Episode 138: Building Biotech Across Borders – Translational Science, Hearing Loss, and the Reality of Drug Development

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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 with me I have Dr. Gareth Willis. Gareth is an experienced biopharmaceutical R&D professional with decades of experience in drug development and scientific strategy, and his resume boasts some familiar names like Harvard and Boehringer Ingelheim, as well as a few startups. And he and I have worked together for many, many years in various capacities, so Thank you very much, Elaine.

Pleasure to be here.

And you are calling in, I mean, it's late where you are, 'cause you're across the pond in London too.

It's, it's okay. It's, it's 7 o'clock based in the UK.

Okay.

But in this sort of global time zone, I'm used to calls at all times of the day.

Perfect. Well, all right. So, set the stage for our listeners. What led you into biotech and pharma?

That's a long story.

I love it.

Perfect.

Now we'll fill up the time.

Yeah. So I had no aspiration whatsoever to get into biotech or pharma. I actually, I started out on a very different journey. So I actually wanted to be a nutritionist. That's where I started. Yes. And yeah, I was going to say, for everyone listening, Elaine and I have known each other for some time.

Yes.

And yeah, there's going to be things today perhaps that you find out you did not know, but yes, I wanted to be a nutritionist. nutritionist, and I went down the route of studying nutrition. It just so happened that if you eat the right foods and you take certain drugs and you exercise, you don't get diseases like diabetes and cardiovascular disease. So I actually got interested in the mechanism by which certain foods work and the underlying molecular underpinnings which can regulate these processes. So I then sort of transitioned into the world of science. I ended up doing a PhD in the UK at Cardiff University and then pursued the regular academic route. I actually was really enjoying the science in academia. So as you know, I actually started out purely in academia.

What was the change?

That's another long story cut short. So I ended up enjoying academia, quite frankly. I enjoyed my time doing my PhD. It was very very reverse translational. So I actually was doing a lot of clinical work and reverse translated the clinical work back to the bench and was, sometimes I would say biochemistry, sometimes I'd say pharmacology. I'm one of these people now sort of incubated in research. So I don't like, I can't brand myself as a straightforward flat-out pharmacologist. I'm incubated in research, I think is the easiest way to conceptualize it.

Yeah.

But, so I enjoyed the translational research, ended up doing postdocs, went to the other side of the pond, then came to The ecosystem that is Boston. I've done the typical story. I came for 2 years, ended up staying for about 10 in the end, and ended up enjoying myself a bit too much. Had the fortunate opportunity to be at Harvard Medical School and Boston Children's Hospital at the cutting edge of science, working on really complex biologic cell therapies.

Yeah.

In the context of cardiorespiratory disease. And this is where, through scientific funding with the likes of big, medium pharmas, United Therapeutics, to name a few, working in the lab of Stella Kourambanis, I actually got great exposure to the initial translational medicine, a successful IND, taking an exosome-based product into the clinic and working in Boston Children's Hospital, which is a very special place. We was also translating these really complex biologics to patients who were at the, the most fragile patients in the world, newborn infants, premature. So, it was a really humbling, but also a fantastic experience to be part of. And this was my first insight into the world of biotech and pharma.

I mean, that's a great, that's a great crash course right there of biotech and pharma. I mean, being able to, to go right into, to to trials with, with infants. That's probably nerve-wracking, I imagine.

It was. I actually tell this story quite a lot. And the one thing, when the first patients were enrolled in the study, obviously this was a double-blind placebo-controlled randomized study. We didn't know what these patients were having, but I just remember being so petrified of all the data we've done to this point, believing in it. Is it real? And just wanting to double-click and make sure that all the science is as solid as possible. And those were the lessons, quite frankly.

Yeah.

Which has translated going into all the other endeavors. We're going into the world of pharmaceuticals. So when I left academia, went into pharma, and then with what we are doing now in the world of biotech jointly, right? Making sure that we have the, the best pharmacology packages to Maximize chance of success in the patients.

