 So my name is Aaron Kessler. I'm a faculty member at the Center for Bioethics of Preston Medicine at Harvard Medical School. And I run a research group called Portal or the Program on Regulation, Therapeutics and Law. And it's our pleasure and myself and Leah's pleasure to welcome you today to the Health Policy Bioethics Consortium about a topic that's very close to our daily work and our hearts and I think will be a great conversation, making pharmaceuticals accessible and affordable. We have a couple of great discussants and a moderator for you today. And I think it's going to be a really, really interesting conversation. We'll go to the next slide. So we are set up to have some introductory remarks from the moderator and two expert discussants and then some roundtable conversations after that. And then after that, we'll be opening up to audience questions. If you'd like to submit a question, you can do so at any time through the Q&A feature at the bottom of your screen. Don't use the chat to submit questions. The chat is only for technical issues or other questions. Please put all of your questions in the Q&A. And then we will get to them towards the end of our 90 minutes together. If you are moved to Tweet or Maston or whatever about what we're going to talk about today, you can use the hashtag HMSBioethics. And if you're interested in all of the various programming at the Center for Bioethics, you can go to the Bioethics website where you can see it there. Next slide. So as always, this is a monthly consortium that we run during the academic year. And our goals are to bring together interesting around or bring together experts around interesting topics to try to understand key controversies at the intersection of public health and the health care system and to think about different potential solutions or to analyze the question from a couple of different perspectives in order to try to stimulate conversation and to move the conversation in the field further alone. Next slide. This is one of a number of different consortia that the Center for Bioethics runs. Our final health policy biotics consortia of the year is coming up in April. But as you can see, there also are opportunities to get involved with ethical discussions related to other areas as well. And again, those can be found in the Bioethics calendar. So let me turn the floor over to my colleague, Lea Rand, who's also a faculty member at the Center for Bioethics and a member of Portal to help introduce our topics for today. Thank you, Erin. So it's my pleasure to introduce our discussant and moderator this afternoon. So moderating today is Sean Tu, who is a professor of law at West Virginia University, a scholar at Georgetown University's O'Neill Institute for National and Global Health Law, and a good colleague of Erin and mine at Portal. He holds degrees in chemistry and microbiology from the University of Florida, a JD from the University of Chicago, where he was a research assistant for Judge Richard Posner. And he received his doctorate in pharmacology from Cornell University and completed a postdoc fellowship at La Jolla Institute for Allergy and Immunology. He is a member of both the Virginia and DC bars and is also a registered patent attorney. Dr. Tu has extensive pharmaceutical patent prosecution and litigation experience and practiced at Fole and Lartner in Washington DC. He's a legal scholar who focuses on patent prosecution and works at the intersection between FDA and Padded Law. He's also the co-author of three textbooks on Padded Law and has published numerous scientific and legal works. So we're really pleased to have him today steering our discussion. Our two discussants are, starring us off will be Maria Elena Bottasi, who is the associate dean of the National School of Tropical Medicine, professor of pediatrics and co-director of Texas Children's Hospital Center for Vaccine Development at Baylor College of Medicine in Houston, Texas. She's an internationally recognized vaccinologist and global health advocate for neglected tropical diseases. With more than two decades of experience applying the product development partnership model, she's built sustainable biotechnology capacity and has successfully transitioned several vaccines from Benage up to phase two clinical trials. As a global thought leader, she has received national and international highly regarded awards, has more than 120 scientific papers and has participated in more than 200 conferences worldwide. She is a fellow of the American Society of Tropical Medicine and Hygiene, the Hedwig-Ven Ameringen Executive Leadership in Academic Medicine, the Leshner Leadership Institute Public Engagement of the American Association for the Advancements of Science and a senior fellow of the American Leadership Forum. Currently, she is also an emerging leader and health and medicine scholar of the National Academies of Medicine. Dr. Batazi was born in Italy and raised in Honduras where she obtained her bachelor's degree in microbiology and clinical chemistry from the National Autonomous University of Honduras and she then obtained a doctorate in molecular immunology and experimental pathology from the University of Florida. Following her will be to hear Amin, who is a founder and executive director of the Initiative for Medicines, Access and Knowledge, a non-profit organization working to address structural inequities in how medicines are developed and distributed. He has over 25 years of experience in intellectual property law during which he has practiced with two of the leading IP law firms in the United Kingdom and served as IP council for multinational corporations. His work focuses on reshaping intellectual property laws and the related global political economy to better serve public interest by changing the structural power dynamics that allow health and economic inequities to persist. He is a former Harvard Medical School fellow in the Department of Global Health and Social Medicine and a TED fellow. He has served as legal advisor consultant to many international groups, including the European Pand Office and the World Health Organization and has testified before the US Congress on intellectual property and unsustainable drug prices. So I'm really excited to welcome both of them to be speaking about different ways in which we can use patterns and intellectual property laws to advance access. And so, Sean, over to you to start us off. Yeah, thank you so much for that kind introduction. I just wanted to say how excited I am to hear from both Maria and Elena and to hear. I think underlying both of their scholarship and their work is a really important policy kind of goal, which is to get medicines to patients in need, whether that be tropical diseases or diseases that are underfunded or understudied or getting generic medicines into the hands of patients. These are really life-changing kind of policy changes that both of our discussants are going to talk about today. So I really want to say how excited I am to hear from you guys because I want you guys to know that you're really making a difference in many people's lives. And a lot of this stuff goes really unappreciated. So with that, I'll let you guys start and I'll chime in if we have any questions. Wonderful. So I think it's my turn, right? Maria, so thanks so much, Sean. And I look forward to the discussion with the here. I'm going to share my screen. And the way that I wanted to, a little bit set the stage for you is telling you a little bit of the story and the model that we use at Baylor College of Medicine, Texas Children's Hospital in an academic health center with a scientific view as a scientist of how the work that we do from even the discovery, how it can really catalyze these models of not only transferring technologies, using, of course, the vaccine sciences as my example, but really with a purpose as we've been saying, how can we actually get it to be accessible and even producible and usable in everywhere around the world? So I'm actually going to start by just very rapidly putting you even back in the context of a couple of decades ago, actually with the launch of this 21st century, everybody was rallying around the momentum of the millennium development goals that really kind of brought convergence and kind of resurgence of this importance of not only, of course, reducing poverty, mortality, increasing education, better health and everything, right? That the world really has challenges to kind of like improve, but in the world that I was living in, and of course, the people in my team and alongside even Dr. Peter Holtes, that's exactly when we kind of first joined forces was this concept, a couple of concepts, right? The importance of again, these infectious diseases, how we even brand ourselves in the context of all these infectious diseases that are a huge problem around the world, we of course work in a sector within these infectious diseases that are really these neglected diseases, the diseases of poverty, as you can see in the slide, a lot of very interesting looking parasites and vectors afflicting many people neglected, not because of the burden, but certainly neglected because of the fact that there's not a lot of commercial incentives because many of these are to try to be tackled in poverty regions around the globe. It was very important that at the same time, this concept of trying to build partnerships and that if we're gonna really tackle these activities, we need it to work together. And as examples, I just present to you some important foundations that were built and created with this model, right? Of doing things in partnership like the Bill and Melinda Gates Foundation, or even others, but also agencies in our case, like