We’re looking forward to attending SAE Media Group’s Prefilled Syringes & Injectable Drug Devices East Coast conference this year.

Several members of the Suttons Creek team will be there: David Urban, Jennifer Engels, Alex Spivak, and Paul Chao

As a Gold Sponsor, we’ll have a booth on site and will be spending the event connecting with teams working through the real-world challenges of developing injectable combination products.

While there, we hope you’ll join Alex Spivak for his presentation, “The Predictable Ways Combination Product Programs Derail — and How to Avoid Missing the Signs.” Many drug–device programs don’t fail because of a single catastrophic mistake. They derail through small, predictable patterns that compound over time. Alex will explore several of the most common ones, including:

• Timelines based on supplier optimism rather than demonstrated capability
• “False parallelism” that creates the illusion of speed
• Siloed partners whose interface problems surface too late
• Regulatory shortcuts that reduce long-term flexibility
• Underestimating device and quality complexity

At this year’s PharmaEd Combination Product Summit…

“The combination product journey doesn’t end at approval.”

Most teams agree with that in theory. But in practice, post-market changes are where programs quietly lose time—because the underlying concepts aren’t always clearly separated:

What is a design change vs. a regulatory change?
What triggers global impact?
What actually needs to be reassessed—and what doesn’t?

On May 28 at 1:20pm, Jonathan Amaya-Hodges (Suttons Creek) will walk through these questions at the PharmaEd Combination Product Summit. The session is designed to bring structure to a space that often feels reactive—so teams can assess and manage changes with more clarity and less disruption.

If you’re attending and navigating these challenges, it’s worth the conversation. Feel free to reach out ahead of the event to connect.

Suttons Creek will be at SAE Media Group’s PFS & Injectable Drug Devices West Coast event as a Gold Sponsor from June 8-10.

Most challenges in PFS and injectable device programs don’t appear all at once—they take shape early, in how decisions come together across device strategy, regulatory expectations, usability, and manufacturing.

Join Steve Badelt, Rob Schulz, Kelly Wedig, and Karen Keeley on site. Each brings a different perspective—across regulatory strategy, device development, program execution, and commercial alignment—but all grounded in the same goal: helping teams make confident, well-integrated decisions in combination product development.

We’ll be there for straightforward, thoughtful conversations around where programs tend to get stuck—and how to move forward with greater clarity and alignment.