Business Of Biotech
The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. SUBSCRIBE to our new newsletter at www.bioprocessonline.com/bob. We bring you insight into organizational, finance and funding, HR, clinical, manufacturing, regulatory, and commercial challenges you’ll face as you navigate your company from an idea to success in the clinic and beyond. Each episode features guest commentary and best practices from accomplished founders and biopharma industry luminaries. The Business of Biotech is produced by Life Science Connect.
Business Of Biotech
Executing A Product Pivot With Vir Bio's Mark Eisner, MD
We love to hear from our listeners. Send us a message.
On this week's episode of the Business of Biotech, Dr. Mark Eisner, EVP and Chief Medical Officer at Vir Bio, talks about the company's post-COVID pivot into infectious diseases (Hepatitis Delta and Hepatitis B) and oncology (solid tumors), how he reprioritized the company's development candidates and assimilated Sanofi's acquired T cell engager platform, and his own transition from healthcare provider to clinical research.
This episode is brought to you by Avantor. For more information, visit avantorsciences.com
Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.
Subscribe to our monthly Business of Biotech newsletter.
Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com
Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/
This episode of the Business of Biotech is brought to you by Avantor. Every day, science has the power to change lives for the better. Avantor partners with the scientific community, pioneers and innovators in the lab and in bioprocessing to help solve complex scientific and operational challenges. Avantor delivers end-to-end support, from discovery to commercialization, for the global biotech and biopharma ecosystem, providing mission-critical products and services that are integral to advancing life-changing innovations for patients. Visit avantorsciences. com for more information. Welcome back to the Business of Biotech.
Ben Comer:I'm your host, Ben Comer, chief Editor at Life Science Leader, and I'm pleased to speak today with Dr. Mark Eisner, Executive Vice President and Chief Medical Officer at Vir Biotechnology. Mark received his medical degree from the University of Pennsylvania, following a bachelor's degree in human biology at Stanford, and went on to complete a residency at the University of California, San Francisco, where he stayed on as a researcher and professor for the next 25 plus years, and then, in 2010, he decamped to Genentech and spent the next 10 years moving up the ranks to become senior vice president, global Head of Immunology, infectious Disease and Ophthalmology Development. Since 2020, he's worked variously as an Executive and Chief Medical Officer and as a Scientific Advisory Board member across a handful of companies before joining Vir Bio last year. I'm excited to speak with Mark today about his career and Vir's change in direction and to get his insights on how to execute a pivot in strategy and development focus. Thanks for coming on the podcast, Mark.
Mark Eisner, MD:Thanks, Ben. Thanks for inviting me. Exciting excited to be here.
Ben Comer:Mark, you worked in academic medicine at UCSF, as I've just mentioned, for nearly 30 years. What precipitated your move into product development at Genentech in 2010?
Mark Eisner, MD:Yeah, no, it's a really good question. I mean, when I think about my career and why I went into medicine in the first place, I originally thought I would be taking care of patients one-on-one and one-by-one, and I did find that really very gratifying. But once I was at UCSF and got involved in clinical research, I realized that it was really exciting to be able to answer clinical questions that could help large numbers of patients as opposed to just patients one-by-one, which is still, of course, extremely important. And then, when I got the opportunity to go to Genentech, I got really excited because I thought, you know, that would be a place where I could make an even bigger impact for patients because of the resources and the ability to test novel therapeutics and really to potentially change how medicine is practiced and help patients on a larger scale. So that was why I made the move and why I'm still really excited to be in the biopharma industry.
Ben Comer:Do you ever miss the one-on-one you know, as opposed to the kind of once removed one-to-many versus the one-to-one or no?
Mark Eisner, MD:I do. I mean, you know I think there is something very special about the interaction of a healthcare provider with a patient and I think you know there's something I do miss. But you know I did do it for a long time and I feel like a lot of the problems that we're trying to solve here at Vir do ultimately come down to thinking about individual patients and their diseases and the therapeutics that we're trying to develop. So I always try to keep that in mind. You know what the individual patient would want or need.
