Joseph Palumbo, Head of R&D & Chief Medical Officer at BioVie Inc

Speaker 1 (00:01.366)
podcast. Today I'm with Dr. Josep Palumbo. He is a physician and scientist with a distinguished career in psychiatry, neurology, and clinical pharmacology. He has successfully led registrational programs at major pharmaceutical firms including Mitsubishi, Tanabe Pharma, Johnson & Johnson, Janssen,

Zenerbia and Sanofi. So Joe, it's a pleasure to have you here. I'm honored.

you're very kind. Well, thank you. I'm delighted to be here and I think this is just gonna be a lot of fun. We, you know, for those of you who are listening, we had a pre-conference before this and I think we got along really well. I'm looking forward to

Good, good job. Thanks for joining the podcast episode today. And I look forward to the conversation. I'm sure there's do as well based on the comments that we got on LinkedIn after I published the announcement that we were gonna record this. And I saw like 20 of your friends commenting on the post, which is very encouraging. excellent. So it looks like people wanna hear

Well, you have to say. You're a celebrity.

Speaker 2 (01:21.944)
have to say as well.

Anyway, so let's get started Joe. So let's start with a personal and professional journey. How is it that you got to where you are?

I've been incredibly lucky. Wonderful things have happened. And mainly I would say it's teachers, it's mentors. These are the things that really, I think make the big difference. I grew up in New York City, in the boroughs, I took up all the schools. And I will say that...

I had wonderful teachers, even at the elementary school level, recognized that I had questions, I had interests in science, and who spent the time. And everything that they did to help a little kid find an interest in science and pay attention, it's just wonderful. Even down to the teachers who helped me learn how to speak in front of a group. We kind of joke about,

know, elementary school plays and those sorts of things, but to learn how to sit and stand in front of an audience, sing, dance, all those things, they're all transferable into the skills we use every day in teaching and doing the work that we do in pharmaceuticals. So it starts there. For me, the first time I really recognized that I was interested in how the brain works, literally walking up and down the supermarket aisles.

Speaker 2 (02:54.384)
wondering what did people who advertised, what did they know about how our brain works that maybe wasn't in the textbooks I was reading? certain colors appeal to us? Why did certain textures appeal to us? And that started this career in neuroscience trying to understand what

appeal to us? Why did we respond in a certain way to colors, smells, etc. And really very much an interest in perception and how perception influences behavior.

That's exciting and very intriguing as well. Okay, so you went to medical school. Yes. Where? George Washington University? Because you have ties to George Washington School of Medicine and Yale University.

Yes, I still do. Particularly George Washington. I went there to medical school in Washington, DC. And with its proximity to the NIH and other sources of learning, of science, it was a tremendous place to go to school. And I'm very, thankful for it. Because medical school isn't easy for anyone. certainly wasn't easy for me. And again, having mentors, people who helped me.

along the way in a research career, had done a bench side laboratory research from an early age, continued that into university at the University of Pennsylvania, and then brought that really into neuroscience at George Washington. work primarily in neuroanatomy, neuro regeneration studies, but again, having

Speaker 2 (04:40.706)
the mentorship to get through. Medical school again isn't easy and having people support you I think is enormously helpful. And at this point I'm working for the Dean of the George Washington University School of Medicine, who was actually a resident when I was a medical student. He is tremendous and is doing a wonderful job leading the

Wow!

Speaker 2 (05:05.47)
school, an increase in the amount of research, academic output, and I think that's remarkable. I'm happy to be a part of that.

Excellent job. And you know, I can totally identify with what you are saying because my brother, Pedro, as I told you in my call with you a few days ago, went to Harvard. He trained at the Bed, Peace, Health Center at the Harvard Medical School. So imagine the chances for a guy from Colombia, South America, especially from

the place we came from, we came from a small city in Colombia, it's probably the fourth largest city in the country. But it's not Bogota, it's not Medellin, it's not Buenos Aires, it's not Sao Paulo. Especially at that time it was a very small city, 40 years ago. And Pedro says, when you talk to him, he's the first to recognize that he's where he is now because of his mentors.

Absolutely.

And I think you've been very humble. think Pedro is humble too, because I think what you're really saying is that you attract those mentors because of your personality, because of your curiosity. And professors and the people around you kind of sense that. we are just beings of service. Just wanna help people. You just wanna...

