Business Of Biotech

Serving The Underserved With Gates MRI's Claire Wagner, M.D.

Matt Pillar

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On this episode of the Business of Biotech, Bill and Melinda Gates Medical Research Institute's (Gates MRI) Dr. Claire Wagner joins us to share insights into her work as head of Corporate Strategy and Market Access there. She shares the development of her North Star while working with the incomparable Dr. Paul Farmer in Rwanda, and how that experience translates to the growth of a biopharmaceutical company taking big swings for grossly underserved populations. We discuss the nuances assoiated with setting strategy and enabling product access in a unique not-for-profit setting, and how, perhaps counterintutively, the Institute's work fits synergistically into an ultra-competitive for-profit biopharma landscape. 

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Matt Pillar:

The Bill and Melinda Gates Medical Research Institute, well known as it may be, does not get a ton of ink in the biotech business trades, in part because there's no trading going on. Gates MRI is a nonprofit biotech launched in 2018 and funded by the Gates Foundation. As such, there's no dramatic story of a hard-fought and oversubscribed Series A During COVID times. There's no plans to IPO in a bear market. There's no clawing its way back from the brink of bankruptcy. But the things that Gates MRI does have in spades and the things that more traditional public and private biotech companies can learn from it are many. It's got drug development partnership deals with companies like GSK, merck, novavax and others. It's got an all-star leadership team.

Matt Pillar:

Astute listeners will remember that Gates MRI head of CMC, Dr Piper Trelstad, joined me on episode 132 of the podcast and Bioprocess Online followers might recall my recent profile of the juggernaut chief operating officer, deborah Weiss. Perhaps most importantly, gates MRI has a carefully curated pipeline of candidates, custom-built to address unmet medical needs primarily affecting women and children in underprivileged parts of the world, and those candidates are moving fast. Its B Infantis candidate is in phase three. Its tuberculosis vaccine just entered phase three and it's got four or five additional clinical programs at various stages in Shigella, tuberculosis and malaria, and a handful of preclinical programs beyond that. Central to the global humanitarian mission at Gates MRI are its people, many of whom have more than just hands-on in the lab experience developing new medicines, but also boots on the ground experience building the life sciences industries in underserved parts of the world.

Matt Pillar:

I'm Matt Pillar. This is the Business of Biotech, and my guest on today's show is exemplary of that persona. She is Dr Claire Wagner, head of Corporate Strategy and Market Access at Gates MRI, and on this episode of the podcast we're going to get to know her. We're going to get to know her work and the broader impact of Gates MRI in the business of biotech. Dr Wagner, welcome to the show.

Claire Wagner, M.D.:

Thanks, matt, great to be here and thank you for a very kind and generous introduction. It's really lovely to be part of your show.

Matt Pillar:

It's super lovely for you to be part of our show.

Matt Pillar:

I was excited at the opportunity to have you on the show and talk with you, in large part because of your super rich experiences even prior to coming to Gates MRI, and I want to start there.

Matt Pillar:

I want to start by sort of getting a sense of who Dr Claire Wagner is, and I'm going to give our listeners just a little bit of background on you to set that conversation up. You followed up your Dartmouth undergrad in anthropology with a Harvard Medical School MD and an MBA, and when I look at that mix and I think about the current position that you're in at Gates MRI and the Gates mission, it seems like that was a carefully curated foundation for the role that you play today. I'm sure it wasn't, though, because there were a lot of stops along the way that we're going to learn about today, but if you take us back to that time, like coming out of Dartmouth going to med school and kind of thinking about what you wanted to do professionally, what were your intentions I mean assuming that you weren't carefully curating this role prior to Gates MRI even being a thing.

Claire Wagner, M.D.:

No, I think that's right, matt. There is, as with many people's careers maybe everybody's careers it's really quite nonlinear and I would say a lot of the decisions that I ended up being able and having the privilege to make from a career standpoint and an education standpoint came from some luck and the identification and seizure of that luck and so seizing of that luck. And so after college I had the incredible opportunity to take a role working in Rwanda. It was supposed to be a 10-month role. It ended up being a three-year full-time in Kigali role A couple of years after that back and forth, and as my now late mentor, paul Farmer, used to say, there is no post Rwanda, there is no time in your life where you won't be connected to this place that will give you so much. And that was really true from my experience there.

