[00:00:16] Speaker A: Welcome to the latest episode of the Few and Far between podcast. I'm your host, Chris O'Brien. Did you know that close to 28 million adults and children in the US have asthma? It's one of the most common and costly diseases in the world, and deadly as well, with about a million annual emergency room visits caused by severe asthma triggers called exacerbations. Today's podcast guest hopes to bring innovative treatment to these patients as well as those suffering from primary ciliary dyskinesia, a rare genetic lung disease. Dr. Carsten Rudolph is the CEO at Ethris, a German biotech focused on delivering MRNA based drug products to multiple organs via inhalation. On today's episode, we'll follow Carsten from his esteemed academic career to the start of his first company with co founder Professor Christian Planck. We'll also zoom in on the rarity of German biotechs, MRNA stability and the future of nasal vaccine technology. We really enjoyed having Carsten on the show and I hope you enjoy the episode. Okay, let's start the podcast.
Dr. Carsten Rudolph, welcome to Few and Far Between. This is a conversation I've been looking forward to.
[00:01:31] Speaker B: Yeah. Hello, Chris. Great for having me. Great to be here today.
[00:01:35] Speaker A: Terrific. So I have so many questions for you. You are the CEO of Ethris, where you are developing intranasally administered MRNA vaccines. Let's start with what was the fundamental insight or insights that led you to focus on this? And I want to add that for our listeners, you started looking and thinking about MRNA quite early. I believe so. Can you tell us a little bit about that?
[00:01:58] Speaker B: Yeah. So basically this goes back to my academic career. Yeah. So before starting the company, I was heading a research team at the Department of Pediatrics here in Munich at the Ludwig Maximians University. And as you know, cystic fibrosis is a quite big disease there. You know, my focus and my team always centered around developing ideas and approaches based on gene therapy for the treatment of genetic diseases. And cystic fibrosis is quite common. We always looked basically into pulmonary diseases. So that's the background where we come from. But as you know, there are limitations coming with gene therapy approaches. And that's why we thought before starting the company, let's look into alternatives and obvious. Now everyone knows this basically, but messenger RNA of course popped up and we indeed found that messenger RNA is much more efficient than plasma DNAs. And we found also a way, and I think we will speak about this and everyone knows this right now to make messenger RNA basically non immunogenic where we thought that's the key, because that's what we learned at the very beginning, you know, that the standard MRNA induces acquired immune response. And with the work that I did with the team at the university, we found a way to navigate around this. This was, so to speak, the start, the kickstart for Atheros. Because what I thought, and with my partner, Christian Planck, you know, who comes from the delivery side, which we will touch as well. Yeah. Which is a key element also for sexual MRNA drug. We thought if we don't start the company, then the technology and the knowledge will just end up in a draw. And so that's why we then in the end, I have to say we were brave to do this, but I'm very happy because. And I think we will speak about this today as well. What you mentioned already, the first program has now completed a phase one trial. And that's of course fantastic and very exciting for a founder of the company.
[00:03:53] Speaker A: Congratulations on that. Yeah, that's incredibly exciting. I agree. Let's talk for a second about Germany as a hub for this. I think many of our listeners will be in the United States and will not think of Germany as a hub for startups in biotech. Obviously a center for research, obviously an enormous source of medical talent, but not as much a home for startups. But MRNA is maybe a little different. I think there was. Am I correct in thinking much of the original excitement and research around MRNA happened in Germany?
[00:04:22] Speaker B: I think retrospectively? You're absolutely right. Because we have also the colleague from other German companies, qvac, of course, was, I think, one of the very first ones pioneering using messenger RNA as a vaccine. So really credit to them, I have to say. And by Biontech, very early stepping into using messenger RNA for oncology purposes. And it's a good question why so. But why we tapped at the same time into using messenger RNA for therapeutics. You're right. This happened here in Germany. So. But I can't tell you that there was a certain environment or something like this. I think it's just about the people who started it who had at the same time ideas of using messenger rna. But of course, we met in those early days, so we knew us in those times.
