BoB@BIO: Biotech Investing And Deals With Sofinnova's Maha Radhakrishnan, M.D.

This week's episode of the Business of Biotech was recorded at the BIO Convention in San Diego, where guest Maha Radhakrishnan, M.D., Executive Partner, Private Equity, at Sofinnova, spoke about her move from big pharma and biotech to private equity investing, and what makes a late-stage asset deal work. Maha also talks about how China-originated programs are changing development timelines, and where the next wave of CNS and metabolic innovation could come from. 

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Transcript

Live From The BIO Conference

Ben Comer 0:03

Welcome back to the Business of Biotech. I'm Ben Comer, Chief Editor at Life Science Leader, coming to you from San Diego and the Bio Conference. The annual bio conference happens every summer. It's so big, P. T. Barnum would blush probably if he uh if he visited uh Bio, but it's uh a great time to speak with uh experts from across the entire life sciences ecosystem. And I'm thrilled to speak today with Dr. Maha Radhakrishnan, MD, uh executive partner at Private Equity at Sofinnova. Um Maha is an experienced biopharma executive. Um she has worked as a global CMO at Biogen and SVP and global head of medical, um, global medical at Sanofi's primary care uh business unit. Um, after Sanofi acquired uh Bioverativ, Bioverativ, um where you worked in several different leadership roles, I believe. Um, just prior to joining Sofinnova, she was a consultant to the CEO at Dyne Therapeutics. Uh she's on three panels at Bio this week. And because the episode uh that we're recording right now will come out after the conclusion of Bio, I thought Maha could give us a preview of some of the discussions uh to come over the next couple of days. Um I'm also too excited to find out kind of broadly what's happening in the deal space uh in biotech and life sciences, um, what Maha is looking for at bio and looking forward to uh in the future. And um I'm thrilled that you're here. Thank you so much.

Maha Radhakrishnan, M.D. 1:43

Thank you, Ben. It's a pleasure to be here. Thanks for the opportunity.

Ben Comer 1:46

Absolutely.

Learning Medicine In Russian

Ben Comer 1:47

I wanted to start out with uh your background. I I saw on uh maybe it was LinkedIn or or one of your bio pages, uh, that you had, I think, uh a master's degree in Russian languages and study and got your um doctorate degree, your PhD uh in Russia. Uh how did that come about? Um, you know, are you still fluent and uh um keeping up with uh with Russia, the Russian language?

Maha Radhakrishnan, M.D. 2:13

Yeah, thank you, Ben. Yes, yes, I do have a master's in Russian, and I'm certified to both teach and interpret the language because I did my medical school degree in Russian, so the medium of instruction was Russian. How that came about was pure serendipity. It was uh an exchange program between India and the Soviet Union back then, and it was a scholarship completely paid for.

Ben Comer 2:35

Oh, that's cool.

Maha Radhakrishnan, M.D. 2:35

And it really helped my patient, my parents, because um at that time we were not really doing too well financially, and uh it almost had stopped my dreams of being a physician. I've always dreamt of being a physician, and so this gave me the path uh to do that, but also in addition to that, going into a new country with the language I did not know anything about, did not speak it, um, appreciating the nuances of the language, the culture, the cuisine, the people, and also really um blending into the diversity of what USSR and then which became Russia offered for international students like me was quite an eye-opener.

Ben Comer 3:11

Has that uh ever helped you in your life sciences career? Uh, that that Russian knowledge you've had, you've held a number of uh of global positions, um, so I'm sure that it probably has.

Maha Radhakrishnan, M.D. 3:21

Definitely. It just made me much more um cognizant of the diverse perspectives that people from different walks of life, different parts of the globe can be bring. How people think, how people associate, what different cultural views are. It relates to medicine, healthcare, how do patients view, you know, even simple things like injectables in Asia are something that are accepted. You know, and patients think that in order for them to get better, getting an injection may be actually a better way, much more potent. As opposed to, I would say, in other parts of the world, people think, I would like a tablet. Sure. I don't want to be injected, I don't want to poke, you know, I should be fine. So I think even those little cultural norms play a big role in really understanding, as because as part of my career, I've been part of uh 16 different launch teams. I've been fortunate. Um, really thinking about the commercialization aspects of what would fit well in terms of patient acceptance, physician acceptance, how do you position products in the market in terms of cultural nuances? Is this a US-only program? Is it a global program with Europe and parts of Asia? Will this be launched in countries like China and Japan, etc.

