it was really meaningful to us to even see the dots connect, because oftentimes we're in our own little isolated areas of being in drug development or being in the clinic or experiencing the loss or dealing with the disease that we don't see the And the patient, right?

Like, I think when you're in a boardroom or when you're in the lab, seeing that there's a patient, it's more than humanizing. It requires you to maybe put that extra oomph when you don't have it to be like, you know, I'm a part of something here that, yeah, it's late, but we got to keep going.

Got to keep going.

Yeah.

Well, now let's get into a little more sort of philosophical questions I'd love to ask you. Could you share an example of a policy or a program design that you feel like had a real tangible impact besides, obviously, the Affordable Care Act had a huge impact, but something else that you saw a tangible impact on a patient?

Yeah, I have a couple of examples. I'll start with this. And then I want to get your take on this too, because it's something that happens at Tulane. Something that I have struggled with early in my career through probably up until the early parts of the pandemic were the concept of decentralized clinical trials. And for those who don't work on this, this is a very nerdy thing, but it's a—

It is.

It is the issue that Gets that science from the lab into someone's arm. And the improvements in decentralized clinical trials and the rich data that emerges from trial designs that really incorporate populations from different parts of the country— I mean, taking into account greater diversity in age, race, epigenetics, sex differences—

Yeah.

As an example, can help in terms of us being able to create a therapeutic that increases a sponsor or investor's likelihood of getting through the FDA's regulatory process. Keep in mind, the FDA exists for toxicology and safety, right? So—

Right.

But we're creating models to have more people participate. That one demystifies science and probably creates more trust in science, but we've also advanced technology. And that technology, the data management that comes from that, it probably doesn't take away the need for brick-and-mortar trials, but it is a way which, in which we have captured more of the population and we've gotten insight into how we can make more effective therapeutics. To me, we have moved the needle so far because of it, though, because of something terrible like a pandemic, but we took advantage of it. At least industry took advantage of it. And I feel like there's no going back.

Yeah. It can be so hard to Convince patients, though, that are not typically— I mean, the standard sort of white man has been put into clinical trials for decades and decades.

Absolutely.

Getting others to participate in clinical trials, I mean, there's historical distrust.

Yeah.

And it's really hard to rebuild that trust, but also show the benefit. I mean, it's not just a safety thing, it's also you're gonna have a drug that might work better for you. And I mean, that's the other benefit. I mean, if you want to put the money hat on it of like drugs, you know, drug companies wanting to have more diversity in their clinical trials, it's so that they can make sure that their market is going to be impacted or not.

That's correct. That's correct. I want to take your point because it's not only the market, we're talking about the future improvements of, say, a drug that could be built upon.

Yeah.

Where a compound, if improved, you know, generations just one or two removed can benefit. And this is what the companies are really trying to do, and we should be supporting them in doing that.

Well, and taking on one of the things that you mentioned around technology and clinical trials, what are your thoughts around AI these days and policy?

Certainly needs to be safety. I think that Artificial intelligence design is only as good as the people who design them. They're still manmade.

Mm-hmm.

And I think as people with biases, medicine has a history of having to combat biases that we're still dealing with. If an AI model was to come about with safeguards, with an algorithm that takes into account not overweighting or underweighting Again, sexes, ages, different comorbidities, things like that. If we can get smart about making it as fair as possible, we probably advance the ability for manufacturers to get through the FDA process and probably take— lower the cost of doing it. So I'm all for that. But I think that first part does have to get addressed and we have to be more thoughtful about.

Yeah. Do you— how do you think Washington is viewing it? Do you think that it's a little overly optimistic?

Um, yeah, I think it's exciting. I think anything that's exciting is— and new and fresh is something that we should apply it to everything. Well, I think that that's one way to look at it. The other way to look at it is if you did it incrementally and you did it thoughtfully and you tested your theory and you treated it as a tool that you can improve upon, you're probably gonna be in the long run better off.

It just really concerns me. I feel like there's a big push to get away from animal testing, which I really have felt, and I hoped in my lifetime we would be able to move away from animal testing. That has been a huge, you know, dream of mine, but I didn't think that we were there yet. And it feels like there's a big push to Now we're going to do organoids and organs on a chip, and AI is going to be able to do all of this predictive stuff. And it feels way too early for that. I want to get there 100%, but I'm not comfortable taking a drug that hasn't first run the gamut yet.

I agree. And I don't think we— I don't think we do ourselves any favor with people who need to rely on drugs if we couldn't say we have seen this work in a biological system and Its efficacy is at, say, like 60, 70, 80%. I want to make sure that people are comfortable, not only with the products that they buy, but also with the science that went into it. And a lot of times that means, and I spend a lot of time with scientists, that means the trust in the system. And right now the trust in the system does need animal models. And I'm with you, if we can get there and we can hit those toxicology or safety— benchmarks for sure, but right now I just want safe products on the shelf.

Yeah.

And that's just gonna require animal testing.

For now.

For now.