[00:05:08] Speaker A: Yeah, maybe. At least it's comforting to know there are other smart people who are wrestling with the same challenges or opportunities. The history of science is full of these clusters of content. Okay, so in the early days there's some initial excitement, but I remember a period of deep skepticism about mRNA, you know, pre Covid I remember a conversation with a, with a scientist. I will not name this person who was saying moderna, they've been doing this for many years. They've got nothing to show for it. You know, the community is pretty skeptical about whether this technology is actually going to be, be viable. And that obviously seems, in hindsight that seems foolish. But was it difficult to raise funding, maintain your own motivation, the motivation of your team, or did you feel like, no, we're really onto something. What was that experience like?
[00:05:55] Speaker B: Good point. I think this goes hand in with also with other RNA modalities. You know, at the same time the people were speaking a lot about sirnas. Yeah. So I think what was definitely helpful is there that there were really great progress also made with Sarnas. And you know, after we had the first ERG on petrol as an approved drug product, this was, I think, very helpful for the entire field. And otherwise, you know, Chris, it's like with any new drug modality. Yeah. You need in the end then the great breakthroughs like with the vaccines and the right time, fantastic for this technology to show it's really its advantages that this brings basically to stimulate an entire field. Yeah. So that of course for us also is very helpful since we know now with this new drug modality that this is approvable. So regulators prove this as a commercial drug and that's of course very important for anyone, not only for you as a drug developer, that you can make it, but also of course for investors, because it's all about risk mitigation and then you get one risk out of the equation again. So that was indeed extremely helpful.
[00:07:07] Speaker A: Fascinating. Okay, so let's talk a little bit about the formation of the company. Many of our listeners are, are in academia or have been in academia recently. So you took the bold decision to start a company and you mentioned some of this was you could not imagine letting this technology sit in a drawer, which makes sense, but still, tell us, how did you acquire the necessary business skills, et cetera, to move from an academic scientist to the CEO of a biotech company?
[00:07:35] Speaker B: This was a lot of learning by doing, I have to say. So, you know, in these days for us, that was helpful. I think there was a time when there were a lot of business business plan competitions here in Germany where you could take place. And that's, you know, what just Christian and I did. We wrote business plans. And this helps you, you know, to structure what's the idea behind it, how to position it, where's the need that you address? Yeah. What's the Budget behind, you have to start to plan. Also just legal requirements. You have to fill. Yeah. And all these things. So this was a kind of process where Christian I went through together, then we went to various meeting and found also some ports from initial. You know, how you say it?
[00:08:23] Speaker A: Is it angel investors or an angel investor?
[00:08:25] Speaker B: That's right. But thanks, Chris. Yeah. And this was the starting point then. Yeah. And then you simply have to say, okay, if you want to take some activities serious and want to do first contract, you just need to be a company. So then you have to start and the kick start, so to speak. And then, yeah, sometimes you should not think too much about it. Just do it. And you will find solutions if you need.
[00:08:48] Speaker A: I think that's actually a very profound point, especially for scientists who sometimes wish to be able to research their way, all the way through a problem. And as you say, you kind of can't do that with starting a company, can you? You know, some things, but some things will be unknowns. Many things will be unknowns initially.
[00:09:04] Speaker B: Exactly. Yeah.
[00:09:05] Speaker A: Yeah. Fascinating. Okay, so you mentioned upfront your partner in the development of the company and his expertise. Christian's expertise is in delivery mechanisms. Will you talk a little bit about the fundamental problems that you were trying to solve? And just as a reminder for listeners, this is an intranasally delivered vaccine that you guys are building. So tell us a little bit about the core technologies that you built.
[00:09:29] Speaker B: Yeah, just their upfront information. It's not a vaccine yet. So we develop an immune modulator, basically, if I come to this, that activates the immune system to inhibit replication of viruses. But it's a therapeutic. It's not a vaccine.
[00:09:45] Speaker A: Thank you for the correction.
[00:09:46] Speaker B: And we see, Chris, great potential in using our technology for nasal vaccines. Indeed. And I believe that's the next step. Also what we learned from the pandemic, where a new generation of vaccines could really be helpful to us. But as you say, when we speak about nasal administration or also inhalation, we all know that you need some technology to generate something that you can inhale. That means you have to produce droplets that can be administered to the respiratory tissue. And we all know that, that this of course causes a lot of energy and stress on the material that is nebulized. So that's really a very important challenge we had from the very beginning to see how can you stabilize these nanoparticles with the messenger RNA in a way that they are not destroyed during this nebulization step. And just for your information, is that when we look at the commercial vaccines with the LNPs, they are very fragile and we have on the label mentioned don't shake them.
