How One Leader United 120 Experts to Transform Cancer Care | Samir Khleif (Part 3/4)

Intro - 00:00:06: Welcome to the Biotech Startups Podcast by Excedr. Join us as we speak with first-time founders, serial entrepreneurs, and experienced investors about the challenges and triumphs of running a biotech startup from pre-seed to IPO with your host, Jon Chee.

In our last episode, Samir Khleif shared how his time at the National Cancer Institute shaped his dual identity as a clinician-scientist and how that mindset helped him build a world-class cancer center from the ground up. If you missed it, check out part two.

In part three, Samir reflects on his return to government service, where he led a national reform effort at the FDA while continuing to advise on biotech strategy abroad and still keeping his lab running. He also shares how academia gave him the freedom to innovate, what it took to recruit top-tier talent, and how one scientific break and a shift in mindset led to the founding of Georgiamune.

Jon Chee - 00:01:12: So now they're self-sufficient. They're stood up, and the torch has been passed. What was the next step on your horizon? Was this when you decided to get into academia, or did you go back to NCI at this point?

Samir Khleif - 00:01:25: No, I went back to NCI at that time. I was asked by the NCI director, who was Andy von Eschenbach, who was also the FDA commissioner—he was doing both—to go to the FDA and be a special assistant to the FDA commissioner. Again, I always kept my lab at NCI, so I was always doing my research. But I was asked by him to lead the oncology critical path at the FDA, and I did that. I was doing that while also helping the King of Jordan develop the biotechnology strategy of Jordan and what it would take to move it forward.

So I was doing those three things at the same time, but the FDA one was really critical because it was a process that the FDA and Andy von Eschenbach put together to develop a reinvention process of drug development and approval and how you connect that whole thing together. You know, you can make it more efficient—same safety, better efficacy, but more efficient.

So I worked with the commissioner for three years, putting together a team of 120-some experts in the country. And we developed that process under six different pillars, and we gave the report and the recommendation to the commissioner after three years. But that was also a very great experience, and I believe it helped a lot.

Jon Chee - 00:02:51: That is incredible. Assembling 100 people is just... I think I see a through-line here. It's just that if you put your mind to it, you can get a lot done.

Samir Khleif - 00:03:05: Yeah. And this is one of those things that, again, you need to really think outside of the box of how we do it. Because when we thought of what needed to be done and how it needed to be developed, there was a white canvas. So I started putting the puzzles together, what needs to be done, who's going to do what, what are the different topics, and what are the things that we need to accomplish at the end.

So it's really a building process of things that you think about, but you cannot just do it out of the white canvas. You need to dig under the canvas, similar to what we've done in Jordan. You go find out where the caveats are, where the holes are—not only in the center but also around the center. It's in the community. What does the community need? So you need to really look into the focus and around the focus, evaluate it, understand it, and then say, "Fine. What's the end goal?"

Well, the end goal in Jordan was to get this to the best level of a Western-style, US-style cancer center. Fine. Then what is needed? Then you start building it. Right? So you fill the holes and you build. Same thing at the FDA. This is exactly what we did. What is needed to be done? What are the things that are not there? And then how do you put them in? Who are the experts that know 6,000,000 times more than I do? Bring them together and start thinking about this. And this is what happened. That's before I went into academia.

Jon Chee - 00:04:21: Yeah, and I love that too because I think recruiting that much talent is an incredible feat. And I know "sales" has a certain connotation to it, but you must also learn how to persuade talented individuals to join your cause. And here's the thing: smart people have opportunities everywhere. So, how do you convince really, really talented people who have tons and tons of opportunities to join a cause like that?

Samir Khleif - 00:04:48: That's a great question. And I'll tell you, most people want to serve. Most people want to do something that has value. For the project at the FDA, when you call your friends and colleagues, and you say, "Look, this is something that would be of value," most of the time the answer is, "Of course, we'll do it," because that's how we do things. And I think we take advantage of that. People know and understand that what they do is beneficial, and they want to do something that would be of help.

Same thing when I went to Jordan, talking to people to convince them to go back. I mean, look, one of the people that I convinced to go back is now the Minister of Health of Jordan. He was at NIH, and I convinced him to go back and lead the development of the ICU at the cancer center. And three or four years ago, he was appointed as Minister of Health, and he's still Minister of Health.

Jon Chee - 00:05:44: Oh, he's got it.

Samir Khleif - 00:05:44: It's great. Right? It's great because you feel like, if we didn't do this, the man would not be there, and he's a fantastic Minister of Health. So another person who I recruited from Duke University, he became my deputy, and then he took over when I left. Now he's building a medical school in Jordan, which is going to be a major medical school for the region.