Ben Comer 4:27

Sure. Um what was your first foray into life sciences? You got your your um your doctorate, you became an MD, and then what what kind of pulled you into drug development?

From Clinical Practice To Pharma Impact

Maha Radhakrishnan, M.D. 4:38

It was again, I will, you will see that I used the word serendipity a few times during our chat this morning. Um I did not really know what it meant for a physician to be working in pharma. You know, uh all along I thought I'm trained to be a physician, it's going to be actual patient physician care that I'm gonna be focused on and clinical practice. And uh very um serendipitously I was headhunted, you know, to kind of say, consider an opportunity on the pharma side. And uh, you know, I was applying for my boards, had cleared my boards, and I said, let me take a sabbatical to understand, you know, what it really is. Six, nine months in. I may say, okay, I'm gonna go back to getting to my programs. And uh it gave me the chance to really um join Reed Alsevier back then as a publications leader for what was then the Risperdal franchise at Janssen. So that was my first foray into psychiatry. Uh, really appreciating the nuances as an internist cardiologist, psychiatry is not front and center. Again, no offense. Today I think like a psychiatrist, I act like one, I act like a neurologist more so than an internist cardiologist, because fast forward 22 years in pharma, I never looked back. I feel like the impact that I could have made as a physician, uh, you know, kind of managing patients one-on-one on a daily basis, uh was not, could not have been as much as the impact that I have been able to make through my career on the pharma RD and commercialization side. Because someone the other day on our company was really looking at the number of patients that potentially could have been impacted or served by the number of launches I've been fortunate to be part of. It's upwards of 85 million patients globally. Wow. So I just feel humbled. You know, I feel like I've been honored with this opportunity to be able to serve so many patients. So clinical practice was just the was just the shining gem I went after. I did not realize what pharma RD was. And it just gave me the platform to think like a physician, but with the business lens on, with the corporate lens on, thinking about patient outcomes, thinking about patient peer needs, thinking about how to launch and uh how to be successful.

Ben Comer 6:45

Yeah.

Maha Radhakrishnan, M.D. 6:46

And it uh it really kind of I would say uh has helped enrich me as an as a as an individual as well.

Ben Comer 6:53

I mentioned uh BioVarative, I mentioned Biogen and Sanafi. You've worked at Biogen twice, I think, in two different periods. You also worked at BMS, um BMS twice as well. And we we actually had uh Al Sandrock on uh on the business of biotech uh a couple of weeks ago. He maybe you did you take his job when you came into biogen?

Maha Radhakrishnan, M.D. 7:14

Al is my mentor, he's my role model. I look up to him, he's my guru, as I say. Uh he was the one who was part of my interview team the first time I joined Biogen in 2013. He was part of my person, he was one of the leaders who brought me back to Biogen in 2020 as a chief medical officer. He is a visionary, a true visionary, but one of the incredible human beings I've had the chance to interact with. You know, so full of knowledge and wisdom, but also just one of the most humble people I know.

Ben Comer 7:42

Well, let's uh let's bring it up to um to Sofinnova

Moving From Operator To Investor

Ben Comer 7:46

Uh what made you decide to transition away from internal company operations to the private equity side?

Maha Radhakrishnan, M.D. 7:54

Yeah. You know, I've I'm I'm I'm a very curious person, as you see. You know, I'm someone who uh loves to take uh calculated risks. Uh I would not say jumping off a cliff, but uh being able to be thoughtful about, you know, uh what else could I be contributing to, what else could I be learning? You know, this lifelong learner in me, you know, I've been in pharma for 22, almost 23 years, pharma RD, payer, startups, as you said. But then the one thing that I felt I had not done, which would kind of bring me full circle, was really understanding what it meant to be on the investment side in terms of private equity. You know, it's not more the public as much as the private, because it would have gave and I would say now, I started talking to people, many different companies, one of which obviously was Sofinnova Investments. I took with I spoke with our general partner, Maha Katabi, and uh was just um thrilled to be and inspired at the same time to say, okay, what has her experience given her and how has she come along? She's just a core investor for 25 plus years, and I've learned tremendously from this kind of opportunity to join Sofie Nova. And I am thankful that they chose to bring me on board. I'm thankful that with zero investment experience, they said my role as an operator in Pharma would be invaluable to this organization, which is also what sets Sofinnova apart. So if Nova Investments, we have a group of executive directors, and each one of us brings different aspects of drug development and commercialization, different therapy areas of expertise. Collectively, we've launched more than 50 different products. I have been able to, as I said earlier, 16 products, uh launching 16 blockbusters. And uh I think this also in many ways shows why Sofinnova Investments has had a track record of 38 product approvals with the FDA amongst our portfolio companies. So we stand number four in terms of industry product approvals. No small achievement. It is just incredible. So I feel pretty proud that I was able to join this group of individuals who work tirelessly.