[00:10:53] Speaker A: Yeah, yeah, yeah. Okay.
[00:10:54] Speaker B: And doctors should not do this flicking against the sirens, you know, because they aggregate. Yeah. And this is exactly something that we have to solve. I think we were very creative and we found a solution here. Yeah. So first of all we developed not cationic lipids for the delivery of messenger rna, but cationic lipidoids. Yeah. So these are lipid like materials. Yeah. And they the property of condensing that means packaging messenger RNA more tightly.
[00:11:21] Speaker A: Fascinating.
[00:11:22] Speaker B: Okay, this is already an advantage. But most important is what we developed is what we call a stabilizing excipient. So this is an excipient that you can add to these LNP formulations and they stabilize the formulation against any stress. That means you can shake them now, vortex them for half an hour, full speed, no change. You can nebulize them, There is no change. You can highly concentrate them. That's very important. Without any aggregation. And they also on top allow us us to now dry them very nicely, these formulations. And we believe that's a very important step. Yeah. Because we want to achieve a better storage conditions. So that's what you can achieve with a dried formulation, be it on the one hand side lyophilization or spray drying. And spray drying, you know, that's the technology that people use to create these micro particles that are used in dry powder inhalers also, you know, in the asthma field that you can just carry around in the pocket of your hands basically. Yeah. So and this is exactly where we want to be in the end because we want to provide long term then to our patients a very easy to use drug product.
[00:12:35] Speaker A: Carson, does that mean that the technology also has real implications for delivery in the developing world in countries that might not have good cold chain and good controls in place for these fragile MRNA therapeutics that were otherwise developing.
[00:12:49] Speaker B: Indeed. Yeah. So we believe that we can really help there and advance the field because this is I think also learning from last pandemic, basically. So it was fantastic. Fantastic and really credit to Biontech and Moderna Pfizer who developed this with this huge high speed vaccines. But in the end it's then also about distribution to get the vaccine to the people to vaccine. And I think one important element was definitely this ultra cold chain that need to be followed basically. Indeed. We believe with this technology that we develop we can really make it easier to distribute the vaccines and also potentially to enable much easier stockpiling so that better prepared to directly have it available vaccine for a better rollout. Yep.
[00:13:42] Speaker A: Hi, this is Chris O'Brien, host of Few and Far Between. We'll be right back with this episode in a moment. I personally want to thank you for listening to our podcast now in our fourth season. It continues to be an amazing opportunity to speak with some of the top thought leaders in the clinical trials industry. If you're enjoying this episode, please leave us a review on Apple Podcasts. It really helps people discover the podcast. And don't forget to subscribe to Few and Far between so that you never miss an episode. One last request. Know someone with a great story you'd like to hear me interview. Reach out to us at Few and far between. Irasi.com thank you. And now back to the podcast.
You have an interesting strategic question, don't you? Of you could provide an enabling technology for other people's MRNA therapeutics or vaccines and of course you're going to use this for your own. Is that how you think about it? That the technology could be used for delivery for lots of MRNA treatments, including those developed by other organizations or no, no, indeed.
[00:14:41] Speaker B: So I mean, Chris, we focus on, of course we have to be very focused now on core programs basically, but we see also great value enabling partners who have other ideas for using messenger RNA and provide technology and help them and be it in the vaccine space. Indeed we do it also with other partners, but also potentially other areas. No, of course, because I mean we're a small company, we can only do what we can. Yeah. So. And there's so much beyond. And it indeed would be great if we can provide our technology also to other partners to use it to generate great messenger RNA drugs with it. Absolutely fascinating.
[00:15:21] Speaker A: Okay, so this was one of the problems that you had to solve, which is how do we nebulize this therapeutic and deliver it? Tell us what the other big scientific challenges have been.
