Rare Disease Targeting and Novel Therapy Delivery with Kymanox' Evan Edwards

Commenting on a wide range of therapeutic targets, Kymanox president Evan Edwards joins Supplier Horizons host Tom von Gunden in highlighting opportunities for drug delivery innovation. Front of mind for Evan as he considers areas of advancement are human factors engineering for increased self-administration, targeting rare diseases with novel therapies, and, in general, addressing the challenges of delivering large molecule biologics.

Interested in joining Tom on an episode? Contact him today.

Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader:

Welcome to Supplier Horizons, the series that provides updates and insights on innovation from suppliers to the drug delivery industry. My name is Tom von Gunden, Chief Editor and Community Director at online information exchange Drug Delivery Leader. Today I am joined by Evan Edwards, President, at life sciences professional services firm Kymanox.

Welcome, Evan.

Evan Edwards, President, Kymanox:

Thanks, Tom. I appreciate it. Happy to be here today.

So, let's get started with our first question: As president of a life sciences professional services firm, what do you currently see as the greatest drivers of, or opportunities for, innovation in drug delivery?

It's a great question. Obviously, there's this elephant in the room of GLP-1s that we see. It's exploding. It's making a lot of headway in our industry in a lot of different behavior, from swallowing up manufacturing plants with some of the big players here. But most importantly for the patient, you're getting more and more patients doing self-administration at home that they've never done. They never experienced, maybe, doing a pen injector or a prefilled syringe and self-administering.

And that's going to be a continued trend as they go and expand different indications outside of, just for example, obesity. I think you're going to see more and more patients, instead of going to the doctor's office, where they may get administered by a healthcare professional, actually having to do it themselves. And to me, I'm very passionate about that.

My background is in human factors engineering [HFE]. Way back, early in my career, I started a company around an invention idea for an epinephrine autoinjector. My twin brother and I grew up with severe allergies, and we saw some of the challenges with being compliant. And how do you ensure, in the case of, for this example, an anaphylactic emergency, that you can have access to a drug delivery device that's going to work every single time?

And I’ve spent most of my career trying to develop that, in the case of AUVI-Q^®. So, I'm very passionate about usability and how you can mitigate use-related hazards. And I think as we see trends in the industry, more and more biologics [and] pharmaceutical products are going from the hospital or from the doctor's office and into the patient's home.

So, Evan, what are some of the trends you're seeing that would indicate that we need to move forward with some of these advances in drug delivery innovation sooner rather than later?

That's another great question. What we're seeing in the industry is increased emphasis on cell and gene therapy [CGT] and novel therapies, which I think is very exciting for patients ―treating new novel conditions, some in rare disease.

Obviously, immunology and oncology are going to continue to thrive for therapeutic areas. But I get excited when I'm seeing rare diseases, these orphan drugs, and even things like Alzheimer's, you're now starting to see. And all of these new biologics, new pharmaceutical products: they're going to have to get to patients somehow. And I think that those are great areas and some therapeutic areas where advancements in drug delivery technology will continue to thrive and be important in order to determine how we're going to get these therapies to patients.

So, what are you doing to work with biopharma companies and other organizations in the industry on innovations in drug delivery?

At Kymanox, we work on hundreds of projects a year ―small, medium, large ― and [with] the largest biotech and pharma companies in the world. And it has been really interesting to see the different trends, especially around drug delivery.

We're seeing less and less companies look for custom drug delivery solutions. And there are a lot of companies out there that have invested significant capital on their own innovation. These are drug delivery device companies, [for example] autoinjectors.

You're seeing larger volumes that have to be delivered. Traditionally, it used to be like 1 mL for parenteral drugs. And now you're seeing 10 mL, 20 mL on-body delivery systems being developed. And we continue to try to help those companies determine what is the best platform for their candidate. And how can they ensure that not only is it going to achieve their clinical outcomes ― their goals of having a safe and effective drug or biologic ― but also that the end user is going to be able to use the product correctly that is best suited for their particular drug or biologic ― that it's stable?