Speaker 2 (06:39.222)
Yes, of course.

see somebody flourish, right? If you're a professor and if you see a kid who has this open mind and the kid wants to know more, you kind of take advantage of the opportunity to be of service and break it up, right?

Absolutely. think like attracts like, but there's also something that we as professors love. We love it when students approach us. Yes. And then we'll go completely out of our way to help those who are interested in the work we're doing. when someone walks up to me and says, you know, the university level or in the work I do now and has an interest, you know, it appeals to us. I we're all human.

And when someone likes us, easily like them.

Yes, yes, yes, yes, yes. I agree. I agree 100%. All right. So Joe, let's talk about trends. I'm very curious to hear what you have to say about trends in the clinical research industry, in the biotech, bioforma space. What do see happening that is relevant to our discussion about global clinical trials in general?

Speaker 2 (07:50.272)
I think there are so many wonderful, exciting things happening. In my career, the increase in diversity. was at a meeting on COVID just this past week in New Mexico. And the number of women has certainly changed. international

Okay, that's great.

presence is just remarkable and has changed so much from when I began my research career. There's a new interest in people who are skilled in multiple areas and it's not just the sort of MD, PhD, which, you know, certainly has use utility, but it's people who have skill in different areas of medicine. It's the number of people who are engineers.

who are also physicians, are also scientists, changes how people look at research, the research enterprise, and invention. So many of my patents have come to realization from working with engineers and their way of working with the world, which is different.

from basic scientists, which is different from physicians who were trained in different ways. And what that makes available, what that makes happen is let's take a look, you know, look at, look at immunology. Immunology wasn't so important in neuroscience so long ago. But now we look at the advantages that are gleaned from the knowledge of immunology. And we understand that so many

Speaker 2 (09:27.182)
of our disorders, whether they're psychiatry, neurology, et cetera, oncology relate to the mechanisms of the immune system? Just for instance, and this is not just about immunologists, it's about oncologists, it's about cardiovascular, this is about how the vasculature and its sensitivity affects neurology. We didn't have.

very long ago, we didn't have people understood this kind of systems biology and this ability of people to span multiple areas of interest and to then think about questions. And that's what the engineers are doing here. They're thinking about solutions.

that allows us to integrate this knowledge in a very, different way. So I think that's, a scientific aspect, incredibly important because it allows us to make use of AI. It allows us to make use of different technologies. The other thing that I think is really remarkable is that people are now asking questions that allow them to use technology rather than using technology first.

That's an intriguing comment.

Many for many scientists, a new technology comes along and it's wonderful. It allows them to explore domains that they hadn't explored in quite that way. But what I'm seeing more and more and more of and that I absolutely applaud is this concept of I have a question and now I've got a new tool that allows me to understand that differently and better.

Speaker 2 (11:14.058)
And it allows people to interact again with these people who are specialists in multiple areas. It allows the mathematicians to talk to the physicists, to talk to the biologists in a way that we haven't done before. other, I'm going to call this innovation, but it's not so much an innovation. It's an awareness. It's an awakening. It is the power of the advocacy community.

to say, all of you out there who are developing molecules, all of you who are developing treatments, interventions, please hear us. And it's really important because the research enterprise goes in the way that it goes. And that is often in the way of where funding is. It is often in the way of where there is general interest in the field. It is not necessarily.

in the disciplines, we're patients, we're advocates, we're family. This is really what we need. Certainly, we've seen changes, we've seen innovation, but working in vaccines as I've had in the past, working in orphan diseases, ALS, fragile eggs, autism, et cetera, et cetera. The energy of those communities.

when they reach out to us directly, frankly, we really appreciate it. And it gives us energy, it helps us talk to the people who fund, and it just makes the work better, more direct, and frankly, we really appreciate that.

Fascinating comments, Joe. You know, I'm very curious about your background and going back to my original question about your journey, how is it that you jump from being shifted from being a doctor, a physician, seeing patients, if you ever did, to the industry?

