Significant Challenges for Emerging Drug Discovery Companies

In a conversation with Pharmaceutical Executive, Yerem Yeghiazarians founder and CEO of Soley Therapeutics, discusses the company's innovative drug discovery platform, which leverages stem cell research and AI/ML technologies. The platform, developed over 25 years, focuses on understanding cellular responses to stress and identifying novel molecules that drive desired cellular outcomes. The company aims to transform drug discovery by identifying drugs at the cellular level and then matching them to diseases and patients. Yeghiazarians emphasized the importance of a strong team, deep science, and adaptability in overcoming challenges in drug development.

A transcript of Yeghiazarians’ conversation with Pharmaceutical Executive can be found below:

Pharmaceutical Executive: What are the most significant challenges emerging drug discovery companies face today?
Yerem Yeghiazarians: Drug discovery is difficult. Nobody's saying that it's easy. There's a lot of failures, unfortunately, and it requires time and funding, you know? So, all of those are concerns that we all have, trying to raise adequate funds, trying to have a good team to actually execute. You may have a good idea, but if you can't execute, then you can't bring the ideas forward.

I think those things are applicable to everybody, you know, and at the end of the day, I think executing a good clinical trial, designing a right clinical trial, figuring out the dose that you're going to go into patients with, these are things that there are no easy answers for honestly. You can do all the animal studies you can do to different types of animals, small animal models, mice and rat and large animal species, but none of them actually translate to humans.

As we all know, over decades, we've cured a lot of cancer, a lot of diseases in animal models, but 90% of time, they don't translate to humans, right? So, I think that some of the things that we're doing to prepare us for the clinic, we have to do them. They're mandated for all of us to do them. They're FDA required, and I understand it and that we need to do things from a safety perspective, but I'm not so sure if all of these are actually applicable to drug discovery.

We do a lot of studies that are very expensive, they're very costly, and 90% of time they don't translate to humans, and in fact, the FDA has come up with a statement that we need to start thinking differently about how we discover and develop drugs, and I'm totally in that camp now. How to do it, though, is not an easy task, and we believe strongly that our maps, the Soley maps that we're creating, will help us answer this question, because we're actually using human cells and human biology to decode the cellular alphabet for drug ability, for toxicity, and for which patients and disease to treat.

We strongly believe that once we essentially make progress, our platform will be transformative in how we and others will test their own drugs on our platform to bring them forward, but that will take time we need to validate our own drugs first, which is why we're so excited, but these are common things in drug discovery that I'm sure every executive, every researcher, thinks about, and of course, you know, as we all know, there is a lot of flux at the FDA. A lot of changes are happening, and you know, how is that going to impact us and others? I think these are, of course, things that I'm sure everybody is looking into. We're following it very closely, but we're excited to work with the FDA this year. We're going to be speaking with them frequently, and we're very excited to get our clinical trial going, and I'm most excited to actually get to clinic and help patients.

I've been a physician and a surgeon for 30 years almost now, I'm aging myself, but it's been an honor to actually take care of a given patient one at a time. But if we have a drug that helps millions of patients, or, even more importantly, to me, if we have a platform that allows us to efficiently and effectively discover novel therapeutics for many different diseases, that would be what we're after. How we can transform pharma way after we're all gone from this world? It would be something that we can leave our generations, and hopefully they can take good advantage of it. So, we're very excited about it. This financing is a big turning point for us, and we've been operating in stop mode for five years because I strongly believe in just putting our head down and working, but we believe that we're poised to transform breakthroughs into real medicines here.