Talking drug development trends with SmartLabs

If you want to paint a picture of the biotech landscape, Amrit Chaudhuri would be among the first people you approach for insight.

Now CEO of SmartLabs, he began his career with eight years dedicated to drug development, working with R&D visionaries across more than 100 universities, biotech firms, and major pharmaceutical companies.

Today, Amrit stands at the forefront of the global drug development sphere, his work being focused on expediting the process of bringing life-saving drugs to market.

In this interview, he joins FierceBiotech’s Rebecca Williamson about the major disruption the sector is going through, and where he sees the next chapter unfolding. He touches on the profound progress being made in being able to target disease on a more granular, definitive scale.

With that, however, comes challenges, not least around scaling these capabilities in a way that is financially viable and thus accessible to patients en masse.

“I think what's happening is that this industry is now focused on efficacy as much as it is proof of concept,” he tells us. “It was all about proof of concept. Can you even make this thing? Can it actually work. Now that we've proven you can make drugs using these technologies… the next step is how do you effectively make drugs?”

To hear more from Amrit, watch the interview in full.
 

Rebecca: Hi there. My name's Rebecca Williamson. I'm the publisher of Fierce Biotech, and I'm here today with Amrit Chaudhuri, CEO of Smart Labs. Amrit, thank you so much for joining me.

Amrit: Thank you for having me, Rebecca.

Rebecca: So to kick us off, tell me what we think about the future of biotech. Where do you see the biggest opportunity for the industry moving forward?

Amrit: This industry is going through a major disruption, right? We're going from an industry with a certain limited set of tools, small molecules in biologics, and with mRNA and the various types of cell therapies and gene editing and precision medicine that's happening, we are able to target disease more definitively and on a more granular scale. And in many cases, we are for the first time ever able to truly eradicate disease outside of something like a polio vaccine in modern history. Things like being able to bring cancer cells in your blood down to almost a undetectable limit. And I think that the opportunities that this next stage of development for the industry, where now we have 20 different modalities instead of two, is both a really, really large opportunity for the world and for patients, but also really, really challenging. How do you address that diversity of science? How do you develop all of those things to a point in place where it's commercially viable and affordable? Right? Take a look at mRNA. RNA based therapies have been around now for almost a decade being worked on more than where we look at companies like Alnylam. But it wasn't until a really globalized effort to fix some of the major hurdles in supply chain logistics, feasibility of RNA based vaccination in this pandemic, globalized, coordinated effort for that to become something you can invest into again, right? RNA investments went up and then went down, and then now have picked up again because we've really unlocked and fixed a challenge space in other areas like cell therapies, autologous cell therapies, we still haven't cracked the nut of how do we get that broadly to the patient, right? So while we have CAR Ts and a huge amount of autologous cell therapies that have tremendous potential, we haven't yet figured out as an industry how to get that in a cost-effective way into the patient, which limits the ability for us as an industry to invest into that sector. Tremendous opportunities like world-changing opportunities, but tremendous challenges ahead of us as well.

Rebecca: So tell me what emerging technologies or scientific advancements do you believe will have the most significant impact on the biotech industry in the coming years?

Amrit: So interestingly enough, there are some common things that are happening that I think are really interesting. One is for the development of these novel modalities, figuring out the scale up model. How do we make these things, how do we standardize IPS based stem cell therapy in manufacturing so that now it's not complete bespoke invention of manufacturing, its customization on a kit of parts approach. That's what we've done with biologics over 30 years. That's what we've done over a hundred years with small molecules. We have to get there in autologous and other areas. But then there's an entire alternative perspective of precision medicine and autologous cell therapies that requires a shift from a scale up single location manufacturing approach to a scale out distributed manufacturing approach. And that is, I think if we can crack that nut and make that viable, we will have unlocked the ability of getting therapies to the patients in need in a way that today we still haven't figured out. Look at CAR T. We have 8,000 doses by the four major pharmaceutical companies working on CAR T and a patient population of 68,000 in need. So even with the therapy that cures cancer, a child can't get that therapy because of the logistics around making this drug and the cost of that drug.

Rebecca: So shifting gears a little bit here, as venture capital returns to the biotech community, what do you anticipate the biggest priorities, areas of investment to be for those biotechs seeking to advance new modalities for patients in need of breakthroughs?

Amrit: I think that what's happening is that this industry is now focused on efficacy as much as it is proof of concept. So for the last decade with some of these modalities, it was all about proof of concept. Can you even make this thing? Can it actually work? Can it do what you intended to do in a patient? And we are at the first inning of seeing that happen with the CRISPR-Cas9 therapies for sickle cell anemia on the verge of eradicating sickle cell anemia this coming year with CAR T in bloodborne cancers. Now that we've proven you can make drugs using these technologies, mRNA, et cetera, the next step is how do you effectively make drugs? How do you do it at a cost basis that doesn't cause a skyrocketing ROI required and a patient cost required. And so I think investors are focused on now if streamlining, well, how do you invest in the infrastructure? How do you invest in the talent? How do you invest in the partnerships? Do you have to build everything in house? Do you need to build your own transport mechanism or encapsulation or drug delivery mechanism? And so what we're doing today is what happened, biologics in the eighties, nineties, and two thousands, we are learning and developing as industry just in a very diverse and high diversity way. And so that's what I hear is a really large focus. How do you take, what five years ago people were doing with a hundred million dollars? How do you get that same phase one trial with 40 million? Right? So what changes in mentality do you need to do to get there? Because capital just costs substantially more today.

Rebecca: That feels like a good area to close out. Thank you so much for joining me today. I appreciate the conversation.

Amrit: So much fun.