Episode 152: “State of the Union” in a Changing Biotech and Science Policy Landscape

As it relates to science and policy, we know the road ahead is going to be a little bit rocky, but hopefully we'll provide you with a compass and a map today. You're listening to BIO from the Bayou, empowering biotech leaders with the tools, assets, and expertise to improve healthcare outcomes.

Each episode provides insights and information to expand your network, advance your product line, and help your company thrive.

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. And you may remember him from a previous episode that we did as it related to science policy. He is a principal at Louis Burke Associates and a seasoned health policy professional with experience in the government as well as the private sector. Welcome back to the show, Srinu.

Thank you for having me.

All right. So since we last had you on, a lot has happened in general, but also in Washington. And I would really love for you to kind of give us a State of the Union for science and healthcare policy as it stands today, how would you describe things?

I would describe things as fragile. I think in overall health policy, I would say our system is being tested in ways we have not seen for the likes of— I can't imagine ever. We're seeing implementation of policies impacting our healthcare delivery system, particularly in Medicaid. That will put strain on the system. At the same time, in terms of science, I fear for a continuous underfunding of our basic science research, which will have direct impact on our ability to generate ideas for translational medicine. Overall science, I think folks that work in applied sciences are doing fine, but for our work, I would say we're at a fragile place. It probably covers the spectrum not only of like biotech, but like where we are in terms of investing in biotech as well, which I know you're gonna, you're gonna get us down soon as well.

Yeah, fragile's a really good word for it because it's not necessarily going to break. There's still hope. So let's talk a little bit about what our listeners who are a mix of scientists and biotech executives, what are some things that we can look towards as we think for the next 6 to 12 months or so?

I would say in the 6 to 12 months, I would be positive about the growth of artificial intelligence and what those AI models really look like as we not only think about delivering healthcare, but what does it mean for the science and developing healthcare? I think what's happening on Wall Street and Silicon Valley live on a separate track than the development of artificial intelligence and large language models in science, and particularly in medicine. We've been ahead of the curve, essentially, as folks that work in biotech for a very long time with the use of artificial intelligence. It's not only made our lives easier, it's also allowed us to do the analytics of science a lot more productively, but deeper. We're able to think about the needs of a patient and the needs of a population in a way that's probably more impactful. And I cannot see that stopping. Whose model creates what, to us, that should almost be a sideshow for where we are.

That makes a lot of sense of AI being a little— I mean, you're right, we have been ahead of the curve in so many ways over the past, you know, decade, honestly, as it relates to the base technology, as we think about NVIDIA and, and what they've accomplished and, and how long we've really been utilizing AI. Now let's switch gears towards, I'm gonna call it traditional. I, I'm not gonna call it old-fashioned yet. I mean, we're still, but let's, let's, let's talk a little bit about how we're thinking about drug development. We've had some new I guess rumblings around not utilizing animals in research, and there's been a push towards different types of systems. What are some of the things that you've heard around that area?

It's interesting. I think the rhetoric gets ahead of the science on what they call new approach methodologies. For folks out there who haven't looked at this, we're really talking about methods that don't use animals, but are also Maybe beyond your in vitro models, we're talking about what scientists would call in silico models or things that can be used in the computer. I'd say across the board, we are not at a place in the lab where we are on the rhetoric and on the scale of where I think the current administration's NIH and FDA are. I don't mean to be bearish on this, but I'll give you my take on it and talking to folks around the country. The essential state of play is we have to start to move towards a place that our reliance on models has to become much more diverse. And that will include not only how we interact with computer systems, but cells. So like organ-on-a-chip, things like that that folks may have heard of, our reliance on anything from a rodent to a non-human primate, our ability to develop the therapeutics needed to really have a better impact or higher impact on patients is still going to be reliant on those models. We're not going to see ourselves, I would say, even for 2 decades, being able to become less reliant than we are now on some of those models. Now, we have seen in the past some ability for scientists to really go to the FDA with proven ability to show toxicology, side effects, things like that. that using in silico models, but it's rare. We really need to see the systems work in place, and we need those animal models. I think the FDA and the NIH have a desire and aspiration to get to a place— this administration, this HHS in particular, really heeds that aspiration. But in the lab, it's really not matching. We do need to use those models, but at the same time, to get to where This administration wants to go with less reliance on animals. We actually need to test, verify, and get smarter. Now, artificial intelligence is a part of that. Advanced computing and chip development is a part of that. But we need the scientists who are willing to take the risks to make that and get that funded. That's harder now, because if we constrain federal investment in basic science, particularly in healthcare, we're not going to get to the point where we can develop these non-animal— models and new approach methodologies. I'm happy to go into further detail, but I think that that's the big picture where we are, rhetoric and science not matching.