So all this has an impact. Right? The amount of impact when things are done and you bring the best people together, it becomes compacted. It mushrooms, which is really fantastic. So people want to serve. The most important thing is to choose the right people and to convince them to be part of that process—not because you want them, but because they want to be there and they want to serve.

And more importantly, which I learned, is that when you recruit people, you need to make sure that they realize and understand that's a growth experience for them. It's not something where they're going to go and stagnate. So you need to present it, not falsely so, but rightly so, because this is what you're doing when you lead something. Is that, "Look, here's what you could do, and here's the growth opportunity, not only for you as a person but for what you're going to be serving." And that by itself will help you grow. And I think that's probably the most critical part of convincing anyone to join you in any project. It's not only for your charm, not only for your good luck, not for your friendship, or for doing you a favor. It's more about what is in it for them to grow and feel that they've accomplished something.

Jon Chee - 00:07:32: Absolutely.

Samir Khleif - 00:07:33: I think that's the most critical way.

Jon Chee - 00:07:35: And that's an incredible lesson because I think it's very succinct. And also, once you have that kind of succinct lens, like you talked about, person selection is important too. You can quickly start to screen, and if there's no resonance there, if people are not driven to the mission and not have a growth-oriented mindset, maybe it's not a good fit.

Samir Khleif - 00:07:57: No, absolutely. Exactly. Some of that you discover afterward.

Jon Chee - 00:08:00: Yeah. Yeah. That too.

Samir Khleif - 00:08:01: Which is fine. Yeah. But you need to discover it early.

Jon Chee - 00:08:04: Yeah.

Samir Khleif - 00:08:05: And you need to make sure that it's either corrected or you move on. When you take any institution in general, you need to know who is there to move with you and who's going to be pulling you back. So these are very important understandings of that landscape, and then you need to deal with that. Because otherwise, the pullers become a real impediment to progress. So that's what is important.

Jon Chee - 00:08:30: Absolutely. So now you've assembled this Avengers' lineup of talent at the FDA. What was it that drew you to academia, and how did that opportunity come about?

Samir Khleif - 00:08:41: So I was still at NCI at that time. Even when I was at the FDA, I was at NCI; I was detailed 50% of my time. But I felt that, look, my career at NCI was very unconventional. I mean, NCI scientists are NCI scientists. They're in their lab, they're in their clinic. So when I was at NCI, in addition to starting a whole area of research and developing a section, which is the cancer vaccine program, I was able to build a cancer center, and I was able to serve as an FDA commissioner.

So there are lots of things. Right? So at the end, after so many years at NCI, you feel like, "I think I've done what I could do." And also, in all honesty, serving in government, there are certain rules and limitations on your ability to do things. Right? You cannot go and commercialize things. You cannot go and build things with commercial entities. So there are certain limits that you have to abide by, which is rightly so. While academic institutions, they have more freedom to do that.

So I felt I reached a level where it was time to move on. And then an opportunity came along where I was approached to be considered to build the state cancer center for Georgia, which is at the Medical College of Georgia. And I felt that, you know, I just built a cancer center. It was a great opportunity, a great experience. I like to build stuff. I built this thing at the FDA. So it was something that would be another way of evolving and doing something outside government, so I went to Georgia to do that.

Jon Chee - 00:10:21: Very cool. And I would imagine as you're also building this cancer center, you're also starting to teach.

Samir Khleif - 00:10:28: Teaching was there even when you're at NCI. You teach because you get students, you get postdocs. So that's part of what we do all the time. As a researcher, you always teach. Anytime you have a lab meeting, anytime you have a project meeting, you teach. So that's part of it. But it's a place where you can start programs now because you can grant degrees. So when we started the cancer center, we also started a PhD in higher education in oncology, like a Cancer Biology PhD. So we started those things. These are things that you can build as you go and make further programs for education. But yeah, teaching is a big part of what we do anyway.

Jon Chee - 00:11:11: Very cool. And so at Augusta, it sounds like you were given a bit more freedom outside the confines of a governmental institution. Can you talk a little bit more about that expression of your creativity? Obviously, you talked about creating a program for granting degrees.

Samir Khleif - 00:11:29: So there are two things. One is, in Augusta, at the medical college, what we wanted to do was really to build a state program, a state cancer center. So what we were able to do is build a great cancer center plus an oncology service line, which is integrated. So this is how we did it. I used the same principle that I've learned at NCI of how to integrate basic science with clinical. So we put them all under one umbrella, and we built them.

