First in Human Episode #13 featuring Ameet Nathwani

In episode 13, we chat with Ameet Nathwani, CEO at Dewpoint Therapeutics.  Find out why you shouldn’t underestimate the complexity of the biology and the disease as it pertains to global approvals. First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder & guest host Co-Founder, Andrew Brackin. Episodes launch weekly on Tuesdays & Thursdays.

Simon Burns: [00:00:00] Ameet, thank you for joining us on First In Human.

Ameet Nathwani: Glad to be here, thank you Simon. Thank you for the invite. It’s a pleasure.

Simon Burns: Well, let’s jump in with quick introductions. I’m, of course, Simon, co-founder and CEO of Vial. Ameet, tell us about your background, and how’d you get to where you are?

Ameet Nathwani: I’m a physician, I’m a cardiologist by training. I’m the CEO of Dewpoint Therapeutics, but before I came to Dewpoint, I was the chief Medical and Digital Officer at Sanofi, I sat on the executive committee. Before that, I spent a lot of my time as the Head of Medical and Cardio-metabolic Research and Development at Novartis. Prior to that at GSK.

I’ve got a passion for developing drugs in the cardiovascular space as my primary goal, but, I’d love the chance to do something pretty cool with both digital technologies in drug development and digital health overall.

Simon Burns: Your depth and breadth of experience is really remarkable. With the number of global approvals, the number of programs you’ve worked on, I’m sure countless biotech founders are asking you what the lessons learned were going through [laughs] all of those programs. Maybe distill it down, what key lessons, key learnings from taking as many programs as you have through to global approvals?

Ameet Nathwani: I’ve been very lucky. So, drug development is a lot of probability and a lot of luck. I’ve been very fortunate up until now with my luck. But success is a lousy teacher, so I’ll give you the six key things [laughing] that really I’ve taken away from. I’ve done over 20 drugs from beginning to end, but I’ve killed more drugs than I eventually developed, so I think it’s an important lesson to learn as well.

if I just take away from all of the time I’ve been doing this, which is over 26 years now firstly don’t underestimate the complexity of the biology and the disease. we think that we know everything by the time you start on development, and we’re just at the start of journey, and usually when things go wrong, we just realize what we didn’t know before. So that is one of the first things that I take away.

The second thing is paying attention to the little details. It sounds trivial, but when we’re introducing a brand-new innovation into a brand-new healthcare system, and you have it innovated around the healthcare system itself something that should talk about in terms of virtual trials and decentralized trials and things as well. But if you’re building an innovative drug but you’re introducing it into an old system, the likelihood that’s going to give you the benefit and you’re going to make errors along the way is pretty big. Those details are important to fix early on. 

The third one is just being bold. In many of the trials that we did, people were trying to, in committees, large companies tend to be reductionist in risk. They always want to reduce the risk because it’s such a high-risk business anyway. But if you’re not bold, your innovation will never really get to the aspiration you believe. I’m a big believer in if it’s a great idea, then it should stay a great idea, and you should really be confident that you want to exploit it. And if it doesn’t pan out, so be it, but at least you’ve given it its best shot. 

The fourth thing is that drug development is probability and productivity. Take as many shots on goal as you can. I’ve developed 20 drugs, but the number of hundreds of compounds I had to screen or start before we got there was huge. The other piece is productivity. We’re looking for ways to take the most expensive thing we do in industry, which is this drug development process, it’s incredibly expensive, it’s laborious, it’s time-consuming and make it more efficient. So look for everything that you can do to make it efficient, and decrease that cost, increase the speed, and increase the precision of what we do.

The fifth thing is make sure you talk to experts all the time. I was lucky that I set up a committee of 10 of the best cardio-metabolic experts in the world. I worked with them for over a decade, I met with them as often as I could as a committee. And, they really challenged me, and challenged me and my team across the entire journey. And we never could suffer from mediocrity because I’d have to face my 10 folks on a regular basis, so it was like do your best at all times.

And the last one is don’t be afraid to adopt technologies. The problem with drug development in big companies is it’s a pretty industrialized process. So, they tend not to want to innovate too much because it’s a high-risk business, people have got institutes across the world doing these things, day in, day out, and it’s a machine. But when there’s a new thing you could do, it tends not to be adopted in big companies. Just use technologies zealously in this, because that’s the new world. And try to project the use of your drugs almost seven, eight years out, so technology’s going to become embedded, so use it as early as you can. Those are some of the key lessons.