Ben Comer 9:55

So do you have a specific portfolio at Sofinnova? Is there a sector of the industry that that you're most focused on? And I don't know if it's modality or company size, but yeah.

How Sofinnova Invests In Clinical Stage

Maha Radhakrishnan, M.D. 10:07

So it's not company size, it's uh let me just tell you a little bit more about Sofinnova investments. It's actually our 50th anniversary this year.

Ben Comer 10:14

Okay. So congratulations, Sofi Nova.

Maha Radhakrishnan, M.D. 10:16

Thank you, thank you, thank you. Uh so as a company, we're focused on clinic stage investments. So when I say clinic stage, what that essentially means is six to nine months from an IND, having a TOX package that kind of allows us to really put a good assessment into from a GLP chronic talk standpoint, what does that mean? Uh we are therapy area agnostic, okay, platform modality agnostic. So do a via if you look at a pie chart of our investments, it starts off with you know oncology, CNS, immunology inflammation, um, CBRM, so cardiovascular, renal metabolics, and rare. That kind of completes our pie chart. We don't invest in the infectious diseases space because we've done that in the past and we feel like the opportunity is more in the other areas. Uh, we usually like to lead or co-lead investments and come on board as board directors or observers. The size of our checks are usually anywhere from $15 to $25 million to begin with. And once an investment in a company is made, we usually have our chief financial officer make allocations so that as the company progresses, we do have funds to be able to allocate. So over the course of the life cycle of the company, whether it be taking it public or whether it be pursuing the MA strategic path for a transaction, we go anywhere from $90 to $100 million in total investment in the company.

Ben Comer 11:33

And so the asset is the kind of the entree and the Sofinnova. Is that how you would uh a company would get on kind of in your in your view is that the asset, it could be a platform. Okay.

Maha Radhakrishnan, M.D. 11:44

You know, a recent investment that we made in this uh, you know, very, very uh intriguing company called City Therapeutics is uh on the platform, right? So they have programs coming in in the clinic, coming to the clinic, uh in the canonical, GalNAc-siRNA space. But what is even more intriguing to us is the novelty of the City RNA platform, which allows delivery of programs not just to the liver but extrahepatic to other tissues like in the CNS, in the eye, in the muscle, uh to the adipose tissue. There's a lot of talk about you know being able to impact fat and not the lean muscle. Right. So again, we have quite agnostic, and sometimes we invest in assets, single assets. Sometimes we invest in companies with multiple opportunities to build multiple programs based on the uniqueness of the platform they have or the modality they have.

Late-Stage Asset Value Starts Early

Ben Comer 12:34

Let's talk about um maybe some of the panel topics that you've got coming up in the next couple of days. Uh the first one that I wanted to ask you about is I think on the subject of maximizing the value of late stage asset deals, correct me if I'm wrong about that. I think that's kind of the line that it's that it's taking. So um what I guess would you say uh about that? You know, what what makes a good late-stage asset? Uh what kind of uh deal aspects are are you looking for? Are there things that uh where companies go wrong in making these kind of uh late-stage asset deals?

