The Race to Get Drugs to Market

JOHN WHYTE: Welcome, everyone. I'm Dr. John Whyte. I'm the chief medical officer at WebMD. I'm here at the American Society of Clinical Oncology meeting, talking to my good friend, Elcin Barker Ergun, the president and CEO of Menarini Group. Elcin, it's great to see you again. 

ELCIN BARKER ERGUN: Happy to be here and catch up. 

JOHN WHYTE: I last saw you a year ago in Florence, where one of the best slides you've had that everyone has picked up is, you talked about there's a renaissance. We were in Florence, but still a renaissance in drug development. Do you still feel that way? 

ELCIN BARKER ERGUN: I do. I do, actually. Yeah. So we have more and more interesting things coming. Last time we spoke about diagnostics a bit. We talked about biomarker drugs. I think maybe we talked about AI a little bit. And then of course there are ADCs. Many companies are now looking at ADC platforms. There's cell and gene therapy. So there's a lot of excitement and a lot of development. We talked about very difficult-to-treat mutations like KRAS, et cetera, and drugs coming.

And when you look at here, there's more data that we are seeing. I think it's all also about how they will come together. Oncology, when we talk about oncology, oncology is all about sequencing. So I always think it's very good that we will have drugs like ADCs, but at the same time, you will always have room for small molecules because, again, based on the characteristics of the patient and more and more targeted ways we are going, you have to really use them in the right sequence. 

If you think about some metastatic diseases, breast, et cetera, if you do that sequencing right, you're going to give patients, even in metastatic disease, say, up to 10 years, rather than maybe 3 years. And you know what I mean, maybe then not so many things afterwards. 

JOHN WHYTE: Now, something that's moving very fast is the topic of AI. And when you and I chatted a year ago, you were very measured about it. There are some folks who think it's going to change the whole drug development process and the way you treat patients. You were more like, "Hold on, John. It's a wait-and-see approach." How has your opinion changed, if at all? 

ELCIN BARKER ERGUN: I'm still there. But if you look at what has happened afterwards, so it's always like a rush. It's a gold rush. I never see it like that because I still think that in discovery, you get a lot of efficiency with this approach, and which I still see is the No. 1 place where generative AI is going to help us. 

But then you need chemical platform in order to validate that. In order to really make sure you have a really great lead asset, you optimize that and then you validate it through the traditional methodology. And the last time I remember, we spoke about regulation. And actually very quickly after that, both US and Europe came up with a regulation. Regulation is needed, definitely needed, and they're putting a lot of emphasis on screening. 

JOHN WHYTE: Something you've been a leader in, and enough CEOs aren't talking about this, is the issue of antimicrobial resistance. And you and I chatted, when we were in Florence, you and I chatted about it a few months ago by phone. What do we need to be doing because here we're talking obviously a lot about cancer care, which is important, but at the same time, we've learned certainly over the last few years the issue of AMR? And do we have good stewardship? Do we have good drug development and investment? 

ELCIN BARKER ERGUN: I'm really glad you brought that point again, because I feel we haven't made a leapfrog there. So it's still a very little, little improvement in the sense that some-- 

JOHN WHYTE: But why? Why given how many people are impacted?

ELCIN BARKER ERGUN: You're right. I think the issue is fit. Correctly, in the beginning, it was more about how do we make sure there's a pipeline coming. The fact is, with some of these IFPMA-supported fund, AMR Action Fund, et cetera, there are some drugs that are coming now out of the pipeline. The problem is there isn't enough incentive, pricing access incentive, to get them to the market. And that's a big problem. 

Now, essentially the problem is accumulating and accumulating because there isn't a real-- currently the drugs are not reaching the market. And that is a huge problem still. And it's a big threat for everyone because it was 1 million, then 2 million, 3 million. And at some point, the death toll is going to be very, very high. 

JOHN WHYTE: But when you focus on where you're going to put priorities, is AMR one of those areas? 

ELCIN BARKER ERGUN: For us, as a private company, we still want to stick to this area. But in Europe, we're one of the very few companies who still carry a portfolio. But it's a difficult choice, I can tell you, in terms of the overall portfolio, in everything that we're doing. 

But we're putting a lot of effort to really create an awareness of the extent of problem and how difficult for others, because everybody comes to us. 

All the US biotechs come to us in Europe, but we are saying, "Look, as long as we cannot change the environment and really create more amenable policies, it is also difficult for us to get more drugs into our manifold." 

JOHN WHYTE: One area where there is a lot of drug development is the area of cardiovascular. And you and I have talked about it as well last year. What's your current assessment of where we are in the cardiovascular space? 

ELCIN BARKER ERGUN: I'm very optimistic about the renewed interest in the cardiovascular area. I think for a while, everyone shifted investment oncology. And in a way, it has been somewhat, I don't know, forgotten that cardiovascular is still where we have the biggest, highest mortality. So there's a lot of patients still who are not under control, even after statins, et cetera. They don't have their LDL under control. 

Approaches in cardiovascular in different areas where there's a huge unmet need still is very healthy. And there's more and more companies now going into the research, again, for cardiovascular. I think we will see a renaissance, a mini-renaissance in cardiovascular area in the coming 5 to 10 years. 

JOHN WHYTE: You don't think we're currently in it? Because if we look at metabolic disease, which is a subdivision in a way of cardiovascular with the GLP1s and others, we have a lot of advancements. 

ELCIN BARKER ERGUN: Correct. I think in areas like metabolic-related obesity, we've seen really, really breakthroughs. But when you come to cardiovascular, you have anti-thrombosis-- 

JOHN WHYTE: We are even rethinking that in terms of how we use beta blockers, how we use other medications in terms of revascularization, and what that does for symptoms, and whether you should have it done if you don't have symptoms. That's what's very interesting. 

ELCIN BARKER ERGUN: Renaissance in that area was 20, 10 years ago, even 20 years ago. And now we had a period of a little bit stagnation. Now that is happening. By the way, immunology also. So now there is renewed interest in immunology. I think what we're going to see, even CNS, the next 10 to 20 years will be, in my opinion, more balanced, maybe still majority oncology, but we will see a more balanced approach of oncology, immunology, cardiovascular, and some other areas. 

JOHN WHYTE: There's lots of things I admire about you. One of the things I admire about you, though, is this ability to look at things from a long-term view. You don't think about things like 2 years, You're always talking to me about like what's in the short-term, maybe 2 to 5 years, but you're also thinking 10, 20 years. What is it about your training? Is that your engineering background, am I right? Or is it your work in the current space? Not everyone thinks like you in the pharmaceutical industry. 

ELCIN BARKER ERGUN: I think it's a matter of, I guess, in our industry, we should never forget that you can bring a shampoo with a little bit of differences quite quickly maybe to the market. 

JOHN WHYTE: Like a ME2. 

ELCIN BARKER ERGUN: But our industry does require a lot of long-term thinking. And if you haven't done that long-term thinking right, you may actually fail, also drastically. So you have to always see where are we going, what is the unmet need, how can we shape policy environment to still help where the unmet areas are and collectively work on it. 

That's why for me, that holistic thinking is important. But to your point, I think it's a matter of the fact that we discussed last time, I'm an engineer. So I've done finance, I've done commercial, I've done innovation. I think that gives you a more holistic approach that also, I think, helps. 

JOHN WHYTE: That works in health, that works in industry as well. So Elcin, thank you very much for taking the time today. 

ELCIN BARKER ERGUN: Really thank you. 

This interview originally appeared on WebMD on June 27, 2024