The second thing is we built something called CCARE, which is a cancer education and awareness for underserved populations, which I actually had a hearing in Congress about—how to put it together and how to develop and evolve it for underserved populations. But more importantly, what I would say the difference is, that in a university, you can discover at some point when your IP can be now taken one step further, and you can form a company.

At the government, you cannot do that. Right? Even if you have IPs, the government has to license them to somebody outside. You cannot actually decide to do that. When I was in Georgia, I had multiple IPs, and I decided I was either going to leave it at the university—and I get quoted a lot about this—I feel that majority of universities' IP... I mean, universities are cemeteries for IP. I don't know if you want to keep that or remove it. But short of a few really entrepreneurial universities, IP gets shelved because either they don't have the bandwidth, the funding, the ability, or the connection, anything. Right? So I had multiple IPs at the university, and I decided to take the bull by the horns and form the company. At the government, you can't do that.

Jon Chee - 00:13:24: Mhmm. Yeah.

Samir Khleif - 00:13:25: Right? So I think that's part of the entrepreneurship that you have. Right? You start a certain program or you develop a society in a university or whatever. So that partly was, you know, I was either going to leave it to the university to do whatever, and then God knows what will happen, or I'm going to take it and develop it. So I decided to spin out the company and take the license for my IPs from the university and just put them in the company and move it along. And that's what happened.

Jon Chee - 00:13:54: Very cool. And can you tell us a little bit about your experience tech-transferring out that intellectual property that you had developed? What was that like?

Samir Khleif - 00:14:07: So it was a learning experience because I had no clue.

Jon Chee - 00:14:11: Yeah.

Samir Khleif - 00:14:12: Right? And in general, there are no people that tell you how to do that at universities. Right? So I had to start calling friends that had some idea of what to do. And by that time, you don't know too many friends that know how to do it because your friends are limited to academia, and they haven't done that before. But then I really got outside that circle and started calling friends that knew how to do that, who started introducing me to more and more people, including my current lawyers, the current attorneys at the company who know how to put things together and expand them and negotiate licensing and all these kinds of things.

You know, when you do anything, you might not know how to do it. But this is why I said, when I went to Jordan, going back to Jordan, I had never run a cancer center.

Jon Chee - 00:15:05: Yeah. Yeah.

Samir Khleif - 00:15:06: But you learn because of that. What I told you is to start knocking on doors and asking questions and learn, right, and get the people that know. So, yeah, so it was painful because I really did not know how to do it. And I was exploring that and learning more and more from people and getting people to help me connect with other people, and finally, the process aligned.

"Okay. So this is what we need to do next." "Yes. This is what we need to do next." "Okay. Well, let me call the university and tell them I would like to actually put the license together now." "Oh, but you need a company." "Okay. Well, let me look for a company." So all these kinds of things. Right? But that was the process. It was a learning process. It took longer than I expected. That usually takes longer, probably because you learn as you go. But that's part of the spirit. Right?

That's part of how you do things. You should not be frustrated. You should ask. You should get people that know, and you should not be let down by failures because that's the end of it. So that was the licensing process. We formed a company, and then it took some time to understand what the process was. And then finally, we developed the licensing agreement, and I got the people that know how to negotiate licensing agreements to put it together. I mean, seriously, that's the process. Right? Because there's no structure for it, and I did not have a structure for it. So finally, we did, and then we spun out the company, and the company started to work.

Jon Chee - 00:16:32: That's awesome. And were you also at Georgetown at this time?

Samir Khleif - 00:16:36: It was overlapping. I formed the company, then I left, and then I came to Georgetown. And then the company was there, and I was working on developing it slowly by myself. So first of all, I actually put my own money in the company so I could fund it. And I got it to a level where we got a small space in one of the incubators, put the company together, hired a couple of people, put stuff together until we reached a level where I felt that now I could raise funds. That was, yes, during my time at Georgetown.

Jon Chee - 00:17:12: Very cool. And I love the one-foot-in-front-of-the-other mentality. It's just like, "We're just figuring it out."

Samir Khleif - 00:17:20: But that's exactly the case. I wanted to say this is usually not planned. It's, "Well, I see where I'm going to put my foot now. Okay. I'm going to put it there. Let me see where my next one is. Okay. I'm now going to put it there." But that's how it works. But this is why, Jon, I say persistence is a critical point. Persistence is a critical point—not to let the process get you down. And it's a rollercoaster, as you very well know. Right? And third, ask. Ask. I tell everyone, just knock on the door. Pick up the phone and call. No one's going to tell you no. Break that barrier and just do it because people will help, as I do, as everybody does. People like to help. So never not pick up the phone. I don't remember any time I wanted to talk to somebody and ask a question that they said, "No, I can't help you." Never. It's very important.

