Episode 80: The Biotech Journey – Bringing Healthcare Innovations from Bench to Bedside

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Serving the entire Gulf South, but recorded in the heart of New Orleans. Hello and welcome back to Bio from the Bayou. I'm Dr. Elaine Hamm, the Executive in Residence at Tulane University School of Medicine.

And sitting right alongside Elaine, I'm James Zanewicz, the Chief Strategy Officer at Tulane School of Medicine. At Tulane, in reality, all throughout academic medicine, we have a saying of taking things from the bench to the bedside. And what that really means is the journey of taking a technology, an expertise, anything that we can develop that can help the world, From the academic enterprise out into the real world to help patients. And we want to talk today about how you can optimize this process yourself if you're in this space, because it comes from many different directions. It's not just people in academia who contribute to this.

Yeah, it's a process. And I like to say, from my bench to everyone's bench. That's my TM, TM, TM. I'm going to trademark that.

And then can I say, from my bedside to everyone's bedside, or is that creepy?

Oh, nope, nope.

Nope, okay. That means something different.

But it is a hard thing. It's a hard journey, and I've been on it from both sides. When I was in graduate school, I created something that I thought was really helpful for me because I was a lazy graduate student and I didn't want to purify protein for 2 weeks, and I found a way to take it to 2 days. And again, that was one of those things—

That was your patent, right?

Yeah, yeah, yeah, yeah. We filed a patent on it, and that was sort of my first taste of sort of the business side of everything. But at the same time, I mean, it's one of those Things of like taking something from my bench to someone else's. If it helps me, it could probably help a lot of other people, and it's a hard journey. And then being on the startup side and the tech transfer side, as you have been too, it's not as easy as it sounds to take something from wonderful, incredible science to an actual product.

Yeah, because that early-stage research is really that kind of concept bit. The favorite bit is where you hit your proof of concept, and that's something that you've done a lot, both on the academic bench And in the industry, Bente Lane. And I wonder if you can tell folks a bit about what that's like for you.

Hard. Really hard.

Hard, expensive. Yeah.

And hard, expensive, and sometimes really sort of demoralizing in some ways because actually the thing that I just talked about, you know, just because I wanted it doesn't mean that it actually ended up being something that other people— I mean, it was actually a really great process, but What I didn't take into consideration is that— so it was a manufacturing process that I had developed, but it also required other companies to reset up how they did their own manufacturing. So they would have to buy new equipment, train their staff to do a new technique. And it really wasn't that much of a cost savings for them to be able to switch all of the things that they were doing to something that, even though it was cheaper and faster, it wasn't cheap and fast enough for them to stop what they were doing and do something new. And that's really the trick, is how do you get people to stop what they're currently using and switch over? It's a really hard peak to climb.

You know, as you're looking at that, one of the steps we have to take is that intellectual property protection. And it's actually something that I studied and then passed the bar in. And so, well, I know enough to be dangerous. It's not something that I've done myself per se, but I've been, been a part of the process. And that's something really intriguing for a lot of scientists because I don't think they completely understand that, that when you're looking at intellectual property, especially with patents, it doesn't necessarily give you the right to do What you've come up with, it gives you the right to stop other people from doing it. Because what if you're using a piece that somebody else already has a patent on and they're not giving you the right to do it? They have the right to stop you, which I always find really fascinating when you explain to people like what, and then you walk through kind of the three-legged and four-legged stool. Say you have a patent on a three-legged stool and somebody invents the four. The four still has three legs, so you're technically infringing on that patent and you have to have both. And all you can do is stop the person with three from putting a fourth on theirs, but you can't produce yours. And it's things like that that I think are interesting. They get much more complicated. when you get into areas like what Elaine works in, drugs for treatments of things like Parkinson's, tinnitus, all those kinds of things. But those are some of the simple concepts around that area.

