During his leadership of the President's Emergency Plan for AIDS Relief during the George W. Bush administraion, Dr. Mark Dybul, M.D. shepherded programs credited with saving more than 25 million lives. For many years after that public service drew to a close, he continued the mission as executive director of The Global Fund to Fight AIDS, Tuberculosis and Malaria--working in lockstep with not only the world's leading scientists, but the likes of Bono and Sir Elton John along the way.
But, it wasn't all glamor and heroics. Dybul had to influence some decidedly conservative global political machines of the importance of addressing the AIDS epidemic, particularly, at the time, in Africa. He had to fight through federal and global beuracracies for every dime of funding earned. His leadership required resolve in the face of complexity and adversity.
Nothing could have better prepared him for biotech leadership, which has dealt Dr. Dybul an unfair share of unique adversity that's, quite frankly, the stuff of a Dateline NBC episode. On this epsiode of the Business of Biotech podcast, Dybul, CEO at Renovaro Biosciences, gets introspective on leadership forged in the fires of public service and battle-tested in the private sector.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
During his leadership of the President's Emergency Plan for AIDS Relief during the George W. Bush administraion, Dr. Mark Dybul, M.D. shepherded programs credited with saving more than 25 million lives. For many years after that public service drew to a close, he continued the mission as executive director of The Global Fund to Fight AIDS, Tuberculosis and Malaria--working in lockstep with not only the world's leading scientists, but the likes of Bono and Sir Elton John along the way.
But, it wasn't all glamor and heroics. Dybul had to influence some decidedly conservative global political machines of the importance of addressing the AIDS epidemic, particularly, at the time, in Africa. He had to fight through federal and global beuracracies for every dime of funding earned. His leadership required resolve in the face of complexity and adversity.
Nothing could have better prepared him for biotech leadership, which has dealt Dr. Dybul an unfair share of unique adversity that's, quite frankly, the stuff of a Dateline NBC episode. On this epsiode of the Business of Biotech podcast, Dybul, CEO at Renovaro Biosciences, gets introspective on leadership forged in the fires of public service and battle-tested in the private sector.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
The business of biotech is produced by LifeScienceConnect and its community of learning, solving and sourcing resources for biopharma decision makers. If you're working on biologics process development and manufacturing challenges, you need to swing by bioprocessonlinecom. If you're trying to stay ahead of the Cell or Gene Therapy curve, visit cellenginecom. When it's time to map out your clinical course, let clinicalleadercom help, and if optimizing outsourcing decisions is what you're after, check out outsourcepharmacom. We're LifeScienceConnect and we're here to help.
Speaker 1:If you told me that Dr Mark Dible ever backed down from a public health challenge, or any challenge for that matter, you'd have to bring some very hard evidence to convince me of it.
Speaker 1:He's a guy who earned his place on the global stage running point on AIDS relief, in a presidentially appointed position during the mid-2000s, after his early career was dedicated to AIDS research and clinical care. He's faculty co-director at the Center for Global Health and Quality, a professor in the Department of Medicine at Georgetown University Medical Center, and was the executive director of the Global Fund to find AIDS, tuberculosis and Malaria. He's also the biotech entrepreneur currently leading Renovarro Biosciences, a company developing therapeutic vaccines and therapies in oncology, hiv and hepatitis, and one that's seen its own share of very unique challenges, from leadership, change to the integration of cutting edge AI technology and more challenges Dr Dible has steadfastly navigated. I'm Matt Piller. This is the business of biotech and I admit that there's a lot of detail to be filled in there, but I'm thrilled to welcome just the man to do it, the honorable Dr Mark Dible himself. Dr Dible, thank you for joining me. It's truly an honor, and welcome to the show.
Speaker 2:Thank you. It's great to be with you, Matt. Thanks for inviting me.
Speaker 1:My pleasure. We have a lot to cover, but I want to get started by rewinding, like going way back, rewinding the clock quite a bit. I want to get a feel for your professional trajectory, Way back when you were in your undergrad and contemplating post-grad studies. What was it that inspired you to pursue an MD?
Speaker 2:It's a great question, especially because I began trying to decide between a doctoral degree in philosophy or theology and didn't take any science classes and undergrad oh really. I read an article yeah, it's not a career path necessarily to recommend to anyone and not to do anymore. Then I read an article about HIV in Africa and it just consumed me and decided that I needed to shift and spend my life fighting HIV. Going to medical school seemed basically you become an advocate or you go to medical school. If you go into medicine, you can do both. You can be an advocate and do the medicine. I decided to go in that direction. I went to medical school specifically to join the fight against HIV.
Speaker 2:At the time, everyone was dying. I did my fourth year of medical school in San Francisco holding the hands of 17-year-old dying alone because their friends and family wouldn't visit them. For those who lived through that in the United States, if you went to Africa at the time, that horror was compounded a thousandfold in ways that are almost indescribable. I changed my career path and went into research.
Speaker 1:What year was that? Sorry to interrupt you. Yeah, no problem at all.
Speaker 2:I went to medical school in 1998. I graduated in 2002. Then did my residency in the University of Chicago in internal medicine and fellowship and infectious diseases at the National Institutes of Health. Now the National Institutes of Health is somewhat unique when you're accepted into a fellowship you're actually accepted into a laboratory. You do your clinical time but you're already accepted to go into a lab after your first year. That lab happened to be Tony Fauci.
Speaker 2:I met Tony in 1994 and then was accepted into his lab and started work with him. We were doing work on basic immunology virology. My first supervisor was Drew Weisman, who just won the Nobel Prize for the COVID vaccine. I've stayed in touch with Drew as an amazing scientist and person, as is Tony. Then I was running a section of Tony's lab, immunology virology. We were doing work in Africa, studying antiretroviral therapy in Africans.