For now. Yeah. Let's talk a little bit about the NIH and some of the challenges we're experiencing right now. There's been a huge effort, one, you know, speaking of the animal testing piece, it feels like they're really pushing us to move away from animal testing and not funding that type of thing. The other piece is not having foreign involvement. And a lot of drug development these days, I mean, well, for quite some time, have utilized, you know, other worldwide international companies and CROs and CMOs.

Mm-hmm.

And frankly, there's a lot of financial benefits for a small company to utilize services outside of the US. But more and more, we're being pushed to only use American companies. How do we navigate that? Because we're kind of, you know, facing cost issues, but also now our federal dollars aren't allowed to be used on anything but the US, and we're an international business, you know?

Yeah. I want to answer it this way, with the caveat that everything in this world evolves. So, I think we've taken a step back in our ability to realize how much cooperation can lead to advancements in science. And what I mean by that is, you're right that we can work cross-borders with scientists who have— maybe operate by a different set of rules. Maybe they publish and you don't see the efficacy that they see. But you know what? You want to learn from them.

Right.

But I always want to make sure that the American public understands you have safety and guardrails in place for a product to be on the shelf or for a doctor to prescribe it. It had to have gone through rigorous tests. And even if you said, well, even in Britain they have their tests, that's just not good enough. In the United States, even though they're very strict in Europe, we— you still have to have it cleared by the FDA.

True.

And there's still post-market analysis and testing that's done. We are a very safe country, but we also don't do ourselves any favors by not exploring what's happening in other parts of the world. And if we cut ourselves off, it's not that I worry about— only worry rather about our competitiveness as a country, because these small startups are going to need to get smart about what's happening in other parts of the world to make investment decisions and to receive capital. But there are also going to be less opportunities for our investigators to do more and to grow. We will hit a ceiling. We've retreated and it's hard to gain ground. It doesn't mean we won't, but it is going to take some time to, even after one year of retreating to and continuing. Yeah. To get back on track, which I hope we do.

Well, so if you could change one federal process tomorrow for safe, equitable access to healthcare or innovation, what would it be? And then on the follow-up, what can our listeners do this quarter to help make that happen?

So I think about this a lot. It's a really great question. The one thing that comes to my mind is we're starting to see 2 tiers, maybe even multiple tiers of providers in this country. And I think we're getting to that point not at any fault of any political party or anything like that. It's just the way we've created a mechanism by which we've develop advanced therapies and technologies like gene editing or CRISPR or CAR-T therapy.

Sure.

But they're done in very specific settings so that, say, like what I can get at an academic medical center is probably not available at a community hospital. I would love to see what policymakers, innovators, and regulators could do to create parity between settings for advanced therapies.

Yeah.

To me, it is critical. If you have a child who could advance from CAR T-cell therapy, they shouldn't be flying out to a different part of the country, uprooting a family's life. We should be able to do that in a community hospital because that's where most people get their care. Go.

Yeah.

Right. To me, we've created a setting problem, but this can be fixed. And I believe that if we put our mind to it and we put innovators around it and say, oh, you want to do gene editing in Say, like, a rural hospital, here's what I'd need. And then say, okay, well, here are the investments that you need. And then get the physicians, be creative about how the physicians can spend time working in those hospitals. I think it will take some effort and it will take money, but it is important. I would change that.

All right. One last question, and that is for our listeners, which are scientists or biotech executives. How do you recommend they talk to their policymakers? Like, how do you— I mean, is it email? Is it phone call? And then when you actually do get a hold of them, what do you say?

It's a human interaction. And make sure that you, first and foremost, those are people that got elected by individuals in your community. If you're meeting your local rep or senator, they're there to learn because they have to make decisions. You're there because you have specific goals in mind, but you're both going after the same thing. We are looking to protect patients. We're trying to make healthcare safer and more effective and easier, more accessible in this country. How do we do that? There's a lot of players involved, but if you simplify it and connect as people, I think often enough you'll find that everyone knows someone who's a diabetic, may have had Parkinson's disease, was in the military and had some disorder, lived with a disabled parent.

Yeah.

All of a sudden, we are all tackling the same issue. Someone's doing it from the law, someone's doing it from the science, but we're all after the same thing. If we can communicate at that level, believe me, you will get much farther along. I hesitate to write very technical talking points for scientists. Often I'll say, that individual went to the same university that you did. They didn't take the same classes or they're fans of the Lakers or something like that. All of a sudden you just connect. Yeah. And then we'll get to what your new therapeutic design looks like.

Right. Talking to each other and seeing each other as people. What a novel concept there.

Yeah.

Probably advice we should take beyond interacting with our policymakers, but with each other too. So feels like a good place to end it there. So, I love that. Yeah. Srinu, thank you so much for your insights, for the help that you provide Tulane and our researchers and ultimately our patients in navigating the healthcare system and helping make diseases a little less scary.

I definitely appreciate this opportunity and I love working with Tulane, so I'm looking forward to our next chat.

Sounds good. As always, we'll have more information about TriNu and LewisBurke Associates in our show notes. Please check it out.

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