Maha Radhakrishnan, M.D. 13:08

Thank you for the question. First of all, I have to say I'm thankful to the organizers. In this case, it's Estela's pharma who's supporting and sponsoring this panel. And and the topic is very relevant, you know, not just for today, but for all times to come. And when you talk about late-stage asset, you talk about deal valuation, you always need to kind of go back in time and say, what makes a late-stage asset attractive? And that's where, you know, when we come in, for example, in series A or when we start talking to companies, we say, this is great science, but now let's talk about how are you going to build a narrative of making this great science a reality? Of how how do you kind of really potentiate the value of this program? What could be the target product profile or TPP of the asset you want to move forward into? So that's where we start thinking about you want to move an asset in a specific area. Is there a clear unmet medical need? Right. How big is a need? Is this a saturated market with too many? Are you going to go be first in class or are you going to be a best in class? We don't want me -to's. So you really want to have a profile that's differentiated, which is why carving out an aspirational target product profile at the very get-go is super critical. And the target product profile then evolves over time as new data from the asset comes through, from the program comes through. What we also then tell is is there a clear, clear clinical development path? Or are you going to go into unchartered territory to really be able to have discussions on novel endpoints, novel outcomes? And it's not that you can't do it, you can, but it's good to have awareness of that at the very get-go. And then combined with that, clinical development path is the regulatory landscape. So are there precedents in the space, or do we need to really again go forward and uh champion some new dialogue with the regulators to be able to really build a new regulatory plan to go forward? All of these three things unmet need, clinical development pathway clarity, and regulatory clarity, then kind of funnel into what we call as probability of commercial and access success. So commercialization on its own doesn't stand. It's always about are you able to have a dialogue with the payers to be able to justify the value proposition? Are you able to really carve out a premium approach to pricing because of certain aspects of the outcomes data that you've generated? Is it just clinical outcomes that are statistically significant or can you make them clinically meaningful? Two physicians, two payers, two patients. What role does patient reported outcomes play in all of this? How do you then talk about creating a dossier for the payers that will help them really think about the added value of this program over and above what's already being reimbursed in the current market by the payers? Okay. So, you know, so late-stage asset development is a fascinating topic. So I'm really looking forward to this topic in terms of how each of us plays a role. And this is where a company like Sofi Nova Investments can come in, because we have what we call as operators like myself who tag team and come to the boards of all of these portfolio companies we invest in to really give them advice along, as I said earlier, you have the science, you're thinking you're going on a certain path, let's make sure there's a clear unmet need, clinical development path, a regulatory path, and let's, as we move this, let's think at what point do you want to get the payers involved to engage with them and think about what outcomes would matter most to payers. Integrate those outcomes into your phase two, phase three program. So when your data reads out for regulatory submission, you also have the data package for payers.

Ben Comer 16:40

So when you say when you're talking about late stage asset deals, this is from the investor perspective or from the big pharma perspective?

Maha Radhakrishnan, M.D. 16:48

It's more of a pharma perspective because we come in pretty early. We feel like coming in too early, but we do guide the teams. We are there with them every step of the way as they move the programs along to late stage. But you know, um, as and and there are folks from big pharma on my panel as well, which is what would make it really interesting. It's what are they looking for in an asset? How do we make sure that what they're looking for and what the companies offer doesn't match? Right. And that's where investors like us can come in and help guide in terms of if you're looking for a certain value proposition on a target product profile, how do you then start thinking about it early on?

Ben Comer 17:26

Okay.

Maha Radhakrishnan, M.D. 17:26

And then we also help the companies to say, okay, if you want to take the public route or if you want to take a two-pronged approach of a public pathway and or a strategic transaction, at what point would that be right? How do you create those value inflection points?

Ben Comer 17:39

So from the big pharma or you know, pharmaceutical company perspective, a late-stage asset, you're looking at phase three.

Maha Radhakrishnan, M.D. 17:48

And the phase two is a situation.

Ben Comer 17:51

So it's looking at finishing the development, not necessarily just a commercial deal, not like a licensing and approved product, or it could be.

Maha Radhakrishnan, M.D. 17:58

It could be. Okay. It could be. I mean, you've seen companies do um, you know, for example, um licensing deals of products that are in the market, mostly XUS, but sometimes in the US as well. It all comes back to where is the pharma's pipeline, where are the gaps, and how do they want to fill the gaps? Are there opportunities that the pharma are able to take a look at, which they think is promising enough to fill the gap in their pipeline?

unknown 18:22

Yeah.

China Deals: Speed With Warning Flags

Maha Radhakrishnan, M.D. 18:23

People make the choice.

Ben Comer 18:25

Well, that's a good segue, I think, to the second panel topic I wanted to ask you about, which is uh China, China deals, um, doing deals uh with Chinese biotech, whom uh unless you've been living under a rock, you know uh Chinese biotech has really exploded onto the scene in the last couple of years with uh some really incredible science and a lot of it. Um but there's you know still some risks there with the way that um FDA, the U.S. in particular thinks about Chinese clinical data. There's pending potentially regulations, the Biotech Investment National Security Act, which could possibly dampen some of the activity. We don't we don't know yet. Um but uh what what would you say about what's happening, I guess broadly, what's happening in China and what it means for the you know the global biotech ecosystem.

Maha Radhakrishnan, M.D. 19:17

I mean again I'll start with my views on it as a physician.

Ben Comer 19:20

Okay.