[00:15:30] Speaker B: Yeah, so that's definitely. And I think we can tick the box here. So that's really great and it's quite unique. I think what we have achieved here, another one is to have really control about delivery. So what do I mean by this, Chris? I mean here is that's what we desire and if we speak about the respiratory tissue. Yeah, we really want the activity of the messenger RNA only in our nasal tissue or in the lung tissue, but to have to maximize the activity there and we don't want to have it spill over into the circulation so that it is distributed to other organs like liver or heart Et cetera. And this is indeed what we have achieved with our formulation technology. So it is really retained at the site where you deliver it and why do I mention it? And this is also of observations coming from the commercialized vaccines. Although they are injected locally into the muscle, they are not fully retained at that site. So they distribute also to other organs. And we believe it does not need to be anywhere else. Why should it be there? So, and I think that's really good. And we could also, we saw this in our preclinical studies, but we can also confirm this now phase one study. So it's really locally retained at the site of delivery. So that's really good. We have a good control of what we do there. Another challenge we spoke about it is of course having a non immunogenic or at least immunogenic messenger RNA available. And that's also learning from the vaccines. We saw that those companies that use this modified messenger RNA were successful. And what we have done at Atheros, we have developed also our own modification technology which is different from the one that is used in the commercial vaccines. And we believe it also has another adv manage because that was recently published, that was in December, that there's a full replacement. That means commercialized vaccines, you know, where you replace each U with a modified uridine and one methapserudine. It's reported this can lead to N plus one frameshift so that there some other proteins, non desired proteins are produced. And we don't see this with our modification technology because this is only a small light touch of what we say of modification because we only replace a small amount of of standard nucleotides with modified nucleotides and that's fully sufficient to change the pattern of the rna, you know, because that's what you have to change because our innate immune system that recognizes patterns. Yeah. So we changed the pattern. We believe that's a really critical technology that we have developed so really to minimize immunogenicity. And then I think it's important it's also look, let's look into manufacturing. Chris. Yeah, and we have done there also and started early on thinking of the question how can we potentially satisfy the supply? And we thought always for pulmonary drugs that might be larger amounts than for a vaccine. And we looked into a process that is not using or not based on hplc because the standard processes are used on hplc and HPLC is not easy to scale up basically as we looked early into a very easily scalable process. And it's called Tangential flow filtration. That's an absolutely standard process used in industry and it is very nicely scalable. And we really have achieved very good process with this to achieve very high quality messenger rna. It's much faster than the standard process and it is purely aqueous, so it does not need any solvents. And so that's another element, I think, that was important for us, that we have achieved here, four key elements there. It's their modification technology of the messenger rna. It's highly efficient LNP technology based on our cationic lipidoids with very high stability and our stabilizing excipient on top that enables us to drive our formula.
So, yeah, and that's what we have in the clinics now.
[00:19:39] Speaker A: If someone were talking to you five years ago, some wise person, they might have said to you, that's too many things to try to do. You should not try to do all four of these things at the same time. Don't worry about scalability, perhaps, or don't worry about something else. Just focus on getting MRNA that can be delivered effectively. So you guys did not do that. You thought ambitiously about, you thought about the end, I guess, that you were aiming for, which is scalable drug production that is effective and stable. Is that right? Right. Obviously it seems to be working. So I'm not criticizing your enormous success, but did you think about this?
[00:20:13] Speaker B: Of course. That's very important, that you know where you want to go and where you want to be. But we also needed this in our preclinical programs. We needed these stable LNPs, because otherwise they just aggregate when you nebulize them. So you can't control whatever you nebulize. You know, for preclinical studies of mRNA, quite high amounts. You know, if you aerosolize these materials to some rodents, they just breathe about 1% or something like this, so you blow 95% into the air. So we had a quite high demand from the beginning. So I think it's bold a little bit, Chris. Yeah.
[00:20:49] Speaker A: Okay.
[00:20:50] Speaker B: But we really also needed to solve very practical things here.
[00:20:55] Speaker A: It's very nice when strategy and necessity align. It sounds like that's what happened here.
[00:20:59] Speaker B: Yes, that's right. Very good.
[00:21:02] Speaker A: Okay, tell us a little bit about the you've won that has completed phase one, but another headed to the clinic. Is that right? Or what's the status? And tell us a little bit about these drugs.