Yeah. And I also think that, and you've probably experienced this, where people sort of view the patent as the thing to achieve. And really, it's incredibly expensive to file for patents, to maintain patents, and to have a really solid patent foundation. And so it's not the be-all end-all. Having a patent is just the protection. What you do with the patent is more important. And so I want to, I want to emphasize that, especially to our researchers out there, that the patent is just one step. Is it something that people actually want? And so I look at, I mean, there's lots of different types of patents out there. In my world of drugs, I have learned that a method of use patent isn't all that valuable. What you really want to have is a composition of matter patent. That's much more valuable. And then you can't just have a patent in the US. You also have to file in foreign countries as well. And so there's a lot of strategy that goes into what countries you file in, and you have to do some market research for that.

So where is there actually that disease? Where are people likely to adopt it? Is it a therapy, you know, a treatment, a drug, whatever it is that would be used there? Because cultures are different. And some cultures, it doesn't matter if it's great, they may not just use it. And you have to evaluate all those pieces and things, which, you know, is hard. And once, once we've gotten to that point, so say you've, you've done your research, you've established your proof of concept, that's enabled your intellectual property, you've got your patent either going or issued. What do we do next, Elaine? We got to find somebody, right?

Well, you know, I'm going to— let's start from like, you have a drug, it cures cancer, you file the patent. And I like to recommend you file a provisional patent and then spend that next year figuring out how does this compare to what other people are doing? I mean, picture writing down what it is that your drug does on a piece of paper and putting it up on the wall and seeing what other drugs are out there and finding the white space. What else is out there? Where do you fit into what is currently being used as standard of care? If you're just as good as standard of care, that doesn't help. Now, are you safer? Maybe that's the key to that. But you really have to look at what else people are doing and how do you fit in? And then going and having those conversations with people that are, you know, in, in my world, my, my customers are technically the pharma companies that we hope to sell to. So we, I look through their portfolio of drugs that they're already developing and their areas of interest. And then I go have conversations with their scientists. I go have conversations with their business development people to better understand, would this augment their portfolio? And what kind of data do they need to see from me in order to get them interested in it? So, and what types of data? That's always hard. Like, oh great, you have a nice model and you've done it in this mouse model. We don't care about that mouse model. We only care about this. And that's a hard lesson to learn.

And that can be similar for medical devices and other things as well. While the pathway may be slightly different, it's still good to You know, to take that time to optimize, to tweak, to figure out what else is there. And it may be a faster path to market for some of those things, given what the regulatory routes are or such. But, you know, it's still similar concepts to apply.

Yeah, absolutely. In switching gears a little bit and looking at things like medical devices and more of the AI-based types of technologies, you're instead having conversations and making sure that what are people using? So if you're doing— you're creating a device that a physician will use in surgery, for example, you have to better understand How are they doing those surgeries right now? And is your technique different enough and valuable enough to get them to switch over? Again, that switchover is really, really hard. Does it fit into their workflow currently, or would it require them to do something completely different? And having those hard, hard conversations and getting excited to hear what you don't want to hear is what I tell people, because that's really, really important. This may not be the thing that successful that you thought it was going to be.

And that's all, I think, part of, you know, the conversations is not just the potential customers or users, can also be industry partners for your entity, you know, who may either partner with the startup you've started to develop this or could be someone who would take it straight in as a license. But starting those conversations early so you're producing what they want to see to evaluate, because God help you if you spent all this money and done the wrong kind of data, as you just said.

Yeah, absolutely. And it's going to be the experiments too that are really, really boring, unfortunately, that could kill you. So Safety data is really boring to, to— don't come after me, toxicologists. You may find it really interesting. I find it super boring. Pharmacokinetics, ugh, I know they're important, but man, they're boring experiments to do. You know, is it safe? Where does it go when you put it into the body? And then the, the really boring stuff I think is, is it easy to manufacture?

Mm-hmm.