Ben Comer:Yeah, absolutely. That makes a lot of sense. And I do want to ask about some of Vir's development programs. Hepatitis Delta was sort of a new one for me, so I'm looking forward to you know learning some more about about that disease and what Vir is up to in that category. Um, you, you know, across your academic career and your career in industry, you've worked in pulmonary and respiratory disease, now oncology, immunology, infectious disease. Is there a disease or therapeutic area that most interests you personally, or is there a through line that connects those various fields of research and development?
Mark Eisner, MD:Yeah, no, I think my interest in pulmonary critical care was partly because, despite the name, it does involve diseases that affect all organs, all part of the body, and requires one to think very broadly about physiology and medicine. So I've always been fascinated by what causes different diseases and how to treat them. A disease like asthma or rheumatoid arthritis, where the immune system is either responding to abnormally to self, either in an autoimmune way, or to an antigen, like an environmental antigen in the case of asthma. Similarly, you know, an infection like hepatitis delta or cancer are both essentially foreign invaders and your immune system is not always functioning properly to treat those. So that's where I think there's a commonality in what we're trying to do here at Vir, which is to leverage or power the immune system to treat disease and transform the lives of patients treat disease and transform the lives of patients.
Ben Comer:You joined Vir as EVP and chief medical officer last June, relatively new on the job. That was on the heels of a strategic reorganization that closed a few R&D sites, led to some significant layoffs at the end of 2023, but that also led to the acquisition of Sanofi's via Amunix Pharma's three clinical stage masked T-cell engagers. First off, what can you tell us about the thinking or logic behind the reorganization and acquisition and maybe, if you could speak to the challenges that come along with? You know a pretty decent change in focus there.
Mark Eisner, MD:Yeah, so great question. So to go back a little bit, I mean Vir, I think, had a major success rising to the challenge of COVID in the pandemic and developed Sotrovimab in only 15 months, which is really record speed for discovering and developing and getting to market a new, totally novel therapeutic for COVID. But, as we all know, the virus continued to evolve and mutate and Sotrovimab was no longer effective and is no longer being used in the U. S., certainly, certainly and minimally across the world. So the company had to rethink its priorities and its strategy. And when I joined it was right at a perfect time because we're right in the middle of those discussions. So looking at what are the projects that we have that can really move the needle for patients and what else do we need to bring in to make the pipeline successful.
Mark Eisner, MD:So you know, really prioritizing the programs for hepatitis delta, tobevibart and elebsiran for hepatitis delta, which is going into Phase 3 imminently, thinking about our hepatitis B program, and then deprioritizing some of the other programs that weren't really having the same promise for patients. And then the process that the company went through that led to the Sanofi T-cell engager platform acquisition was one where hundreds of companies and opportunities were looked at and I think what we were hoping to find and I think we did find is something that had really transformative science, a big potential to help patients, something that was right size for a company of our size and scope to be able to develop. And I think what was particularly wonderful is that we also brought in about 50 employees who were mostly former Ammunex employees, including those who had developed the technology, the masked TCE technology, those who developed it and really were enabled us to hit the ground running with those programs. So I think that was a really exciting aspect of the deal.
Ben Comer:Were you familiar, mark, with the science of T cell engagers prior to starting work on this? Was that something that you kind of knew and understood, or did you have to learn it following this move?
Mark Eisner, MD:I would say yes and yes. I mean I certainly was familiar with T cell engagers, but I also had to learn a lot in short order and I mean I think that's part of what I love about working in biotechnology is the challenge, because you asked me before about different disease areas and different programs, and you know, getting to work in different areas and learn about those is really exciting to me. And you know also bringing in real experts from Sanofi formerly Amunix who can help us really fully understand. You know the platform and how we're optimally going to develop it.