Yeah. Is that then an opportunity for us to, as scientists, think about implementing and investing in tying those systems together? Is that something that's more fundable perhaps? Is that, yeah, we know that we're going to still have to do the animal models that the FDA requires us, but if we throw alongside a chip an organoid model and the use of AI to tie those things together. Is that something, obviously that's worthwhile scientifically, but is that something from a fundability perspective that there could be more options for?

100%. And I think you hit the nail on the head there. It is on your fundability more enticing. I think not only with the government, but probably in the private sector as well. I think we're seeing that it's probably going to be even more cost effective, but if you can show efficacy and same rates of success in terms of the biological output that you want, yes, you're more likely to not only get funded, but you're probably going to see more interest in your future work, which is what we ultimately want. We don't want you to live in a vacuum or in stasis. We want you to continue to grow. So, if I was advising a university dean or anyone interested in growing their research expenditures, I would say I would be embarking on a 5 to 10 year program that gets you invested in new approach methodologies. What are you doing? And it's never too late. Even if you're hearing about institutions that have already been doing it for several years, that's fine.

Sure.

The computing power, the ability to talk to your peers, it's all changing so rapidly. You can catch up. But you're correct in saying that now is the time to start really thinking about it.

Are there other types of similar areas, going back to putting your advisory hat on, that we should be thinking about? So we have AI, that makes a lot of sense. These— tying these systems together of really connecting the in vitro to in vivo to in silico to human piece of it. Are there other areas that we should be thinking about?

I don't want to steer the conversation too far, of course. You let me know if that's— this is not where you'd want to go. But if I was to think about this, And it's holistically, we can get the technology. The technology moves, the investments are going to be made. We're getting the non-patient interface work right. The patient interface work, we got to work on.

Yeah.

And what I mean by that is the public health and the surveillance and the population health work. We're really starting to live in this bifurcated system where people who can engage with a larger health system, who see physicians, who have access to care, who are able to basically engage and do the things that we expect them to do such that we know that we're monitoring your health, we can segment them off. There's an entire swath of this country where we are not basically paying attention to their needs until it's too late.

Right.

Or if it's not too late, it is incredibly costly to government health systems and to private insurers. And that's what I mean about fragility in the system. If we can do a better job of perhaps even bringing in some of these technologies to do the population health, maybe do the surveillance, maybe start to engage with people before certain diseases become more onset, we can create an advantage for ourselves to not only grow the research, but we could save lives. And that's ultimately what this is about. So, I think we got to do a much better job on the population health side.

Is that an opportunity then? I mean, as we think about sort of cuts too, as we look at Medicaid, Medicare, I think immediately all of the rural hospitals in Louisiana that are going to be affected. Is that the area that you're kind of referencing here? Is that an opportunity for us to invest in like telemedicine more in this time?

That's exactly right. I think the financial model for some of those institutions like those rural hospitals just won't exist without Medicaid being as robust as it is. or having the coverage through the marketplace where it is. And what ends up happening is we're not going to have people going for screening. We're not going to have people going for testing. Compounding that with vaccine hesitancy—

Right.

Compounding that with other things that come about, it's almost as if we need to rethink who our validators are for actually getting accurate information out. So if a hospital or doctors start to leave, how do we communicate it's important Are we talking to churches? Are we talking to community health centers, schools? We almost have to rethink how we approach catching at-risk individuals or even folks who are healthy now but could be at risk. And I think that's anybody. That's me. I'm South Asian. Prevalence of cardiac disease and cardiovascular disease, rather, and numerous other factors are more prevalent.

Yeah.

I do have to go check it out, and I do. Those are the things that I think just a little education go a long way.