the Gavi Alliance has become really important to really not only from the discovery, but even through the delivery that you need to have mechanism that can support countries to really become sustainable and make the right decisions, especially when you want to bring these health technologies to the people. Scientifically, I think we also started seeing the movement of how open science is really important, not only to share, but also to be inclusive. And I'll tell you a little bit about this concept of decolonization and even now, even in communication, right? In sharing, using preprint service or even open access, I guess, mechanisms. And so for us, we wanted to focus on these global morbidity diseases. We can go on scientifically on how they affect so many people that they're, of course, major cofactors. They clearly get worse if you have other social and political, I guess, factors like conflict and even climate change. How even though that you can measure this burden by the number of years people lose because they live in a state of health disability, they also clearly are a spiral of poverty and clearly have a lot of economic productivity losses around the globe. So when we set up our shop, which is a very complicated shop, but an interesting shop because it really brings together academia with a health system as a hospital system, bring it also like the missions of education, research, the clinic, the community. But we wanted to really create this hybrid infrastructure by doing cross cutting research, of course, even including some of these emerging infectious diseases. We didn't wanna focus on just a single disease. We were really interested in the whole neglected disease arena. We recognize the importance of global partnerships, but we wanted to be very cautious with the type of technologies that we would try to develop or bring this innovation. And that's why we created a little bit of a philosophy, if you wanna call it a little framework that we use as our guiding principles, stemming in this concept of the vaccine sciences, but also some diplomacy that of course predicated on this concept of open science, on team-based approaches beyond scientific teams, even bringing in lawyers and engineers and ethicists, everybody appropriately diversified to make sure that we knew where the cultural intelligence should focus, what would work, what would be important for different regions and communities. And this brought this concept of reverse innovation, to really incentivize ownership from the countries that they would need to use these technologies and achieve this improved health outcomes in the most safe and cost-effective manner. And therefore, by hence, value engagement with all the stakeholders and try to remove man-made barriers as much as we possibly could. And we're gonna talk about this concept of IP and patents, but at the same time, we really needed to come up with ways that could enable this work by bringing potential funding strategies. And of course, predicate on diplomacy. So we've been quite successful, I have to say for the last 22 years, we've actually brought like, my introduction very kind developed discoveries that were brought all the way to the point where we are, for example, in phase two clinical trials for a couple of human hookworm vaccine candidates. We have an intestinal schistosomiasis vaccine in phase two clinical trials. We are actually now almost starting a phase one trial for Chagas disease, all of these programs done with Brazil, with Africa, with the Mexico, with Asia. So bringing this concept of partnerships. And believe it or not, almost now 12 years ago, we adopted the coronaviruses, launched a coronavirus program, thinking that they're a bit neglected because they come and go based on the emergency needs of when you have them or you don't. We put together the partnership approach and we therefore leverage some of this framework that we already were working on. And of course, as a scientist, I had to show you one slide of science. So what we do is really come up with the technology, right? I think this is important. We create the actual engineer, what we call the starter kits for people to be able, in this case, create a vaccine candidate or prototype that could then be not only scaled, produced. We prepare the processes of production, which are the recipes, if you wanna call them, with all the body of regulatory and quality science behind it, which are all the assays. And then our hope was indeed, right? To do this tech transfer, right? To these manufacturers, but do it in a way where we would not just be left outside of the process, right? We wanted to be part of the code development, support them, learn, right? Learn the transition and doing this, keeping in mind the publicly open access intent, making it globally accessible, right? And here is where I wanna just maybe finish with then, what were some of the considerations in this commercial sphere, right? So we knew that our core invention, in the case of COVID, was a well-known technology. The IP really was only centered into the modifications of this receptor binding domain antigen. There was really less room for broad patent fence covering because of related novel technologies. Most likely there would be very little interest to look for broad IP protection. We were of course facing the fact that even as a technology, we were competing with an mRNA technology that everybody thought that proteins would be slower, even though we had a lot of experience and all they showed that eventually wasn't that slow. We probably would not have had first mover advantage. The regulatory fast track was uncertain. In fact, we even put in some fielders with the regulators and they were not very interested in fast tracking. A lot of dogmas, eventually, even some political potential policy failures. We had a previous experience with SARS before COVID that we anticipated most likely an office action rejection because of prior art, right? And we also knew that variants were popping up, that we needed to have a rapid evolution. We couldn't really narrow the claims. And as you know, the opportunities were really to provide this to the global South. So what we ended up was really just leveraging the key relationships that we had. We wanted to stay in that global access space. We therefore looked for partners that had prior experience, right? Demonstrated track record in these protein-based vaccines with the platform that we were using that already had manufacturing infrastructure, they had the workforce, they had the equipment. They already had the same kind of philosophy of keeping low costs and massive scales of production. We also wanted to make sure we incentivize them, but at the same time, putting very clear milestones and what would be success in commercialization. And of course, we needed to make sure also our institutions were on board, right? Because we were not going to be asking for any major monetary, I guess, returns, right? Our interest was, can we participate? Can we bring an emergency solution? Can we, of course, get the visibility that we needed, but at the same time bring a product? So we actually did this, and I have to say that we did it all by ourselves. We actually were able to work some very important groups within this network of developing country manufacturers, which I think it actually even the name gives them a disadvantage, right? Because they always are perceived as these follow-on manufacturers. They're never really accounted as first-rate innovators that maybe they always wait for mature products to kind of filter down from the big multinationals, which of course is a great model, but sometimes you need to also balance, right? How much can they receive from someone else while at the same time make, empower them to be first-rate innovators? We actually, this probably was one of the first models where you actually show that they can first-rate innovate, receiving a research technology from a lab in a Houston, you know, academic environment that is crude and rough and really bring it all the way to the inception. And we actually ended up with three business models, more or less. The first model was we started working with the big, like the bio-ease and the bio-farmers and even Bangladesh, where we knew they had established processes where we started by giving them evaluated MTAs, where we give them our technology, they would try them out, they would try to see if they could scale them and eventually they saw a value of receiving our reagents, our know-how, our documents and eventually ended up into these, you know, very global access licenses. The second scenario was when we started working with groups that had really no infrastructure, but they were really interested in building it. And so we joined forces, not only with academia, with other entities and we really created, you know, these partnerships where they could also work with the scenario one people to build infrastructure while we teach more academically, how do you go by doing vaccine development? And then to be very honest and very surprisingly, there was also a scenario three, which our papers were published, our recipes were published. And, you know, a group, for instance, the Cuban case, they certainly, we know them scientifically, we don't have a lot of opportunities to really work directly with them, but based on the reading of our papers, it opened up the option for them to really even base their Abdullah vaccine, which is practically the same design as our RBD, you know, with a very similar formulation strategy. And therefore they basically were able to deploy their vaccine strategy. So big impact, right? Bio-E, Bio-Pharma, you know, has now more than 100 million vaccinations. I