Jon Chee - 00:18:06: That's a critical tip. And I think a lot of the time, it's just not taking that step. It's like the squeaky wheel is the one that gets the oil. Not to say that you're squeaky and complaining, but it's just that you have to say something. And then you eventually get the oil to help you move, but you just have to say something.

Samir Khleif - 00:18:24: It doesn't mean that every call is going to help you. Right?

Jon Chee - 00:18:26: Yeah. Yeah. Yeah. Totally. There are plenty of times you're like, "Alright. That's okay. I'm going to move on to the next one." And you just have to keep it moving. And I'd love to just... seeding the company with your initial capital and then doing it incrementally, derisking, hiring some people, getting into an incubator space, derisking it. Can you just talk about... you know, we're now getting to the current day of Georgiamune. Can you talk about, maybe, what was the IP that you were like, "This is it. This necessitates company creation in order to effectuate this and to get it to patients?" Talk a little bit about that and the mission and values of the company.

Samir Khleif - 00:19:08: I think the main idea for me was when I was in Georgia, we discovered the master switch of the regulatory cell, and we were able to develop a hit. So we found a drug. For me, that was the absolute moment that I felt, "I have to do this." This is something I've been working on for some time. This is a drug that clearly—that one drug—can make a difference. Of course, that's not the final drug, because you need to develop the drug afterward, but there is a potential possibility for us to do something that is very unique. People have been looking into this for years, and we found it. And we can help people.

So in this case, I had that option. Right? Either keep it at the university to do it, because I didn't know anything about how to do it, or as I mentioned, take the bull by the horns and say, "You know what? Doggone it, I'm going to do it, and I'll learn how to do it. And we'll make a company, and we'll take it forward."

It wasn't a struggle. It wasn't even a sit-down moment saying, "Should I or should I not?" I mean, it was an absolutely natural process. It's, "Yep. Clear. I'm doing it. Done." And this is where I formed the company, and this is where I thought, "That's it. Let's start it." So when I formed the company, I was still there, and it was still incubating for some time. But then I decided, "That's it. We're going to take it forward."

But to answer your question, that was the moment. It wasn't the only IP that we took out. There were other IPs. But when you start thinking in those terms, then you look at the other IPs and say, "Yeah, but this one also can be something." Because now the whole mentality has changed from only discovery to now more development and commercialization, or development and getting it to patients. So now you start thinking, "Oh, yeah. But this one also can be something, and maybe this one." And then this is why we took it all as a package. Although some of it was not even a drug, it was still an idea, but that's it. The mentality is set now. So one of them was at the beginning of a drug—we made them two drugs afterward—and one was even an idea. And now the mentality became, "So we're making a drug." And even the idea now became a larger idea, and there are multiple other drugs that came out of it. But it's a mentality change. It's a whole direction of how you're thinking about an issue. Is it, "Now I'm going to continue discovering stuff?" Or since I have that in the back of my mind—how we're going to help people—"now I can take it and help people." Right? So that's the change in mentality. And when you do that, you look at everything differently.

Jon Chee - 00:21:57: Very interesting. And I didn't realize you can do package deals like that where you can create almost like a portfolio or a ring.

Samir Khleif - 00:22:06: No, it's a portfolio. We licensed all the IP that I had, and we had multiple IPs that could develop into drug IDs and therapeutics, and they did.

Jon Chee - 00:22:15: That's very cool. And were all these IPs things that you had developed while being a professor? This is a long... one of the early episodes of the podcast, we interviewed Steve Visco, who was one of the early tech-transfer success stories out of Lawrence Berkeley National Lab, and it was one of his patents that they were tech-transferring out. He said in the early days, his company would pay a licensing fee. And because he was a patent holder, the licensing fee just went back into his pocket because he was still working at Lawrence Berkeley. So he's like, "I'm licensing it for myself." So it's kind of this circuitous cycle of life. I just thought it was funny.

Outro - 00:22:12: Thanks for listening to part three of our conversation with Samir Khleif. In the final episode of this series, Samir shares how he built a mission-driven team, raised early funding, and brought a portfolio of first-in-class immunotherapies from concept to clinic. He also discusses what set Georgiamune apart, how science and culture shape its strategy, and why adaptability and alignment are essential in today's market.

If you enjoyed this episode, be sure to follow the show, leave us a review, and share it with a friend. See you next time.

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