Claire Wagner, M.D.:

Five years I spent doing work in Rwanda and with colleagues in the global health space after college. Those were the years and the experiences that ultimately drove me to pursue medicine and then later to pursue business. And I actually had, as you said. You know, there wasn't much strategery to it. I did not have an intention to be in this role. Certainly this organization didn't exist. I hadn't even done pre-medical training, so part of going to med school for me meant going back and doing physics and chemistry and organic chemistry and biology the classes you usually take when you're 18, 19. I was a decade beyond that and I'm grateful that I had the opportunity to go back and do those studies and pursue the advanced degrees that I then was able to do in service of the values that were inst the, the values that I was, that were instilled in me during my experiences in in Rwanda.

Matt Pillar:

Yeah, take us. So we're going to get into that and I've got I've got some questions for you about Dr Dr Farmer. I've I've read up on him and watched some of his interviews on YouTube and and I've I've formed an opinion of the man. I want to ask you about yours, before I offer mine but before we get to that the opportunity to go to Rwanda. How did it present itself and why was this even a thing on your radar? Why was it an option? My kids are doing amazing things. I've got a 20-year-old and an 18-year-old. I've got a 20- 20 year old son. If someone came up to him and said, hey, I have an opportunity for you, you can go to Rwanda for 10 months, he'd be like, yeah, that's really not on my bingo card. So what at the time? Why was that an appealing move for you?

Claire Wagner, M.D.:

I some of it was part of growing up in a very international home where my parents that was part of my childhood was being at the dinner table surrounded by colleagues and friends of theirs from all over the world. My dad does international education work, was in the Peace Corps in Morocco in the sixties, still works in Morocco to this day, and so I had a lot of exposure to global-oriented things from an early stage and ultimately realized that, and as I went through my studies and then in college, knew that I wanted to make a contribution to global issues in some way, shape or form. And it was during college that I was exposed to what is called, or has later been sort of called, global health, which is really a catch-all phrase and maybe doesn't describe the field perfectly. But those were some opportunities that I had while I was in school to work and do research. I did research in Tanzania and also did some work in Mali when I was an undergraduate and knew that I was interested in being part of global health efforts broadly speaking.

Claire Wagner, M.D.:

And then a very fortuitous thing happened and the president of Dartmouth College in my senior year became Jim Kim. He was hired to be the new president and he had founded Partners in Health with Paul Farmer and Ophelia Dahl, and so suddenly there was this influx of global health enthusiasm and excitement on campus. And it was through Jim that, who became a mentor to me and still is a mentor to me, that I had the opportunity to meet Paul and meet the who would be the future minister of health of Rwanda, Dr Agnes Benaguaho, and be aware of and then apply for the opportunity to go work for Dr Agnes and Paul in Rwanda. So that's really the kind of long story of how I came to be aware of that opportunity. But it was a one-line job description so I didn't know exactly what I was going to be doing and give us, give us the Cliffs.

Matt Pillar:

You don't need the CliffsNotes on a one line job description, but like do you remember the exact line? What was the line?

Claire Wagner, M.D.:

Yeah, I remember the moment I opened the email and all of the rest there's an opportunity to be the research assistant to Dr Agnes Binagwaho in Kigali. Full-time in Kigali, rwanda period.

Matt Pillar:

And you're like yeah, yeah.

Claire Wagner, M.D.:

I said, yeah, I had applied to a bunch of other jobs, rescinded my applications and a couple months later I was on a plane to Kigali.

Matt Pillar:

So the Dr Farmer connection was established with Dartmouth. Did you know at the time that Dr Farmer was kind of a big deal?

Claire Wagner, M.D.:

Yeah, it was right around the time or it must have been after, but there was a book written about him and he was a legend already then in my head and in many people's heads.

Matt Pillar:

Let me interrupt you real quick, because I also happen to know that he too was an anthropologist turned medicine maker. Were you aware of this? Was this alignment part of your calculus?

Claire Wagner, M.D.:

Were you aware of this? Like was it? Was this alignment part of your, your calculus? Oh, there was no calculus, but I was definitely the inspiration and drive and I thought I thought the world of him, think the world of him, and I also was really curious, through the experiences I had as a kid about international education through my dad, about global issues through coursework. I had the opportunity to take on and really knew that I wanted to contribute in that way, and so having the opportunity to learn through the lens of anthropology made a lot of sense to me. It just clicked for me that approaching, approaching a, an opportunity to contribute with the lens of curiosity, engagement, respect those are all part of the kind of tools that you learn when you're studying anthropology how to ask questions in certain ways or others, how to engage in a community in certain ways or others, certain ways or others, how to be respectful of cultures and how to embed yourself in a new environment that might be unfamiliar to you.