Yeah. I mean, that's perfect. You led into my next question that I had on my little sheet of paper here of what you've been across a number of different environments. What did each one of those teach you? And, and really, how should people think about choosing the right environment for their career? Because that's a toughie. You think sometimes you think that, oh, I meant to be in a lab. That was me. I was like, I'm going to be in the lab forever. And that was not the case. It was not a great environment for me. So. What do you, what are your thoughts and lessons that you had?

I thought you wasn't going to ask me any deep or hard questions I'd have to consider.

I mean, not hard, but definitely deep. I mean, it's late night. I mean, I'm going to call it late night for you. So let's get, let's, let's get into it.

Philosophical. So I naturally transitioned from academia, even though I was having a fantastic time. I was very fortunate to have the academic currency, the faculty positions, grants, papers. We were set up in a really good place, but the translation to the human That was the catapult, the fire in the belly. This is the thing I enjoyed the most, actually doing research for a purpose and that translation into humans, the drug development process. This is what I enjoyed. So my first sort of recommendation is do what you enjoy. I think that's what is the best thing in, in all of science.

Sure.

What you enjoy. Having lessons learned though, and what I thought, so I've had the opportunity of great opportunities with Vertex Pharmaceuticals, Boehringer Ingelheim, Invox Pharma, biotechs, and startups.

Yeah.

The more experience you get, the better it is. And I have learned from great mentors in big pharma. I have learned from great mentors in biotechs, in startups, yourself. We're across all of these foundations. I've learned a lot. And I think the more you can absorb and the more you can get exposed to, sets you up for increased likelihood of success, hopefully. But you also, you absorb so much, you know, and that's what I enjoy.

And career diversity. I mean, I feel like it, I mean, having a lot of different opportunities throughout your career and very diverse opportunities, the more hyperbole you are, it gives you so much more options. You pull out this Swiss Army knife of skill sets that are like, okay, well, this sounds like an interesting opportunity. I did this, you know, 2 years back. So this is something that I can pull up again and, and go for it. But you still, you're right, you have to love it. I mean, that's a key piece for me as well. And I mean, we all love science. That's why we're in it. We wouldn't put ourselves through what we put ourselves through to get here. But it's finding the day-to-day love, the things that like you really, I really do look forward to getting outta bed and to going to my desk and cracking through it. So, but that can be a hard journey to figure that.

I'd say that it's never linear, is it? It's never, it's never the path you think. There's always going to be, if you actually, let's take a step back. The failure rate of drug development is astronomical. If you think of just some broad figures of 1 in 10,000 to 30,000 sort of ideation therapeutic concepts actually make it to an approved drug. We are immune to failure, right?

Yes.

So because failure is, failure happens so much, you have to enjoy it. And every time you walk into a room, also need to develop optimal processes to take learnings, buy them, and try and try to get a better process and understanding of the drug development, the science. So you increase the chances of success in what is a world which is frivolous with failure.

Yeah. And you, you're right. You do sort of, I mean, you somewhat get immune to the failures, but I think that it prepares you. Yeah. Yeah. Oh my gosh. I mean, it's a rollercoaster for sure. There's a lot of highs. There's also a lot of lows, but you have to know that there's probably gonna be a high on the other side of it too. And, and you kind of have to like, you know, I bought the ticket and I'm excited about this, you know? And I feel like I didn't realize at the time that being a scientist prepared me to be an entrepreneur too. I mean, if you look at, I've mentioned this before, I've had an executive profile made and it was, my executive coach was like, you don't look like you would go into startups because you're risk averse and that's startups. Well, When you're in science, I mean, there's so much failure, you just kind of get used to it. You have plans A through M, you know, ready to go because you've thought it through.

Somebody once said to me, if, if in the career path of drug development, you can tick the startup, the big pharma, the academia, biotech, and also CROs, CDMOs, if you can tick these boxes and learn from all of them, all of a sudden you get a holistic understanding of how processes work. You see it all across the lifecycle. So, I don't know. There's, there's, do what you enjoy is the bottom line of it. But, um, I think we, we share similarities with passion for the science.

Absolutely. Well, since you've worked across the spectrum, was there any environment, is there anything that you had to unlearn moving between the different careers?

