BioWorld Insider podcast: Gene and cell therapies will propel innovation, says Astellas CCO

Introduction: The BioWorld Insider podcast.

Lynn Yoffee: This is the BioWorld Insider podcast. I’m Lynn Yoffee, BioWorld’s publisher. Our guest today is Claus Zieler. He’s the chief commercial officer at Astellas Pharma. He’s had that job since 2023 but he has three decades of experience in pharma. He’s held top positions in R&D, production, general management, also in sales and marketing in the U.S., Japan, Singapore, Latin America and Europe. With that kind of vast experience, Claus has unique insights into how the innovation cycle is funded, and how to build a sustainable path to ensure access to new medicines. Welcome, Claus.

Claus Zieler: Hello Lynn, and thanks for having me today on the podcast.

Lynn: We’re glad to have you. Claus is talking today with Lee Landenberger, who’s a BioWorld staff writer and the BioWorld Insider podcast host. Lee, over to you.

Lee Landenberger: Thanks, Lynn. Claus, it’s great to have you with us today. I was reading your CV. It’s impressive, and you speak six languages. Let’s just stick to English. That’s all I can handle.

Claus: [laughs] That’s absolutely fine.

Lee: Thank you so much for joining us.

Claus: Thanks for having me.

Lee: I’m counting on big picture view on several items today from you. Want to start with sustainability. I’m curious about, how can we, in your view, sustainably ensure access to new medicines. Because health care models are shifting from chronic disease management to one-off treatments, it’s bound to create some disruption.

Claus: Let me start by saying I truly believe that the pharmaceutical industry is one of the main innovation drivers in the world. Most people will probably say, “Oh, it’s gen AI, or it’s software.” Yes, that may be more visible, but the underlying understanding of biology, of diseases, of DNA, of cells, has truly revolutionized the way we can now target diseases and drive healthcare solutions for patients to live a better life. Let me just give you a couple of examples. The most prominent probably is COVID. It’s overused. Everyone uses it.

Look at how this industry, in the span of one year, took a completely new technology, mRNA, applied it to a vaccine setting, developed a solution, got regulatory approval for a solution, got funding for a solution, produced the solution, and shipped billions of doses to be injected across the world to save patients from contracting COVID. There are other examples. Take cancer care, which, in the last 20 years, in some cancers, we have doubled the expectancy at five years. The survival rate at five years.

There’s examples in heart disease. There’s examples in infectious disease.

The contribution to people’s health, to living a better life, to living a longer life, is unedited, what has happened especially in the last 20 years in this industry. I think you have to take that as a context.
Now, you asked about sustainability. I think here comes, in a way, the catch, because the more we contribute as an industry to health care solutions, the older people get and we see that across the world. Our societies are aging. In some countries, they’re aging extremely fast. Even in Europe, even in the U.S., we have significantly older societies than we had let’s say in the ’80s or in the ’90s.

What happens when you hit that famous 65 is your need for health care goes up exponentially. There are studies which show that 90% of health care is actually catering to people over 65 as a cutoff. You get these aging societies with a significantly increased demand on health care services, on pharmaceuticals, on innovation in the sector. How does a government pay for that, or how does the private sector, like the U.S., pay for that? That’s really at the heart of the sustainability question. If we can’t pay for what people need to receive health care, then all of this doesn’t work.

That’s, I think, where not only scientific innovation is called for, but systems innovation is called for. We need to sit down. It’s probably best to sit down in collaboration with governments, sitting down together with industry, sitting down together with health care providers and people who know how to run a hospital or who know how to run a reimbursement agency or a PMO in the U.S., and sit down together and say, “How do we strategize for solutions to provide sustainable health care in such an environment where our demographics are driving demand in a significant way?”

There’s probably not just one solution to that. There’s probably a number of solutions to that, such as we could make the system more efficient. We could use digitalization. Digital health records are essentially already standard, but are they really linked up? Are we really deriving efficiencies in care, or are we still duplicating the X-ray in one setting and then it’s repeated in another setting? It costs money but it doesn’t add value. Whereas taking that same money instead of doing the second X-ray and using it for the more innovative medicine, that would create value for the patient.

