Discovering Therapy Options for Hard-to-Treat and Rare Cancers with Sanjeev Luther, President & CEO of Rafael Pharmaceuticals: Audio automatically transcribed by Sonix
Discovering Therapy Options for Hard-to-Treat and Rare Cancers with Sanjeev Luther, President & CEO of Rafael Pharmaceuticals: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Kyle Wildnauer-Haigney:
Hey, everyone, this is Kyle Wildnauer-Haigney, your host for the Outcomes Rocket Pharmaceutical podcast. Today, I have the distinct pleasure of introducing Sanjeev Luther. Sanjeev is the CEO and President of Rafael Pharmaceuticals. He joined Rafael in 2015 and is bringing more than 30 years of experience to the team. He has held positions in business development, strategic alliances, commercialization, and operations within Fortune 500 corporations, some of them, including Bristol-Myers Squibb, Novartis, Bosch and Long, GE Health Care, and others. Leveraging his expertise in pharmaceuticals and biotech, Sanjeev has shepherd Rafael as it continues to refine its corporate strategy and elevate its business portfolio. Thank you, Sanjeev so much for joining the podcast today. Welcome.
Sanjeev Luther:
Thank you, Kyle.
Kyle Wildnauer-Haigney:
So you may be to kick things off. I’d love it if you could just tell me about yourself. What drew you to the pharmaceutical value chain?
Sanjeev Luther:
Great question. So a little bit you talked about me, to start with, as as you pointed out, I’m in the presidency of Rafael Pharmaceutical. I’ve been in the industry for a very long time. What about myself and then what drew me is actually connected. I’m an individual who has a passion for what he wants to do. And one of my passions has been hope that to help as many patients as we can. And that’s what drew me to Rafael Pharmaceuticals.
Kyle Wildnauer-Haigney:
And so just kind of expanding that, I’d love to dive into that a little bit more. But what really excites you? It sounds like that hope and providing hope to individuals. Why don’t you tell the audience a little bit about what Rafael Pharmaceuticals does?
Sanjeev Luther:
So Rafael Pharmaceutical is a unique company, very different than many others out there. We are in cancer metabolism, which is by itself set you apart from other oncology companies. So cancer metabolism, of course, that sort of gives you in that we are in cancer helping people with hard to treat cancers like pancreatic cancer, stage four metastatic like aml relapsed refractory setting, and then many ultra very, very rare diseases like Burkett’s, where there are only about 300 patients in the US and their survival is anywhere from 30 to 60 days max.
Kyle Wildnauer-Haigney:
Wow.
Sanjeev Luther:
And there is no other company who is actually doing a trial in Burkitt’s today except Rafael Pharma, because, as I pointed out, it’s all about that hope. And our goal is and continues to be for many years now that if you can help, let’s go out there and help as many people as we can.
Kyle Wildnauer-Haigney:
Yeah, that’s great. And so these kinds of rare diseases or rare forms of cancer, is it just kind of one type of cancer that you focus on? Or is there, I guess, how many individuals across the US could be treated through your therapies?
Sanjeev Luther:
So the drug is that investigational drug right now. But given where we are in terms of indications, you could treat upwards of a hundred thousand patients once the drug gets approved. After the trials, as I pointed out, pancreatic, pancreatic is a very large patient population just in the US alone. But of course, across the globe, it’s even larger. The survival is anywhere from six to 11 months and then relapsed refractory aml the same. The company actually is in many disease areas in cancer, not just the ones I’m sorry, AML, it’s pancreatic, colorectal, it’s Bellary, it’s MDS, it’s T cell, because the cancer metabolism drug, as I pointed out, sets us apart. It’s agnostic, the tumor type. So it doesn’t matter whether it’s blood cancer or it’s a solid tumor, like pancreatic cancer. The drug works across, at least based on our trials to date, it works on all these. And let’s see as the trials readout, especially in the phase three program in the latter part of this year. So that’s a little bit that sets us apart. And that’s why you’re able to go and treat many, many, many more people than a single drug would do. It would be able to do.
Kyle Wildnauer-Haigney:
And so, you know, the drug completes phase three later this year, which is very exciting. I’m sure it’s been a long time working with them since 2015, bring these products to market. When can patients kind of expect to start receiving these treatments? Is it just right after kind of complete phase three?