[00:21:11] Speaker B: Yes. Eth47, you know, that's the program that has just completed our single ascending phase one study is Addressed to meet really or a high unmet need in the asthma field. Yeah. And at the first glance you may think that asthma, what kind of new drugs do you need there? So, you know, all these asthma sprays, you think, oh, everything is solved. Yeah. But if you look a little bit deeper there, you see that there is still a quite large proportion of patients that go through asthma attacks that you can't fully control right now. And these asthma attacks that are called exacerbations, you know, this is shortness in breath, cough, wheezing, awakening at night. Really, these are also traumatic events. What you have to know there is that each exacerbation comes with a decrease in lung function for the patient, which is not fully reversible. Yeah. It is really something that you have to prove for the patients to maintain the lung function there. It's important to know that about 80% of these exacerbations, they are triggered by virus infections. This can be an 80% very harmless viruses like a rhinovirus and a rhinovirus. If this infects you, you have a little bit of a runny nose.
But for an asthmatic, this can lead to a cascade of inflammatory events that leads to this dramatic exacerbation. We don't really have anything there to prevent these asthma exacerbations. And then it's important to consider that the host response is dysregulated in these asthmatic patients. And in particular there's one very central immune modulator that is called interferon lambda, an interferon of our muco surfaces which is critical as a first line of defense to keep control about a virus not to replicate. And this molecule is dysregulated and also with a delayed onset in asthmatic patients. And you know, the concept that we Follow now with eth47 is a Minister Interferon Lambda encoded by a messenger RNA with our technology to the nasal cavity. So that in the nasal cavity there is interferon lambda produced that then activates these antiviral interferon stimulate genes that they called that are dysregulated so that the host resistance is basically normalized or restored again. That means if then a virus hit the entry site of the patient, that's nasal cavity, it does not trigger virus replication which comes then with the exacerbation. So that's the concept left behind that we follow. We are very excited that we can demonstrate that this works basically in our phase one study, you know, that was in healthy volunteers single ascending dose study. And we can see for one it's very well tolerated. Yeah. So it is really no serious adverse events or severe adverse events. No change in vital signs, cytokines, all really, really good, I have to say, even with highly concentrated dose drug, drug product at the highest dose. And we see, and that's important, confirm that it is locally retained. That's what I mentioned already before. So we don't see any components of the formulation, be it the messenger RNA or our cation lipidoid in the circulation or also the interferon lambda produced. And what is important is we see dose dependent production of the interferon lambda in the nasal line, including of the nasal cavity. That is in the predicted or even much above the predicted therapeutic level that you need. So we are really, really happy with these results. It's a great confirmation. The concept works also on top because we see that the produced protein leads to this downstream activation, what it's expected to do. So we know the biology is activated in the way that we want it to be. And that's why we are very pleased with those results.
[00:25:29] Speaker A: Yeah, that's incredibly exciting. And obviously, potentially, as you said, it's a large population that can benefit from this treatment if you continue to progress with these results.
[00:25:37] Speaker B: Yeah, yeah, exactly. So we have just in the US to give you some numbers. We have about four and a half severe and moderate, moderate to severe asthma patients. And of these, about 1 million annual emergency department visits we see and even 100,000 hospitalizations worldwide. It's about 270, 80 million asthma patients. So it could be really, really a change for these patients. If it works, then. Yeah, but that's the way to do. And I hope we will still have then some additional podcast in the meantime. Chris.
[00:26:09] Speaker A: Exactly.
[00:26:10] Speaker B: I can report on that.
[00:26:12] Speaker A: We'll be very happy to welcome you back as progress moves forward here. Okay, so that's your primary asset. That's the first. But I think you have a second asset under development as well.