Taking that patient-centric view and saying, “How do we now efficiently provide health care services to the patient and derive efficiencies that we can then deploy to pay for innovation?” That’s one approach.

At the end, I think it’s also a question, perhaps, of governments reviewing what they spend money on, and realizing that an older demographic simply has a different composition of where you spend your money than a younger population would have.

I surmise it’s probably a mix of solutions that will get us there in the end to make this innovation cycle sustainable, because at the end it benefits patients. As I always say, you and I, everyone listening to this call, we will all be patients one day.

Lee: Speaking of innovation, I’m curious about the pharma innovation cycle gap that you see, or that you may see between the US and Europe. Can you talk a little bit about that and what some of the causes and solutions to any problems might be?

Claus: Yes. [laughs] The difference between the two regions is quite stark today. It was not always that way. If you go back 20 years or 25 years, the investment in Europe and investment in the U.S. were pretty much at par in terms of health care innovation. Really, medical scientific innovation. There’s a gap that has opened, and I think it has partially to do with the fact that the U.S. just has a more attractive market, and attractiveness in a market in pharmaceuticals is always the combination of, when I market an innovation, how much protection period do I have, and what price can I achieve during that very limited time that we are protected when we market an innovation?

Don’t misunderstand me, I’m not pleading to protect everything. I’m pleading to make the innovation cycle work. In medicines, our contribution to society is not only that we invent new medicines. We actually, more than invent something, we create enormous data sets around that, safety data, pharmacological data, bio-absorption data, clinical data, how to use it, how often to use it, data for the doctor to administer correctly. These data sets are so enormous. If you printed them, you wouldn’t be able to fit it into one truck just to get it to the FDA. It’s the data generation around the invention that’s the major contribution of our industry.

All that data, once the patent lapses, so once the data protection lapses, is in the public domain. We donate it. We, as an industry, donate free of charge. Everything we have invented, every data we have gathered on a medicine, we donate that to the public good, and everyone can use it. Generics can reference it. Everyone can read it up, and study it, and use it, and cite it, and refer to it. I think the public probably underestimates the value generation and the donation of value that occurs from the industry to the public domain on a continual basis.

In order for that to happen, I’m pleading for a limited protection that works. If you take a patent that is worth 20 years of protection, 10 of that is spent developing a medicine. You can actually recoup your investment only in about eight to 10 years of those 20 years of protection. That’s where the price comes in. If the price is reasonable, you get a return on your investment, and all of a sudden that innovation machine starts spinning and saying, “OK, now I have resources to deploy in the next innovation cycle, in the next good idea,” that, again, helps patients live a longer life and a better life.

You need to keep that innovation cycle going. It’s very shortsighted to say, as the European Parliament was suggesting, let me cut the protection period, I will get quicker access to cheaper drugs. Yes, you will for the current generation of drugs. The problem is, after that, there will be no more innovative drugs to refer to. That’s where you shoot yourself in the foot as a society because you’re just stopping innovation in its tracks. I think the regulatory framework in the U.S. has just become more attractive vs. Europe.

If you take, for instance, FDA review times of 200-plus days vs. European Medicines Agency review times of 400-plus days, you already see almost a two-to-one factor in timing. If you then add the reimbursement cycles in Europe, which are state-by-state, it’s not a centrally governed process, it’s a country-by-country process. You go from essentially reimbursed on Day 1 in Germany to reimbursed on Day 700 and something in Romania, 700 and something, that’s almost two years that patients in Romania have to wait until the government decides to reimburse new medicine on average. These are official statistics in the so-called weight index. It’s not something I’m citing out of the blue.