Claire Wagner, M.D.:

And I got a lot out of that kind of mindset and training and so it just clicked. I mean it was certainly the inspiration of Paul and Jim having done that, and it also was how I was brought up. I think it worked. It worked in my mind. My mom is a psychologist and of is a good way to approach learning in a global environment.

Matt Pillar:

Yeah, so tell us. And I feel bad for our listeners, because if you're not familiar with the work of Dr Paul Farmer, we're about to make you, albeit be briefly familiar with who he is and what he did. So I want two perspectives from you, dr Wagner, on Paul. One, just share with our audience who he was from a professional sort of standpoint. And then, two, I'd like you to share a little bit about who he was to you on a professional and personal level.

Claire Wagner, M.D.:

So we could spend an hour talking about all the professional yeah.

Matt Pillar:

I'll interrupt you again real quick. We'll give you the CliffsNotes for real this time. Just hit YouTube. I mean, there's so much fascinating content featuring Dr Farmer and his work.

Claire Wagner, M.D.:

Yeah, so Paul co-founded, as I mentioned, Partners in Health with Ophelia Dahl and Jim Kim in 1987. Partners in Health has then become a very major global health organization around the world, with sister organizations in many countries around the world. And in addition to that work that Paul did, he taught for many, many years in the Harvard Medical School community courses in global health, medical anthropology and so forth, and I think there are a lot of. There are a lot of pioneering, there's a lot of. There was a lot of pioneering work that he did and a huge number of changes that he ushered along and fought for in the global health community that we can look back and say, yes, that was Paul, that was Paul's work. In addition to the innumerable ways that he changed the global health landscape and global health architecture, he also brought up many, many people and I am a very fortunate one of those many, many, many people who he took under his wing and he made every mentee that he had feel like they were the only mentee of his.

Claire Wagner, M.D.:

And it was a? Yeah, it was.

Matt Pillar:

It was a remarkable thing, and I feel very fortunate to have been, uh, mentored by him for the years that I was mentored by him for the years that I was, he, he, he, this guy had access like he I mean, he had access into the upper reaches of of, you know, important people in global health. And yet, like I get that sense I was going to say I wanted your perspective and then I was going to share, just, I mean mine, from a million miles away. You know, I think those YouTube videos I referenced are a great example. Go check them out.

Matt Pillar:

Like you get the sense that this guy's presence, like his presence with you, with the person who's asking him questions, with the person he's working with, is uncommon. Like it's uncommon for a person to have that kind of presence and engagement right, in a meaningful way, with the person that they're, that they're, they're speaking with. And I get the sense that, like he took that with him wherever he went. I mean it. And it didn't matter what, what color the person was that he was working with, it didn't matter what language they spoke. He was engaged for humanity.

Claire Wagner, M.D.:

He was, he was, and you know, on our badges here at Gates MRI we have the he was, he was. And you know, on our badges here at Gates MRI we have the. We have the phrase all lives have equal value, and he lived that. Every day he would spend the same amount of deep, quality conversation time with the Head of the WHO as he would with the with the person who was in charge of sanitation in one of the hospitals that he helped found. He knew the names of all the patients on the way. It was just incredible, and I would round on patients with him in Rwanda, which wasn't often he knew every patient's name, every patient's parent's name who was there with them. He knew he just. He just had this way about him, just like you said, of being so deeply connected and embedded in the community that he was in and having the presence with each individual in a way that I think is quite unusual.

Matt Pillar:

Yeah. So how did that sort of inform you? You know you said you went into it with international and cultural curiosity. How did that experience kind of form up your next steps? I mean, I'm assuming you kind of doubled down right, like how did that experience kind of inform what you did next? And we'll talk about those positions that you, that you took between then and Gates MRI.