It's so important. I have drugs that have, that have just been killed in the early stages because unfortunately cool drug takes 10 steps to make. And that is problematic. We want it cheap. We want it— maybe you're even using material that is flammable or combustible, and they can't put it into a manufacturing process. So when I— I mean, we're currently looking at our drug right now for MS, and we've gone to a specialist of like, we have it down to a decent number of steps, but they're finding a way to make it even— that process shorter and to use materials that are allowable within a manufacturing organization.

Yeah, and a big part, I think, of getting that information is that partnering aspect where you go out, you meet with companies, you meet with investors. And we could delve deeper into that, but I feel like we We actually have a podcast on that. So maybe we can just ask Ian to put that in the show notes so we can move forward from this one and have people go back and listen to our whole podcast on partnering. What do you think?

I think that's a good— I think that's a good point. And we're headed to Milan in a couple of weeks to have those very conversations. And our conversation isn't buy our thing. Our conversation is, you know, here's what we have to date. What additional data would you like to see? And that's what we really go back and tell our scientists is said, hey, you know, This pharma company really likes what you're doing, but they would like to see this kind of data. Now, that's an interesting step for probably another podcast of like, how do you then set up that collaboration? Because this doesn't mean that you have to go do those experiments by yourself. This could be something that industry would be very willing to collaborate with you on.

Or sponsor it or do it themselves. And that, that is really called preclinical development, which is our perfect segue to our, to our next step in this process, which you've done with multiple companies, is preclinical and clinical development. And I'm curious if you, because you have a tremendous expertise from, from, you know, your battle wounds, plus just your general knowledge base in this space. But can you explain the difference between preclinical and clinical and what that's like for folks?

It's not, it's a very specific type of experiment. So you have these sort of proof of concept studies that you do, efficacy, some additional little safety studies, some, some PK, but then if, when you have your lead compound, then you go into the IND-enabling studies, which are very specific to pull together for your drug application that you file with the FDA.

Yeah. Which is necessary to get on that path to regulatory approval, which is—

Exactly.

Which is so crucial.

Yeah, absolutely. And it, those are very prescribed steps and they're gating criteria as well. I mean, so when When I get feedback from potential investors or pharma partners, they, you know, we only invest in things that are at the IND stage or after Phase 1. And sometimes they'll even get after Phase 1B, you know, they'll get very specific as to sort of those milestones. So there's a, there's very prescribed sort of milestones that occur. It's just learning what those are are important.

I agree with that. Absolutely. And it's, it's that regulatory process, which is just, you know, so critical and figuring out what is my pathway for regulatory Approval, which is different because there are different pathways that are all like, you know, numbers and letters and some combination thereof. And people like you rattle them off and know exactly what they mean for drug, device, therapeutic, this, that, the other. But for people, you know, even me sometimes, and I'm in the space, and then folks like Ian, who often is like nodding and learning in the room, it's like, we're like, is this alphabet soup? Did someone like throw words and numbers in a blender and mix them up? It's kind of crazy.

Yeah. And I sometimes feel that way too, even though I've been in it for many, many years. But, you know, it's The clinical side is something that you have to think about when you're even looking at mice. I mean, I've cured a lot of mice of MS. That's fantastic. But now we have to think about the patient population. And that's been something, even though we're not at that stage yet, and we're at our IND-enabling stage right now, we are having conversations with clinicians to best understand, you know, is there a subset of patients that have MS that might be better suited for our drug? Is there a drug combination that might work better with our drug? And so we're really thinking and having the conversations with clinicians to best understand what are the next steps for us long before we even get to the clinic.

So say you've done that, you've gotten through preclinical and clinical, you've done your regulatory filings, and you're getting close to approval. How do you scale and manufacture, and what components are crucial there?

The manufacturing piece is something you should be thinking about from the very beginning. And there's lots of— it can be really complicated depending on your modality. So I mean, small molecule girl, and so it's actually sometimes pretty straightforward. Gene therapy, cell therapy, incredibly expensive. I was actually— I mean, the biggest sticker shock I've ever had in my life is when I worked with a gene therapy company and I got my quote for our manufacturing piece and I wanted to throw up.