Sanjeev Luther:
So great question. So the 20, the phase three program, which is one of the largest phases two programs in pancreatic cancer done globally. The trial was actually completed about 17 months ahead of schedule last year. But now the readout, of course, so that readout of phase three, the expected in Q4. Depending on that readout, you know, then you have to file an NDA with the FDA and that takes and it does have fast track designation. So fast track allows you to get approval a little bit faster and you can do a rolling NDA and so forth. But of course, the data has to be read out before you can do any of that stuff. If everything goes and, well, you can expect to have this drug next year, or at some point in the later part of 2023. Or 2022. Sorry.
Kyle Wildnauer-Haigney:
That’s fantastic. And that really cuts connects back to what you were saying earlier about hope. I mean, cancer is such a prevalent condition out there in such a horrible disease and it sounds like what you’re working on is really going to value or impact many different patients out there. So that’s just fantastic. You know, I think one thing I’d love to get your perspective on is, you know, across the industry, there’s just so much innovation going on. There is innovation, the type of innovation that you’re working on, developing new assets and new therapies to treat patients. And then there are also changes in the value chain itself and how drugs are delivered or marketed to individuals. What excites you most about where the pharmaceutical industry is today?
Sanjeev Luther:
And what excites me most is that I think there is more. There are two things which are happening more than they used to have. One is collaborations. You know, there is always this view that you are my competition. So why should I? I always say, no, you’re my competition. Why not? Why should I not work with you? So I think that has started to change a little bit in the industry. And I think that creates even more innovation. Imagine two large companies working in the same area, but working separately from each other. But once they start to share the information, which then leads to this reliance on even though we use this word called AI, big data, all of this stuff actually existed many, many years ago. We used to call it a data warehouse when I started in the industry. I think these two things are sort of going hand in hand. And so the industry has started to innovate faster, actually. And because of those collaborations and use of AI information and I think that is what is really exciting me about this industry and continues to be. You know, I’ve been in this industry for such a long time and I would I wouldn’t dare not work in any other industry. But this is the most rewarding. Yeah. It is a challenging industry because not every drug makes it to the market. But on the other hand, when you see the smile on that patient’s face, you know, it says, well, yeah, I think I accomplished something today.
Kyle Wildnauer-Haigney:
And so the sharing of data across different organizations, do you see that as helping the industry identify new potential targets for therapies, or is it kind of accelerating the time that it takes to bring a product to market? How does that play out?
Sanjeev Luther:
I think both, except I would say that acceleration is a little bit dependent on regulatory affairs, too. So I would say both of them. But I think it’s more about the innovation of the next generation molecules. I think my view is that a lot more fastness, as you pointed out, is going to happen.
Kyle Wildnauer-Haigney:
Yeah, I mean, we’ve had many guests on the show and all of them are kind of looking at the pipeline of innovative pharmaceutical manufacturers such as Rafael and kind of understanding that there are new molecules being developed for these very specific patients. And you’re trying to figure out how can we bring these to market so that as many patients as possible can have that hope that you talked about.
Sanjeev Luther:
And I think just to add to that, Kyle, I think the one other may be a different thing which is happening now than happened 10 years ago, there is more focus on the platform. It’s no longer about a single drug coming out. I think it’s the focus of the industry has changed in more of a platform based on that platform that generates many molecules, not one, not two. So I think that’s partly being driven by AI and collaborations that the pharmaceutical industry is moving more towards platform-based development rather than a single molecule development.
Kyle Wildnauer-Haigney:
I’d love to double-click on that. So, you know, this platform play. It’s very common in tech and consumer tech specifically, but then kind of taking that model and applying it in the pharmaceutical space, is that mostly comprised of, you know, the drug discovery process and early-stage testing? Or there are other facets of the platform that helps bring molecules to the market.
Sanjeev Luther:
Right. That’s a great question. So it’s, of course, linked to discovery, but once again, discovering more broader stuff. So, for example, let’s take cancer metabolism as a big platform. So once you have a drug, which has a signal in this area, you can then develop several to follow on the same platform. So, yes, it’s part of the discovery. But rather than doing a single molecule. Wait, wait, wait, wait. For several years that it fails right here, you have multiple targets as part of the platform and you start to look at all of them simultaneously.
Kyle Wildnauer-Haigney:
That’s great.
Sanjeev Luther:
That’s more targets, the better hit rate. The fewer the targets, the worst the hit rate.
Kyle Wildnauer-Haigney:
So, yeah. And I guess how many in your pipeline you’re going through stage three or phase three right now. But how many different targets are you looking at?
Sanjeev Luther:
So the company has several pipeline targets actually as we speak right now. And the question is, how many of them can you can bring to phase one? So, as I said, the more the better the hit rate, Right? Fewer, the less the hit rate. So our focus is let’s generate as many as we can and then see which ones are the most potent and safer.