Well, and we also need to be thinking about ways that we can tie into already established systems that people are willing to do. I mean, let's take mammograms, for example, and the opportunity to be able to read a mammogram and also be able to tie in some cardiovascular secondary diagnoses and taking sort of the infrastructure that we already have. Like, you're here, while you're here getting your breast exams, we can take this technology and extrapolate out your risk for cardiovascular disease or, or, you know, that's just an example.

That's 100% right. Like, not only can we do the image, which is important, but let's take a blood sample or a saliva sample and then just take a look. Yeah.

Well, let's switch gears a little bit. Something I'm gonna put my selfish hat on, and that is, I can't remember if the last time you were here where the state of SBIRs have been, STTRs, SBIRs, which are really the lifeblood for a lot of early stage companies. And really the, the sort of the helping hand as companies leave universities and move on into being a company, bridging that gap between university R01s and investment funding. It's gone through some reauthorizations that occurred, and now we're seeing, well, one, there's obviously a backlog that has happened because of that purgatory that it was in for a little bit. So, there's obviously a backlog, but Mm-hmm. there's also this foreign piece. And I wanted to know if there's, you know, something that you can, I mean, we've seen rejections on foreign, if we've been using, you know, a, a large company that has headquarters not just in the US, but in other, other countries like China, et cetera. Is that something that we need to be more cognizant of as we think about our next set of funding?

Unfortunately, we do. That is going to be a prevalent theme throughout the rest of this administration. It's what the administration will call now almost like a foreign risk assessment.

Risk.

Yeah. You're going to essentially go through having to convey why you're not putting the nation or what would ostensibly be a simple research project, why someone who's co-authoring a paper with you happens to have citizenship from a place like China. Or even a collaborator from Germany or the UK or Mexico, I've seen why that STTR may not work. It is alarming. It is happening. We are worse for it.

Yeah.

Because of it. Can we fight it on the government relations side? It is hard. We're really hitting a wall with it, but we have to lean into the idea that When we collaborate, the science gets better for the American public. It supports us. And doing this drumbeat from here until it starts to open up is important. But you're right to relay this because for better or for worse, startups that rely on foreign collaborators are the most at risk. And it's not going to stop, I think, for at least another 2 years.

Yeah. I mean, just knowing that sort of roadmap and knowing a timeframe can be helpful of like, hey, you know, Think of some alternatives in the interim. Think about how you're using your money that is not tied to the government, and how can you leverage government funding to help move your science and your product forward without compromising on— we work in an international business where we're, you know, sometimes the model that we need is in the Netherlands, and that's just the nature of it. But being cognizant of it and knowing the potential, where the potential mines are in the minefield, I think is always— I think that's right.

It's no, it's never a problem to tell a public policymaker that Dutch companies also need to clear drugs in the FDA, and they come to the United States and we have to put them through the same bit as our companies do in Europe. So, Yep. I think there's always ways around it. If you have a listener that's affiliated with a university, your university general counsel's office will often be able to tell you ways of workarounds with, creating different sets of agreements. Not hiding, we're not cheating, we're not trying— no, but the government can show that you're shielding off one aspect of it by getting the intellectual heft that you may have with a collaborator from the UK, of which we know plenty of people who do, or from South Korea, places like that.

Yeah, and I think that that's— we're going to have to think beyond the walls of our labs and our companies to move this forward, and you're gonna have to reach out. Like you, as you said, if you're at the university, have a conversation with people like you. You, Lewis& Burke is obviously helping Tulane. We have our own legal office that can help navigate these things.

Wonderful.

Yeah. And, and if you have, if you're a small company and you don't necessarily have that, I mean, you have the ability to reach out to your, your own representatives. That's something that I have done myself. As you know, I, I have a meeting with my congressional representative Next week. And it really wasn't, I just said, hey, here's some interesting, you know, stuff that's going on. We're hoping to bring money and jobs to our state, and here's our pitch deck. Nothing for you to do, just an awareness. And we have, here are the grants we have pending. And they responded, and they, they sent me to the right person I need to talk to as it related to the NIH and the DOW. And they want to hear about this. We're gonna talk to them about the positive things, but I think we're also going to talk to them about sort of, here's where we're hitting some roadblocks, and that you need to be aware that when things like this happen, this is the consequence. It can slow our business down.