Ben Comer:Yeah, and following on that, the Amunix employees came in. You have an opportunity to work with them. But I'm curious, maybe from a step back, broader perspective, as a new CMO coming into a company to help lead the R&D teams to success, you know, and progressing, new modalities for new indications, new indications. How do you, I guess, how do you motivate and invigorate the teams that you manage, which are, you know, everyone's?
Mark Eisner, MD:new to each other at this point. Yeah, no, that's interesting, I think, first of all for me as a leader. I always keep the patient front and center and try to think about, you know, what problem are we trying to solve for the patient? You know, as we develop therapeutics for the patient, and that's very grounding, and I think that's very inspiring for people who work in R&D and in my teams. And you know to always try to bring it back to the fundamentals, right? What are we actually trying to achieve. But I think also it's around trying to create an environment where people can do their best thinking and their best work and really contribute, and that's something that is very very important to me, and I've always strived to do and to create the space where people do feel empowered and feel that they can really contribute in their most optimal way, that's also a very important element.
Ben Comer:Are there any specific attributes or kind of characteristics of that kind of environment that you could mention on kind of a ground floor level? You know? What does that environment look like? How do you create it?
Mark Eisner, MD:Yeah, great question. I mean I think for me it's around. You know, if I'm leading a team discussion, what I really like to do, and I think is important to do, is to really ask questions and to make sure everybody is heard from and actually keep a bit back from that and be facilitating a discussion. And usually what happens when one does that is you get people to really express their ideas more fully and usually the solution suggests itself, you know, during that process and as opposed to one where it's very top down and you come in and just say this is how we're going to do it. You know that I think is very challenging to not do for someone like me, but I think you know I've really that's a skill I've really worked on and I think it's really helpful for people to be able to really contribute their best ideas.
Ben Comer:Yeah, and in terms of motivating a team, I'm sure that you had to do some of that in your academic career. You know, prior to at Genentech, that you know that served you well on that topic of getting the best and most out of your colleagues now at Vier.
Mark Eisner, MD:Yeah, I mean I guess you know, working in academic medicine one always has medical students, residents, fellows, people who are learning. So you know part of the job is to teach people and, to you know, find out what they know and you know, help them learn what they need to learn. So I think that that's an important skill I learned in academic medicine.
Mark Eisner, MD:But there are some pretty big differences. For example, you know, if I'm attending in the ICU and a patient is having trouble breathing or low blood pressure, I mean there are times where you just got to basically direct people what to do. There's not a lot of time to react and that's not really a great way typically to lead teams in biotech, pharma. And I did have to learn that actually, because I think things are much more team oriented in the biotechnology and pharma world than there are in academia, where it can be very much driven by an individual principal investigator or attending physician and you know you kind of spend time directing people and setting their priorities. But in the biotech world I learned you got to be much more of a coach and much more of a mentor and really try to work in that way and try to bring out from people. You know their contributions, which of course could be important in academic medicine too. But I think, given the very critical nature of cross-functional teams in our work here, it's a different skill set that's needed.
Ben Comer:I want to get to hepatitis delta, but before I do, we already spoke about the pivot, so to speak, or change in focus and strategy at Vir. This is something that happens at a lot of companies, if not all, if they exist for long enough, right, and I wonder if, if you ever went through something like that at Genentech, where there was a strategic reprioritization or, you know, an acquisition that caused some changes to the work that you were doing, have you had to kind of work through that type of situation before?
Mark Eisner, MD:Yeah, of course I have, but I think it's it's more. I have, but I think it's more. I mean, for example, we started out as a product development immunology and then we added infectious disease and added ophthalmology, and that required some reshuffling of priorities and thinking. You know, bringing very different groups together.