Claire Wagner, M.D.:

Yeah, so much of my time much of my time in Rwanda was working with Paul. Also much of my time in Rwanda was working with the minister of health, dr Nyespina Guajo, who is we could spend a whole other podcast talking about her career and the pioneering work that she did. And all that I learned from her and I have a colleague who says every day with her was like getting a master's degree and I would stand by that and the changes that she made to the global health architecture are also too numerous to count, and she and Paul were thick as thieves in doing the work that she made to the global health architecture are also too numerous to count, and she and Paul were thick as thieves in doing the work that they did. And so one of the things, though, during those years that I was there, I did have the opportunity to, on my personal time, shadow in a public referral hospital in Kigali. That gave me a lens that was quite different from working in the public sector at the level of policymaking and product introduction.

Claire Wagner, M.D.:

Here I was in a pediatric unit specifically shadowing physicians who were taking care of kids who had heart disease and cancer, and what I observed at the time there was a setting that some described as being like HIV was 20 years before, 10 or 20 years before, where patients go to this ward, pediatric cardiology ward, basically to die. There was no solution, there were no oncology products being procured in the public or rural hospital at that time, and so I witnessed, through the patients that we rounded on unfortunately many of whom did pass away during that time and watched as the physicians tried to pool their funds to source drugs on the private market to try to treat these kids with cancer, for example, that there was this gap between technology and products and people who needed them. It is pretty obvious, right, it's not a big, profound realization, but the fact that that gap felt. So this is not really a word, but unapproximatable, right, you couldn't. It was very difficult, almost intractable, to approximate those, the product with the patient in those settings.

Claire Wagner, M.D.:

I got really curious about that and I and I and I applied to medical school because of that and I applied to business school because of that, because I am driven by this idea that it doesn't have to be that way that the products are out there, the money is out there, the people are out there and the patients are out there and if we can get the right kind of architecture set up between all of those stakeholders and resources, we can make a big difference. And that is why I set out on the journey to go back and do all of the schooling. And then, ultimately, what led me to Gates MRI? Because of the mission that we have here to develop products for diseases that have a tremendous burden in low-income settings low and middle-income settings and the opportunity to build out how we're going to ensure access, affordability, equitable distribution of the products that we develop in those marketplaces. That is what makes me excited every day to go to work.

Matt Pillar:

Yeah, with your credentials, your experiences, your background, you could. I'm just going to pose, I'm going to pose the question like this you could have very likely taken a position with any number of pharmaceutical, biopharmaceutical, even biotech companies that profess the mission toward the democratization of medicine. There are a lot of them. There are a lot of companies out there that are you know, yeah, we want to. We want to make them more affordable, more distributable, more equitable. We want to democratize access. Why? Why, gates, mri?

Claire Wagner, M.D.:

Well, first up. So Gates MRI, we are a six-plus-year-old organization and we get to be at this intersection of big global health problem and commercial approaches to solving that problem without the need for a return on investment, so that means that we have the privilege it's really a privilege to make certain decisions on access, on creating target product profiles, on addressing different characteristics that the WHO will look for in a policy recommendation, for example, that other entities may have more constraints on. We don't have shareholders per se that we're answering to in quarterly earnings calls. We have a very different set of metrics that we are accountable for, and those have to do with developing products, products that are aligned with major global health disease burdens and that can be accessible in the marketplaces that we serve. I do think, though, that I'm glad there's competition. I hope there's competition.

Claire Wagner, M.D.:

One of the great outcomes of the Gates MRI, as a let's call it an experiment of the Gates Foundation to found us six plus years ago, would be that there's more Gates MRIs.

Claire Wagner, M.D.:

That would be a great outcome, in my view. You and having other biotechs and pharmaceutical companies take on roles in the global health ecosystem through their charitable foundations or through their commercial branches of their in their global health groups, and we work with some of those groups and they're fantastic, and I think it's the more the more the merrier, and even Paul would say that right More people around the table to do this work, and another element of our business model that I think is is is is another privilege that we have is this opportunity to collaborate, our ability to work through and with and in partnership with both commercial partners, philanthropic partners and downstream partners. That will help us ensure access to our products in low and middle income markets, to our products in low and middle income markets. That's another element that really drew me into this organization and is a big part of what we do at Gates MRI.

Matt Pillar:

Okay, yeah, so walk me through this. I'll use the term that I've read this before. Explain to me like I'm 11. How you rationalize, how you can rationalize, so like, if I dumb this down to the lowest common denominator and I say, well, a capitalist would suggest to you, dr Claire Wagner, that running a business that moves product regardless of need anywhere, without any expectation of return on investment, is not sustainable.