I'd say there's, there's trends which are, which are ubiquitous across all. I think the previous dogma of academia and industry being 2 distinct languages I don't buy into all of that. I think science is the universal language. The things in terms of learnings, I'd say rather than unlearn, there's definitely learnings. I think the ability to speak different languages in terms of, you have to speak BD&L, you have to speak patent attorney, you have to speak development, you have to speak early. Also, you mentioned the rollercoaster ride as well. The roller coaster ride in trends is something that you have to pursue as well. What's hot? What's in vogue? You have to be at the cutting edge frontier of science to hopefully make an impact. Don't get me wrong, me too, me better, generic. They're fantastic for a reason. But I think from a scientific innovation perspective, you always want to be at the forefront to try to push the boundaries. So with that, there is always a roller coaster ride. It's in from a Competitive intelligence perspective, you monitor that. We are seeing the influx of how AI can accelerate and support this and this new frontier of technology to enable us with the journey we're on. Even from a modality perspective, right? We take it modality indication agnostic. Everything is a rollercoaster ride. We have the ups and downs of cell and gene therapy. We have the ups and downs of certain areas like the microbiome buzzword.

Yeah.

Everything comes in and out of fashion based on success and ultimately data. Yeah. Ultimately failures, data, successes, more often than not some failures. Yes.

Yeah. Yeah. That's what I found challenging with gene therapy. My, my one little toe dip into gene therapy, you'd have one failure and then everyone would just clam up and it became very challenging. And so with your competitive intelligence, like, let's talk like, what's the sexy new thing then? If you were to put some money in right now, what would be the thing that you'd bet on in Vegas or the equivalent in the UK? What's the equivalent of Vegas in the UK?

I don't, I don't, I don't know. You should have known that.

There's only— Gaming halls.

There's only one Vegas. I don't think there's—

There's one. Yeah, fair. That's fair.

Wherever you go in the world, you'd struggle to find another one. But what's hot in the world of drug development? I'd say obviously the enabling technology of AI is at the forefront of what I would say is ultimately the most hot topic. If you think of like JPM Bio, the recent big partner conferences.

Oh, the Insilico deal with Lilly, just incredible. The work that they've done to just completely compress the timeline for drug discovery and development has been incredible.

Exactly. I'd say, I'd say that's definitely one of the hot things, which is universal in drug development at the moment. In terms of modalities, we're still waiting for the uptick, you know, the rollercoaster ride in cell and gene therapy.

Yeah.

In terms of your question specifically, we do have a side venture.

We do.

Which is exceptionally exciting. So if I was to bet, I'd bet on us, quite frankly. Hearing loss is the— hearing loss is a debilitating disorder.

Hearing loss is definitely, I mean, white space, of course, there's nothing out in the market for hearing and hearing disorders too. But how often do you get to work on one of the senses? That's what always gets me excited about being in that space. I mean, to work on vision or hearing loss, I mean, that Those kinds of things of helping someone hear or see again, it feels monumental. I don't know. I don't know how to describe it. I don't know how you feel about it.

It's something which I think is so everyday life that it becomes somewhat of a norm and it's really unfortunate. And the white space in terms of lack of effective pharmacotherapy for these regenerative or symptomatic in terms of being disease modifying even. It's really a shame. Take a scenario which happens regularly. You are in the pub, you're in an environment. I love the way that I picked the pub as a scenario which happens often.

It's true. And it's translatable here in New Orleans to also the UK. So it's okay. I own, I own a wine pub. We call it actually a wine pub, but no one really gets what that means here. But yes, please go on. You're in the pub.

You're on Bourbon Street, right? Or let's make this geographic. We're on Bourbon Street or we're in the best wine bar or wine pub in Oklahoma, to which I have frequented.

That's right.

And you're having a conversation and there's background noise and the people start leaning in and they're catching every other word. And all of a sudden you're going, how often does this happen?

Right?

And this is something which is just, oh yeah, it's overlooked as something which is not impacting life. But there is a pathological cascade which has really deleterious actions on their mental health, their wellbeing. They start becoming excluded from so many normal daily activities.