think one side note that we did with Bio-Pharma being a Muslim majority country, all our work and our focus on ensuring regulatory enablement also led them to be able to certify their vaccine as a Halal certified, which I think as you can see the cultural importance of how technologies are developed is important to do. But I wanna finish then with, okay, how is this gonna now hopefully help us for the future? And we are hoping that, you know, our hope for vaccine and Shisto vaccine and Chagas vaccine eventually get to the point that we really can build the second value of death, right? Like bringing them after the phase to clinical trials. And I think some levers and enablers really have to, again, focus on how can we really incentivize more of this first rate innovation within LMICs and within the manufacturers and even the trialists, the clinical trialists, the regulators, how can we make more workforce capacity, people, knowledge, materials? How can we reach some sort of also standardization of, you know, not only reagents, but models? Quality, quality, quality, right? It's super important along with the regulatory. But how can we really sustain these partnerships by providing some cost structures or some innovative way of incentivizing, right? So I hope that maybe now Tahir can give us a perspective of how iMac has looked at this and how can we certainly move forward with potential even more legal framework and ethics framework to enable these kinds of models. I'm gonna stop share and send it back to either Tahir, I think Tahir, right? Yeah, thank you, Maria. Thanks for all your amazing work and for all the work that you did during COVID and continue to do that. Interestingly, I was on a human rights watch conversation this morning on Twitter and it's kind of this week marks the third year since the pandemic started. And I think the conversation around intellectual property rights has never been so heightened, at least in my 20, 25 years of working in this field. And it's from there that I'm going to perhaps give some background to some of the access to medicines issues that I've experienced through my work, but I'm sure others are familiar with it when I actually arrived in India in 2004, just before India actually had to become fully compliant with the World Trade Organization Trips Agreement, which is a trade related aspects of intellectual property that governs what we might call the political economy of a sort of intellectual property. This is an agreement that sets minimum standards that all member states of which there's some 164 have to comply with the basic standards of protection of patents, copyright trade marks, all these various different forms will come under the umbrella of intellectual property. And arriving in India at that time, India basically didn't actually have patents on what we call pharmaceutical products. They used to give patents for the process to make something, but they never gave patents on the actual end product. And this was something that came about in the 1970s actually there was an investigation in India back in 1950 to start in about 1958 and they realized they had some of the highest prices of pharmaceuticals in the world. And they had this old colonial relic of British patent laws still on their books. And in 1970, they decided to not grant the patents on pharmaceuticals, but also food products. And that was really the birth of what is probably one of the biggest generic industries in the world. And when you think about what came after that with the HIV epidemic in the late 90s, 2000s that really kind of was the birth of what we call, at least in the civil society world, the birth of the access to medicines movement. And that all came about in 2000 when some 40 pharmaceutical companies actually gathered to sue Nelson Mandela's government for trying to actually issue what we call the compulsory license is where you override the patents. A government can override a patent in order to allow it to bring in generic versions so that the cost can be much more, they lower the cost and makes the drug more accessible. And this was for, I think it was an antibiotic drug, but they had a view to doing it for HIV medicines as well. And they got sued by some 45 sort of companies. Inevitably it was a PR disaster for the companies and I think they've always sort of licked their wounds from that, but that was really the sort of the cradle of what this work that we see today that is when we come back to the present of how we try to get vaccines to the global south. It started back really then and the intellectual property system was, it wasn't not many people knew about it at that time as a lawyer working in private practice. I knew about the TRIPS agreement and in the private practice for us, it was actually great. You know, we have this body of law that could harmonize everything around the world for our corporate clients and it would make it a lot easier to get all our IP rights. But then when I moved to India, I realized that actually this was stifling the development and technological development of countries that were emerging from, many of that emerged from empire. And in fact, it was actually in the 70s that as these countries were emerging from empire they saw the lopsidedness of the political economy of technology and how they were going to enter the new economy. There was this effort to kind of create the new international economic order which was supposed to be kind of almost like a reparation for the years of plunder and empire. And then basically to kind of reorder the political economy so that they could actually have access to science and technology developments that they hadn't had been able to as they were under colonial rule. That never happened. The, unfortunately, the US trade policy was basically saying we need to focus on the global north and then basically sort of to repeat any kind of sort of developments to the global south which never really happened. There wasn't any technology transfer as kind of a form of technological colonialism. And then what that then gave way to the beginnings of the trips agreement which incidentally the FISA actually had a role in playing in pushing in the 1980s. And when I arrived in India, one of the things, the biggest concerns was what we're gonna do now that the patent laws are on the books. So we did build in some safeguards. India actually became one of the sort of beacons of how do you actually develop a patent law so that you can prevent some of what we call this excess patenting that goes on by pharmaceutical companies. And a lot of our work as an organization in the, focusing on the drug pricing crisis in the United States really looks at this is how pharmaceutical companies are using the patent system not just really to invent something new but to actually prolong their monopolies and prevent competition from coming in much earlier. And we successfully challenged the first line and second line HIV drugs with a lot of our colleagues and other groups in India in order to make sure that generic Indian companies could still export to Africa. I think at that time, and it may be still the case today, India supplies some 80% of HIV and drugs to Africa. But that was sort of between 2000 and 2008. So there were a lot of successes. We were pushing back against sort of international regime of intellectual property, which has become globalized. And all under the guise of that, this was good for the global south international economic development. And soon after the HIV epidemic, we had also this other silent epidemic which was hepatitis C. And there were some new antiviral drugs that were coming out of the oral pills. The previous treatments were a lot more toxic. It was a peggalated interferon. And again, we challenged, we were the first organization to challenge the patents even before these were approved. And it helped to at least get some licensing deals and get the pharmaceutical companies to the table in order to improve access. But these were all sort of drug by drug scenarios. And just last week with a bunch of other organizations have written a letter to the USTR for the drug Pracafta, which is a drug which treats cystic fibrosis in children. And we've said to the USTR not to sort of put pressure on a number of countries like India, South Africa, Brazil if they were to issue compulsory licenses for these drugs. Because people have not been able to access it as far too costly. And because what typically happens is when countries try to use what we call these flexibilities in the TRIPS agreement, i.e. a compulsory license or that you can challenge a patent, the United States and the European governments come down on them heavily and they put a lot of trade sanctions and pressure on them. And this is a fundamental problem is why many countries in the global South have huge problems trying to access medicines. And I think ultimately when we look, when we come back to the present and we look, think about what's happened with COVID. Many people said, oh, well, you know these global South countries, they can't develop these technologies. I think Maria has already shown that there is capability there and it just needs, there needs to be a better collaborative model to kind of bring a lot of these technologies to the fore. But the other thing is also, you know, a lot of people have spoken about the MRNA technologies and what have you. Interestingly, there's a lot of litigation going on at the moment between Moderna and Pfizer. And Aaron and I wrote a piece actually in the inquiry about this when we mentioned that whereas Moderna and Pfizer were out there blocking a waiver of intellectual property at the World Trade Organization which was actually proposed by India