Simon Burns: I’m sure we could spend hours just on that alone. Let’s talk about technology, and technology’s increasing impact in all things drug development and discovery. You had an amazing purview, seeing really everything over the course of several years give us a sense of what surprised you the most. You got to see decentralized trials come to the fore, machine learning and AI approaches. Several different approaches. What caught your eye most, and what was the most surprising? 

Ameet Nathwani: When I was in Sanofi, one of the biggest things I was privileged to do was looking at the entire process end to end in pharma, from drug discovery, right through to the commercialization. But if I just take the drug development piece alone, the technology pieces that we were playing with at the time have now started to become more widely-used. 

So decentralized trials, virtual trials, however you want to call it… tokenized trials [laughing] that’s here to stay. We were just at the start of the journey in the pre-Covid times. And what was fantastic is that when Covid came along was it was terrible for the world. But it was fantastic for the innovation in drug development. What we saw was this rapid shift into telehealth, massive adoption of wearables, massive adoption of decentralized trials, because the entire industry came to a halt and couldn’t do clinical trials.

The [00:05:00] conservatism that we used to experience just literally just disappeared in very short space of time. What I loved about it was physicians got on board, pharma companies got on board, the technologies really stepped up to the mark and were tested. The regulators came on board and said, ” We’re going to help you do this because it’s really important and try and facilitate that.” And we saw all of the different approaches in analytics and everything else as well.

Now, that was great because we’ve now . Gone into the burgeoning of telehealth as its own practice within physicians and everything else, so the whole healthcare system also pivoted at the time. But alongside this, one of the other pieces that were working on was this whole digital therapeutics. You now prescribe digital tools to make people better. We’re at the cusp again of a number of these really starting to escalate.

Can you combine drugs and digital technologies together to improve outcomes for patients? I think that was in the early days, but now we’re getting to see much more of this. It’s almost a precision medicine approach, where you use technology instead of genetics to improve individual patient care. And that’s just wonderful. Because you can do that in virtual trials.

The use of real-world data in synthetic arms. Real-world data was being present, but I think this whole field has moved on now, and we’re seeing real-world data used in earlier phase trials, we’re seeing it as long long-term use of these really characterizing benefit/risk of drugs. And the beauty about that is you’re now able to do it in a frictionless way with physicians, patients at home in long-term care. I think we’re still at the early stage of using synthetic arms more effectively.

Once people start to get tokenized or digitized so that the data is accessible, then developing control arms which are truly in silicon will become much more normal. You will take away the ethical issues of using placebo in diseases where you don’t have to because you’ve got very good detail and high precision on how the disease is behaving, and you have that data densely.

So those are the things that most excite me. I think that the world of trials is fundamentally shifting in the right way, which makes it better for physicians, patients, and also healthcare systems.

Simon Burns: So going from your big pharma experience to now CEO of a biotech company, a rapidly scaling biotech company, but still a much, much smaller institution than you came from, walk us through that transition. How did you go about starting your own company and go about, leaving big pharma for biotech?

Ameet Nathwani: First off, the transition has been wonderful. I’ve always enjoyed my time in pharma because the potential to really have a big impact globally across many diseases has been very high. But, there’s always been things nagging me. The first things were pipelines of big companies were becoming more incremental in their real impact and I was looking for something truly disruptive. And then, drugs were becoming more complex, they were becoming more expensive, they were addressing smaller populations, they weren’t really reducing the cost of burden in healthcare, which is one of my big areas of passion.

When Dewpoint approached me about the opportunity to pivot into biotech where most of the big ideas were coming from, this was really beguiling because this was a big idea. It was the start of Covid and the opportunity represented the convergence of the most cutting-edge biology together with the opportunity to embed technology at its outset then apply it to big populations and with affordable technologies like small molecules, right?

So this was just a privilege for me to do. That’s what really excited me, and I think that trying to build a multiscience approach. So it’s physics, biophysics, computational chemistry, material sciences, all embedded into one. Together with AI it’s too good to miss out on. [laughs].

Simon Burns: It feels tailor-made for you in a way. You closed your Series C not too long ago. What advice do you have in writing a fundraising process and going out to the biotech venture market? Specifically in today’s market, what nuances should biotech founders consider? 