Claire Wagner, M.D.:

So that may be. I mean, I learned something in business school and that may be not untrue, right. But so you need there has to be some generation of money in the bank, right? You've got to bring in financing to do the work that you do, because it's expensive work. If you look at any of our press releases, you will see how many zeros are in the dollar sign of how much it costs to do the studies that we do.

Claire Wagner, M.D.:

So our own goal at Gates MRI is not profit. We are a non-for-profit. Our goal is impact and we're fortunate that our funders are looking for that. Right, that's what they're looking for. So when we go to our annual meeting with our funders and when we have our governance meetings, that's what we're accountable for is impact and potential for impact through the products that we're developing. I think in a normal, in in a sort of in the biotech, biopharmaceutical ecosystem, it is quite different. As you say, you do have a different set of metrics by which you're being measured and cost of capital is not cheap in for many, for many young companies trying to do big things, and the financing world is evolving to address some of those problems and there's a lot of new types of non-dilutive financing that are out there. But I see it as a real opportunity for us to play a big role in this ecosystem because we get to, we get to be measured by impact, and that's a that's a special thing.

Matt Pillar:

For sure. Yeah, you joined. When you joined Gates MRI, you joined as chief of staff. Is that correct? Like you didn't, you didn't come on in your current role, although it seems like you were. You know, kind of custom cut for the current role that you're in. What was the opportunity as chief of staff?

Claire Wagner, M.D.:

Just like any other organization, we have grown and we've evolved, and four and a half four plus years ago, when I joined, we looked quite different.

Claire Wagner, M.D.:

We had a different set of things that we were doing, we had a different composition and it was COVID. So we weren't even in the office I don't think I met. Great part about being with a young organization is the opportunity to identify a business need and start to test out how to solve that business need. Need was chief of staff and as I continued on here at Gates MRI and as we evolved and our portfolio grew and the products in our portfolio advanced to later stages, we identified this new business need to really think about access and how are we going to work with our partners at the Gates Foundation and with our other commercial and philanthropic partners to ensure access and impact. And so that was then the business need, and I'm fortunate to had a chance to be a part of in Rwanda, working with the WHO on the essential medicines list, working with Dana-Farber Cancer Institute and a number of different roles this really is. I am able to bring in a lot of prior experience to this role.

Matt Pillar:

Yeah, yeah, and that role I mean as, as we said, head of corporate strategy and market access. Um, you know, it occurs to me that, looking at the mission at Gates MRI, you know there, there, you know multiple things that are like super central to that, like the legs of the stool. You know, like we need to, we need to produce, you know in volume, vaccines and therapeutics, that that that address these unmet needs in these places. We need to get them there. You know that's that's central, like we need to get them, get them there, to get them there in a timely and efficient manner. That element of your job, like figuring that out, seems like everything. I mean, it may not everything, but it's one of the things, right, that that that has to happen for Gates MRI to to address its mission.

Matt Pillar:

Um, what does that feel like? Like it feels pretty like a heavy responsibility. Um, so I guess I'm going to get to a question here what does that responsibility feel like and what are you doing to meet it? Like, what does that look like? I mean, you say you're drawing a lot of these experience from your past and when you, I guess, scale those experiences up from, you know a hospital that Paul built in Rwanda to a global mission. What do those responsibilities look like? So terribly worded question?

Claire Wagner, M.D.:

No, no, no, I gotcha. So our portfolio spans different disease areas TB, malaria, infant malnutrition. It also spans product types. So in TB, for example, we have a TB vaccine, we have a TB treatment program, and in malaria, we have a malaria monoclonal program, monoclonal antibody program, as well as a as you mentioned at the start, a program to address infant malnutrition called our B infantis program, which is a probiotic.

Claire Wagner, M.D.:

Each of those, being at various stages of development, requires a different lens in terms of so-called market access. And when I refer to market access, I'm talking about the suite of activities that are required basically to get a product from, let's say, r&d to a patient. It's very broad, it's used in lots of different ways and different functions and it can take on lots of different meanings. But in this particular setting, let's take that as our example. So for an earlier stage product or let's say, a product that you haven't quite brought into your portfolio, that might look like doing things like a global policy landscape, developing a value proposition, demand forecast and so forth. And as you move through, as you're refining some of those vantage points on the actual product, you're going to start looking at your cost of goods. You're going to start developing your end-user segmentation, your business plan to get this product to market and, for example, in our TB vaccine program, the M72-AS01 program.