[00:26:21] Speaker B: Yes, yeah, exactly. This is a little bit behind. So the real focus right now is on eth47 for asthma also because there is a great expansion opportunity also in COPD where we see also correlation between virus infections and exacerbations. The second program, we call it eth 42 here in house, addresses a rare genetic lung disease. You know, this disease, it's called primary ciliary dyskinesia. So these patients, they suffer from mutations in genes that drive the motility of our tiny hairs that cover our airways, you know, and they are called cilia and their movement is required to transport the mucus out of the lungs. And this is a natural mechanism to keep our lung particles free, basically. I mean we inhale every day so many particles and we don't want to have them in the lung, but we want to have them cleared from the lung. So and that's one mechanism to get them out of the lungs. And you can imagine if this does not work, these patients have only a wet coughing to remove their mucus from the lungs. But this is not very efficient. This leads to chronic bacterial infections. This is then can lead to bronchiectasis in these patients. And in the end it's a progression lung function decline in these patients. And we don't have any treatments available for these patients patients right now. So the concept, I mean you can a little bit think about that. The symptomology is somehow similar but not identical to cystic fibrosis, which might be more present because it's more prominent, this disease. Exactly. And the concept behind it is now to deliver a messenger RNA that encodes for the missing protein in the cilia to replace this missing protein so that the cilia are start to beat again. And we see indeed that the concept works. So you know, if we, if we take up out from these patients cells from the nasal epithelium and grow them in a dish, so that's called an airway, liquid interface cultures and treat them with our candidate eth42, we can very nicely see that for one we can restore the structural defect. That means that the missing protein is back in the cilia. But what is more important is we can see also that the cilia start moving again. You know, we use high speed video microscopy for this and it's beautiful to see this. Before treatment, there's nothing going on in the cell culture dish, but after a few, few treatments you can see that the beating kicks in.
[00:28:54] Speaker A: Yeah, that's magical. That's very, very impressive.
[00:28:56] Speaker B: It is, it is, exactly. That's why we are very confident that eth42 is doing what it's supposed to do. We have already also granted often drug designation for the from EMAAR and fda and we are now currently in the end of our preclinical pack to move this towards CTA filing towards the end of next year, autumn next year. It's a little bit behind our Eth 47 program.
[00:29:21] Speaker A: Very, very cool. Very, very exciting and extraordinary progress. I'm going to now ask us to step up to a higher level. One of the questions that we like to ask is scientists are in the business of being careful and not over promising. But if this technology really works, if it really goes the way that you hope it can go, what do you think the scope of impact is? What can you imagine? Imagine, because you have both direct therapeutics, you're developing, you have the delivery mechanism. What might the world look like for ethras in five or 10 years?
[00:29:50] Speaker B: We hope that we can really help to provide new medicine to patients who have no options for treatment right now. Yeah. Be it with their, like I said, with the asthma patients or with the PCD patients. If we think beyond, there are many other diseases where we still don't have a really good medication. Yeah. And this is, for instance, we look into the disease space of the lung, you know, Alpha 1 antitrypsin deficient. This might be really helpful. Then look at those really severe diseases like idiopathic pulmonary fibrosis, where we also do not have really something that we can provide.
Look into acute respiratory distress, where we have really drastic mortality rates in these patients. So there are still a lot of other indications where we believe with our technology we can really help patients in the future. But also on top. And I mean we spoke about this and this is what you mentioned in the very beginning when you introduced atheros. It's vaccines. Yeah. So we are very confident that our technology holds great, great promise for these true nasal vaccines. And why do I say it? Because it's also one learning from the pandemic that the standard vaccines, you know, that are giving systemic, that means intramuscular, they were fantastic. Fantastic. To reduce hospitalization rates and mortality. It's fantastic. But they were not capable of preventing transmission.
And this is still something we believe in the field, I think, believes could be achieved with mucosal vaccinations via nasal sprays. So that you have transmission blocking vaccines. Because then at the very beginning you could already much better contain pandemic.
[00:31:39] Speaker A: So exciting. Yeah.
[00:31:40] Speaker B: And it would also have the benefit, you know, that this could be self administered. At least you don't need any medical personnel for this. Yeah. Because it's not an injection. Yeah. And I think with our data that we know now that a messenger rna, when delivered to the respiratory epithelium of a human gives rise to the desired protein. This can also be an antigen, of course. Yeah. Yes. I think this really opens huge opportunities into this direction. Yeah. So we can definitely not heal the world, Chris. But maybe we can make this a little bit better. Better for the patients with our technology. But of course we also need a little bit of luck here. But we are very, very passionate to do this. And in the end, it's also all about perseverance. Yeah. So that's what we do here.