and South Africa in order to help more access to technologies in order to so that these countries could develop their own capabilities. Pfizer and Moderna are saying, no, it wasn't needed. And yet when you see the litigations that they're involved in now, they had in essence give themselves a waiver to kind of impinge potentially on other people's IP which was the nanolibid particle technologies that various companies had actually had. And so it begs the question of, is like it's one rule for one and another rule for others. And it's usually the global south that suffers from this. And what's more interesting is public citizen had access to some of the agreements that for example, Pfizer and maybe some country governments in the global south. And one particular one was with Columbia. And in that agreement, they had asked the Colombian government to indemnify them against any pattern infringement or IP infringement. And as soon as I saw that clause, and this was before all these cases broke out about all the various infringement actions that they were all taken against each other. Kind of like reminds me of an image from Reservoir Dogs saying, I own the technology, I own the technology. And that indemnification clause, the first thing I saw that is that somebody's infringing somebody. Because that basically allowed Pfizer and Moderna in my mind to get ahead. And yet at the same time, they were holding the rest of the world back. And these companies have made billions of dollars largely through public funding in many ways. That's not to say that they didn't add value. But I think this is where I feel, and this is a controversial point I often make and many people might disagree with me. But I think this is where I think we confuse invention with innovation. Innovation in my mind is the commercialization of the knowledge and technology that exists. And we knew a lot of the mRNA stuff existed. I mean even Moderna just recently has agreed to pay royalties to the NIH for the upstream technology development that had happened in mRNA. And what we do is we hand patents out on innovation, which is actually more the commercialization, which I'm not saying is not important, but I think that's not the social contract that I understand the patent system to be. Which then begs the question of, really is the patent system about invention or is it about investment? Now, I remember a great quote by a UK judge, Sir Hugh Laddy who unfortunately has passed away and he in my mind was one of the probably the best supporters of the patent system. And he wrote this seminar, he said what's invention got to do with it? Because he said most things are obvious when we think about it from a patent standard. Forget about everything else, from a patent standard most things are obvious. But he says, but we need the investment. So that's why the patent system works. Which begs the question, and I take that point a bit further, is the patent system really an artificial construct of managing knowledge when really it's about driving investment? And if it's about driving investment, why don't we have an investment for reward system rather than pretending all this stuff that I invented this and I hold the knowledge on this? Because what we have is a winner takes all approach, which holds a lot more back than actually making it accessible. Because I think ultimately science, and I think Maria may agree here, it's a collaborative process. People are building knowledge on top of knowledge. The idea that there's a single person in a lab with a white coat inventing something is a myth. And I think it's a myth that has been perpetuated in American culture and society far too much. And I think it's kind of, we need to break out of that. There's so much collaboration. I think the open science aspect that Maria talks about, I think that's the way to go, particularly who are gonna actually tackle some of the greatest pandemics that we probably haven't even faced yet. And when we think about climate change and the technology and mitigating technologies there, are we gonna basically just be doing that on a charitable basis like we did in COVID? I don't think that's gonna help any of us. And so I think the pattern system, yes, it's served its purpose up to a certain point. But I think the way the company is now manipulated, and we see this in the drug pricing crisis that the US faces. And our studies have shown that the system has become so financialized in the sense of it's all about giving the sort of making a shareholder's happy and actually making sure that the lifecycle of one product that's a blockbuster continues. I'm not gonna really invest in real new technologies and new developments of drugs and medicines that we really need. I'm just gonna make sure that I kind of just do these incremental tweaks, call it innovation, call it incremental innovation because everybody loves innovation without questioning it. And then basically keep the shareholders happy. But meanwhile, you're sitting on piles and piles of knowledge that nobody else can really access. And you're fencing off huge swaths of research. And if you just have to look at the upstream patterns that these companies now, they're literally scorching the earth around anybody for coming in to do any work around it. And all that is sitting idle. So this is where I think the open size aspect is it needs to happen. I mean, one suggested I've made in the past is that if you don't use it, you lose it. And that means basically after three years, if the patent is not being put into some kind of clinical effect or trial or something, then basically the patent falls away. Because at the end of the day, there's a lot of knowledge that's sitting idle because companies decide what they want to do from a purpose of profit. Thank you. All right. Really interesting talks. We have a question from the audience. It says, what can the WHO do to ensure accessibility to these patented high priced essential medicines? Thinking about benefit slash high priced patented medicines are increasingly listed on the essential medicines list yet access issues continue. Is there a bigger role for advocacy there? I don't know, Maria, if you want to go first. Well, I can give you again the more scientific answer, which has been our experience working with these producers in India and Indonesia, which they've actually already even had precedent of understanding how they interact with the World Health Organization to seek that quality stamp of the pre-qualification. And what does WHO pre-qualification give you? What do they give you? Is one, it's a parallel review of all the quality system from even auditing your factories, making sure you have a quality, evaluating of course, the dossiers, the technical, the scientific, the regulatory, et cetera. And then once, for example, a product receives WHO PQ, it doesn't matter if he has not gone through a FDA, EMA, or one of these stringent regulatory bodies, then smaller countries rely on that WHO PQ to then say, okay, we don't have to worry about reviewing all these dossiers and doing all these audits and things in India or Indonesia. We can then receive the products, import those products, register them or approve them for use because they've gone through this process. And in the context of COVID, which we then assume that they've already have experience with these developing country producers, even though these pre-qualifications are product specific, that they would be accelerated at some level. And that did not happen. Clearly it did not happen. If you look at WHO got received any PQ level approvals, they're pretty much the same multinationals that in fact have also received big stringent regulatory approvals. And so really none of their smaller or even global South producers were able to be accelerated in their review. And so there's clearly also a little bit of inflexibility in the policies and even in prioritizing where to put their efforts in. And we know that everybody was pretty stressed and overworked, right? Nobody had enough people or even money or time to attend to this, but clearly there was also a disconnect. And so this is also another example, right? Of who should they focus on in playing a role as a World Health Organization? I think probably that it would be ideal if it can be revisited and make it better, right? And make it more less talk of equity and more real action of equity. So I'm gonna stop there. All right, great. So I have a question or a comment and then a question for you, Maria. I think my comment is people really don't focus on commercialization strategy when they think about IP. And I don't think people recognize that it's a really big lift to move from the science to getting a product out there. Not only the manufacturing and creating all of this infrastructure needed to create the drug, but also going through that really expensive regulatory approval. It's interesting that you are doing this with no patent protection. I remember seeing one of those slides. And I'm wondering why you decided to do it that way versus patenting it yourself and then giving it away, like similar to what Jonas Salk did with Polio. My fear is, as Tahir had mentioned, a lot of people are trying to get incremental innovation and patent protecting that. And my fear is that if you give away the core technology, then wouldn't you have other companies who would try to patent these follow-on innovations and kind of take that away from the creative commons? Well, it was also very specific as it relates to COVID, right? And the fact like, I think I mentioned that we did try to process a provisional and we even had a provisional when we were doing the original engineering because our core technology, like you said, right? Maybe