Ameet Nathwani: The market was spiraling as I closed Series C, so I was very lucky that I just got in before the whole thing really was imploding. And also, I just got out before the nadir. The good thing is, at least during Covid, I could do all of my investor calls, and I had over 400 virtually. 

Simon Burns: Can I double check, you said 400? [ laughs]

Ameet Nathwani: Four hundred, yeah. I did 400 investor calls, yeah. [laughs].

Simon Burns: That’s remarkable. 

Ameet Nathwani: It was a year. The reason for that was there’s a lot of education with a brand-new science which is cutting edge. As the market starts to spiral, people got a bit anxious about it, so we had to do lots of repeated calls with folks. But I could do that virtually, so that was the good thing.

The main thing that I advise all CEOs today is don’t be afraid that the market’s spiraling. If you’ve got a great idea, you believe in it, the science is really good. Then learn to tell your story, stick to your story, and then find people who believe in you. If you have one or two incredible investors don’t give up.

The market is always going to change. We’re just going through the nuclear winter of the biotech world right now. It does mean that the audience may shift a bit. There’re some people who will be more excited, and other people who won’t be, you’ve just gotta find them, and you will find them with time.

And the other piece is, make sure that you understand why you believe so much in what you want to do, because the people are looking for that belief. If you have a credible science, a credible leadership team, and a few investors that are always going to believe in you, the rest will fall into place. It just takes time.

Simon Burns: Let’s dig into a topic we’re passionate about here at Vial, which is clinical trial technology and applications of technology to drive more efficiency, something you’ve thought quite a bit about. Where are you thinking about applying technology in Dewpoint’s clinical trials, and where do you see the biggest for new efficiencies to be found?

Ameet Nathwani: So [00:10:00] we’re still a couple of years away before we start our trials, we’re obviously now starting to think about how we will design the trials and what we would like to do. So I’d like to think about modern trials. Can we now develop the toolbox for synthetic arms, right? That would change us. We’re in the oncology space, but we’re also in some other rare disease spaces, and control arms, synthetic arms, would be fantastic for us.

Are we looking at sites that have good digital records that we can get into virtual care? So can we get to a point where some of it can be telehealth through trials? Because I want this to be as frictionless for both patients and physicians as possible, and also it gives us a density of data that we can. I’m already looking to see whether there are some wearables that would be fit for purpose for some of our diseases so we can get the patient reported outcomes from their home base, getting much denser information about the outcomes we’re trying to change. And also, use of ambient intelligence where we can to try to get that in a home setting, where we can record it.

I’m already starting to plan those and we’ll be looking to find sites that have that capability and find physicians who are interested in doing it in that way. But it’ll take us two years or more just generating some of the insights to make sure that we can convince ourselves that’s the right approach and not take a risk with synthetic arms until we’ve developed the dataset that we need ahead of time.

Simon Burns: Earlier this year Dewpoint filed a patent for your foundational platform technology. Give us a sense of some of the technology you’re building and what are you most excited about in terms technology?

Ameet Nathwani: The technologies we’re building right now are more around the basic science, so we have- AI-driven condensate genetics. It’s a machine that allows us to look at mutations, their relationship to diseases, but also helps us to point to where is there a condensate abnormality that’s likely to be leading to that disease? Which is different.

We got a big investment in computer vision. We have state-of-the-art computer vision, which allows us to look at the sub-cellular compartments with immense fidelity and density. And another piece of it.

We’ve patented the way that we address these macromolecular bodies called condensates. Which are usually a thousand or more biomolecules of proteins and nucleic acids. You’re not targeting a particular protein, you’re targeting the entire behavior of this thing. The characterization of it using AI, using different live imaging, is all part of what we’re currently embarking on.

And even the chemistry that gets into and modulates these bodies is different, so we’ve built unique libraries and platforms around studying that as well. That’s where the technologies are, and we’re putting lots of patents in place because these are proprietary to our approach right now.

Simon Burns: Great. Well, with that Ameet, thank you so much for joining us. Enjoy the Swiss holidays, and I appreciate your time on First in Human.

Ameet Nathwani: Thank you very much, Simon. Good luck with Vial. You’re doing a great job,. You’re part of the future we’re looking forward to. So thank you very much, and best of luck. 

Simon Burns: Yeah, thank you so much. Take care.

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