And that's where groups like NIMBLE are so incredibly helpful though, which is the National Institute for Innovation and Manufacturing Biopharmaceuticals. And I got it right, and I was so worried about screwing it up. It's not written down, I rattled that off. But that is a group housed at the University of Delaware, funded by government to help people in gene and cell therapies figure out how to do it better, cheaper, at a larger scale, more stable, all those kinds of things. And so there are a lot of resources out there through the government, or at least there have been up to this point, if you ask.

Yeah, no, absolutely. And those are one of those industries where the innovation has gotten ahead of the manufacturing innovation. And so there's a— it's a big bottleneck that we've seen in that area of just the manufacturing being sort of the layer of moving these drugs forward. In fact, you even see gene therapy companies setting up their own manufacturing units. So 2 important things from that. One, think about the manufacturing piece early and often. But if you're someone that is working on refining manufacturing in gene therapy, and you have an interesting technology or technique that you've been utilizing to streamline it in your lab, think about that as a potential innovation that you could bring to the market and focusing not on the drug, but how do you make it?

And I think the other thing that is so important to be thinking about the whole time is that next step of commercialization and market adoption. Because if you don't start thinking about that early, you're not going to get there. Yeah, absolutely.

So crucial. Yeah, you have to think of the patient. You have to understand, is this patient going to take your drug? And, and that means a lot of different things. So I was developing a hearing loss therapy, and we looked at it from a, a very specific submarket of chemotherapy-related hearing loss. So there's certain types of chemotherapy, like cisplatin, that can cause hearing loss. But it was complicated because when a patient is faced with very serious diagnosis of, of cancer, hearing loss and preventing hearing loss may be the last thing on their mind.

Mm-hmm.

And so if you're making them go through a very complicated surgery, for example, to, to get the hearing loss treatment during their chemotherapy, that's a really hard ask. And will you have market adoption? Market adoption and patient, you know, compliance is a really big piece of a drug success. It's something you have to think about early. If you have to do a really complicated surgery to deliver a drug, it depends on, you know, how serious that disease is of whether someone is going to do it. Our MS drug is oral, and we think that's a big value prop And so they're having to go to these infusion clinics to get their drugs, and that's complicated. And so we're hoping that a pill that they could take would help from a compliance perspective and make sure that patients were taking it.

Yeah, and it's looking at the patients, what would patients do, but also looking at your collaborative partners, your larger industry, if you're going to have to partner or get acquired, and are they willing to do that? Because if they're not, sadly, it doesn't matter if patients want it and would take it if nobody will partner with you to manufacture it at a larger scale or to distribute it. Those things are crucial too. And, and a lot of really great potential therapies, treatments, whatnot, may not make it to market because it may not make business sense.

Yeah.

And, you know, it's not just the patient, it's also a business, and companies have investors. And, and, you know, they don't have to make obscene amounts of profit, but they do have to make a profit because for every drug that comes to market, is it 1 out of 10? Successful? I don't even think it's that high. It's like—

It depends, it depends on the stage. So the stage I operate in, preclinical, it's a 10% success rate, and that's a lot of money to invest, and they, they do need to recoup those losses and the investment that it's re— you know, that requires it. But, you know, if you have, if you come up on these hurdles, so say that you have a formulation problem, there are tons of companies out there that are, are, that's their whole jam is making new kinds of formulations. Maybe you have, I mean, one of our drugs has a lot of different pills. Well, Could we find a way to make this a patch and reformulate it a little bit differently? And that's a whole new collaboration and potential, you know, customer that could acquire us is someone that's doing drug delivery. So that's, that's a new sort of way that we're thinking about partnerships and collaborations of like, hey, you know, we have a great drug, it works, we need to make it a little bit differently. Let's go find a partner that can help us.

So say you've thought about all these steps, you, you made your plan. What next, Elaine? What do we end on? Where's our hope?