And so, we continue to see less and less of, we're going to spend a lot of money on developing something unique and novel on the device side. But we're also seeing that there are unique advances in drug delivery on the drug and biologic side, like we talked about before ― cell and gene therapy and some of these targeted, personalized medicine solutions.

So that's very, very exciting. I'd be remiss if I didn't mention artificial intelligence [AI] and how that is, in itself, becoming a unique innovation. It's a big buzzword as you all know in the industry ― kind of a shiny object right now. Traditionally, when we look at it, it has been really helpful in drug discovery, using AI, as well as [in] things like clinical trials.

But more and more companies are actually using AI to better target certain disease states and provide solutions to patients that could impact drug delivery, including connected health and supplemental applications that are companion apps to those solutions. And that is, I think, very good for patients. It helps them along their journey and increases compliance.

Excellent. Sounds like tremendous work.

It has been a lot of fun. Not without challenges, though. A lot of this stuff, as you know, Tom and team, takes a lot of capital. And there's a lot of regulation. The big thing that I think about for patients, in particular, and things we need to think about in drug delivery, is also access.

And patients deserve a lot of different options. So, another thing that we see are biosimilars and other drugs to create competition. And I think competition is really, really healthy. Just having one biologic or one branded therapy can be a challenge for patients, especially from the economic side, the cost side. But we do work with a lot of pharma and biotech companies that are doing what they can to advance new therapies, biosimilars, [and] generics to give patients options. And I think that's a good thing.

So, when it comes to innovation, what are some of the biggest challenges, questions, or problems out there?

We see more and more, I'd say, “three gals and a molecule.” These are virtual companies that stand up ― and they have amazing candidates ― drugs and biologics, but they don't know how to deliver them to patients. And many of [the candidates] have to be [delivered via] drug-device combination products. So, they're trying to look for partners, companies, and education, frankly, to determine, once we advance these through preclinical and Phase 1, Phase 2, what are the right ways? Who are the right partners and what are the right technologies and advancements we need on the drug delivery side?

How do we actually select? Is it going to be in a prefilled syringe? Should it be in an autoinjector? Should it be in an inhaler? Should it be in a transdermal patch, depending on the molecule? And those are things that I think companies are going to continue to ask: How much money does it cost to get there? And what do we not know that we need to know?

And there are a lot of FDA implications, even global implications and other regulations, that impact their development programs. And we see a lot of questions come our way and they just don't know, oh, wow, this is going to be regulated as a combination product. That's going to take us a few more years and maybe another $30 million.

Those are those are big, big items that affect, ultimately, their development programs. So, I think we're going to continue to see this push to understand more the implications of drug delivery and how they can ensure that it actually gets into patients’ hands. And there are some tradeoffs on lifecycle management on how they determine to do that.

So, if successful, what would any of these innovations and advances bring to the life and health of patients?

I think that's why we're all here, right? I think patients deserve options, and patients deserve better. And for some of these really horrible disease conditions, I get excited because I'm on the forefront of seeing a lot of different programs being developed.

And without going into detail on specific sponsors, I can say, when you start looking at impact to cancer, rare diseases — when you look at even the brain and some of these interesting novel drug delivery mechanisms and technologies people are trying to deliver directly to the brain and get past the blood-brain barrier [BBB] — that's pretty exciting.

So, I think we're going to continue to see unique advances in drug delivery and innovations. But from the patient perspective, I think you're going to see patients’ lives improve for some significant conditions that didn't necessarily have treatment before. That's why I think the CG&T, the cell and gene therapy ―that's not going to go away. It's going to continue to grow because you're talking about certain areas that can truly make an impact: CAR-T and some of these technologies that are actually solving problems that have never been solved before, and that's exciting for our patients. I think that will increase the longevity for some of these patients’ lives and [enhance] their quality of life.

And I think, for individuals in the drug delivery space, in particular, there are huge opportunities to work alongside pharmaceutical companies and biotech companies in order to achieve that goal of impacting patients’ lives.

Well, those are all fascinating insights, Evan, and I appreciate you joining me on this episode of Supplier Horizons at Drug Delivery Leader.