Speaker 2 (13:27.342)
Well, yeah, OK. Well, being a physician is an honorable thing. It's a calling. It's almost, you know, to me, almost like the priesthood. There's a responsibility. There's a calling. And I hope people still accept that because physicians have an intimate relationship with people and their families that really doesn't exist in any other discipline. And that's something that needs to be addressed.

honored respected. being a physician is very, hard. Being a physician who does research with human subjects takes that as burden because we're asking people to give of their bodies. Yeah. Sometimes, you know, simply to take a placebo. Yeah. And for people to give of themselves in that way to advance science.

is something truly important and more than valuable, right? It's really helping the angels to their work. And we hope in science and medicine and research that we are helping to do that work. We're hoping to answer prayers that we are part of this kind of goodness. And so for me, that transition was I was taught how to do research, questions to answer. And so it was

something of a natural transition because this is where I saw my skill lying and it helped me then put together teams of people who were like mine.

Interesting. You know, it reminds me of the stories of my father. He died about 15 years ago, but he was, as I said, physician. he, mean, probably today he'll be 100 years old. So I remember him telling me stories of his, there's something in the developing countries in Latin America that

Speaker 1 (15:39.458)
probably you know about, it's called civil or rural work. After you finish medical school, you are obligated to service, to be of service to the country. And you are sent to a rural community for a year with very little salary, basic salary and.

years.

Speaker 1 (16:05.44)
you are sent to these remote areas where you are asked to serve the community. So it's called rural service. That's how they call it in Colombia. And they have a similar set up in different countries in Latin America. So the point is that I remember my father saying there were only three important people in town, in every town, as a doctor. The police inspector or the chief of police

the mayor and the doctor. And sometimes a priest. Sometimes a priest depending on the town. Exactly, yes, exactly. So the doctor is perceived even today in developing countries, specifically in Latin America, as somebody who is of service to the community. So I am 100 % aligned with what you're saying.

That's good fun.

Speaker 2 (16:45.704)
I'm as I am.

Speaker 2 (17:03.702)
I think that's absolutely important for physicians. Medicine has certainly changed, but I think the best physicians, at least for me, are the ones who understand that role. It's almost a sacred one in working with patients. It's not just a technical role. for the people who...

I enjoy working with the people who've been successful in pharma, in development, and coming up with new therapies. I think that the people who have been at bedside, and I think that's important because it gives you as a physician, as a scientist, an experience that...

Into the human side of things that I think yeah Because what we really want to do is reduce suffering right that that that's what physicians we hope to that's a Concept that I think we have to embrace and so the work that we do it has to be respectful It has to be driven by the pursuit of reducing suffering

Yes. And I think that's absolutely critical. It's part of what we do in my work. It's part of what I cherish. So yes, in order to be respected by the community, you have to be part of the community.

Yes. Absolutely, absolutely. You know, it reminds me of, I was having a conversation the other day with somebody about the role of AI healthcare. And he asked me about how do I see the patient-physician relationship in this new age of AI? And I replied, you know, I think

Speaker 1 (18:56.53)
It is giving back doctors the gift of time with patients. Why? Because AI is now doing all these administrative tasks and activities that doctors don't really want to do. You can automate a lot of these backend process. So when my father was a doctor, spending an hour, I remember I was five years old. I used to go to his office and see patients. I will sit alongside

My father behind his desk and the patient will come in through the door and the two of us will just see the patient for an hour. And my father will ask about their family, their uncle, their aunt, this and that. The patient will bring food to my father. I mean, it was like a communal thing. was a ceremony between a conversation between the patient and the doctor. And there was a beautiful thing.

And I see now my brother, who I described to you, Pedro, interventional cardiologist, he cannot spend, because of the way the system works, than five minutes with a patient. So how can you develop a relationship, a human relationship with a patient for five minutes? It's just...

think that's really a critical question. Yeah. And it's hard to answer. What I will say, it's those moments that we would spend doing that interview for a physician who's very well trained, every nanosecond of that Yeah.

Yeah, it's diagnostic how the individual walks into the office help. Yes, they sit down or get up. Yes. How they track you with their eyes. ability to smile. watching someone fill out a form. All of that informs the physician. And yes, each AI to do some of that. Maybe that helps. But I will say that I would much rather talk to the receptionist.

Speaker 2 (21:07.498)
I'd love to have a smile at the staff because it is very much that you may element. They can take a very scary interaction with a physician. Yes, we go for regular checkups, but when we have the concern, do we want to talk to a machine? I guess some people do. But in those scary moments, we probably want someone more like your father.

Yeah.

from position of warmth, interaction, and sometimes ritual. We know what to expect in those bad situations. I think AI is wonderful. I use it for many different things. It has the knowledge of the past. it can have is the knowledge of the future. And my experience with AI has been

Yes.