Speaker 2:When President Bush had the bold idea to do something huge on HIV globally, he turned to Tony, as any sensible president would. Tony and I were doing the work in Africa I got involved with creating with a very small group in the White House Tony and I were the only outside what became the President's emergency plan for AIDS relief, which I was then asked to run as a Senate confirmed appointee. I was still a civil servant, but in a political job. That program grew from zero budget and eight people in the basement of the State Department to six and a half billion dollars a year. It's now saved over 25 million lives. It was building a startup in the US government, which is not the easiest thing in the world to do.
Speaker 1:Like I said, Dr Mark Diable is not one to back down from a challenge. Before we get into that, you fast forward a little bit beyond where I wanted to go. I wanted to get a sense for the early work that you did in HIV, your academic years. Obviously, that was a completely different time as far as AIDS treatment and therapeutics were concerned. Did you practice for a time?
Speaker 2:I practiced at NIH. I was clinical at NIH. It's a unique environment. There's an astounding clinical center. It's a real jewel in the American health system. Basically all the work you do is tied to clinical basic and clinical research. We all in my group anyway, while we did clinical work during my fellowship to be certified in infectious diseases and went to various hospitals around the Bethesda, maryland area in Washington DC and Baltimore, then also we had a clinic, an HIV clinic at NIH, but then did clinical research based out of that and then expanded that clinical research to Africa. I was an active clinician with a license up until I became the deputy US global AIDS coordinator running PEPFAR, at which point it became too difficult to manage Running of a growing $1 billion a year program and maintain a clinic.
Speaker 1:Yeah, you characterize it interestingly when you say you were a civil servant effectively developing or leading a startup within the US government. That's an opportunity, an amazing opportunity on one hand. On the other hand, getting into politics and government is there are plenty of folks who would say you know what? I think I'm going to apply my talents and expertise a different way. Tell me about your mindset at the time. What inspired you to like, obviously, the prestige right? What else inspired you to embrace that role as a civil servant working within the US government?
Speaker 2:I actually never thought about the prestige of it at all. In fact it was the opposite. It was more humility of being able to become involved in the largest international health initiative in history for a single disease, the humility of the people involved in the US government, in Washington and in particular in the countries visiting villages where people were literally giving everything of themselves for their neighbors. It was a very humbling experience. I think what drives people to do that and I hope you know in this world today people don't think highly of government all the time but the opportunity to do huge things you can't do outside of government and to do an international initiative across the Department of Defense, the Department of Health and Human Services, the State Department, some of the three biggest departments, what's called USAID, our development agency, the Department of Labor, the Peace Corps, to bring all of that together to support what was thought to be impossible by the public health community the scale up of anti-retroviore therapy in Africa, where literally the vast majority of the public health community said it was impossible. The systems couldn't be built, there weren't enough health care workers. And they were right. There weren't enough health care workers. There were no logistics systems, there were no supply chains. No one had ever tried chronic delivery systems in Africa at all. There was no roadmap, there was just a vision and a trust that it can and needed to be done, and so the opportunity to be involved with that was what motivated all of us.
Speaker 2:But it was a startup. I mean, when we began, people just thought about how much money are you spending? The answer to any. What are you doing in education, health? The answer would be we're spending X amount of money. Not we're achieving this. It was very clear in direction from President Bush don't ever come back to me telling me how much money you need. Tell me what you're going to do and how you're going to do it, and I'll find the money.
Speaker 2:So it was a bottom up, results based approach Bottom up budgeting very common in business bottom up management and top down management with command and control, with very specific results that we managed against and got results reported every six months and managed against those results moving money, moving managers, basically bringing business across the US government and a startup mindset, and that there's nothing harder.
Speaker 2:When people say, oh, it's so difficult to run a public company, I'm like try running a startup in the US government across multiple agencies. You basically have a board of 700 people the entire Congress, the entire executive branch, the Department of State and all the agencies. So it's like having multiple divisions, but secretary level, four star general level as your division heads trying to push and then dealing with all the countries and the systems, and each country is different. So you can't do a more difficult startup and it was very exciting and I learned a great deal about management. I learned a great deal about results based orientation. I learned a great deal about setting targets and meeting them. So we met in the US government on target on budget, the results, which has now saved 25 million lives.
Speaker 1:Yeah, and similarly to running a startup, going into that appointment, I mean you had to know that your time there would more than likely be finite, which is often the case in startup environments. I've interviewed a lot of biopharma executives on this show and very few of them have 20 plus year, 10 years, with the same company. Nor should you Sure Right, yeah, yeah Right. You take opportunities to have more, different, better impact.
Speaker 2:And train the next generation. Try it, yeah, and you should be putting yourself out of job. Change the next generation of takeover to think creatively differently, to have vision. No one person is ever going to be responsible. It's always a team effort and you have to bring that next generation up.
Speaker 1:Yeah, what were your thoughts as that? Well, first of all, I'm curious how that wound up. I'm assuming it wound down as a result of sort of your appointment, specifically wound down as a administration change, a political thing.
Speaker 2:I was actually asked to stay on by the Obama administration for a period as a functional civil servant. Then, with that ended, I went back to NIH with Tony, stayed there for a couple more months and then decided to go over to Georgetown University and leave the government very happily after having had the opportunity to serve.
Speaker 1:What remains of what you again fully recognizing that the AIDS therapeutic landscape has advanced considerably, thanks in large part to a lot of the work that you did, so I'm sure it's a different effort now, a different organization. What sort of remains of the legacy that you began to build there?
