It’s not a stretch to say that Corealis has been attending AAPS PharmSci 360 since our beginning. In fact, we may owe our very existence to this event — well, that and a conveniently located Cheesecake Factory. That’s a true story. It was there that Yves Roy, Patrick Gosselin, and Yves Mouget met in 2004, and over a casual dinner, discussed founding a new CDMO that did business very differently in the one way that matters most.
On a related note, I often get asked why I joined the Corealis team, and it came up again at AAPS. So while I’ll explore a few other topics — including new GI-simulation tech and how I see our industry evolving — I also thought I’d answer the other question for anyone else who might be curious. But before we talk shop, let’s talk science.
Preclinical in-vivo testing has never been ideal. Animal GI tracts are very different, and they are often not reliable predictors of toxicity. While some regulators are starting to indicate an openness to using GI-simulation technology where it makes sense, we have to recognize that this technology is still in its infancy.
That said, at Corealis, we do see a future where this type of technology can start to make drug development clearer, safer, and less expensive. So we were excited to share our booth with some of the folks from Kanadevia and Innnoreal — the team who commercialized the GIS-α. As it happens, dissolution technology was quite the topic of discussion, both at our booth and in a session I was fortunate to attend.It’s always difficult to step away from the booth, but one of the technical program's highlights for me was a Tuesday morning session on biorelevant dissolution technology (like the GIS-α and subsequent models). The session included talks from Sandra Klein, Fady Ibrahim, Yasuhiro Tsume, and Stephen Stamatis.
The room was packed, and that alone was a very welcome sight. Too often, biotech companies still underestimate the importance of smart formulation — a critical knowledge gap that contributes to consistently high rates of failure during clinical trials. The size of the audience on Tuesday indicated that the tide may be turning and that the industry is eager to learn about and apply novel approaches to gain a better understanding of a formulation's absorption potential as early in development as possible.
As these techniques are applied more broadly across the industry, we will be one step closer to the FDA's goal of animal-free drug development as enacted in the FDA Modernization Act 2.0 in 2022.
I always look forward to attending events like these because I can connect with colleagues I’ve known for over 20 years. Pharma is a surprisingly small world; this year, even brief, casual conversations confirmed some of what I’ve been seeing and hearing from clients.
For example, this year at AAPS, besides the BIOSECURE Act, it was made apparent to me just how much the pandemic had adversely affected drug development in a few key ways. I heard story after story from colleagues about the practices that have become “the new CDMO normal,” and many of them aren’t good.
Here are a few common complaints:
Apparently, these things have become so normal that when you don’t behave this way, it tends to stand out in 2024. So I was pleased to hear people sharing stories about how Corealis has gone “above and beyond” for them. However, I put that previous phrase in quotes for a reason.
Delivering on time and on budget should be a given. And treating clients the way you’d like to be treated should be normal. The skills we provide are important, but so is the relationship.
Corealis has always operated this way. And yes, sometimes we have truly gone above and beyond. But apart from that, we’re simply approaching drug development with integrity, respect, and solid science. And apparently, now that makes us very, very different.
So, just for the record …
I know, I know. Everyone says that relationships are important, that their customer service is the best, and that integrity is an important part of their culture. That’s very easy to say. And unfortunately, it hasn’t been how a lot of organizations actually operate. If that’s been your experience in my industry, I’m very sorry to hear it.
On paper, Corealis has many of the same types of equipment as other CDMOs. We have many of the same titles and skills. But what’s fundamentally different is the team and how they treat people. Again, everyone can say that. But here’s what they can’t say:
What I spent my time at AAPS saying over and over again is this: Just come visit. If you do, you’ll probably become a client.
Corealis’s reputation made it an easy sell for me, and it makes it an even easier sell for those who are familiar with us. Our biggest challenge has been that because we’ve never overcommitted ourselves, we’ve worked with a tighter group of clients. Therefore, our name isn’t as well-known as some.
But in 2024, that’s already starting to change. When I attend conferences like these, I’m starting to see that more people know us, know what we do, and know why they should meet with us. That’s a wonderful change. But to be honest, neither this nor the dissolution presentation was my favorite part of attending AAPS.
AAPS also has academic networking events in the evening, which meant that I got to celebrate Gordon Amidon’s 80th birthday with a whole host of University of Michigan alumni.
Not only was he instrumental in developing the Biopharmaceutics Classification System (BCS), but he has also been a pioneer in developing GI-simulation technology. This celebration was the perfect opportunity to recognize not only his own achievements but also how he continues to empower and inspire a new generation of pharmaceutical scientists.
It was also much, much more than that.
Just watching people take turns talking about the difference this man has made was a joyful and touching experience. If you ever need a reminder that you can make a difference to an entire industry, there, on every smiling face and in every heartfelt speech, was your proof.
If you missed AAPS and would like another easy opportunity to schedule a quick 1:1 with a member of our team, check out our upcoming events page.
But since you’ve read this far, if you haven’t made the trip out to Laval, I’d love to invite you to see first-hand why this place makes such a lasting impact on people. You’ll be able to tour our new facilities and meet our small (but mighty) group of scientists and project managers who make me proud to work for this company every day.