the recombinant protein technology is pretty generic for the most part, but our real tinkering with the genetic code and how do you really frame it in the context of the platform, some innovation in the formulation science, right? For mode of use or as an immunological inducer, right? But we knew when we were actually working on the SARS that there was a lot of pushback because all of this was really prior art, right? So at some level, it also, as I think Tahir mentioned is what was the purpose of the patenting really going to be for, right? Even as you said, what's the purpose of patenting if eventually we're gonna give it for free or relatively free, right? Or open access. And then I have to also tell you that the cost of maintaining these provisionals and this submission of the patents and then we wanted to also have the international applications that adds up and we were struggling on getting even our grant money and nobody really pays for that. And then maybe to answer the whole argument of the amount of yes, value of death, transversion of not going from basic to clinic but then clinic to really deployment. We saw that we needed to play a bigger role in this regulatory enabling work because where a lot of the companies or the private sector or the multinational sector sees that they have an issue is in the risk, right? Risk of failure. And in the fact that when they work with academia they always think that they get such not regulatory and not so high quality records and data that they actually have to redo everything from scratch, right? And so we for decades now we have recognized that we wanna be partners and therefore they have to stop perceiving us that we do some great science but that we don't take it into the regulatory pathway. And so investing into changing our own culture of everything we do has to have a regulatory enablement, right? Even from how we write the experiments, the standard procedures and having our institutions buy into that because that also requires their investment has been amazing, right? Because now more we think that's actually an incentive, right? Why did BioE came to us? Because they knew we had high quality data that they didn't actually have to redo again, right? And I think that also helped and therefore avoided having to do all these more legal patents or even IP protection. Excellent. I have a question also for to hear. I really like your kind of separate dichotomy between patents as an investment or patents as actual innovation. And I'd like to push you a little bit and question you as to like, can you imagine a system where we, instead of having this kind of win or take all system with using patents, instead use a prize system? So for instance, I can imagine a system where we say, okay, you don't get patents on drugs but what we will give you is regulatory exclusivity which you can then recoup your costs and also make a profit that way. And then it becomes much clearer and you don't play these games to kind of determine, well, is this patent really innovative? Is it valid? Is it non-obvious? Can you talk a little bit about that? Yeah, it's a great question, Sean. And I think that's somewhere where we need to get to whether it be a prize system or whether it be like you get a fixed period of like here's your exclusive period that you're gonna get so that you can recoup your investments or what have you. I think the price system actually, there's some aspects of it that I like, there's some aspects that I'm still sort of figuring out and I'm sure we all are in terms of how it would work because at the same time, even with a price system is like, you're all probably still collaborating or taking knowledge on knowledge. So who gets the prize? I mean, I think about, I think about just even like the Nobel Prize. It's like usually it's a whole bunch of people that contributed to whatever that Nobel Laureate gets or whatever. I don't think that's, I don't like prize systems for that purpose. I think that people forget forgotten in that process. And that's why I think something more, where there has to be a more of a collaborative nature to the prize if it is that everyone gets recognized for their involvement and role. And then how then do you divvy up the sort of spoils? But all the, one of the discussions I know that's going on sort of back channels is like, well, let's do away with patterns and let's just give companies like say X number of years of market exclusivity. I think that's possibly one way to go because obviously, companies are going to invest or want to invest and want those rewards. But I think it, you're right. It would take us away from this mass, I think wastage of resources and litigation. And I was just speaking to someone and this is kind of, I'm not going to say who it is, but somebody who just brought a bias is trying to enter or get a biosimilar version of her, you know, one of the best selling drugs onto the market. They spent $40 million on mitigation. $40 billion trying to get through a whole bunch of patterns. That is such a waste. The patent system is actually one of the most inefficient models now that we have today because of the way he's been worked. I'm not saying that that's how it was intended when it started, but that's how it's become. And I think we need to move away from that. We need to have some kind of like, here's your reward and whether it's like 15 different people share that reward and can go off and do whatever they like with it. Cause ultimately that's competition. And then if you make an additional sort of variation of it, that's kind of when you make the product a little bit more easier to take or whatever, then the market decides your reward because I, hey, I've got a slightly different better product. I'm not going to get another patent or whatever. But you know, what we're doing is, you know, there's an interesting, I'm just reading the question here is, is it going to, we're going to have an intended consequences. We have unintended consequences now. Millions of people are dying because they don't get access to these men because we have certain power brokers that hold all the knowledge and power. And I think when the way I think of it from a sort of logical rational sense is, if we have a system where we are actually too scared to change it because the other side says, well, we're not going to invest, then you know fundamentally something wrong with that from the outset. You would not tolerate that in your own household. You would not tolerate that in any other place, but yet we tolerate it on some of the most important decisions and policies that we make today. I find it flabbergasted. So I'll add on to that, you know, like when Hatch-Waxman, and this is stuff that Portal and Aaron has written about pretty extensively, when Hatch-Waxman was actually created, it was a system that actually worked pretty well. You know, you would see people getting onto market, litigating to final judgment in validating patents and going on to market. With that said, I think the industry kind of got wise to this and started playing games, right? And this is, you know, this is not the way it was in the 80s, like you'd have like maybe two or three key patents on your drugs. Now we see lots and lots of methods of use, formulations, all sorts of dosage strategies, and all of this is just garbage that makes it more difficult for generics to, it increases my transaction costs, right? And at some point in time, if I have to clear 100 patents versus two, it's gonna cost me $40 million to do that. And what does that mean? That means that only a small number of companies are going to kind of take that risk, right? Because if I lose, then I'm out $40 million, or it just means that we're gonna get less drugs out there that are cheaper and it's not really, and I'm of the opinion that I've looked at a lot of these patents is a lot of them are just not that innovative. With that said, so the counter argument that you're gonna get is that, well, although they're not that innovative, they actually do add value, right? So we do see things like Albuterol and Hillers that have the dosage counters. Yes, it's actually valuable for me to know how much drug I'm taking or an extended release pill that allows me to take one pill instead of two pills. I'm all for that kind of innovation. With that said, I don't think we should be paying a thousand times what the drug costs the manufacturer because you created a pill that is encapsulated by something that dissolves a little bit slower and has the exact same pill in the center that you patented and that patent expired like 20 years ago. Could I just add to that, Sean? I mean, it's a very simple point because people say, oh, we need the innovation, we'll have you and now don't you want a sort of subcutaneous version of a thing or a different type of tablet instead of a pill? As somebody who's been in the patent business for a long time, when I think of it, you get a pattern for showing that it's novel, that it's something that didn't exist before. It's got to be non-obvious. So that's not commonly practised or well-established in the field. It's got to have, you've got to be able to write the description in the pattern so that it actually, you actually ingrast of the actual invention. You're not trying to just do some broad strokes and somebody can then work it once it's actually gone off. And then the fourth is actually, which I think often gets forgotten, but is the main argument of a lot of people that why they give patents for these things, the utility, oh, it gives some benefit to society. So when I think about it and deconstruct that, we've forgotten about the first three steps and we say, oh, we want the utility aspect of it, but we