Oh, so so you have your you've created something that cures cancer. You filed your patent. You've gotten great feedback from from pharma.

You've endowed the business development office at Tulane. Will take anyone's name and anyone's money. You know, or Ian would love to be the IQ cancer multimedia specialist of Tulane and endowed forever. Hell yeah! Hell yeah! Sounds great.

Well, if you're at the university, the tech transfer office is the office that can help you do those things, and offices like ours as well to help you find those collaborators. collaborators and, and get the license agreement and, or whatever the collaboration agreement looks like. So, you know, follow all of those steps and, and hopefully you can get there. But if you don't, don't take it personally. I have had lots of failures in this space, but I'm so glad to have the failures early on. Like, that would be devastating is to, if I didn't do my diligence and we get into the clinic and it didn't work and there was something I could have done at the very beginning of, of the process to make sure that, that we had something or not.

Mm-hmm.

I mean, when I had my, my first Very big girl company I did was a fatty liver disease company called Keros. And we knew going into it, like, if we can't do this— because fatty liver disease is a huge market, and there's— it's such a crowded market. And we knew, looking at that, what— where's the white space? We needed to fix fibrosis. And that was the very first experiment we did. We did not fix fibrosis. We did a lot of great things, but we didn't solve what we set out to solve. And we, we closed the company down.

Yeah.

And we learned a lot from that. And I was very glad to do it at that early stage, with, with not very much money, and we actually returned money to our investors.

This is like the old song, right? Know when to hold 'em, know when to fold 'em, know when to walk away, know when to run.

And know when to walk away. Yeah, exactly.

And do it soon.

Know when to walk away.

Yeah.

Think about, think about that from the very beginning. If I can't do this, I don't have a thing.

I think it's a great tip.

And don't take it personally, just business.

And a lot of this, I think, comes back to the principles of project management, 'cause you've realized that your job is project management. And so I think one link we should have in there Is that Project Management for Non-Project Managers book that you had us all read as a team?

Absolutely. And I'm also reading a book that I, that is about sort of endings and how to walk away. So if I like that book, I'll talk about it on another podcast, but I mean, it's really—

And if not, you won't, and then you'll be sad author. Yeah.

But walking away is the hard part, but it's all about what you learn. I mean, think from our other podcasts where we talk about resiliency. It's not about the failure, it's about what you learn from it. So. I mean, there's hope even in the failure.

So that's, I guess, what comes next is what did you learn and how can you apply that to your next project?

Absolutely.

It all comes down to the patients, moving things forward to benefit patients and getting up and trying again and taking another swing.

100%. I've done it many times. If I can do it, you can do it.

That's a perfect ending, I think, Elaine.

Thanks so much. Oh, I like that. I know. If I can do it, you can do it. If this dumb dumb can do it.

Is this Anything You Can Do, Elaine Can Do Better? She can do anything better than you.

That is absolutely true.

And I got to sing on the podcast now, and I'm so happy.

Oh, that was really good. Yeah, now you have a whole new other career avenue you can pursue.

Ian will probably make it into a ringtone now. You've just been waiting for years to sing on the podcast.

I would get that ringtone. It only took 3 years.

Only because I said Elaine can do better. If I said I could do better, you'd be like, nope, nope, not using it. But anyway, I guess we should wrap up with that.

Anyway, as always, make sure that you check out the information links that we post in our show notes.

And keep an eye out for BIO on the Bayou, our conference, which returns October 28th and 29th of 2025. And rumor is that on the 27th, there might be a bullpen pitch fest in the afternoon. So make sure you come in the morning before, because there may be a whole half day of opportunity for companies to pitch before, you know, potentially family office investors, foundation investors, corporate investors. Looking at a little different, different kind of spin with the bullpen this year. And we're excited to continue our partnership with them.

A diverse mix of investors, which is always a good thing to help you take your drug from bench to bedside. Now that's the way you end it right there.

Love it.

All right. See you guys next time.

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