Speaker 2 (22:00.258)
Very very very interesting. It helps me understand the world's history. It helps me understand where other people have gone But it's not as good at creating hypotheses And if the data is based on what's been published, doesn't necessarily tell you where to go next So that coupling still right of human interaction human technology how we think how we predict now AI may get there but

way I see it is it's a tool. It is something that helps us. Instead of having to go to the library, or online, it gives me a hint of where to go. It helps with our inventiveness. And yeah, it probably makes life a little bit simpler for a lot of people. But I hope that as medicine continues to evolve, we'll see somehow a return to the human

Yes, exactly. I think it's going to happen. All right, Joe, let's move to the third part of the conversation, which is about what exciting projects you're working on. What wakes you up every morning with energy to change the world? Tell us about your company. Tell us about the programs you guys are running. What exciting things you guys are doing.

What wakes me up, what gets me out of bed, of course it's science. Of course it's the ability to take a therapeutic and develop it and hopefully make lives better.

But it's the knowledge of where this is going to go. It's looking forward into the future and seeing the faces of patients and families. It's the kind of brilliance, the people I work with every day, the people who are inventors. Now we have two really important programs going on at BioDate and I'm running the research there. And what a pleasure. Our CEO, Kong Do, he is...

Speaker 2 (24:06.734)
philanthropist and he comes to this as a philanthropist. Oh wow. is an immigrant to this country, actually a refugee who came here from Vietnam with nothing in mind and has given of himself and of his resources and treasure to do wonderful things. Taking on the leadership of this company is one of us.

Brilliant.

Speaker 2 (24:34.606)
working with Penny Markham who runs our programs Liver, working with Chris Redding and Clarence Ollum who discovered our molecule. think it's really amazing. These are the things that help me wake up in the day. These are the things that keep me engaged. We just have a wonderful team of people and this is these projects.

particularly those that we were doing in neuroscience right now, tell us about the power of nature. So if there's an abiding love that I have in science, it's what do we learn from nature? What has nature taught us? And for our company, again, we work mainly in neuroinflammation.

and neuroinflammation in terms of how neuroinflammation affects how the brain thinks, the brain behaves, how our bodies move.

you may remember 20 odd years ago, there was a tremendous amount of well supported information about a natural occurring molecule called DHEA. And DHEA was everywhere in the press because it anti-inflammatory. I remember. But it never crossed that species boundary from rodents.

Yeah

Speaker 2 (26:03.054)
to humans, it became incredibly elusive. it's, you know, the belief in this as something that was going to be transformational, waned and went away, except for this team that worked with Chris and Clarence, who are the founders of a company. What they discovered was that there was a different pathway in humans, in primates, that

rats and humans dealt with DHEA quite differently and they discovered the molecule in the brain that was already there. It's called beta AET. That's the beautiful element. It is a naturally occurring molecule that's already in our brains, but it doesn't last very long. In medicinal chemistry, these folks figured out how to stabilize the molecule.

And that became Bezister and that became any 3107 pre-dolistinal and that company is HD 3286. So this is the human active molecule for DHEA and that's what we're exploring. And what that does is it gives us a tool, this molecule to treat inflammation in the brain.

take the drug, a pill, or capsule orally twice a And so we're exploring this right now in Parkinson's. We're exploring this right now in long COVID.

So I

Speaker 2 (27:40.014)
This is what's remarkable. And again, for a small company with a wonderful idea, these scientists apply to the Michael J. Fox Foundation.

I was gonna ask you that, yes, I saw your bio.

A small wonderful study in primates in which they were able to reverse the effects of Parkinson's.

That's a horrible disease by the way, right?