Yeah.

But it's actually really a debilitating and can be a very severe disorder.

Yeah.

So there are lots of hearing loss related diseases and disorders out there to which if we can actually support the patients to which we've got a great chance of doing, I'm very looking forward to seeing this have an impact on the patient's lives.

Yeah. Yeah. And so we have 2 assets that you and I worked on and are working on currently. One is for hearing loss, regrowing hair cells, which is the holy grail. And then tinnitus and tinnitus above all of the indications I've ever worked on, it's the one I get weekly emails from patients desperate because of the absolute agony that patients are in from a mental health per— you know, perspective, because it's just this constant, constant ringing. That's very motivating and, and sometimes frustrating because you want to be able to give them something and we're so close. You know, we're looking to go into a phase 2 trial, you and I, and it's, we're so close and we're, it's really exciting to be able to provide some hope and change my email response to, to the patients that email me. So.

That is the goal. And I just realized when I do thumbs up on a podcast, no one can see it. So I'm doing it here.

I can see it. I always like to have someone give me a thumbs up every now and then. I mean, there's worse hand gestures I've been given. Okay. One last question. You have been on the competitive intelligence side of pharma and you've seen a number of different deals. You've seen failures, you've seen successes. So what is the handful of things that you have seen that can really make a difference in a preclinical program becoming successful? Besides having someone like you at the helm, I'm just saying. Throw that in there.

Yeah.

Gotta butter up my guest. Come on.

Well, actually, in terms of the, some of the core principles, I've had the luxury of working with some very talented people, very talented, very smart, brilliant minds. And the talent pool to support you on the scientific journey of drug development is most certainly at the epicenter and the key to success. In terms of the drug development process, I think people learn it on small molecules. I did, at least. I think it's very much learned on small molecules of how you can get your lead candidate and take it all the way forward. You need to throw that roadmap out the window when you're working on complex, new novel modalities and biologics and really pave the way forward. That being said, there are a few core principles which can be applied. One is a clear articulation of the value proposition. So what is the therapeutic concept? How does it work? How does it impact? How does it work at a molecular level? And what is the benefit you will see to the patients? Is that benefit also one, what the patient wants to see? And is it clinically meaningful? And the reason why I say that is, You really need to leverage the holistic support network of drug development and consider patient advocacy groups and so forth, and the patient voice right from the very beginning. This is absolutely critical because let's say we improve hearing function by X decibels. So you have an improvement in hearing. What does the patient want? The patient wants to have a conversation with their grandchildren. The patient wants to go to the shop and have a conversation. And be able to communicate with a bus driver whilst getting on a bus.

Yeah.

This is what it means to the patient. So you really need to make it apply and be very patient-centric right from the get-go and know what these translational strategy and pharmacology packages look like. This also then boils down to your differentiation hypothesis, and that always gets mixed up. I think people always assume that's just what's different. It's not. It's how are you superior? How are you differentiating in a way which is showing superiority over the current standard of care and/or the competition? And that's where you need your value proposition, your differentiation hypothesis clearly articulated right from the get-go, the patient's voice at the epicenter. Everything else then, your core documentation, your processes, Comes into place. And if somebody gives you a nice cheque to go and do it, that helps as well in terms of accelerating things. But ultimately the packages of solid pharmacology remain central to success.

I love that. Tying, tying the pharmacology to the patient and, and vice versa. That's a great place to end on this. And thank you so much for joining us. I appreciate it, and I look forward to pitching to other people after this call, actually.

So wish us luck. Straight onto a VC call.

That's right. Wish us luck, Ian. Give us all the, all the good, good vibes. Good luck.

Good luck.

Also a visual thumbs up. That doesn't help.

Yeah, I know. I know.

I know. Come on. Good thumbs up. He also got a good thumbs up. Awesome. Well, as always, we're going to have information about Gareth and some of the things that he's working on, some of the courses he teaches. I didn't get into that in our show notes. Be sure to check them out. And thank you once again for joining us on Bio from the Bayou.

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This podcast was edited by Resonate Recordings.