don't care if it's novel or non-inventive or whatever, but isn't the patent system that I mentioned? And I would add enablement, right? So you also have to teach us how to actually make and use this thing. But I think a lot of economists, they push this, oh, but it doesn't matter if it's inventive, we want the utility aspect of it, then why do we have the patent system? Right, we could use it prizes too. Okay, so I have two questions and I think we've touched on both of these answers. One, both of these questions kind of tangentially, but I'll ask them kind of just to get them out there. One question is about unintended consequences. And the question asks, if pharma companies have the most resources to develop and produce drugs, but won't proceed unless there's a potential for a minimum amount of profit, is there a risk that moving the profit incentive may actually reduce innovation or that democratizing innovation may lead to more snake oil that is difficult to distinguish from safe and effective medicines, such as ivermectin for COVID? Maybe I can just make a quick note because I think there's always this thought that it's all or none kind of thing, right? There's always gonna be some profit, right? You know, like even if you sell your $1 dose vaccine, there's always profit because of course then you have more volume and then of course it depends on how you really also quantify when that profit will come, right? I think people are always used to like, I need my profit tomorrow. And sometimes these things are like very long term, right? I mean, especially the vaccine is very much more complex than maybe small, mild fuel drugs or even diagnostics because the realization of the value of your intervention, it's really very long term, right? You're preventing diseases, so you're improving the health of a population that from when they're a child and then when they become an adult, right? So I think, and I think there's also this perception that again, that the farm or the multinationals are either really the bad guys or really the good guys, but I have to say they play a role in multiple ways too, right? You know, like the donation of Prasequanto, the donation of the parasite, the warming medicines, those eventually, they're basically subsidized by these multinationals, right? Of course they cannot always be subsidizing for everything. So of course they have to make their profits, but I think it's based on the context, right? If it's an emergency situation, there should be a different model than when you're indeed having a not emergency situation. You know, the fact that you even have models where you maybe you can do some tier pricing approaches, right? When you have dual use, right? When it's in the private sector, you know, commercialization versus country subsidizing a product because it's to be used for poor people. You probably know more about this, you know, I'm not a business nor lawyer or anything, but I am sure there's some ways that you can balance the thing, right? I mean, it's not all or none, right? All the multinationals are bad, all of us academics are good, right? You know, there's kind of like, has to be like middle of the way ground and flexible enough that you can change, right? According to the situations that arise. I'll have a kind of an add-on question to that, which is, I mean, we've seen solutions come up from COVID, right? Here in with the COVID kind of situation, the government actually invested heavily on both winners and losers. They just said, here's like $10 billion, we need a solution today. And what they did was really interesting, which was de-risk that process, that commercialization process by saying, hey, whoever gets there to a solution, we will pay you for X amount of doses for X amount of price, right? Can you imagine this kind of situation for other diseases? Is this a good kind of governmental solution for underserved populations, other diseases, or maybe even moving it into like the brand kind of company situation? I'd like to hear from both of you on that kind of idea. Well, maybe I'll start and then here, I would hope you can join in the conversation. I mean, for us, I agree. I mean, it was ideal, right, to have that. But at the same time, it was hard to understand how the selected beneficiaries were of these big $10 billion, and that, right? You know, it was a little, we didn't get a penny, right? We nor maybe even many that probably would have had a solution that was even maybe less shiny new toy, but clearly something that would have really raised the axis and the equity, right? You know, a very traditional recombinant protein technology was not supported. In fact, it was probably not supported not only in the US, but pretty much nowhere in the world, until later when they realized that you need something that it's more conventional because you have the infrastructure than relying on assuming that people would learn how to make RNA vaccines from zero to billions of scales, right? So the decision makers is something that I still don't understand, like who do we entrust to make those decisions if you have this pocket of money? And then what happens indeed with those who fail, right? Or that cannot deliver, and therefore what are the potential negotiation, right? We're seeing now a little bit that case of Novavax, right? What's happening that we even hear that now they even potentially are going bankrupt. I mean, how could that happen, right? Why couldn't there be things that would even then enable them to be successful, right? After all that they were supported with, regardless of whether their vaccine was successful scalability wise, but we cannot let them then just totally go under, right? I mean, there has to be ways, right? And how do you bring more the, again, the vision of the global vision and not just the nationalistic vision? So I think that, you know, so many, many questions of how can we improve in this concept? Yeah, I would just add, Sean, you make a valid point and it's often a phrase that's kind of been used a lot now is sort of socialize the risk and privatize the gains. And I think that's what we saw a lot of in with COVID. Again, not to say that these companies did not play a role. I wrote a piece actually in stats sort of just at the beginning of COVID and I was just looking at some of the data and sort of global funding for basic research and product development for neglected diseases sort of about four billion in around 2018. 64% of that came from public tax dollars. 19% came from philanthropic organizations. The private pharmaceutical sector contributed just 17%. That's $650 million, which is a drop in the ocean when you consider top 20 pharmaceutical companies revenue in 2019 was $661 billion. That's less than 1%. So this idea that the pharmaceutical companies are the ones that actually deliver the sort of the investment and the funding and it's a lot of it, so it's public dollars. Now the thing is, is these companies play a role in, as you said, bringing it, you know, getting it manufactured, scaling up all these things. You know, even Pfizer got money for, Moderna got money for scaling up their sort of the manufacturing plants. I think the government, for example, the NIH in this case or any government that's actually supporting its local industry, what have you, is doing a bad job. They're probably the worst business people in the world because when they sign these contracts they give everything away and they don't get anything back for it. And I think we need to change that kind of culture at the NIH and anywhere else. You know, now Moderna's paying back some measly license now that the, you know, Stefan Bansal is kind of multi-billionaire and all made off of our taxpayers' money. I think there has to be a better deal somewhere. No one's denying anyone profit. No one's denying anyone significant amounts of money but at what point do we say is enough? Okay. Yeah, that's really interesting. I want to say something really controversial now. What if the government got into the drug making business? All right, so can you imagine a situation where, I mean, maybe that's the solution in that these pharmaceuticals are really characteristics are the poster child for public goods, right? So it seems to me that, you know, again, my intuition is that NIH researchers, researchers who develop these drugs, they're licensing them out to Big Pharma. Why? Because they're the only game in town, right? I can imagine a situation where if the government is, and I'm not going to say this again, but if the government gets into the drug manufacturing business, my intuition is that a lot of these researchers would say, hey, yeah, let's license to the government and let them produce it, let them get a reasonable profit so that they can invest not only in winners, but invest in losers, right? And we'll get better drugs cheaper and maybe my royalty rate would be even higher than if I had gone to a private company because they're not really beholden to shareholders. Like, you know, at some level it is sort of done. But for example, who do we transfer our technologies? For example, who made our corn vaccine? Who made our Shisto vaccine? It was Walter Reed, Army of the United States. They have a pilot manufacturing facility. Yes, they're not a commercial industrial, right? You know, they make pilot products that you can use for phase one, phase two, right? But the intent is there, right? Who eventually is really in the global health space of bringing these products to even the populations? You know, the U.S. Army, again, you know, these body of, you know, DOD, you know, all these, you know, agencies, they already play a role, certainly overseas. If you look, for example, you know, Biopharma is a public-private