Maha Radhakrishnan, M.D. 19:21

I think what's happening in the global ecosystem in terms of innovation and moving forward, good, fresh science is great. It's very invigorating to see that there's so much happening at the end of the day, you know, who have who benefits is the patients we serve. Right. But but when I put on my hat as an investor, I would say that um there's a lot coming through from China that we obviously take a look at, but then there's also a lot that we are screening through. There's a lot that we say, not really. Uh I would say there's a lot of um uh engineering happening, protein engineering in terms of innovation, we are not yet seeing quite a lot. Um there's a lot of innovation happening here in our own country, sure, which I'm really proud of, and we continue to kind of seek out those opportunities to make investments. As it relates to China specifically, uh quite a few things have changed in the last five or so years, right? One is the quality of data coming through from China has become global regulatory quality. So, from the standpoint of regulators like FDA and EMA, they're becoming more and more open to reviewing the quality of the data packages coming through clinical packages.

Ben Comer 20:25

Is that true for manufacturing as well? So I'm relating to that.

Maha Radhakrishnan, M.D. 20:28

That's why I said quality clinical. Okay. Um so thank you, Ben. I mean, you know this better than I do. Um, so um, that's one. Secondly, is the speed at which the studies can be conducted, earlier stage studies. Again, I want to caveat that. Uh, and the costs. So the costs are about 25 or 30 percent, maybe sometimes even 35% lower to do those early stage testings. So, what I see is happening is there's a collaboration happening. So there's a hybrid movement to say certain aspects are conducted in China, certain aspects are moved X to make it either global or US or Europe-centric. So, uh, for example, your phase one studies to get quick POCs, a proof of concept as we call it, understanding the PKPD dynamics, the translational aspects of potential biomarkers to study, to predict patient response, prognostic and predictive biomarkers, initial tolerability and safety signs. These kind of studies can be quickly done in China, even countries like Australia and New Zealand. There's a lot happening. Yeah, absolutely. So these packages coming out of entities that are not US or Europe, these packages then then can be moved here. Again, patient-specific clinical data packages. Now, coming to the question you raised, there still remains quite a lot to be clarified, a lot more work to be done as it relates to CMC aspects, as it relates to IP and overall quality control. And I was part of a panel yesterday, the Bay Helix panel, which I actually did allude on these topics as well, and it was my my colleagues on the panel agreed because we had. Big Pharma, we had BMS, VDMD Serrano, I had a fellow investor from Foresight, and I had a fellow biotech entrepreneur CEO from Pilates Bio. Is that the focus of the Chinese, I would say, clinical development landscape or entrepreneurs should be not just saying I have a lot more patients and the quality of my data coming out is great, but also things like aspects of CMC, aspects of freedom to operate, or FTO as we call it as relates to IP, and overall quality. You know, those are the aspects that are also being flagged by regulators.

Ben Comer 22:34

Well, uh yeah, I think there's a recognition of the opportunity and what's available in China. Or would you say that those are some of the biggest risks or dangers right now? Is that the same thing? Those are those are flags.

Maha Radhakrishnan, M.D. 22:46

Those are flags, uh, which is why, you know, what we as a company also do is usually when we identify some assets that we think potentially could be good ones from a differentiation standpoint, are always the goal is to say, okay, are there opportunities to potentially create new courts where we incorporate the company here with a new leadership team to be able to do the you know, kind of manage and execute on these programs in the way we would think it has to be. Obviously, the syndicate that's formed from an investment standpoint, it's a syndicate of uh they come on the board, help guide, and uh otherwise we say, okay, are there opportunities to bring assets and put them into our portfolio companies? You know, so um there are lots of different ways that we look at it, but we feel that uh bringing in assets. A recent example being uh the company called Expedition. Maybe we brought in a DPP-1 inhibitor from China, uh, created this company called Expedition to study the program in both COPD and bronchiectasis in the lungs. So again, um lots of success stories. Aeolus was a company that we had created as part of one of our portfolio investments that was that went on to be acquired by GSK later on. And um, you know, again, we've got examples in terms of Synccor, Baxtrostat, which is Baxfendi, which is with AstraZeneca now, another success story of one of our portfolio investments of an asset coming from outside the country but developed here and um getting into a global platform

New Biotech Operating Models

Maha Radhakrishnan, M.D. 24:10

right now.

Ben Comer 24:10

That reminds me of something else I wanted to ask you, which is about um biotech business model and maybe China notwithstanding. Are there any new, and you may have just suggested one or two uh in that uh in that response, but are there any new models? And I guess I'm talking about biotech operating models or business models that strike you as compelling or or interesting?