It is a terrible disease. But with this molecule in that study funded by Michael J. Fox, they are able to show that giving this drug looked to be as good in that animal model as the standard therapies. Of course, that's an animal model. So what we were able to do pretty recently is to recapitulate that model in humans. It was a very small pilot study, but we saw

Speaker 2 (28:38.422)
lots of things in that study that looked like what we saw in the animal models. And that was great. That was an add-on therapy. And we got a whole group of experts together, showed them the data. And the next step was what we're doing right now, which is to look at this molecule. And people who are very close to needing medicine, but who are willing to try this molecule as a first line therapy. So these would be folks who would normally be saying to their doctors, you know,

my Parkinson's symptoms are severe enough now I want to try something. This is a huge ask. This is a huge ask. This is to ask people to enter a placebo controlled study for several months. We know that regular medicine is available for you. Would you try this? And so we're doing that study now. We're well on our way. We need about 60 patients. Similarly, we brought this information.

forward to the US Department of Defense and they gave us a grant. this drug and long COVID. And again, this is an oral therapy for people who have symptoms of long COVID, particularly trouble with attention trouble with what I call vigilance, I just sort of, you know, watching your attention over time. And who have sort of brain fog, right? And brain fog is hard to describe, but people know when they've got it, as well as fatigue.

And we know that for many people, this sort of inflammatory process that goes on makes it very, very difficult to function. we're doing this as a study with about 200 patients, again, droves versus placebo, to see what the outcome would be. And Dr. Penny Markham is running that particular program. And then we also have the programs we have moving along in hepatic disease.

So we're trying to treat people who have ascites. And ascites is a collection of fluid that builds up in your abdomen if your liver's not doing its job. And not only does it affect your liver and your ability to function, it also affects your kidneys. So what we're trying to do is use a version of a drug called Terlapressin in an infusion that we hope to be able to give to outpatients to keep them out of the hospital.

Speaker 2 (31:04.908)
that will improve their body's ability to handle this fluid overload. And also we hope to protect their kidneys. So a small company, very small company, with wonderful, wonderful people. And I think some really, really good opportunities. So thank you for asking the questions about what we're doing right now.

Absolutely, because when I read your bio I said, mean, this is amazing what this company is doing and I have to ask you, of course, it's very intriguing and especially you guys working with the Michael J. Fox Foundation, means something, you guys are doing something, it's kind of breakthrough, I guess, so yes.

Look, it's looking at systems biology rather than unique small drug pharmacology. So we've moved away from sort of one molecule, one treatment, one molecule, one effect to really looking at how this is all integrated across the full body, across the full brain. again, that's why I was talking earlier about how engineers look at the world. They look at

And I am thrilled to see systems biologists, engineers, others who share this interest in looking at how the body works as a whole. And when we look at, again, at inflammation, immunology.

conditions like Parkinson's, which is more than it's not just a brain condition, it's a whole body condition. Certainly, work we have done in Alzheimer's and want to continue again. I think those approaches are really, really helpful.

Speaker 1 (32:54.048)
Good, good. So Joe, you guys are doing these trials in the United States, outside of the United States. Yeah.

So at the moment, these proof of concept studies, these early studies, they are US bound. But obviously, we want to expand. We are an international team of people. have many people who are first generation or first time in the US on our team. We want to.

Yeah.

Speaker 2 (33:27.916)
be an international company. We certainly want to expand and we're certainly willing, quite willing, to talk to anyone as an interest in our work.

Very good, very good. Well, as you know, we are involved in all US clinical research who have a particular interest in Latin America. And I like to see patients in Latin America having access to these type of innovative therapies. So, yeah, I welcome a conversation about that possibility eventually with you.

Absolutely.

All right, so Joe, we are close to the end of the show. It's been a delightful conversation, certainly over the 30 minutes that I had planned to chat with you. And I think, or I feel like we can talk for hours. And we'll maybe do it again. Exactly. So any final words of wisdom or any final comments?

the usually the audience of my podcast is newer founders newer PhD graduates who are getting into the setup and adventure capital world. So any final comments that you want to make?

Speaker 2 (34:52.812)
comments I would make is that we're doing research that needs to be done. We're looking beyond the status quo. We have good reasons to believe that we're going to be successful and I would be delighted to be back next year. Okay. Because we have our studies to complete in the first half of 2026.

We will answer lots of different questions. One of the questions is, you know, whether or not we can do these studies remotely. that's what we're trying to do. Nurses out to the clinics, actually out to patients homes. We're nursing patients homes to do research in a way that we might not have been able to do before. I some answers about how well that works out.

Okay.

Speaker 1 (35:42.27)
Excellent. Good. Good. I look forward to that follow up conversation or follow up episode together. So thank you so much, Joe. It was, as I said, delightful to have you here on the show. I look forward to seeing you again.

Thank you for the work that you're doing and congratulations to all of you. It's wonderful.

Excellent. Good.