Speaker 2:It's actually still very much running. It's now been 20 years with a total expended of 110 billion dollars and 25 million lives saved. We reached 2 million at the time of five years. It's a hockey stick you get started and you build the systems. And that was the key. You build the system so that you can continue to enroll, and we did these very careful calculations not that common in government. How much would it cost per person for the first six months and then for the rest of their lives? As I said, it's very economic. So that program is still existing. A lot of the foundations that we laid are still very much in place and has continued to grow and expand and build systems health systems that are now the foundation of health systems across Africa and actually allowed them to respond to things like COVID, ebola and other diseases. So the legacy continues in a very fundamental way.
Speaker 1:Very good when you made the decision to go back to Georgetown. So you went back to the NIH for a bit and then went to Georgetown. Was that to pursue, to continue your career in academia? Were you? Yeah, nih?
Speaker 2:is functionally an academic setting. It's one of the best universities, in a sense, in health in the world, if not the best and I'd gone through my government years in academia, except for the time at the AIDS program and I thought it was time to step back after 14 years in government and move to a university base. I went to Georgetown for all my schooling undergrad medical school and wanted to have that base rather than going back to NIH and build something new. So we started to develop new programs around policy and impact in Africa, primarily around HIV and other infectious diseases, and we're funded by the Gates Foundation, hilton Foundation, other foundations, to do important work. Ultimately, and now as a professor at Georgetown while I'm CEO which, as you know, is not that uncommon the programs I started and continue became grantees of the President's Emergency Plan for AIDS Relief and the Global Fund. The organizations I used to run so now I'm based was basically on the other side of those. Yeah.
Speaker 1:Yeah, what were you teaching at Georgetown and what do you continue to teach? I?
Speaker 2:guess, teach in general, public health, public health policy, the HIV, and leadership and management.
Speaker 1:Hmm, very interesting. Yeah, so the trend, as you mentioned not on comment at all to have we've had plenty of them on the show academics who are also CEOs of biopharma companies. What was the I guess the first, I guess inkling of motivation to join industry in your mind, like what was appealing there?
Speaker 2:Well, I've done a lot of other things, but I think what grabbed me is the same thing that grabbed me for PEPFAR an opportunity. So business can move in different ways and I was fortunate to be introduced to some truly innovative technology that could potentially radically change the landscape, first for HIV and other infectious diseases and then, secondly, cancer. And really my mission has shifted and the vision of Renovarro has shifted to and I believe this is possible freeing us from toxic chemotherapy in our lifetime and to provide people with healthy living, with cancer, with healthy longevity, without toxic chemotherapy. And immunology is the basis of that and my entire career has been built on immunology and how the immune system functions.
Speaker 2:And if we can retrain the immune system to recognize tumors in a different way not the way the current immune system is, because obviously that's failing but if we can retrain it using effectively tricking the immune system, using the immune system and what we know about it and building products, cell gene and immunotherapy products around that we can shift the way the immune system works so that it can control the tumors, to retrain the immune system so that it can control the cancer without the need for toxic chemotherapy that destroys not only cancer cells, but all the rest of our, many of our other cells, and that's the vision that I think is fully achievable.
Speaker 2:And it's achievable by understanding the immune system and building products like the one we have, but also by including advanced technology like AI are really a lot of people talk about AI, everything's AI. Now, really, what it is is deep learning and deep algorithms based on massive data sets that are trained to identify things, and the same way we're retraining the immune system, you're using data, massive data sets, and using technology to train algorithms to find things that would be impossible for the human mind or simple experiments to identify, and when you put those two powerful things together, I believe we can achieve extraordinary things in health, longevity and better lives, and that's what excites me now.
Speaker 1:Yeah, yeah, and I've got some questions for you on that here in a minute around your recent merger acquisition, you can hear us.
Speaker 2:It's in process, it's a combination. So we're waiting for the proxy vote, so the definitive agreement has been signed. There were waiting the proxy vote, which we believe will occur, or hope intend to have occur, early next year.
Speaker 1:Cool, yeah. Yeah, we'll dig into that technology here in a minute, but before we get too far away from sort of that transitionary period, one of the interesting, I think, juxtapositions in my mind is what you described earlier as a startup within the federal government, where the Bush administration was basically saying we want to do big things. Don't tell me how much you're spending, tell me what you need. When you found a startup biopharma company, you don't get to go to the president of the United States and Congress and say, hey, where's that blank check? Here's what we need to stroke on that blank check. So tell me a little bit about that, like that learning experience for you.
Speaker 1:Moving from, I often interview execs who came from big, big, big bio before they founded a company and they tell me about, boy, it was one thing being in a super well-resourced organization. It's quite another when you're scrapping for money and you're answering to a board and accounting for every dime. So tell me a little bit about how you reconcile that. Yeah, it gets a little bit to doing a startup in the US government is far more complicated than anything in the public sector, including raising money.
Speaker 2:So there's a misconception that a president just decides to spend X amount of money and that's all and then you're done. You just go, do it. Not how it works. There's an annual appropriation cycle, there's a Congress which is functionally a board of 535 people, and you have to defend why your people are doing it and you have to defend why your program and why money for your program and this is developing money going to Africa is more important than all the other priorities that the US government has, and to go from To increase budgets in the US government is virtually impossible To increase them by a billion, a billion and a half a year for a development program. Money going to Africa is unheard of and has never happened before and is probably never going to happen again. But we had to literally every year fight for every penny, and that included within the administration, because the administration is not the president. There's the Office of Management and Budget, there's the National Security Council and they're all fighting for those resources. So you have to prove that what you're doing is impactful enough Every year and you have to explain to them what's working, what's not working, what's not working, why this vision is better than every other vision. Sitting in front of them, I'll never forget being the Office of Management and Budget and we were asking for an increase of $450 million, which at the time was 50% of our budget, and the president was the governor. The president's brother was governor of Florida, had just walked out as we were walking in and he was like he just asked me for a lot less. Why should I be giving it to you and not the president's brother, who's the governor of Florida? So, in ways that do not exist in the private sector, you have to explain every last penny and you have to convince the entire White House, your bosses at the State Department of Mike's and the entire US Congress every year to do that. There's nothing more difficult in terms of fundraising.