partnership which is really a state-owned enterprise, right? So it is really public, right? With kind of business practices. You know, yes, a biological E is private, but I can assure you, biological E works hand in hand with the India government, right? Because they have to. You know, Brazil, all their manufacturers are government manufacturers, right? Biomandinos and Butantan. I mean, so there are examples there as, you know, and I think you're right, Sean, is that here in the U.S., we always think that it's either or, right? You know, there's less of these public-private relationships. Yeah, I agree, Sean. I think I personally would like to see the NIH take some of this upstream research and actually build on the delivering it out, getting that, you know, last mile or wherever you want to call it. Because, you know, it reminds me of, even though the drug itself didn't work out in COVID, you know, Remdesivir, which was Gilead's, that was the first sort of antiviral pill that everybody, you know, got excited about during COVID, you know, a lot of that was funded by Walter Reed and all that stuff, the basic research, because he initially started off with Ebola. And during the course of that, because it was actually an IV treatment, you had to go into hospital, get it, it wasn't actually an oral pill. And then halfway through, Gilead started thinking about developing an oral pill. Imagine if the government had just done that. I mean, say, assuming it was an effective drill and everything else, it just got stuck in Gilead's hands and they decided when it was suited them to do it for the market purposes. And I think that's a fundamental problem with the system we have today, is actually the government does need, and, you know, we talk about, you know, President Biden's executive order on competition. We need a different idea of competition. Because what we have in the industry sense, and this is what the industry always says, you know, competition is a few branded actors competing with each other. That's not competition. And I think that the pharmaceutical firms have gotten wise to the ability to charge whatever they want, right? We've really seen, and Ben Roem has done a really interesting study showing that, you know, in 2008, the average launch price was about $2,000 per drug, which is still pretty high, but now in 2021, it was like $150,000 per launch price, which is just, you know, it's not inflation that's causing that kind of increase. Yeah, we've got inflation, but not that much. So, yeah, I think everybody agrees that this is probably not sustainable, right? And the real question is like, how are people going to react? I mean, I think part of the problem may be actually in our insurance reimbursement, right? A lot of patients don't see these pricing increases. And I'm wondering if payers actually pushed back on this, how much change we would get if, you know, if my, I take fish oil, right? So I can either buy fish oil from SAMS for $30 a month, or I can get the prescription for $20 for three months, but they're charging my insurance $800, right? But I'm going to always choose the $20 because it's cheaper for me. Like, why don't payers kind of push back on this kind of crazy behavior? Yeah, I wonder if that part of the problem, you know, that everyone's dipping their beak, so to speak. And I think that's probably, as somebody who's come from, you know, the UK, and I'm not saying that's perfect by any means, but at least there's some kind of regulation of prices. And, you know, I remember first coming to the United States after having, you know, if I got some medication over the NHS, you just kind of, it was all subsidized, so to speak, because the government had negotiated and what have you. Came here, the pharmacist asked me, do you want to pay by insurance or do you just want to pay out of pocket? And I had no idea at the time because I didn't know how the system worked. I said, I'll just pay for it. And it was a cortical hysterical. She said, that's $520. I said, I'll pay on insurance, $20. So who's getting that middle? Right. But you're right about payers not seeing it. They don't feel it. I mean, unless you're uninsured, it's not seen. And I think that's the cultural shift that needs to change. Yeah, no, I think if the public were actually to see the actual price, you know, if you were to say, hey, I'm gonna have to pay $180,000 for this drug that I'm taking, I think Congress would move pretty quickly to get a lot of this stuff done. And I don't understand why employers who actually have all these huge insurance, you know, sort of for their employee, why, what, what, what, I mean, I spoke to some of them and saying, you know, why are you involved in this conversation? And that for me is a bit, I'm a bit befuddled by that. Is the risk just spread so thin that the price increases are not seen by employers either or? Yeah, that's above my pay grade. All right, we have one more question, which is directed to you to hear. It says, you briefly mentioned an alternative model of investment reward system to drive pharmaceutical innovation. Can you explain how this model would function and elaborate on why you would believe this could be viable? Well, I think ultimately, you know, as I said about the sort of, you know, the practicing when you and I discuss briefly about it, so it is about investment. That's what the, you know, the patent system as part of the bargain is to drive investment so people invest to make up these, you know, inventions. And if we're going to a stage sort of in the patent system and what we're getting, a lot of these kind of really gimmicky type patents are kind of, that aren't really inventive or they're just building on knowledge and it's not really a winner-takes-all system or it shouldn't be a winner-takes-all system, then let's just get to a system like, you know what, you've invested X to bring the something to the market that's got utility, it's gonna benefit society. How much did you invest in it? Let's open those books. And so if you want to get the reward, you have to show all this stuff. Now, is that gonna be viable? Are people gonna do that? Well, no, you have to get on board because all of the lies, we're just gonna continue in this sort of, I see it as like a spoiled child. The pharmaceutical industry has become a spoiled child. And if you keep giving it candy, it's gonna keep misbehaving. And that's what we've become as a society. We just constantly, and we're so, you know, we kind of almost captured by the idea that unless we do it this way, there's no other way out of it. And I think that's, again, a cultural shift. And I think, you know, the Milton Friedman economics since the 70s that has bestowed upon us and MBAs that basically your job is to get as much profit out of the system as possible, that needs to be changed. That's what driving this agenda. Right, no, absolutely. I completely agree with that. I remember reading a Jim article just recently saying, greed is the driver of our healthcare system. I think it's probably true. We have lost our humanity and empathy for anything but profit. That is where we should start with the conversation. We're gonna take brass tax, that's where we start. It's interesting, Margo Bagley has kind of written a little bit about this idea. And I mean, our corporate structure is designed for shareholder profit, right? In fact, you're not acting as a fiduciary unless you maximize profit for your shareholders, right? So, you know, Benderna or Pfizer or whoever comes out with a COVID vaccine, they're not doing it out of the goodness of their heart or even to help patients. They're really doing it to generate revenue for their shareholders. So how is it that we can kind of change that culture or that kind of idea? Is there a corporate structure kind of solution to this problem? Well, just on that point, no, not to belabor it, but it's interesting, because you see these pharmaceutical CEOs or investors or what have you, they'll say, oh, well, if we don't get this then we're just gonna invest elsewhere. That's always an argument that's made. No, you're not. You're making a lot of money in this anyway. You're gonna stay in this business. You know, that's BS. We're gonna stay in this. You're still making billions. You're okay. You're just not making the multi-billions that you want to do, that you can get away with another current system. You know, they did that in India as well. Well, we won the case against Navarra's on the drug leadback. Navarra said, we're gonna disinvest from India. No, they did it. They're still there. Right. No, I agree also. I mean, if they're making money hand over fist, they're not gonna. But what we've done is we've allowed them to keep doing that in more and more and more and more in fact, we fueled it. And you know, it's kind of like as Milton Friedman said, you know, CEO don't have a social responsibility. They have the responsibility to make as much profit as possible. And that's the culture that we breed. Any thoughts on that? From my side, well, you know, we again, we are, remember I come from the nonprofit, you know, world, you know, where even as academics, we, you know, we, even as scientists as much, and I think there was a question of how can we even enable a changing culture in academia, right? Of, you know, how can we rework the tech transfer policies? And I have to say, the way we've done it as a team, as a group is you actually need to get to learn who those technology transfer offices or who your leaders are, right? And in fact, in our case, we did do what, you know, I think it's Admiral Gupta who put this comment is like our tech transfer policies for COVID were all non-exclusive. The same, I could work with