3 “Unsolvable” Pharma Problems That Are Anything But

An outsider might easily assume that in an industry full of confident, educated optimists and technology enthusiasts, the only barriers to the advancement of medicine are external and, therefore, intractable.?

However, we often find that the majority of OSD clinical trials fail for reasons that are entirely preventable with the tools, processes, and knowledge we already have at our disposal.?

That’s an easy soapbox for us to stand on at Corealis, but it’s also the truth.?

And while pharma is our business, we got into it for the same reasons everyone else here did — to make medicine better. So in our first newsletter of the new year, we thought we’d explore three top issues that biotech companies are wrestling with for 2025, and how some savvy leaders are overcoming them.?

1. A Lack of Funding During Formulation Development

Despite widespread market uncertainty, 2025 is expected to be a record-breaking year for pharmaceutical investment. But there is a twist.?

Precisely where funding would make the biggest impact — very early on in the process — it’s now much harder to come by.?

However, that’s not entirely bad news.?

Drug developers who took unnecessary risks over the past few years have proven to be excellent teachers. And thanks to them, investors have gotten a crash course in how to spot red flags in the early stages of drug development. Their heightened scrutiny, in turn, actually creates more opportunities for biotech companies that prioritize risk management and solid science.?

Organizations that are forthcoming with the kind of information investors are hoping to see will have a much easier time than those who cut corners. And to be fair, the kind of information investors are hoping to see is the kind of information drug developers should be collecting anyway.?

Not only did we write a recent blog that explores this topic in more detail, but we also offer druggability assessments that can be used to de-risk complex projects and, therefore, help attract potential investors.?

2. Inaccurate Preclinical Studies?

Some new approach methodologies (NAMs) can outperform animal models, but for the time being, we can’t yet eliminate in-vivo testing, which is inefficient, expensive, time-consuming, and not as reliable as we’d like.?

But that doesn’t mean that significant improvements to preclinical studies are stuck in a holding pattern until other solutions, like organs-on-a-chip technology and predictive dissolution tools, become more viable options.

Yes, animals that are frequently involved in preclinical research tend to have GI tracts that are very different from those in humans. That’s not news. But a skilled formulator can often account for some of those differences to provide more accurate and actionable data. And sadly, that’s not as widely known.

3. Challenging APIs

Not all APIs are ideal candidates for drug development. Some may, in fact, prove impossible. But a good number of promising new drug candidates with incredible market potential may fall somewhere in the middle — precisely where more advanced formulation techniques can make all the difference.?

For example, hot melt extrusion — a process that involves heating a mixture of drug and polymeric excipients until it melts and then extruding it through a die to form a solid product — can significantly enhance the solubility, bioavailability, and stability of poorly water-soluble drugs in oral solid dose formulations. It’s also more environmentally friendly than traditional spray-drying techniques and can provide better flavor masking and more control with lower operating costs.?

For all of those reasons and more, drugs that have been approved with HME processes are very attractive to large pharmaceutical companies. But there’s a trade-off.?

Hot melt extrusion (HME) requires sophisticated (and expensive) equipment and cutting-edge facilities. That’s a significant hurdle for a startup biotech company. But that doesn’t necessarily mean that newcomers are priced out of the game.?

A CDMO that specializes in providing advanced formulation development services may be able to provide this for their clients. At Corealis, we have added a hot melt extruder to expand our advanced OSD formulation capabilities.

Of course, HME isn’t the only smart solution for challenging APIs. Proper formulation can overcome a number of problematic API properties that otherwise have the potential to completely derail a drug development project. However, too many biotech companies are rushing past this stage in a misguided effort to save time and money.?

Making Your 2025 Easier

Have you noticed that many CDMOs are actively discouraging you from visiting their facilities? We’re not one of them, but this “new normal” was a frequent topic of conversation at the last AAPS PharmSci 360.?

Video conferencing can do many wonderful things, but the easiest way to find out if a CDMO is inflating its capabilities is to request a tour and see for yourself.?

Our advice — if you’re in the process of choosing a CDMO for an upcoming project, request a visit. If they’ve invested in cutting-edge technology, take it from us; they’ll be thrilled to show it to you. If they aren’t, that’s a giant red flag.?

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Have a topic you’d like us to explore in 2025? Don’t hesitate to let us know! You can find additional content about a number of important topics on our website, but we’re always open to suggestions. As specialists within an industry known for being inscrutable to outsiders, we believe that a little clarity and transparency can go a long way.