Speaker 2:Then, on the global stage, when I ran the Global Fund for IDHTV in Malaria, we did three-year cycles. When I took that program over, it was collapsing. Germany, switzerland and several other large donors had withdrawn because of basically some difficulties in management. It turns out there were a lot of issues with management. Not the managers were great human beings, but they were running a massive organization at the time 3 billion, which was half of what I used to run 3 billion dollars a year but it was being run like a small NGO. All the business systems had to be built and put in place.
Speaker 2:I led that effort but I was raising money from every country in the world, every major country in the world. I had to go to every parliament, every head of state, every three years. Bill Gates was involved. He massively increases contributions while I was there and he helped us fundraise. But you had to go every and to keep those three-year cycles. You had to go all the time and explain why your program and all the things governments had to fund was important enough to go from three to four and a half billion dollars and to restore confidence in four years. So it is a very complex thing to do those things. That, to be honest, in terms of fundraising in the public private sector, is much, much, much easier and much less complicated.
Speaker 1:Even though, during many of those years, you had Bono at your side. I mean, you had Bono.
Speaker 2:Bono is a great help and politicians love having pictures, but Bono is unique in that he can explain why things should be done. Bill Gates has that star power, but can also explain why things should be done. They were great allies. And you have to do this in business. No business operates alone either. When we have our oncology products and when we have our AI products, you have to convince doctors and hospital systems why they should be buying your product and not someone else's.
Speaker 2:And that same effort and that requires partnerships. That requires getting people who the oncologist listened to, who the hospital had listened to, who the insurers listened to, so that there's enough of a system Even in the regulatory process. You want advocates out there pushing for what you're doing, knowing how to build those partnerships. That's how business succeeds rapidly. A lot of people think you end when you have a product. You start when you have a product and you start long before you have that product to prepare the pathways so that when the product's available, you're ready to roll and you're ready to move into a market in an aggressive and commercial way. That's very similar to the types of partnerships and things we had to build for both of the programs I was privileged to build and run.
Speaker 1:Yeah, that element of now biopharmaceutical leadership, that passion and advocacy was that in you prior to your global stage and federal leadership experience, or is that something you learned as you?
Speaker 2:I learned that coming along because I was an academic. I ran a lab, very successful lab with lots of academic publications. I'd get flown all over the world to speak on the science, and that was a very different life when I started taking over these programs. We were buying. We were the largest procure. We bought billions of dollars a year in pharmaceutical products, in band-aids and everything that you need for health Thousands of commodities literally and had to negotiate with CEOs of every major pharmaceutical company. Also did public-private partnerships with huge companies, including Coca-Cola, for example, on supply chain. Who's better at understanding supply chain than Coca-Cola? So not only in the pharmaceutical sector, where we were big procure and negotiated, but also did partnerships to deliver healthcare same with huge corporations like Coca-Cola. So it was very much a learning experience, but one that was very exciting to engage at that level and understand how companies work, which is not too different. In the end, everything is run by humans. If you understand human beings, you can understand any part of that in the private or public sector.
Speaker 1:Everything is run by human beings. Right now We'll talk a little bit about AI here. In a minute We'll test that theory. So, run of viral, before we get into the technology and some of the moves you've been making, the company has not been without its own challenges that have sort of tested its metal. Prior iterations of the company have forced you, as its leader, to power through some unbelievable drama. You can read about it on the internet. I'm not going to get into the details right now, but people familiar with the company know there's been some considerable drama in terms of the leadership iterations of the company. So I'm curious about that element. I mean, obviously, me and our listeners. We're sensing your passion, your advocacy, your drive. But when it comes to leadership from an organizational standpoint, especially when there's, as I said, considerable drama happening, what's key to Mark Dible? Maintaining and at times correcting the course of a company that you're trying to build?
Speaker 2:I think some of the things that I learned running massive organizations with enormous political and public challenges as I mentioned the global phone I took over donors were running away from because of some internal management problems and Inspector General reports that found money missing. Imagine what it was like in Washington DC pushing for programs as Democrats, republicans everyone's moving around and the presidency changing over the years. These are very complex things and we were on the front page of newspapers regularly with challenging things. In crises.
Speaker 2:The most important thing is to stay focused on what your mission is, to remain humble and learn. As my former boss used to say, when you're in a hole, stop digging which many people have a tendency to do and be very transparent, and this is something I learned in all of the programs I've ever run, and that's true here Be honest about what your problems are and what you're trying to do, what your solutions are, and be transparent about that. And that's precisely what we've done, and if you maintain those principles, you can manage through anything. But if you see where you're going and what your mission is, you can manage anything, and that's what we've always done. We've seen the opportunity to the opportunity and the potential to revolutionize healthcare for people and the opportunity to manage and remain humble and learn and adapt and be transparent and be transparent with the public, be transparent with the board, be transparent with investors and if you do those things, you can manage through just about anything, and I think we've done an awfully good job of doing that as a team.