Maha Radhakrishnan, M.D. 24:34

Uh I think I I alluded to the new course just now, right? I think it gives you the opportunity to bring in a team of experienced individuals in global drug development and be at the helm of the company to really thoughtfully uh and uh in a more uh agile manner move the programs forward. So that's one. The other business model, again, I alluded to that, is to say what is the current set of existing portfolio companies? Are there opportunities to build on their pipeline in terms of adjacencies or orthogonal mechanisms that could be built into the portfolio companies? That's always something we're looking at. I think both of these models are equally exciting from the standpoint of taking the company public or potentially going down the transaction path, you know, with pharma companies. Um, you know, models are constantly evolving. You know, sometimes people, you know, we don't do this, but I've seen some companies have the hub and spoke model. You know, uh I would say one of our portfolio companies, Vega, just recently got transacted. It was part of the company under the Star Therapeutics Umbrella. We were pretty happy about it. It's in the Wan Willebronn disease area. Excellent team of individuals. And so, yeah, there's lots of permutations, combinations possible.

Ben Comer 25:40

Um

CNS Frontiers Alzheimer’s And Beyond

Ben Comer 25:41

let's uh let's run the full gamut and talk about the third panel that you're gonna be on, which I think is on the topic of frontiers and CNS. Uh what and you and I I don't recall if this was before we started started recording or not, Maha, but you said that you think now like a psychiatrist. And so uh and not less so as an internal cardiologist, more so as a psychiatrist. Um what excites you about uh the CNS and and neuro CNS space and neurology? Or are you on board with the psychedelics that are being developed? Are there other mechan No, you're not.

Maha Radhakrishnan, M.D. 26:17

I am, I so I would say uh I'm gonna break it down, the question, right? So, yes, so when I was doing my medical school, when I came out as an internal cardiologist, my passion was different. I did not, I mean, I would say, you know, neurology, psychiatry was not an area I was deep into in terms of knowledge, in terms of passion and interest. But my my interest and passion was just ignited. You know, I was so inspired by the work uh BMS was doing when we launched, when I was part of the launch team at BMS launching a Bilify. This was the fifth or sixth eight typical anti-psychotic in the market. Um, no one really appreciated the value it could bring. Uh, the team there, and I give uh complete kudos to BMS to making me who I am today because I was my first entry into pharma. All along I've learned from every every every position I've had within every company, but it foundationally made me who I am.

Ben Comer 27:04

I was gonna ask you what your favorite uh company was.

Maha Radhakrishnan, M.D. 27:07

All my companies are favorites. I don't want to end up having, you know, but I love each, as I said, each company has taught me so much that I'm hopeful that as part of my current role, I'm able to give back from my lessons learned and best practices. But BMS really opened my eyes to what it takes for a practicing physician to really come on board and be part of the RD commercialization team to launch a product, think about life cycle management, think about differentiation. The mechanism of action was unique enough, partial dopamine agonism, but the implications of that as it related to the metabolic side effect burden of atypicals on the market was quite something. So opening up the doors to work with the American Psychiatric Association and American Diabetes Association was unheard of, which we managed to do while we were at BMS working with our partner, Utsuka, which was a joint alliance. And um, I would say it really helped build my love and passion for neuroscience. Not just that, I think neuroscience is an area where there are more questions than answers.

Ben Comer 28:03

Absolutely.

Maha Radhakrishnan, M.D. 28:04

Cardiology is uh an area of medicine where you have hard surrogates, good biomarkers, yeah. Good biomarkers, you know it. And you're able to assess what the product and the the medication is doing in the patient much more clearly. It's not as vague. Uh and so, you know, I'm sure you're the same. The curious person in me says, Why so many questions and why not too many answers? And what can I do to get those answers? So from there, obviously my pharma career took off uh twice at BMS, as you said, twice at Biogen, was able to launch products, fortunate enough to launch products like uh Tech Federa at Biogen, be part of the journey with people like Al Sandrock and many others, John Cox uh at DIE at uh not just at Dyne, but also BioVerative. He was my CEO at BioVerative.

Ben Comer 28:47

Oh, he was, okay.