Claire Wagner, M.D.:

We're now at the phase where we're deep into the enrollment of this trial. It's a really exciting time. This is a product that is for the prevention of active pulmonary tuberculosis. A quarter of the world's population is thought to be latently infected with TB. That is a lot of people. Our vaccine is designed to prevent the conversion to active TB. It's a very expensive study, it takes a long time, and yet we haven't had a new vaccine for TB in over 100 years, and so the opportunity that the Gates Foundation saw to bring this into Gates MRI and have us usher forward the phase three development was just an incalculable opportunity for public health impact. So the work that we get to do now, in collaboration with our commercial partner GSK, as you mentioned earlier, as well as our partners at the Gates Foundation and Wellcome that are our funders but also our collaborators on a lot of the actual work that we're doing to think about access, advocacy, policy engagement, new product introduction this is a new product class. There is no adult vaccine for tuberculosis out there the only vaccine that I mentioned earlier, over a hundred years ago or that was developed over a hundred years ago is for, is for kids, it's not for, it's not for adults. So we, our studies, which are being run in, so our studies, which are being run all over the world and in seven countries in Africa and Asia, are really designed to answer the question of could this vaccine be efficacious and have the kind of public health impact that we hope it could have?

Claire Wagner, M.D.:

To your specific question about the work that we're doing now to make that a reality, I'll come back to one of the words that we were talking about before on collaboration. It is really through collaboration, both with the set of our core partners, so our philanthropic and commercial partners also, ultimately the, the, the future payers, the future users, the procurement agencies. There are many, many different types of stakeholders that will, that are being, have been, will continue to be and will ultimately be collectively engaged in ensuring this product gets to market. The work that we get to do now is on really access and launch planning. How will that look? What are the different types of financial architecture that will need to be stood up? What are the different policy recommendations that are on the critical path, the different policy recommendations that are on the critical path.

Claire Wagner, M.D.:

How do we set ourselves up for success with a commercial partner to commercialize the actual product? We will not be the entity on the label, it will be another company. So some of the work has to do with that commercial engagement and due diligence. And you know, the suite of activities under market access is quite long and we could spend a lot of time talking about it going to be around implementing the values that the Gates Foundation has around all lives having equal value, and that Wellcome has around equitable access, and about capacity building and engagement with clinical trial leaders in the countries where we're working, and that's one of the one of the. You know we we are not a human capital development organization, but everything that we do is through brilliant leaders and clinical trialists are all over the world, and so through that we we get to have this opportunity for bi-directional learning and engagement and capacity building in settings that, in the settings where our clinical trials are being done. So yeah, it's.

Matt Pillar:

I mean, if you could just reflect for a couple of minutes I know we're going to run short on time here and I've got a couple more important questions I want to get to. But the complexity, you know. You talk about the payer landscape. You know, usually when I'm talking to a biotech exec who's talking about the payer landscape, they're talking about the landscape in the United States of America or in Europe. You know, maybe in Asia you're talking about a payer landscape that has, you know, a global payer landscape with all sorts of different facets and crevasses and things to negotiate right Between that, like the clinical landscape operating on a global scale as you are. It sounds like it would take an entire practice at Gates MRI to manage the logistics and complexity of those things. Like, how are you going about that?

Claire Wagner, M.D.:

And, yeah, this would also be worthy of a whole.

Claire Wagner, M.D.:

We're going to need to book a lot company in that, under the hood, you'd find all of the same functions, right, cmc, regulatory, clinical development, clinical operations, and so forth set up so that we can be agile to address the needs of the address, to conduct the work that we need to do and address the public health needs, and so, in that kind of setup, which is a certain type of business model, right, and in business school, you learn about all kinds of build, buy, borrow models that you can implement in any organization.

Claire Wagner, M.D.:

That's the same for us, and this is the model that we have chosen to work around or to work with, and that kind of model, though, means that you are set up to work on efforts with your partners, and that has to be a core capability is engagement with your partners, and that has to be a core capability is engagement with your partners, and so I would say that the very short answer to what you your question was, is that we can't do it all.