Speaker 2:Our board is extremely strong. The former interim CEO of Gilead Pharmaceuticals, rew Sciences, one of the largest pharmaceutical companies in the world, who was general counsel before, is our lead independent member. We have other very impressive board members. Our board chair started Pandora Jewelry, so we have a very strong board that stuck with it and the scientists who have been engaged have stuck with us from the beginning and continued and powered through and continue to show tremendous results. So stay focused on your outcomes, your results, your mission, be humble, learn and be transparent, and that's what we've done.
Speaker 1:As manufacturers look to automate, scale and reduce risk in cell therapy process development, there are more options than ever before. Tune in each week to learn about cell processing manufacturing platforms and more. The pod is brought to you in collaboration with Citeva, a global provider of technologies and services that advance and accelerate the development, manufacture and delivery of therapeutics, including cell therapies. Check out their resources at Citevacom. Backslash emerging biotech that's C-Y-T-I-V-Acom backslash emerging biotech. Yeah, that's fantastic advice and I'm gonna ask you one more question on that.
Speaker 1:For the benefit of new maybe first time biopharmas CEOs who face a crisis or a challenge, it's one thing to have that mindset to embrace. Stop digging, start climbing. Surround yourself with the right people, move forward, stay true to the vision. These are like built in in a way, I'm sure like built into your DNA. You learn that behavior, you get good at it. But there are moments in anyone's mind, no matter how well accomplished you are, no matter how confident you are, there are moments where you go home and you say I could do a lot of things. Because I'm accomplished, because I'm confident, I could do a lot of things. Things are going so poorly right now with this thing that I'm trying to do. Maybe I should go do something else In that moment when the fundamentals that you just mentioned are sort of sure built in but they don't seem to be, don't seem to be doing me any good in this moment. Give me some advice. Give some advice to the exact who's like in that moment, going. I don't know if I should fold.
Speaker 2:Look into who you are and what you are.
Speaker 2:I mean if you get to that level presumably you fought a lot and stay true to who you are. So I grew up in the Midwest with very basic fundamentals that you don't quit, you look for opportunity and you fix things wherever you can if the mission is right. And if the mission is right, everyone has doubt. If you don't have that doubt and that humility to learn, then you're gonna be catastrophic because you'll make bad calls and then we all make mistakes. We all make decisions at times we wish we had not made. But if you're focused on your mission and stay strong and just never give up as long as the mission is right, never give up. As long as the vision is right, never give up, find a way. You can always find a way if you remain calm, balanced, willing to learn and remain transparent.
Speaker 2:So I can't not everyone can do that. To be honest, I'm not everyone can, and you learn pretty quickly whether you can or not when you're in leadership jobs like that. And I learned that in the. There were times of President's Emergency Plan for Age Relief when I was being heavily criticized by former friends and public splashed across front page news articles that my family would see for political purposes and I would think about my lovely life back at NIH, being a scientist in Tony Fauci's lab and flying all over the world giving lectures, with none of that ever possible but the possibility of contributing to saving millions of lives. You can't do that. That's not who my parents built so. But it's different for everyone and everyone needs to find their own energy. For me, it's what is the mission, and I will never give up.
Speaker 1:Right, I like the props to Ma on Podd-Dible. Very nice, all right. So that's a beautiful segue into the mission at Renovaral. And when I look at your pipeline, the first thing that strikes me before I dig into some of the cool stuff that you guys have been doing the first thing that strikes me is it's depth and it's breadth right Like HIV, HBV, infectious disease, oncology. What's the I guess, overarching strategy? What's your portfolio strategy there?
Speaker 2:Yeah, the overarching strategy, and I guess you could look at that and say, wait, that's too much for a startup, but it's all built around platforms, and platforms mean a lot, I think, to me personally, but I think scientifically and also as a company, because platforms mean you are investing in something that can attack multiple different approaches, which gives you multiple markets. It saves people's lives, improves lives in multiple areas, but also gives you multiple markets and multiple commercial opportunities, and so those platforms are huge and important. So we have platforms that then can be basically spun into different diseases. Right now, by far lead candidate is in oncology. The data there are super impressive to me scientifically. The woman who conducts those studies, dr Anna Jewett at UCLA, has been doing them for it and actually is one of the leaders in cancer therapy. Matt, did we lose you? Yeah, can you hear me? Yep, can't see, but I can hear it.
Speaker 1:We've lost power. We've lost power here in our office. It's a very, very stormy day in Northwest Pennsylvania. This is the second time that we've lost power. Yeah, so I'm well. Oh, you're back. Power is back on. Can you see me? Yeah, now I can see it. Okay, this, there we go. Yeah, yeah, I'm not sure if that record this records to the cloud, but I'm assuming because we lost power, my camera was off for a split second there. I apologize, no problem. It's the act of God.
Speaker 2:It's out of my control, nothing you can do. We're experiencing that. I'm in the eastern shore of Maryland right now and we have the side of that storm is hitting us.
Speaker 1:Yeah, yeah, it's very rare for us to lose power here. It's extremely windy, very, very windy outside, so I apologize for that. It's a problem. Interruption it's a problem, but we can splice. You were talking about the portfolio strategy.