Maha Radhakrishnan, M.D. 28:48

He was. And I've learned a tremendous amount from him as well. Uh continues to remain my mentor. So I would say neuroscience is part and parcel of who I am. I do have my cardiologist in me that'll never go. I love it, internist, but I think like a neurologist and psychiatrist now, thanks to my mentors and the roles I've been in. So today, you know, and this panel for me is even more important from the standpoint of what's going on and what the future holds in store. So if you look at just the neurology space, my fellow panelists are going to be from BioArctic and Alcecure as well. So you know there've been some amazing uh press releases in terms of collaborations Lily has built with Alcecure on the Gamma Secretase modulator program to really understand what could a modulator do different from what we have today from the amyloid lowering therapy approach. And also Lily has signed a deal with BioArctic to look at the blood-brain transport technology to bring in the a new target jointly to say, okay, what can we do to really get to the frontiers of neuroscience? So hats off to all three companies for really helping further, you know, what is needed in this area of neurology.

Ben Comer 29:55

And of course, Al Sandrock is working on uh gene therapy. Targeting Tau, yeah. What do you think of that?

Maha Radhakrishnan, M.D. 30:02

I think it's very, very intriguing. I think the Bib 80 program, you know, uh with the looking at Tau is just the starting, just the beginning of what is possible. And we all know that Alzheimer's is uh is a very heterogeneous pathology. Right. It's not amyloid alone, it's not tau alone, it's a combination of multifactors, vascular, microglia, anything else. So it's at the end of the day, it's going to be a combination approach. So the more assets we have with a much more favorable safety tolerability profile, the better off we are. So uh I applaud um Al and many others who are in the Tau space. Obviously, you know, you have companies like Roche and Lilly and Biogen and Asi and uh not giving up and GNJ. So I I think this is this

Psychedelics And Next-Gen Psychiatry

Maha Radhakrishnan, M.D. 30:44

is great. So you asked me about psychedelics.

Ben Comer 30:46

Well, are you more focused on neurodegenerative diseases, or are you also looking at mood disorders and things like that? Because I asked you all because I asked you about psychedelics, which is an area I'm interested in, watching it, how this is unfolding. You also have things like RFK Jr. saying that SR and I, or um what did he say? A lot of the depression meds shouldn't be prescribed SSI. Thank you.

Maha Radhakrishnan, M.D. 31:11

Yeah, so we are, to your question, we are looking across the spectrum. So neurology is one, neuromuscular disorders is one, rare is one within neuro, and then psychiatry, neuropsychiatry. So even though we have so many approved products for schizophrenia and bipolar and depression, again, some really good ones, new ones in schizophrenia. Good ones and real ones. Corona therapeutics is one of our portfolio companies. Oh, it is, okay.

Ben Comer 31:32

We had Steve Paul on too.

Maha Radhakrishnan, M.D. 31:33

Steve is amazing. You know, he's incredible. He's at uh Seaport Therapeutics right now, which is one of our portfolio companies, which we just went public, which is great. But again, coming back to your question on, we see a lot of programs coming through our way, both in terms of psychedelics and non-psychedelics, with a much more better hallucinogenic profile, less need for patient monitoring, lesser of a burden. Um, so we are looking and evaluating all these programs. You know, we look at programs that are coming our way, or some of them are mascarinic in terms of really looking at the M4 pathways, M1 pathways. So we are assessing them as we speak. You know, we're looking at schizophrenia, we're looking at positive symptoms, negative symptoms, neurocognition, we look at bipolar, obviously, we look at major depression, treatment-resistant depression, PTSD, generalized anxiety disorder. So you name it, you know, autism spectrum disorder, you know. Um, so we're constantly. And we also in our team have a team of neuroscientists, PhD level graduates who are deep into the neurobiology, epigenetic space. So obviously it's a tag team effort, right? And whenever we lead a diligence, we have executive partners, we have associates, analysts, we have the when you know, we have our general partners, managing partners working together on this. So the area is rapidly advancing. We're seeing a lot more promise. And then obviously, let's not forget the neuromuscular space. So we have uh companies coming to us with programs in ELS, coming to us programs uh, for example, the the impact on muscle in SMA, Parkinson's, Huntington's, uh, DMD, DM1.

Multiple Sclerosis Progress And Gaps

Ben Comer 33:08

So it's uh is multiple sclerosis uh still an area of interest? I I know there are some good treatments now compared with even 20 years ago some dramatic improvements. Uh yeah.

Maha Radhakrishnan, M.D. 33:20

You know, it's funny you say this. I always tell patients, because I people actually not patients, um, I'm always in no matter what role I am, I love to engage with the physicians, key opinion leaders, to really understand the dynamics of how the disease has evolved over time and the face of the disease, as we say. So when you look at multiple sclerosis of the condition, about 15 years ago, you had in if you walk into a physician's office, you saw significantly more patients in wheelchairs than patients who were kind of ambulatory. Today you walk into a neurologist's office, you won't be able to say which patient has MS.