[00:32:27] Speaker A: That's fantastic. I don't think you're obligated to heal the world. It sounds like you are making progress towards healing a part of it.
I think humanity will be very happy to accept that result if that's where things go. All right, I'm going to now ask for some advice. So some of the people who listen to the podcast are either founders or future founders, people who are thinking about fall following a course similar to the one that you did or you have been on. What advice would you offer to someone who is possibly in academia or inside of another biotech company and thinking of starting a company? I'm sure you learned. You learned a lot. We all learn both the hard way and the easy way. So lessons that you learned from things you did right or things that you wish that you had known earlier. Very, very interesting.
[00:33:10] Speaker B: I mean this is of course from case to case, very different of, you know, what, whatever they're given general advice, basically. Yeah. I think it. What is really always to try to think from what you mentioned earlier, from the gold back. Yes. That means really, very carefully think about what are the patients, what is the unmet need that you address. That's I think a very important element. Yeah. And very carefully think about how could a drug product look like. Check what are all the elements that you need to bring together and try to ask as many questions and really try to get in contact with as many, many people possible. Also on conferences, etc. So it's talking is very important. But then in the end it's really some time where you have to decide for yourself do it or not do it. And then I can just recommend get started.
[00:34:02] Speaker A: I love that. Yes.
[00:34:03] Speaker B: Yeah. No, because you will find out when you start. And then I think it's very important. It's not a sprint. Definitely not. It is what people always say. It's like a marathon that you do. And I always say already that this is even not only a marathon, but it's an Ironman on Hawaii, basically because you have to fulfill many disciplines. It's not only running, but like swimming and cycling on top. Yeah.
[00:34:32] Speaker A: So I like that analogy. Yeah.
[00:34:34] Speaker B: Yeah.
[00:34:34] Speaker A: I think the other complaint I've heard is it's like a race, let's say an Ironman, but you don't know actually where the finish line lies. It's an Ironman of indeterminate minute length.
[00:34:43] Speaker B: Good point.
[00:34:44] Speaker A: That's really terrific. I want to emphasize this point that you made about thinking about where you want, what you want the destination to be, what the end point is that you're building not just the technical endpoint for a clinical trial, but actually for the company or the therapeutic or vaccine that you're designing. Would you spend one second and just talk about the difference between academic activity, drug development, et cetera? I've heard some folks talk about that feeling more open ended. And I think you're emphasizing the need to think about where you're going in advance and plan backwards. So would you spend one more second on that?
[00:35:15] Speaker B: Exactly. That's right. Thinking backwards is important. But I think what is also important is in contrast to academia, you sometimes have to make decisions and say, now it's good enough. I move this now forward because otherwise you will never come up with a candidate. So you, so to speak, there's a certain time point when you decide yourself that's good enough. And I do my design log now because then you follow those real development activities. Yeah. Where we have to think about how to manage manufacture this in GMP and what are exactly the components, how are they regulated and how does the tox program, et cetera, look like? And this is something you definitely don't do as an academic. You think, oh, there's still something I can prove here. This does not mean you should not improve technology.
That's what we do every day here. And I could speak now for hours of wonderful improvements that we have achieved at the same time, but they are not part of our initial program now. Yeah.
[00:36:12] Speaker A: Yes.
[00:36:12] Speaker B: And so that sometimes you have to say, okay, I'm good now, and now I move it forward.
[00:36:17] Speaker A: Fantastic. Dr. Carsten Rudolph. We're going to leave it there. That's a perfect point to end. I think what you're doing is incredibly exciting. Yes. We would be delighted to welcome you back for an update as time goes along. Thanks for joining us today on Few and Far Between.
[00:36:29] Speaker B: Thank you, Chris, for having me. It was very nice chatting with you.
[00:36:36] Speaker A: Thank you for listening to the latest episode of Few and Far Between. Our podcast is now available on Apple Podcasts and other major streaming services. Please take a moment and leave us a user review and rating today. It really helps people discover the podcast and we read all the comments. Those comments help us to make Few and Far between better and better. Also, be sure to subscribe to Few and Far between so that you don't miss a single episode. Got an idea for a future episode? Email us at Few and far between irasi.com or contact us on our
[email protected] I'm your host, Chris. Chris O'Brien. See you next time.