Speaker 2:Yeah. So the Dr Anna Giudat, ucla, who's been conducting most of the studies and designed the model to study pancreatic cancer, described as the Holy Grail of Cancer Research. So what we've seen and I'll get into why we started with pancreatic cancer but it's a platform which should be applied to, which should be as powerful against any solid tumor. Pancreatic is particularly difficult tumor to combat and 80% of all cancers are solid tumors and some extremely difficult to treat. So the reason she describes as a Holy Grail is we see four things consistently across five different humanized animal studies. Now, human is important because it basically replicates the human immune system, rather than guessing if a mouse system is gonna translate to a human. In five independent studies that she's conducted, we've seen the same thing 80 to 90% reduction in size of the tumor, which in and of itself, is pretty impressive, but, secondarily, when you look inside, what's left in the tumor sac, what's there? If it's all tumor that 10 to 20%, all tumor that's not as good an outcome, and it's probably gonna come back. What we see, though, is what's inside the tumor sac is effector immune cells that are still there, meaning they would still correlate with ongoing killing of the cancer, and this is after only one cycle In normal in humans we probably do five to 10. The third piece of that is in the periphery, in the blood. We see immunostimulation, both at the cell level but also what's floating in the blood, really important things like gammon or furon that would correlate with the ability to kill cancer, and we find it in the blood. And the reason that's important is the fourth thing we see is no metastases, whereas if you in controls, either with our product but not with all the things we do, like the gene therapy, it's a dendritic cell, allergenic dendritic cell views, those without the gene therapy, or if you don't load them properly with the tumor, what's called mock or fake control there's metastases, the tumor doesn't decrease and you don't find those same immune correlates in the blood and that is very powerful.
Speaker 2:And pancreatic cancer, as I mentioned, is very difficult to treat. We have intentionally focused on cancers difficult to treat, like pancreatic, and in our clinical trial that we proposed at the FDA and we've had our pre-IND meeting and formal IND, there was no comment at all actually on the clinical trial design. We will include not only pancreatic cancer but other cancers that are difficult to treat. We have been selected for sure, but for example, triple negative breast cancer, which is extremely difficult to treat, liver cancer secondary therapy is terrible head and neck cancers. There are some cancers that are extremely difficult to treat, but they're still very common. 60,000 people in the US alone are diagnosed with pancreatic cancer and at five years only 5% to 10% of them are alive, and if you don't get diagnosed really early, only two to 3% are alive. Same with triple negative breast and these other cancers. So we will help a lot of people, we believe, if the data seen in the mice are replicated in humans and improve their lives without toxic chemotherapy.
Speaker 2:But also you can move very quickly through the regulatory processes because there's no available therapy. So, for example, in the recent weeks the FDA rapidly approved CAR T therapy for a certain type of cancer with really not large sample sizes, because there's no option. Crispr was approved for sickle cell disease, with them not a large patient population, because there's no good option. And so when you focus on cancers, particularly in the part of the Food and Drug Administration that reviews biological approaches, cell gene immunotherapy you can move very quickly, and so we anticipate starting clinical trials towards the end of this coming year and having enough results by the end of 2025. That again, if the results are replicated, we could actually receive approval by the end of 2025, early 26, with indications for several very difficult treat cancers and this is, of course, would need to be proven. But if you can use a product and the immune product to treat difficult to treat cancers, you should be able to treat relatively easy to treat cancers and which means you would move into studying in first line therapy.
Speaker 2:So, for example, if it works in triple negative breast, jurelia can work in regular breast, which is a huge population of women who suffer and often need chemotherapy and radiation therapy and radical surgeries. If you can switch to immune therapy for something like that, imagine what that does, and that's why we have this hope, this vision for a future free of toxic chemotherapy. Now we're a business too, and that's one of the beauties of how we've structured ourselves. When you have those types of things off of a platform, you can sell, you can partner, you can build, you can license. There are so many business opportunities that come with that human advantage, that human improvement, that great improvement to peoples and families lives that we're so committed to. But there's a real business side to this too, and how we pursued it, and we're doing that similarly with the combination that we hope will be successful, in proxy with the AI company JetEQ, to promote even more advanced ways to diagnose cancer early, to identify recurrence and the earlier you identify diagnostically or recurrence, the more effective your therapy is gonna be and then also to predict success and failure with therapy, which we believe AI will give us the capacity to do those deep algorithms. So you combine what I describe as bottom up science. What is the biotech side where we begin with hypotheses, knowledge of the immune system, knowledge of cancers, how you could overcome those with cell gene and immunotherapy with almost a top down, agnostic, massive data set, trained algorithms. So we're retraining, we're training data to be used better using algorithms and artificial intelligence and we're retraining the immune system to respond better where those meet. That is a big bang. I mean, that is a tremendous opportunity to rapidly move, not only in cancer but eventually in other diseases that we're very hopeful will radically change the future and in a sense, redefine the future of medicine. Imagine going and being able and this is we're not there yet, but imagine being able to go to a doctor where a blood test in 72 hours in the future, while you're waiting, can pick up very early stage cancer or the likelihood that you will develop cancer and with that same analysis, say this is the best therapy for that. This is unlikely to work. Imagine how that would change not only a person's life and longevity but just the comfort level. The scariest time is when you don't know what you have. You don't know what you're going to be treated with. If we can undo all that, if we can redo all that, then the future of medicine is radically different and the future of therapy is radically different. And that's the future we see. We're not there yet, but that's where the power of bringing biotech and deep algorithms is so important and, to be honest, why.
Speaker 2:I don't think you'll see every day a report of a big pharmaceutical company, a big biotech, buying up or partnering with an AI company. Those are very different cultures we talked about. There's biotechnology and there's technology Very different backgrounds, very different mindsets, very different approaches, and we see those for our own people. It takes a little bit and takes good management to have people understand why they come together.
Speaker 2:That culture clash is going to be extremely difficult in large companies and large bureaucracies and if you don't have that management history of how do you bring disparate groups together, how do you bring people are fundamentally looking at things differently together. Fortunately, I and other managers we have have that background and we're also small enough that we can capitalize on all of this, and we built the company so that we can functionally spin out almost an endless number of subsidiaries, whether they're AI clones or new technologies, and so the future, both for us and for others, I think, is extremely fascinating and a whole new world. It's one of those times in history where technology matched with our current knowledge could lead to a radical leap forward that will improve the lives of many people and have healthy longevity not just longer lives, but healthier, happier, more fulfilled lives.
