AUG is unlocking rare disease drug access by reformulating off-patent drugs that already work for patients who can't get them

with uh artificial neural networks in AI. So basically constructs, biobots that can go out there and solve solve all sorts of problems for us. I I think that that would be amazing as well. That is amazing. I love it. Congratulations and thanks for breaking it down for us. Yeah, this is super exciting.

It's a lot to process. It's not a simple business. This is amazing, though. I'm very excited. But yeah, I mean, we could do a whole hour on this. So, yeah, we'll have to have you back. This is fantastic. Thanks so much for stopping by. We'll talk to you soon. Absolutely. Cheers. Bye. Next up, we have Jennifer Lynn.

uh excited to talk to her and um we we we ran through all our ads. Should we just start back at the beginning? Tell you about RAMP. Time is money. Save both. Easy to use corporate cards, bill payments, accounting, and a whole lot more all in one place. Go to ramp. com to get started. Ramp ramp.

Uh let's bring in Jennifer. Welcome to the stream. How are you doing? Jennifer, welcome. Thank you for taking the time. How are you doing? It's great to have you. Oh, I think we have you on mute. I don't know if we're it's a problem on our side or your side. We are good. Would you mind trying again? Both.

I think you can hear me. We can hear you. Welcome to the show. Would you mind kicking it off with an introduction on yourself and the company? Yeah, happy to. So, I'm Jennifer. Um, and uh my company AUG, we focus on solving the access problem in rare disease.

So there's a large amount of drugs in rare disease that are already effective or potentially effective for the patient. Um it's been tried by a doctor and maybe one or two patients. They wrote up a study saying that, you know, there's been some efficacy here, but the rest of the rare disease patients don't get access.

Um so I'm really working on a drug development company to develop these drugs that already work for rare disease patients that need it. Interesting.

We had there was a little bit of a debate on the show last week between uh two guests who were arguing over the idea of how the FDA decides to approve drugs, whether the whether the benchmark is better than a placebo, better than nothing or better than the standard of care.

Um how do how do you see the FDA's mandate in drug development? What is their goal? Are they trying to protect certain certain IP structures by limiting the access to drugs or is it more purely based on safety and efficacy broadly? Yeah.

Um, I think, you know, so we've had conversations with the FDA and at the end of the day, the FDA is really a group of people trying their best to approve drugs that work, um, and then, uh, you know, reject drugs that might have safety issues or are the same as placebo. Mhm.

Um so for us working in rare disease a lot of the times we are up against placebo or even historical controls um because there's usually no approved treatment um in these specific diseases.

So, it's much easier to get a drug approved there versus if you work in, you know, cancer, which is very common, um, like breast cancer. Um, there's already so many drugs that are approved and effective that you have to run really long trials against drugs that already work.

Um, and that ends up being extremely costly, extremely expensive, and there is some debate about, you know, is there a way to get around this five, sixyear trial?

Yeah, I've seen some biotech companies that will go and they'll pick up a dead asset like a drug that maybe didn't make it through phase three and then they kind of repackage it, IPO the company, and then everyone's kind of betting on, oh, maybe they can get it through phase three now.

Is is that a piece of your strategy or do you think you'll be taking like a completely different uh approach? Yeah. So what we typically do is whenever a drug works for patients, there's so many reasons why they don't have access.

Um one could be the formulation that works is just so much higher and they need um a special drug company to come in and formulate it so that it's stable or it's available as an injection and patients need it as an eye drop um and so on.

So a lot of what we do is we take an existing drug and we basically provide it in the formulation that's actually accurate and effective for these patients. Um but yeah, like repurposing old drugs is a great strategy because you have safety um usually already established for patients.

Now you just have to work on making sure that it's like a drug that works. Yeah. Do you see a piece of the business being partnering with big pharmaceutical companies or drug companies that already have something like that?

It's a shot and they want it to be an eye drop and you come in as a partner to them or is there a completely different pathway because I imagine hey if I own the patent on this drug as a shot I'm not just going to let you take it and turn into an eye drop for free and make all the money.

Uh, so how does the business partnership work? As you know, we probably want to compensate the scientist who actually created the shot even though you're going to do a lot of hard work to make the eye drop version. Yeah. So, there's two sides to this.

We've thought about partnering before and we've done a lot of conversations with top five pharma and what they say usually is cash is king. So, for them like upfront is really important. you know like what regardless of indication you need to produce x amount of cash to you know license this asset and take it forward.

So we've taken an alternative approach which is there are so many drugs right now that are off patent. So their effective life in um a larger indication like autoimmune disease um so on has already expired. big farmers already made that much money and now this drug is, you know, available for very cheap.

Um, and typically what we do is now we take this already invented drug and we add on something that makes it the right fit for rare disease patients. What areas of biotech and drug development right now are most exciting to you? We've obviously seen like a huge boom in GLP-1s.

Uh, crisper has been exciting for years and continues to be exciting in many ways. Um but there are other pockets of uh of drugs that people are working on. Where do you see kind of the most lowhanging fruit in terms of what you do bringing access to uh drugs in different categories uh versus what's the next next thing?

Yeah. So lowhanging fruit um and also what's the next moonshot? It's a great question for us. Lowhanging fruit is we follow FDA guidances very closely. So they just recently released the guidance that um certain biologic drugs, antibodies don't have to go after as much animal testing.

You can leverage a lot of um human clinical trials which is like almost incorporating common sense, right? Like if it's safe in humans, then maybe we don't have to do um a 24-week, you know, mice talk study.

Um so like the antibbody biologic space is really interesting because of the amount of studies you might be able to skip if your drug's already safe. Um and in the moonshot area completely unrelated to rare disease but longevity is very interesting.

Um you know if there's a lot of discourse about can we develop or can we actually develop the first real drug to prevent aging to reduce the aging process.

Um, and I think if you can be the first to market in such an insanely large market, everybody's aging, everybody would like some sort of drug to stay healthier for longer. Um, that's an incredibly exciting space to be in.

Yeah, we talked to the founder of New Limit and we both came away extremely bullish on that category. Please, please just make it work.

Uh I'm curious uh h how does pricing how do pricing models differ uh differ in sort of rare uh for therapeutics in the rare disease space given that the actual market size I I'm assuming things are a lot more expensive just because markets are smaller but maybe that's maybe that's the incorrect read.

Yeah, it really depends. Um and when you talk about pricing, there's also this overall you're taking into account all the insurance um buyer payers that exist in the US.

Um so there are drugs that insurance payers will have push back on and typically that's um drugs for really really large indications for example longevity maybe um Alzheimer's where there's such a large amount of patients even if you charge them 10,000 um per year to the insurer that's hundreds of billions of dollars that they won't be able to um really bear for a new drug.

Whereas for rare disease, if you have 10,000 patients and you're charging 100k per year, um that's actually still a negligible amount spread out amongst all the different payers in the US.

Um so typically those conversations actually go pretty smoothly for rare disease where you say we have a really large impact on this patient and there's only so few patients. That's cool. That's cool. Seems like it's working. uh one part of healthcare that's working working well. It's great.

Uh well, thank you so much for stopping by. This was really fun. We'd love to have you back and get an update when uh you have more news. Yeah. Congratulations on on joining the fellowship as well. Yeah. Have a great rest of your day. Talk to you soon. Bye.

Next up, we have Teddy Teddy Warner coming in from coming into the studio. Uh while we get him queued up, let me tell you about Figma. Think bigger, build faster. Figma helps design and development teams build great products