Mark Eisner, MD:I think what's different about what we've had to do at Vir is, as a smaller company and as a biotech company, it's a pretty big pivot to go from infectious disease to infectious disease and oncology. What I think has helped us is the fact that the underlying need to focus on the immune system and how we target it to treat either an infectious agent like Delta or harnessing T-cells to fight cancer. There's a thematic connection there, I think. Also, fundamentally, at the core of Vir's technology is antibody engineering, which I think is a super important capability. That bringing in the T-cell engager platform allows us to think about the next generation of targets. But there's no question that reshaping a portfolio and reframing the direction of a company, particularly one our size, is very challenging, and I think the fact that we were able to bring in the Sanofi employees and integrate them into our teams is super important, because it just allowed us not to miss a beat.
Ben Comer:Did those employees actually relocate, and are they, you know, in the office physically or did they kind of stay where they were and you know you're working with them remotely?
Mark Eisner, MD:Yeah, well, fortunately for us, they were located in South San Francisco, about seven miles away. Oh perfect, we've brought all those new we call them Virites" new Virites into the office, so everybody's here and it's been really, really nice in that way.
Ben Comer:You mentioned the antibody platform, and so maybe we'll just take a minute to discuss this. Vir has two discrete platforms for drug discovery and development the data AI structure and antibody or dAIsY platform, and then the PRO- XTEN masking platform, the T-cell engager platform that came through the Sanofi Amunix deal. Would you mind just telling us what's unique about each of those platforms?
Mark Eisner, MD:Sure Happy to do that. So dAIsY is an AI-based platform that allows us to really accelerate and optimize the engineering of antibodies. So instead of taking a new antibody candidate and doing mutations one by one, by one by one, which is a gargantuan task, it allows us to leverage extensive databases on protein sequences and develop and prioritize a series of candidates that we can then test to optimize our antibodies. So it greatly accelerates and optimizes the way we engineer antibodies. The PRO-XTEN platform is a masking technology that uses large unstructured hydrophilic polypeptides with protein cleavable linkers to mask both the T-cell engaging arm and the tumor's binding arm of these T-cell engagers to allow us to achieve a really much better therapeutic index, in other words, better efficacy with adequate safety. So they're very different approaches and very unique from one another, as you say, but I think what's really exciting is that they're complementary too, because we can use our antibody engineering technology in dAIsY to work on the next generation of masked TCE candidates, using the masking and the linker technology brought through the platform.
Ben Comer:I see so you're not necessarily deprioritizing the dAIsY platform. It's still very much a player in your current development efforts.
Mark Eisner, MD:Absolutely. I mean, they both are very important complementary technologies. So we're not deprioritizing either, we're working on both of them.
Ben Comer:And you know, because you mentioned it and it's so much in the news here recently and I expect will be in the near future AI, what you know, what is your kind of read on? You know the performance of AI and the dAIsY platform. You know, have you gotten to a point at Vir yet where you know AI has been, you could say you know, extremely helpful in actually getting a candidate, you know, from that discovery phase testing and into the clinic? I'll leave it open for you. You know, what would you say about? You say about the role of AI, at least in discovery efforts?
Mark Eisner, MD:Right. So the specific role of AI in the dAIsY platform, I mean it really does yield tangible advances for us because we can greatly accelerate and optimize the discovery of an antibody and the nomination of it as a lead candidate. So that's very important, I think. In terms of other uses of AI, I mean we are exploring how we can leverage AI in different aspects of what we do. I mean, I think it's a little early to comment in a lot of detail there, but it's clearly something that we're greatly interested in and there are many, many different applications that one could imagine.
Ben Comer:With something like the dAIsY platform? Are you kind of in an iterative way, you know, adding additional components of AI, reviewing new AI technologies to you know, consider to bring in? Or do you have your kind of stack, now that you're set with, the platform is built and it's working, accomplishing what do you want it to accomplish? I'm just curious about, as the field, which is rapidly evolving changes, what does that interplay look like in terms of the dAIsY platform and, you know, emerging tech?