Speaker 1:Yeah, yeah. It's interesting Looking at the landscape of companies biopharmaceutical companies that are leveraging deep learning, machine learning, ai tools, computational biology tools for lack of a better umbrella term. I've had plenty of conversations with super young Silicon Valley red biopharma companies that didn't start as biopharma companies. They started as tech companies. They had the tech tools before they decided to develop a portfolio or a candidate, and then plenty who are selling applications to biopharma companies. I don't want to age you, dr Diable, but for a guy who's adopting computational and deep learning, you're probably on the upper scale age-wise. I guess the question would be when did you fully embrace that? So two-part question when did you fully embrace that? Do you think it matters? Do you think it matters whether a company has that kind of died in the wool tech application background, going into biopharma, or a more traditional biopharma company that grew up in the wet lab and traditional research is now adopting applications to help create efficiencies around discovery and development?
Speaker 2:Yeah, I think it's a great question. There's no right answer to that. I think the challenge is adapting and learning totally different ways of approaching and thinking about something, and that's extremely difficult, and that's why a lot of mergers have failed historically, because you're bringing different cultures, different mindsets, and so you really have to have a group that can adapt. So the tech company that we're in the process of joining with, jettyq, is a technology that started with FinTech actually, and was adapted to health tech. Now it's 10 years old. It's an award-winning technology that uses a multi-omic approach, not a single approach. Not just genes, but proteins and how proteins fold All in these extraordinary stacks that have been developed over a decade, with deep, deep, deep learning, with so many different data points, and through a partnership with NVIDIA and their inception program, they're adding imagery to that, and imagery is a very potent addition and working on pathology additions.
Speaker 2:The CEO of that company comes from NVIDIA, and so the technology piece is hugely important. But I'm not unfamiliar with tech. I mean, I grew up at NIH, where tech was at the forefront of everything, and I also was very involved in AI tech related to biosecurity. I have led commissions and put out such recommendations. I've now been involved.
Speaker 1:Well, I didn't mean to disparage your tech chops, that was a very good question that was an ageist comment. It was an ageist comment that I made.
Speaker 2:Yeah, no, no, no, old people can learn to. But the reason I wanted to make that point is and this is important about how we've structured ourselves. If the proxy goes through well, jettyq will remain a subsidiary and so they can advance their technology the way technologists would. Because you don't want a big company coming in and telling people who know what they're doing in tech don't do it that way, do it this way. You're not thinking you want them to be able to move.
Speaker 2:Same on the biotech side. We don't want tech people saying, oh, that's a, you need to change that and do top down driven, agnostic approaches. No, we have a pretty good idea how the immune system works and we're seeing great results. So both will move independently towards their commercial product. But then the opportunities to bring them together to develop joint approaches that will leverage and have a multiplier effect in both and that's where the skills come in and the ability to listen to each other and learn from each other, without squashing the uniqueness of the approaches that people are taking. Let those flow, but also let them come together and find new opportunities that will create, as I said, almost an endless number of subsidiary opportunities, both on the health tech side on the biotech side, and then the two together, which is the extraordinary piece to me. I think that's where the future lies.
Speaker 1:There are so many levels of levels, opportunities, applications for AI in biotech it's impossible to cover them all in one conversation. But it's a sexy term right now, right, like even folks who are just kind of doing a little bit of dabbling are leveraging that term. A friend of mine, a guest on the show, andrew Sats, put it best. I've quoted him before, but he said AI on biopharma is like sex in high school. Everybody said the kids who say they're doing it aren't, really aren't and the kids who really are aren't talking about it, right. So what do you think about? Like how all in should an emerging biopharma be right now? Is it something that you know? There are applications where you would advise, like testing the water, or is it your mindset like that? If you're not doing this, if you're not applying these tools, you put yourself a great peril.
Speaker 2:Yeah, it's a great question. I love that. I love that quote. Actually, another friend of mine said we need to take the BS out of AI, because everyone's saying I have AI, this side of AI that, and they don't. And that's why when we, when we wanted to engage in deep learning and technology, we went with. We identified a group that has a 10 year track record of developing things, and the fact that you started fintech and moved to health tech means a lot to me.
Speaker 2:I call it Ventech the Venn diagram. Where do these two worlds come together? And then, how do you exploit those maximally? And it doesn't mean you can't succeed either doing health tech alone or biotech alone. You can. But if you're really trying to shape the future of medicine, if you're really looking for what will we be doing in 10 years, I don't see how you do it without the two at the same time. If you don't do the tech well and if you don't do it right and you don't have that 10 years of people who and building the algorithms, you just have something on a whiteboard and you have to be very careful about that Because similar and I think about this a lot with gene therapy think about where 20 years ago, we thought gene therapy was going to solve everything.
Speaker 2:Tech is not going to solve that. Health tech is not going to solve everything. The key is finding that Venn diagram, that Venn help. Where do the two actually come together and create a multiplier effect? And it's not everywhere, and I think that's that, so I, which is why I think we'll see a lot of failures. A lot of people saying, talking about what they're doing in these two worlds and bringing them together, who don't have very deep tech or or or cannot because of the culture and mindset clash has put the two together and don't have the vision for where the two intersect. And if you try to force things together that don't belong together, that's going to fail. So where's the Venn tech? Where do the two naturally cross? Which is why we've structured ourselves so that the two are in in a sense, independent, advancing health tech, advancing biotech, but then bringing them together where that Venn tech exists.
