A Recap of the American DDF Summit, 2024

Not every event in our industry has the same goal, and if you’ve been attending trade shows and conferences like these for quite some time, you know that some prioritize partnership opportunities over content. Those will always present tremendous opportunities for our industry as well, but I know I wasn’t alone in finding the American Drug Delivery & Formulation Summit’s 2024 programming to be exceptional. 

There were four different topic tracks that were featured this year: biologics, device development, small molecules, and technology & innovation. And being that Corealis specializes in oral solid dosage (OSD) products, and small molecule topics, many of which were centered around dissolution and improving bioavailability, these were the talks that my colleague, Yves Roy, and I prioritized. But before I do a deeper dive into one of my favorite presentations, I want to provide a little context. 

What Does Dissolution Mean in Drug Development?

Many of Corealis' clients have extensive backgrounds that are either upstream or downstream of formulation development, so I’d like to briefly explain the importance of dissolution in the early drug development process before doing a deeper dive.

In our world, dissolution refers to how a drug substance dissolves in the human gastrointestinal tract. Only molecules that have been properly dissolved can enter the bloodstream. 

Depending on the Biopharmaceutical Classification System (BCS) class of your active pharmaceutical ingredient (API), dissolution rate can significantly impact the amount of drug available for absorption. Most believe the faster the dissolution rate, the better. But there is such a thing as too fast. Proper analytical methods can help formulators identify and mitigate any dissolution challenges early, but additional testing can also increase time and cost. 

There is a sweet spot, and according to Fady Ibrahim, head of Early Development Biopharmacy at Sanofi, many drug formulators aren’t finding it. 

Dissolution Testing Considerations

Considering that one of the most common “sins” in our industry remains rushing through preclinical studies, it may seem like additional and more comprehensive dissolution testing is the answer. But Dr. Ibrahim actually advocated for taking a middle-of-the-road approach, where formulators keep testing simple and phase-appropriate and refrain from adding so many variables that the resulting data only adds confusion. 

To put a finer point on it, more data is only helpful when it can inform decisions. 

Of course, identifying which testing methods are helpful at each phase — and where you can reduce risk without adding unnecessary costs — is its own skill, which is why many biotechs can actually save money by partnering with a skilled CDMO earlier in the process. 

Water Cooler Conversations

As I live in Massachusetts, I’m more familiar with industry events that take place on the East Coast. However, pharma can often feel like a small town. So, while Corealis is hardly a newcomer, I was grateful to be able to introduce our company to plenty of West Coast-based attendees who have also been in our industry for quite some time but whose paths we never crossed. 

We also hosted a private happy hour, where discussions around slowed rates of investment, the potential impact of the BIOSECURE Act, and lower interest rates made it clear that despite the many challenges our industry faces, we’re incredibly fortunate. We’re constantly surrounded by people who are here for the right reasons. 

Among the mix of partners, potential and existing clients, and, yes, even competitors, it was clear to me that we were all here to do one thing: bring better drugs to market. 

Catching Up With Us at Future Drug Delivery Conferences

I do look forward to attending the American DDF next year in Boston. But that’s hardly the only opportunity to catch up with me or with other members of my team. 

Corealis recently added 15,000 square feet of space to accommodate more cutting-edge analytical equipment and increase our capacity for advanced formulation development and clinical supply manufacturing. So if you haven’t yet explored our new space, we’re happy to welcome visitors. 

Also, if you’re planning on attending other upcoming biotech events, you can see where our schedules align on our events page.