Mark Eisner, MD:Sure, so I think we are with that particular platform. We are constantly evaluating the results and looking at ways to improve how it works. So in that sense, it's always going to be an iterative, evolving way of working with that platform. So I think that's important to note in terms of we are very committed generally in how we apply data sciences in all aspects of what we do. It's a very rigorous process here. We are always thinking about how else can we do things smarter, better with data technologies, so it is a pretty important focus for the company.
Ben Comer:Excellent. I want to get now to hepatitis delta, which didn't, at least for me, have the same kind of name recognition or visibility generally as hepatitis C or hep B, for example. You are on the cusp of commencing a phase three trial in hepatitis delta. Can you tell us a little bit more about the disease and the unmet need that it represents?
Mark Eisner, MD:Sure. So, as you say, I mean hepatitis B is a much more common disease. I mean it affects more than a quarter of a billion people around the globe. Hepatitis Delta is a rare liver disease. It's an RNA virus that requires co-infection with hepatitis B, either previously or at the same time, because hepatitis delta uses the hepatitis B surface antigen as part of its life cycle to construct new virions, new infectious particles. So there is a close interplay between delta and hepatitis B. Where I think the unmet need is it's a very, very severe liver disease, even though it's a much less common one. It can progress to cirrhosis, liver failure, liver cancer and even death rapidly within a five to 10-year period. So it's a very, very devastating infection and there's not much to offer. In the U. S. there's no approved therapies for hepatitis delta. In Europe there is one approved therapy, bulevirtide or Hepcludex, which is an advance, but still, you know, there's great need for better treatments for patients.
Ben Comer:Do you know why that one was never approved in the US?
Mark Eisner, MD:Well, what we know is that Gilead received a complete response letter from the FDA. There's something to do with the manufacturing of the product. We do know that it's a daily self-injection Patients need to reconstitute a dry powder and self-inject. There's not a lot more detail that's been disclosed by Gilead and we also don't know exactly what the timing is for or whether they will resubmit to address the Complete Response Letter in the U. S. In Europe it is being used. I mean, it's a drug that's definitely in advance on current standard of care. But when you think about it, bulevirtide achieves about a 12% complete viral suppression, or what we call target not detected no detection of the virus at all at 48 weeks, which is an advance over zero, which is what patients were facing before. With our regimen of tobevibart and elebsiran, the combination regimen, we believe we can treat the majority of patients and get them to target not detected or complete viral suppression.
Ben Comer:And Alnylam is a partner on your hepatitis delta and hepatitis B clinical programs. What can you say about how that partnership came about?
Mark Eisner, MD:Yeah, I mean Alnylam discovered elebsiran, which is the siRNA component of our regimen, so in that sense it's very important. I think it speaks to the importance of partnerships in finding external innovation. Another example is the Amunix / Sanofi external innovation that we brought in and just I think how important partnering is for biopharma generally, but Vir specifically, and we're very excited to have elebsiran as part of our regimen for hepatitis delta and hepatitis B.
Ben Comer:Is there anything else? I know you have a partnership with GSK and respiratory disease. Is there anything else you would say, Mark, about Vir's more broadly I guess approach to partnering in terms of, you know, partner selection and timing.
Mark Eisner, MD:Yeah, so absolutely. I mean, I think it's maybe a little bit under-recognized in the biopharma industry or maybe in the general public about how critical partnering is, both to bring in external innovation, and part of a competitive advantage we have at Vir is, I think we are able to see what great scientific innovation looks like, and that would be the example would be the TCE platform that we brought in but also to work with a partner like GSK, where you know, Vir was able to discover and bring this sotrovimab to patients in 15 months, but then to have a partner like GSK, with a global footprint, with the expertise in infectious and respiratory disease marketing, and to work together to get this drug to the patients during a pandemic and, just, you know, treat and save, you know, many, many, many lives. I think that was, you know, a testimony to how well Vir was able to identify and work with a big pharma partner like GSK.