Speaker 1:Perfect how you doing on time. You got time for a couple more, yeah, okay, perfect. The Venn diagram and I know this is this is the question that's going to make your, your IR people, a little bit nervous, because I'm going to ask you to make you know, at least wax a little bit on a prophetic vision. So right now, most of the discussions I have with with biopharm companies that are truly engaged in AI, the conversation is around discovery, and molecular design seems like the low hanging fruit applications, at least generally speaking. Where do you see AI, even generally, where is there in your mind the most promise for that technology beyond discovery and design? Perhaps the clinic, perhaps manufacturing, perhaps even real world evidence? Well, after commercialization, where are the opportunities that you're forming up in your mind beyond the early stages?
Speaker 2:Yeah, I think real world evidence is definitely important. It's not something we're going to focus on at the beginning, so let me tell you about where we see the opportunity which gets here some of the comments that you made. Finding potential new drug products is definitely important, but that to me, is the least low hanging fruit. It's a great way to identify a bunch of new products, but you then have to study all those products and I think if you back up a little bit and this is what we think is real potential for rapid change is liquid biopsy, basically blood liquid biopsy, rather than getting tissue all the time and using algorithms to identify predictors of disease or actual disease much earlier. Find those markers and we think that's very possible in a very short period of time and then identify, by following people who have been treated with various things, the ability to predict if a product will have its impact on the person. So, for example, pd one inhibitors biggest thing in cancer therapy right now generally a 60% failure rate. What could you predict? Who's succeeding and who's failing at $50,000 therapy or somewhere in that range? Be pretty good to know if someone's going to likely to succeed or fail with that therapy or any other therapy for that matter, and using deep learning algorithms with the data in them, we, I believe, should be able to find those markers that predict whether or not a therapy is going to work. And the money is an important piece, but think about the patient who's waiting for six months or 12 months for their images to pick up the fact that their cancer has been growing because the product's not working. So you, that person has basically lost their battle against cancer because we couldn't predict whether or not the therapy was going to succeed. So early diagnosis, prediction of likelihood of success to therapy, and then picking up recurrence early so that you can and again, predict which therapy is best. You combine that with biotech or the ability to study rapidly and in that finding of what therapy is likely to work, not to work, you'll start picking up signals of what could work in the people who are failing.
Speaker 2:The other area that is hyper exciting to me is, right now we're mostly an off the shelf allogeneic dendritic cell that's loaded, that's genetically modified and loaded with a piece of the person's tumor, so it's very personalized therapy.
Speaker 2:If you have enough of a data set, you might be able to find common antigens proteins across multiple tumors, either within the same class, say pancreatic cancer, prostate cancer, breast cancer or across multiple tumors. That would then create next version products that could be even more effective. So I think the, the, the early identification predictability, that's a that to me is a low hanging fruit, and the data are telling us it's possible, especially if you don't just use genes, but if you use a fully multiomic approach which gede cube has, which which looks at genes, proteins, trans genes, how, how proteins fold already in the stacks, but then add on to that other modes like imagery pathology, then you have such deep learning across so many things that you can start filtering out the noise and really focus. So I, you know I totally get the, the let's look for the new drug target product and I think that's a great business that people are working on. I think the business were focused on could have that then effect, that then tech effect in a really hyper exciting way.
Speaker 1:Very cool and we'll check with the IR folks later on to make sure that answer was acceptable. Dr Dible, I am abusing your time so I'm going to. I'm going to wrap things up here, but I want to give you an opportunity and listen. I could talk to you for the rest of the afternoon. I could keep asking you questions as long as you'll sit there, but I won't do that to you. We'll do a part two if necessary, but I want to give you an opportunity to wrap up with some, some big next steps for Renevaro. What are you most excited about? That's happening like imminently at the company.
Speaker 2:I'm hyper excited about the potential for this part, this combination with Jettie Q which of course, the shareholders have to decide which we believe will lead to actual commercial products around diagnosis to begin, early diagnosis to begin, and then predicting therapeutic response and recurrence in this coming year, in 2024.
Speaker 2:And then, as I mentioned, and by the end of 2024, we believe that you know that we'll have submitted our IND and begun our clinical trials.
Speaker 2:We're already preparing everything that needs to be done to start that trial as soon as the IND comes in, for starting with pancreatic cancer and then other cancers that are difficult to treat, and if the humans look like anything like the mice, that means we could actually have products to people to change their lives by the end of 2025, 2026 in the market, widely available, and then combining those two together. I can't tell you how excited I am what the future of medicine will look like, and it reminds me of the early days of PEPFAR, when everyone said it's impossible to do antiretroviral therapy in Africa. It's too complicated, there are no systems. All this doesn't exist. There are at least a thousand reasons why something won't work. What we see are that handful of reasons why it will work, and that excites me, because we have the right team, we have the right board, we have the right management, we have the right scientists to put that all together and to truly be a significant player and a poise to do so, to help redefine the future of medicine.
Speaker 1:Fantastic. I appreciate the opportunity to meet you and talk with you and I'm excited as well. I'm excited about following the company. We'll be paying attention and, as I noted, I hope you have it back on the show at some point.
Speaker 2:Thanks a lot, Matt. We're enjoying our opportunity to catch up with you.
Speaker 1:That's Renovarro Biosciences, dr Mark Dible, I'm Matt Piller and this is the business of biotech. We're produced by Life Science Connect with support from Citeva, which puts its support of new and emerging biotechs like Renovarro on full display at its emerging biotech accelerator, which you can visit at Citevacom backslash emerging biotech. We also offer a trove of supportive content for emerging biopharmers at bioprocessonlinecom, where you can find the complete library of the business of biotech and subscribe to our monthly newsletter at bioprocessonlinecom backslashbob. Check it out and, in the meantime, thanks for listening.