How do you create an attractive market for innovation if your regulatory environment takes 200 days longer to approve a medicine and then almost up to two years longer to reimburse a medicine, your protective period is shrinking in that time. Of course, the resources will then flow into a market which is quicker and which commands the capability to approve and reimburse a drug with speed and with an attractive price point. That’s what we’ve unfortunately seen in the last 20 years, that the U.S. has attracted more investment and has, from the same base, just grown a lot faster than we have seen in the European context.

I do think Europe has the opportunity to correct that. There’s legislation that’s been passed by European Parliament that’s being debated by member states today, the so-called General Pharma Legislation, or GPL, that is an opportunity to actually extend protection periods. There is an opportunity for a dialogue with the industry on how to shorten access times. Again, if in a collaborative way the different players got around the table and thought this through, I think we can find solutions to that. It’s not set in stone. It does take an effort of governance, policymakers, health care providers, and industry to sit together and find the solutions together.

Lee: Hey, I’m curious, Americans pay more for the same medicines than patients do in other countries. Is that a government thing or is it something else?

Claus: It’s a policy thing. If you want a government thing in terms of the government sets the policy framework, yes. Remember, the U.S. is a privately reimbursed market. Yes, you do have Medicare and Medicaid, but the large part of your population gets their reimbursement from private entities and not government entities. It’s just a different system than you would find in many other parts of the world. It doesn’t make it better, it doesn’t make it worse. The policy framework that the government has set in place just makes it speedier and makes it value innovation, which is where the price comes in in a more robust way. Then you can’t be surprised that investment flows in that direction.

Lee: Let’s shift gears just a little bit here. I’m curious about your take on the most innovative medicines. I want to say before you answer, I know at BioWorld because we cover development daily. In our meetings, the GLP-1s always come up, but in general, it’s unavoidable, and people are incredibly curious about them. I think in general, we seem to be in a scientific revolution as far as treatments and development goes. I was curious what your take on the most innovative medicines might be.

Claus: No, I would fully agree with you that we’re in a scientific revolution. I think the knowledge we have derived since the sequencing of the human genome about 20 years ago is incredible. I truly think we’re on the cusp of seeing a shift in how we think about therapies. We used to say, OK, we need to understand the disease and we need to understand where to intervene in that disease and then we need a molecule that binds right and inhibits something, or stimulates something. That’s been the approach of the last 20, 30 or more, 50, 70 years, and since probably aspirin was invented in 1898, that’s been the approach, but we can now go about it very differently.

The gene therapy, I think, which also we in Astellas have a very robust platform on, I really think is on the cusp of a breakthrough because we can now replace a gene in the body, and that means we can potentially cure a disease rather than intervening in a disease. The same with cell therapy. Again, something that my company is on the forefront of where we’re now experimenting with developing the right cell, differentiating the right cell from a pluripotent stem cell, and then replacing it in the body where the cell may have died.

For instance, if you have lost your eyesight because certain cells in the retina have died, you could imagine if we could replace those. Potentially we can restore vision or at least partially restore vision. Those are inedited things that are completely revolutionary and that haven’t been really in our hands so far. Now we have the technology to say, “OK, give it a little bit more time and we’ll be there. You can see it, you can feel it.” Even in technologies such as protein degraders, where moving from I have to bind to something to intervene in a disease, maybe you don’t bind, maybe you just chop the target into pieces, which is what protein degradation does.

It targets the targeted protein and it just cuts it, it inactivates it, rather than trying to bind to it. There are many proteins you can’t bind to or you can find a way to get something to lodge into that little shape that is needed to inhibit or to stimulate depending on whether it’s agonistic or antagonistic, so completely different idea. These new ideas, I think, will shape the innovation in the next 10 years. I’m so excited about that, because when I was a student in molecular biology, gosh, it’s now 40 years ago, and we were cloning genes. We were just doing the first baby steps in cloning in the lab, and we talked about that. We said, “Can you imagine a world where one day we’ll actually be able to replace a gene?” Not just clone it and analyze it, but actually get it into the body, the healthy gene into the body and replace it.