India, Indonesia, Bangladesh, whoever, all of us non-exclusiveness, right? So a little bit this concept of patent pooling, if you want to call it, you know, technology pooling, right? Where we had a technology, everybody who wanted it, you know, maybe had some personalized needs and requests like the Halal request from Indonesia. But at the same time, the reason why we could do it is because we spoke with our leaders way early, right? You want us to be academics and work on tropical neglected emerging diseases. Our goal is to make sure that they are enabled, accessed empowerment of local production. So that requires you to also buy into the philosophy, right? And the framework. And then we work with them. We, you know, we worked in them for 10 years, right? Figure this out. What to see that such that in the moment that we needed it, we could kind of like enable it without having to try to convince the president of the United States and we didn't want exclusivity, right? And so it's all pre, you know, discussions, right? And then you adapt based on the situation. So I think it can be done, you know, you can put greed a little bit aside, right? But on the other side of the coin, we of course do need money to work, right? You know, I need to pay my salary, you know, the scientists need to pay their side. We need to buy the reagents, we need to write. So yes, we need to of course, you know, bring ways to innovate and bring funders and supporters. And, you know, and it's becoming harder and harder to even do that, right? You know, to who supports the academic research at this point besides, you know, grant and federal funds. I mean, yeah, I think that's, and I see a question kind of in the queue about this, but when researchers and scientists are not motivated by patents, but motivated by grants and publications, how can you kind of switch that kind of frame shift? And so Nicole asks, we are in a big moment of open science and I agree that open science, principles of open science offers a lot of potential for access to medicines, but could you talk about some of the challenges in implementing open science and pharmaceuticals? Well, from our side, again, it's a very unique scenario because again, it's for neglected diseases, right? So, in fact, by opening the science, we incentivize those who can potentially just try to do it on their own, right? You know, even locally. I don't have experience with like real gang buster pharmaceuticals, right, like creating the next cancer drug, right? You know, and there is some clashes there, right, of ownership of, you know, and how, you know, like, you know, working with private sector that they prevent you even from publishing because, you know, all those kinds of things. In my world, in fact, you know, it's the opposite a little bit, right? You know, that in fact, open science has enabled more impact because then others learn from, you know, our failures, right? You know, like it hasn't been easy, for example, to do vaccine in yeast platforms because you have some very biochemical quirks, but the fact that we resolved it, you know, and we published the failures and the successes, that reduces the investment and resources others have to do because they don't repeat the same mistakes we did, right? You know, they go for what it had worked. So there's a lot of value. I think it's just, you know, everybody, you know, eventually they all, of course, they try to kind of protect their own thing. You know, we see it in a different way, to be very honest. So I think I asked you this question a few weeks ago, which is why does it have to be that way? Why is it that it has to be only for tropical diseases or rare diseases or diseases that affect poor populations? Why can't we apply the same model to cancer or, you know, humera? My intuition is that scientists actually care about getting their products to the public. It's the, it's, as Tahir said, it's the big drug companies who care about shareholder profits that are kind of driving this price increase. I have no answer for you, Sean. I mean, any thoughts on that, Tahir? Like, I think, I mean, you know, it is a moment of focus. I see, you know, I was just reading the other day about during COVID, there's a lot of the, I don't know, it's a little bit different, but I'm just going to use it as a platform to where I want to get to. The, a lot of the publishing houses all went open science because they knew the benefit of the sharing of research and data and information and what have you, and they lauded it. And I'm wondering, you know, why the science community and the researchers, because I was actually just speaking with a group of civil society group, which is a gentleman at MIT who works in the lab there and he's, they're trying to create a movement, like a sort of like a labor movement of researchers who actually want to have some saying where their research goes and what it does and what have you. And I think that's kind of a, maybe a little more sort of activity, but I think it's great because it's, by Dole has killed the researchers, you know, it's like you say, it's like, instead of publishing really useful, it's like they're out there getting patents and making the university look better. And I think, I think we need to go back to where, or have a system whereby if research is getting funding from NIH or what have you in their work community, they have a saying where they want that, they have some kind of involvement in where that goes. Because otherwise it just goes to the tech transfer centers. And you know, when you think about Durham University and they're spinning off all these little biotech firms and the CEOs are getting rich. I mean, when you think about what hepatitis C drug, Raymond Shinazi, who, you know, has done a lot of great work in the HIV space, but he made over half a billion dollars selling farmer set, which was born out of licenses from Emory University. I mean, it's a cash cow for these scientists as well. We need to change that culture in terms of how researchers at universities are getting NIH grants to really important research, that it's not just a case of getting a patent or it's going to the tech transfer centers. It has to go somewhere. And that's where I think we're back to that point you were saying, Sean, I think government, some kind of government manufacturing, they can take on that thing. And you know, the thing we haven't talked about is clinical trials, because that's where a lot of the costs lie in kind of drug development, right? A lot of people are- That's even outsourced, right? There are a lot of companies that do, I mean, that's a problem that money can solve, right? You just throw money at it. I think if the government picks enough winners, then it'll kind of wash itself out. But more and more, we're also seeing that academia is feeling that role of doing the clinical trials, right? Because they have a better way of also being entrusted by the community so we can actually get more diverse recruitment, right? Because they know that it's a study kind of done within a university system, right? And not necessarily led, like you said, by this more artificial kind of CROs that then they even in turn then come and contract universities to do their work, right? So yeah, that area I agree with here, it's even more complex than the manufacturing sometimes, right? How you design all these studies and where you do them and who you include, right? And what the data does it really show as far as safety and efficacy? All right, so it looks like we have just three more minutes left. So I'll leave with one last question which is kind of built on our previous discussion which is if researchers are doing the innovation, if researchers are doing the clinical trials and researchers are helping to get these things to market then why is it that our drugs are so expensive and why is it that researchers aren't the ones who are benefiting and the public at the end of the day? Why is it that we're getting harmed by not having access to these medicines that are really built on the backs of public funding? I mean... My last words is you're right. And even within the big private manufacturing or even these pharmaceutical companies, the anchor is the researchers, right? Because even if I, for example, I transfer the technology to BioE and it was not BioE leadership, the CEO doing the experiments, it was these scientists that really then did the engineering, the scale-up and all the work. So there is, of course, science on both sides. I think it's where pretty much Tahir mentioned is, right? Is how do you then communicate that science and how do you actually measure the investments along the continuum, right? A lot of it that we do is de-linked because we get grants that we don't have to pay back but sometimes these companies don't get grants to do the work they do behind the scenes. They actually get loans or get some sort of investment. So they eventually have to pay back. And I think so it must be where in the formula you calculate those cost of goods, the cost of development, the cost of doing the testing and the cost of then delivering, right? You know, that is where I think we mark up, right? And where the markups go end up is where you probably then, you know, the greed comes into play, right? All right, Leah, did you wanna? All right, well, thank you, all three of you for a really wonderful conversation and sharing the work that you've been doing and as Sean said at the beginning, work that is improving people's lives and really making a difference in the world. So thank you and to our audience, thank you for joining us today. We'll be back in April on April 14th for our final consortium of the year. And so we look forward to seeing you then. Thank you so much.