Ben Comer:Yeah, and we talked about Vir's new focus, which is infectious disease as well as oncology. So I'd like to ask now about the oncology indications that you're pursuing and what kinds of milestones that you're currently working toward in oncology.
Mark Eisner, MD:Sure. So I think maybe it's helpful to start with what is the problem statement? So the problem statement for unmasked T-cell engagers, which are approved for various targets in the liquid tumor hematology space, but for solid tumors they've just been too toxic. Like unmasked HER2 or PSMA-directed T-cell engagers have caused cytokine release syndrome where patients develop respiratory compromise, hypotension, shock and, you know, haven't been viable therapeutics for solid tumors because of the toxicity. So the technology of the masking, with the PRO-XTEN platform, which allows us to have molecules that are masked in the normal tissue in the blood, so pretty much inactive, but when they get into the tumor, microenvironment proteases in the tumor microenvironment cleave off the masks and activate the molecules, allowing them to form an immune synapse between the T cell and the tumor cell and kill the tumor cell very effectively. So that's, I think, fundamentally what's exciting about the masking technology and how it can improve therapeutic index.
Mark Eisner, MD:So we have three clinical stage programs. One is the 5818 program Sorry, yeah, 5818 program which is the HER2-directed T-cell engager which is potentially applicable to a variety of HER2-positive tumors, including colorectal cancer, where we presented some exciting data at a well and we're doing a basket trial, phase one dose escalation trial, where we are testing it out in different tumor types. The 5500 program is directed at PSMA, which is an important target for prostate cancer. So we're currently testing this in metastatic, castration-resistant prostate cancer and we're escalating the dose there, both in Q weekly and Q3 weekly scenarios, because we want to get to a point where we can potentially treat those patients with metastatic prostate cancer. And then the last one is our TCE targeting EGFR, which is a very, very broad antigen in multiple tumor types, including non-small cell lung cancer, head and neck cancer, and we are planning to start phase one trials in the first half of this year.
Ben Comer:Excellent. I wanted to ask a question about the HER2 target. I was speaking with the CEO of a smaller biotech that's working in oncology and a point that he made to me was that the fundamental problem in cancer is therapies being able to attack cancer cells but not attack healthy cells. And this company is working on a kind of logic gating technology that will, you know, essentially include multiple receptors turned on and off, according to you know, sensing a healthy cell versus a cancer cell. And the point that he made to me was that a target like HER2 is becoming increasingly crowded, people throwing a lot of different modalities at it, because it's a target where, in a sense, I guess, maybe your therapy can kill somewhat indiscriminately.
Ben Comer:Now, what you're saying with the masking technology adds some nuance to that. But I wonder, you know, is that, you know thinking about, you know, the next big big leap in cancer therapeutics? Is it, you know, being able to kill cancer cells, kill cancer without the resulting toxicities? Do you see that as the current limitation? Or would you give another explanation for, you know, for what's needed, I guess, for the next big cancer breakthrough?
Mark Eisner, MD:Yeah, I think that's an excellent question and I do think that the specificity is super important here and the masking in particular which allows this mass T-cell engager approach to work, because it allows us to dose escalate to doses that can start to be effective in killing the tumor. So in HER2, it can bind the HER2 positive tumor cell and the T cell and promote the T cell killing of the HER2 positive tumor cell. Normal tissues like heart and lung tissues can express HER2. So, to your point, we don't want to activate the T cell engager in normal lung tissue, normal heart tissue at all, because that just brings toxicity. So I think what we've been able to show so far in our public data disclosures is that we can dose these mast molecules, these mast T-cell engagers, high enough to start killing tumors while maintaining an adequate safety, so only sort of minimal cytokine release syndrome.
Mark Eisner, MD:For example, one of the patients we presented was a woman who had very advanced breast cancer that was infiltrating her skin and she had been treated with nine prior lines of treatment including Enhertu, which is a recently approved HER2-directed treatment, Then you can literally see visually this tumor just clear from her skin with 5818 over a 5 to 10-week period.