That was a dream. Now we have some products on the market that already do that. It’s just amazing what’s happened in the last 40 years.

Lee: Speaking of change, you’ve been in your role at Astellas as the chief commercial officer for, was it a couple of years now? Maybe a little bit more?

Claus: One and a half years. Yes, I’m enrolled, yes.

Lee: What has stood out to you? Because things move fast. I bet you’ve been busy.

Claus: Yes. I would say what I’ve focused on so far is two things. One, we as a company are launching four new medical entities in parallel. For us, that is unedited. We are a mid-sized company, and to have four launches in oncology, in ophthalmology, in women’s health, all going on at the same time, that’s a major program. As always, you can launch, or you can launch best in class. I truly believe that 70% of the value of something comes through the executional excellence. The strategy is important. That’s 30% of the value, but 70% is in the how you do it, how you engage the customer, how you explain it, how you work all those details out. That’s what we are focusing on.

I started last year with a program that I call the growth strategy, where I’ve challenged people to stop saying, “I can’t do this and this and this because … .” I’ve called it unconstrained thinking. I said, “Take a step back. Take a step back. Just pretend all these constraints didn’t exist. There is no SOP, everything you need is there. Now tell me what you can achieve.”

You know what, we gathered from around the organization, medical, commercial, hundred ideas. It was actually more, but we approved a hundred ideas. When we calculated it out, we came to the conclusion that we’ll be able to treat 9 million more patients with innovative medicines.

Nine million more patients will have access to innovative treatments because we just came up with unconstrained ideas. That’s the one thing I want people to remember. Patients are waiting for us to bring innovation to them, doctors are waiting for us to bring innovation to them in an appropriate way to the right patient, but it is up to us to come up with the ideas that actually get it done. That was the first thing we focused on.

Then the second thing we focused on, so we realized the unconstrained thinking is not only a question of having the right ideas or the right initiatives behind a launch or behind a market situation. It also has a lot to do with the ways we work together. I’m very interested now in really creating settings where the cross-functional team as a team becomes the primary driver of decision-making rather than the hierarchy in the organization.

Why do I say that? Because the team is closest to the customer. The cross-functional brand team composed of medical and commercial, and some other functions represented in it, they understand the customer best. They need to respond quickly. They need to see how do we get innovation translated into real practice so that patients can benefit from it. By empowering those teams and furthering that cross-functional linkage, getting those conversations flowing, I think we can derive enormous value in the interests of serving patients the best way.

Lee: Terrific. Is there anything that we didn’t discuss that you’d like to chat about?

Claus: I would just like to close perhaps by saying that sustainability question that you asked in the beginning I know it’s on the minds of governments, I know it’s on the minds of doctors who treat patients every day, I know it’s on the minds of people who run hospitals, who run insurances, I know it’s on the minds of people who run organizations in the industry. At the end of the day, we all want the same thing. We want patients to live a better life and a longer life. We want patients to benefit from innovations that our human minds can invent and bring to market.

I’m absolutely convinced that if we all sit together, we will be able to address the sustainability questions which are real, and we’ll find solutions that help patients because patients are waiting for us to find those solutions.

Lynn: Claus, this has been one of the more inspiring discussions we’ve had on the podcast, and we’re grateful for joining us today.

Claus: Thank you, Lynn, and thanks, Lee, for your good questions. Thanks for having me. I wish you lots of success with further podcasts in the future.

Lee: Thanks. Same to you.

Lynn: That’s our show for today. As always, BioWorld will continue to keep you informed of all the most important scientific, clinical, regulatory, and business updates. We’re a daily news service covering the development of the most innovative human therapeutics designed to improve the human condition. If you need to track the development of drugs, turn to bioworld.com. You can follow us on LinkedIn or X, and if you want to share news with us, drop us an email to newsdesk@bioworld.com. Also, if you’re enjoying this podcast, don’t forget to subscribe via your favorite platform. Thanks for joining us today.

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