Kyle Wildnauer-Haigney:
Yeah, that’s great. From your perspective as president and CEO, what are the biggest challenges that you’re facing in the industry right now?
Sanjeev Luther:
There are many challenges. Basically, they’ve all stayed the same over the years, but some sort of hierarchically move up and down right now. I think the biggest challenge our industry has always had was the discovery, you know, pipeline. That continues to be a challenge. Number two is I think that because of covid, the industry has totally outperformed than anybody ever imagined. So talent. Talent has become a big issue because the turnover rate in the industry is much higher this year than it was two years ago.
Kyle Wildnauer-Haigney:
Wow.
Sanjeev Luther:
That has become pretty big… which is a very good thing to talk about because our industry has gone through some ups and downs over the years. But right now, this industry is in a booming place. Right now you have more opportunities and people.
Kyle Wildnauer-Haigney:
Yeah, do you that the tailwind from COVID, if you want to describe it as that, is going to continue on. Do you think there’s going to be fundamental shifts among regulation or how the industry kind of operates from COVID, or is this just a temporary thing there?
Sanjeev Luther:
Kyle, I think that’s a great question. Nobody knows the future, but I think based on what I see is there are definitely going to be some fundamental shifts. So one of the things you notice is digital marketing. Now it’s funny that digital marketing has existed in the consumer business for a long time. So you are seeing that shift from salesperson calling one on one face to face the physician and all, that is moving to tele. So telemedicine. Remember that you can now have a call with your primary care physician. We have Zoom. Same way a sales rep can detail a physician through Zoom. That I think is going to fundamentally shift in this industry for good. That doesn’t mean you won’t have a touch. You will still have human touch somewhere. But more and more you’re going to see that. Because of this use throughput in the industry, I really believe that the industry is going to take off even more. So right now, there’s a lot of focus on COVID-related. But what that caused was a lot more investment came into this industry than ever before. So I think one fundamental shift that will also happen is you would have to have you’re going to have more players, more investment, and more things coming out of this industry. There’ll be more innovation. And I think that is to stay. I don’t think that’s going to change. There are some other changes which probably will go away, like in a lot of us want to work from home today. I think a little slowly, slowly, even though there’s a lot of resistance right now. But slowly, slowly, people will see. Because in our industry, how do you innovate, sitting at home? Thinking about it. R&D is done in a lab. It’s not done in your home on a desk. So I think that is temporary and that’s going to change. That needs to in my view, some people may disagree with me on that, but that needs to go back because creativity and innovation happen by talking with each other in the same vicinity. That is one thing I notice. In fact, there’s data now available. So ASCO is a very large conference held in the US in June and then in July, you have ESMO in Europe. And one of the things which was very obvious was the industry suffered from research actually. There was very little new stuff presented, actually, in both conferences. And otherwise, you have so many new abstracts and so many new clinical trials, so many new things. And this was one of the least when it came to that for both conferences because one is US-focused, one is European-focused. It was one of the largest conferences in oncology and both of them, I mean, I just wrote to somebody actually a few days ago that I’m seeing the effect of the pandemic, that we didn’t have that many new ideas or new thoughts or new things to present at these conferences, both of them back to back.
Kyle Wildnauer-Haigney:
Sure. And so it sounds like the investment that COVID catalyzed into the industry is net positive, is going to provide a lot of hope for patients that with many rare diseases, where there’s not currently a treatment on market. But there are also some challenges related to COVID, as we’ve all been experiencing over the last 18 months, or what feels like 10 years.
Sanjeev Luther:
Correct.
Kyle Wildnauer-Haigney:
But hopefully, it is coming to an end shortly. And, you know, it’s great having you on the show. And as you aptly said, no one knows the future. But it’s really interesting to hear your perspective and your thoughts about it. I’d love it if you could give us a closing thought and the best place that listeners can collaborate with you.
Sanjeev Luther:
Thanks, Kyle, for giving me this opportunity. I think my closing thought is this is all about hope and everybody should continue to put their head down and keep working and don’t be disappointed if you have a failure because every failure turns into an opportunity at the end of the day, and wish that leads to that. I think the more we collaborate with each other in this industry, the better we are going to be.
Kyle Wildnauer-Haigney:
Awesome. Sanjeev, thank you so much for coming in and sharing your story with the listeners today. I really appreciate it and have a wonderful day.
Sanjeev Luther:
You too.
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