So, keep in mind that that's a great point. Keep in mind that a lot of members of Congress and other elected officials just won't know a lot of these types of very granular Rule changes happen at a very, very specific level and in very technical documents, but they have ramifications that hit local economies. I can't cite a small business or make an innovation park or run a small company with IP that's going to get challenged, or if I can't get an SBIR or STTR loan. And I certainly don't think I can attract a larger company to either invest in me or work with me if I'm at risk. These are the things that if folks on Capitol Hill know, they will be a little bit more worried. I have seen that. They get concerned.

Yeah. It's not a bad thing to just share what you're— I mean, they need to have talking points as well. I think we talked about this on the last podcast. They want to have those soundbites of, This work is occurring in their district, and we have to make sure that we help move this forward. And here are the things and the mechanisms that the government can pull to help make that happen for my constituents in my district. So we have to provide that for them though, and they won't know it if you don't reach out to them. So.

Can I also build on that? There is, there's nothing wrong with also saying, you may think that biotech innovation happens only in San Jose, in Boston and San Diego. That is just not true. We have companies in Tulsa and in Kansas City and in Salt Lake. And it is, I think, frustrating for a lot of us who say, like, some of these therapeutics that you see coming online, yeah, they're coming from large companies and they're coming invested in with investments from New York. They started at universities across the country. We cannot disrupt that ecosystem, which is what we're doing right now.

Yeah. Well, let's try to end on a positive note, or at least some to-dos that we can move forward on. I mean, I would say my to-dos, I mean, don't be scared to reach out to your congressional and your senator and tell them, hey, this is what we're working on. And it just be, we published a paper, we have, you know, this many staff members. I mean, tell them good soundbites that they want to hear of like, here's Here's how this applies to the greater good of our public and hopefully tying it to an economic metric as well. Even if you hear nothing, you've done your part. I didn't hear back from my senator, but I did hear back from my congresswoman and they almost immediately, and they wanted to have conversations. And so do that, invite them to your labs, that type of thing. Anything else that you would recommend as some, some good to-dos as we navigate fragility?

Yeah. In addition to inviting them in and sending them the information that you're doing, Work on, and anyone can do this, you don't need professionals to do this, work on your communications.

Yeah.

Think about what you can do to let people know that the science you're working on broadly. Are you on Substack? Are you on LinkedIn? Be wise getting your stuff out there. People want to know. You may think that your stuff is very technical, but if you're an oncology researcher, start with that. And that level of communication where you are showing that you're not only employing people, but you're actually trying to save people's lives. In an effective manner and doing it in a way where you can now get your voice heard out there a lot easier than we used to be able to do. Before, you had to hire a PR firm and do all those things. You don't have to do that anymore.

I know.

So, please do it. Get it out there. Someone will notice. And when they do notice, those are the kinds of things that you can share, even if it's just a local news story. It's really important for the public to know that in their community, there's science happening. And I think that goes a long way for public policy development as well.

And people want that information. One resource that I have used is something called HARO, H-A-R-O. It's Help a Reporter Out, and they send a daily—

Oh, nice.

Yeah, they send a daily, sometimes like twice a day, here are some reporters that are looking for a dermatologist to give comments on this, an AI computer science scientist to give comments on this, and it's use it as an opportunity I mean, I look at it every day. I've used it for my wine bar. I've used it for my MS company. I mean, it's an opportunity. You never know. So, people want to see these things, and there's people like Help a Reporter Out that want to know how to communicate these things. So—

And if you want to combat misinformation in science, this is a wonderful place to start. That's it.

I love it. Perfect. Well, it's always good to talk to you, Srinu. And, and this wasn't— I have— I'm leaving on a hopeful note, honestly. So—

I'm good.

Well, thank you so much for joining us. And of course, we'll put our things that we've talked about, like Help a Reporter Out and links in our show notes. Be sure to check them out and join us next week on Bio from the Bayou.

Thanks for joining us for Bio from the Bayou, and we hope you'll join us again.

To never miss the latest updates in biotech, hit the subscribe button now.

We'll catch you on our next episode of Bio from the Bayou.

This podcast was edited by Resonate Recordings.