Ben Comer 33:53

Yeah, I I think that doesn't get enough attention.

Maha Radhakrishnan, M.D. 33:56

So the traction you've seen thanks to the disease modifying therapies, it's not just the interference, but when you look at everything that's happened after that, it's just amazing. And that is true transformation. A lot of kudos there goes to people like Al Sandrok and others who've been the scientists, the brains behind bringing these technologies, the fighters, including regulators behind uh phenomenal assets like Tysabri. Again, I've been fortunate to be part of uh huge efforts on TechFedera, on Tysabri, on Plegrity, on Avanex, and many others. And obviously, uh many other companies have been part of this MS crusade, as I call it. Uh, is there unmet need? Yes. The progressive forms of disease are still not being addressed to the way they should. Are there a lot more companies coming our way with programs? Not as many as I would have wanted to. Are there efforts happening on the big pharma side to really be able to tackle the progressive aspects of this disease go earlier? Yes. So the hope still remains.

Next Hot Areas Obesity Muscle DMD

Ben Comer 34:55

Uh this might be a difficult question. Uh, it's it's broad, but um as a way to kind of conclude our conversation, Maha, I'm wondering maybe if there's a specific drug modality uh or therapeutic area right now that you think is just really hot or that people are really excited about that maybe in the next like six months to a year you think there's gonna be some either big approvals or or or something happening, and maybe even it's just uh a rare disease approval or a progression from early stages, proof of concept, to a really meaningful uh clinically efficacious product. Is there any drug modality that that you're excited about right now? And that it's hard to pick one, I know.

Maha Radhakrishnan, M.D. 35:41

He did caveat this at the beginning, saying it's a hard one because you know if you ask a parent with multiple children who's your favorite kid, you're not gonna get a response, right? The response is gonna be I'm gonna pick attributes of each of them collectively, why do they stand out? So as a physician, as uh a person who's been on the pharma side, who's now on the investor side, my answer would be somewhat the same. I would say therapy-wise, modality-wise, platform-wise, there are aspects that do stand out, and I might have mentioned several of them. Sure. In terms of pending regulatory filings or approvals, again, across each of these therapy areas, there are quite a few things that we're eagerly looking forward to. But as I would say that as the other as the time progresses, what I'm more intrigued about, especially let's focus back on my cardiology internal medicine background, is um we have multiple therapies that are impacting weight loss, obesity targets and comorbidities. But I think the field still remains open in terms of uh assets or programs that will help either maintain or rebuild muscle, selectively impact fat, and also prevent the kind of the downstream uh comorbidities because of excessive loss of muscle as it relates to fat. And it also kind of comes back to the field is open in terms of assets, in terms of clinical outcomes specifically, and how the regulators are going to look at it, and ultimately how payers would look at that. So that is one angle. And then this whole neuromuscular space. Uh you have uh DMD and DM1, you know, the acquisition of Avidity Biosciences by Novartis was an excellent step. It actually tells you that Big Pharma is equally interested. And then you have some pending submissions slash potential approvals in the DMD space. Dyne Therapeutics has submitted one with very intriguing data. And I think collectively, as a community, the biotech community focused in the DM1 space has been able to have dialogues with regulators to move away from a biopsy-based splicing approach to a Wii Hot approach where you're talking about dexterity. So I think there's a lot of positive movement for us to say. Platforms modality-wise, again, you know, um uh antessence conjugates, yeah. Novel SIRNAs, buy and try specifics, some of them taking lessons learned from oncology and bringing them into INI, immunology inflammation to me is fascinating. Uh, this morning's uh news about a potential acquisition of apogee by Abvi. Oh, I hadn't seen that yet. Validates that uh immunology still is a huge area of focus. So um, you know, I'll tell you, science never stops inspiring me and intriguing me or um surprising me.

Final Takeaways And Where To Subscribe

Ben Comer 38:16

Well, I think that's an excellent place to end. I really appreciate you coming on the show.

Maha Radhakrishnan, M.D. 38:20

Thank you, Ben. Thanks for the opportunity, and I hope the audience uh enjoys our session.

Ben Comer 38:26

This is Maha Radhakrishnan, executive partner, private equity at Sofinnova. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and check out our weekly video uh casts of these episodes every Monday on the Life Science Leader website. That's life science leader.com under the Business of Biotech tab. We'll see you next week, and thanks as always for listening.

Maha Radhakrishnan, M.D. 38:53

Thank you all.