Claire Wagner, M.D.:

We don't do it all. We work through our partners and collaborators to do it, um, and we and we rely on a uh, we rely on our partners and collaborators and on ourselves to be mission driven and that you're coming to the table because you have a passion to do this work, and I subscribe to the idea that the world runs on passion. The world also runs on money, but the world also runs on passion and I think that we see that a lot here at Gates MRI organization. To get this work done is reflective of the kind of mission orientation that is attracted to this type of organization, including myself.

Matt Pillar:

Yeah, okay. So in the time that we have left one more question for you and that is, as you can tell, I mean throughout the course of the conversation I've been trying, I've been attempting to draw parallels between, you know, the nonprofit nature of Gates MRI and the for-profit nature of, you know, public and private biotechs that comprise the bulk of our business and biotech audience, and you've done a fantastic job, by the way, of exposing the valuable lessons that, whether you're for-profit or not, gates, gates MRI is, is setting, the examples of Gates MRI is setting, Um, so we, we, we've been kind of doing that, uh, as we go. But if I were to ask you point blank, like what's your opinion on the, you know takeaway or two that you would like to impress upon biotechs of all stripes you know mostly the, the, the for-profit guys what would you like to impress upon them? That that the Gates MRI is is doing and doing well and can be, you know, replicated or at least considered in those companies? Access and distribution models.

Claire Wagner, M.D.:

Thanks, matt.

Claire Wagner, M.D.:

Great question.

Claire Wagner, M.D.:

One of the elements that I've seen play out from a number of different lenses that I've had the opportunity to have over time, both in Rwanda with working with the WHO, and now at Gates and Merai, is that it's never too early to start thinking about access From the very earliest stage of product development.

Claire Wagner, M.D.:

When you're just thinking about a product, you should be thinking about access. What are the different characteristics that need to be fulfilled in your target product profile for this product to have a bigger market? What is the critical path for this product to get to XYZ markets around the world? We are so very focused on the US, the EU5, japan and so forth. We haven't quite, from a very, very early stage, yet looked at access with a more global landscape, and I say we, putting myself in that bucket. I think we can always do a better job of doing that, and so where I would really encourage us all in the global biotech ecosystem to look at more is what are those very early decisions that you can make, from the ideation phase all the way through phase three, that will ensure equitable access to a product in global markets.

Matt Pillar:

Yeah, okay, I know we're short on time and you need to leave, so one last question and you can make it a super quick response. You seem happy in this role that you have now, you know, coming off all these awesome experiences. You seem happy and you seem like you're inspired to do good work and you're doing great work. When this tuberculosis vaccine is approved and is ready for distribution, is there a part?

Claire Wagner, M.D.:

Yeah.

Matt Pillar:

Is there a part For those of you listening? There were fingers crossed just now, part of you, a little part of you that you know maybe hopes to be part of the team that's, you know, unloading these things from the airplanes and shipping them to hospitals back in places like Rwanda.

Claire Wagner, M.D.:

Oh my goodness, and a great image to have in one's mind. There's nothing better than to think about that. Yes, I think the impact is the name of the game here, and we are working day in and day out to make sure that that does become a reality. And certainly I hope that that happens sooner rather than later. And we all have fingers and toes crossed that this, that the, that the phase 2B will play out in phase three for this TB vaccine.

Matt Pillar:

Yeah Well, dr Wagner, I will let you get on with your day. I I appreciate you coming on. I thought this was a fascinating discussion, very inspiring. It was an honor to have you on the show and, as you, as you, mentioned several times throughout our conversation, we could go for another hour here, another hour there. I hope you'll consider it. I hope we can maybe have you back on to drill down on some of these topics at a later date.

Claire Wagner, M.D.:

Happy to Matt. Thanks so much. I really appreciate the chance to talk with you and, yeah, thank you so much.

Matt Pillar:

Thank you. So that's Gates MRI. Head of corporate strategy and market access, Dr Claire Wagner. I'm Matt Pillar. This is the Business of Biotech. I'd be thrilled if you subscribe to this podcast anywhere you listen, and equally thrilled if you frequented our Business of Biotech video cast page, where you can actually watch these episodes and see the smiling faces of my guests. You can find that link in the show notes. We drop a fresh episode every Monday morning, so we'll catch up then In the meantime. We drop a fresh episode every Monday morning, so we'll catch up then In the meantime. Thanks for listening.

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