Mark Eisner, MD:it unequivocally had clinical activity in this patient who had been through multiple, multiple other options.
Mark Eisner, MD:And so I think it's case and back to our earlier discussion around individual patients. I mean we obviously need to demonstrate the effects, that these are safe and effective in populations of patients, but sometimes it's a patient like that that really informs us that we're on the right track with a treatment right. And you know we have other patients as well. There's a colorectal patient who got this treatment right and you know we have other patients as well. There's a colorectal patient who got this treatment who's been on drug for more than 18 months and has been very, very stable, and another prostate cancer patient on the 5500 program where you know they've had a very sustained suppression of their PSA, you know resolution of bony lesions on MRI. And it's patients like that that really tell us that we're on the right course and I think also for the teams it's just really inspiring to see those patients kind of get back to more normal lives and it just makes us want to keep working on this and advance the programs.
Ben Comer:Looking forward into the future. Now Vir has completed this pivot. You're focused on oncology, you're focused on hepatitis B, hepatitis delta. What, I guess, are your top goals for 2025 and maybe 2026? And if you, would you know, what do you see as the biggest challenge?
Mark Eisner, MD:Sure. So I mean 2025 for us is a very important year for execution. I mean, on the hepatitis delta program, we are starting three pivotal trials and we're going to be enrolling our first patient in the first half of this year. So that's a laser focus for us and the team is getting those trials up and running. On the T cell engager side, it's continued dose escalation for the HER2 and PSMA programs and getting the EGFR program into the clinic, continuing to show what efficacy we can get with acceptable safety, minimal CRS and other acceptable safety profiles. So it's around really executing on those programs.
Mark Eisner, MD:I think also on the research side, it's using the antibody discovery platform with dAIsY and the masked PRO-EXTEN platform to work on the next generation of tumor targets and to work on, you know, in the research discovery space. You know what's going to come next, you know, besides the clinical stage assets that we currently have. And then the last thing I would mention is we are, you know, going to have functional cure data for hepatitis B, a March phase two study coming in quarter two of this year, and so we're really excited about that. The data at the end of treatment were really exciting, and what we have said is we're looking for a partner to advance that one into further development, because it's a large program, it's going to require a lot of resources and that's a place where I think a strategic partner to develop that globally will really really be important for us to find.
Ben Comer:Yeah, and that raises a new question for me, which is when do you get started on the global development efforts? Do you, you know, is it after this next kind of phase readout, and then you decide, yes, we're going for you know, we're going to look for a partner, we're going to begin development efforts elsewhere. Maybe you're already in, you know multi center locations around the world. I'm not sure, but can you give me a sense of your kind of global ambitions for that product, given you know that it's a really large indication?
Mark Eisner, MD:Sure, so yes, so we certainly have started planning of what the next phase of clinical development would look like the trial designs with the next regulatory interactions that we would have, and we've started thinking about and talking to prospective partners. I think this will be a process over time where our aspiration if the data can support the continued development of the functional cure point, which is, of course, fundamental we need that would be to find a partner who would then work through that with us and then ultimately take over that phase of development for B, while we fully own and develop the hepatitis delta trials ourselves.
Ben Comer:Got it All right. That is Dr Mark Eisner, executive vice president and chief medical officer at Veer Biotechnology. I'm Ben Comer and you've just listened to the Business of Biotech. Find us and subscribe. Anywhere you listen to podcasts, and be sure to check out the new weekly videocasts of these conversations every Monday under the Business of Biotech tab at lifescienceleader. com. We'll see you next week and thank you for listening. Enable breakthroughs in medicine, healthcare and technology. Avantor's portfolio is used in virtually every stage of the most important research, development and production activities at more than 300,000 customer locations in 180 countries. For more information, visit avantorsciences. com or find them on LinkedIn, x-formerly Twitter and Facebook.
