Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience

In part 3 of our 5-part interview series on the current CDMO landscape, Dave Miller, PhD, chief scientific officer at AustinPx, addresses the growing trend of onshoring and nearshoring in pharmaceutical development and manufacturing, noting its roots in the current geopolitical climate. He views the shift as both a proactive strategy and a necessary contingency to respond to global uncertainty. “I think it’s a good strategy… either as a primary approach for developing and manufacturing drug products, as well as, the whole supply chain flowing into that drug product,” Miller said.

While many companies have been outsourcing to Eastern markets for speed and cost advantages, Miller notes that some AustinPx clients who have returned operations to the United States are finding unexpected benefits that include reduced miscommunication, fewer data inconsistencies, and avoidance of repeated work. Although domestic operations may initially appear slower and more expensive, the overall process can save time and resources by eliminating inefficiencies and improving quality control, he adds.

Miller observes that what began as a reaction to tariffs and geopolitical instability has evolved into a broader recognition of the value offered by high-quality domestic CDMOs. The trend highlights a shifting emphasis from cost and speed alone to prioritizing quality, reliability, and regulatory confidence—factors that can ultimately shorten timelines and improve outcomes when “doing it right the first time.”

Check out previous parts of the interview series with Miller:

Part 1 - Collaborative Innovation in CDMOs: Dave Miller, PhD, on Early Engagement, IP Strategy, and Advanced Formulation

Part 2 - The Importance for CDMOs of Partnering With a Sponsor’s Mindset

And be on the lookout for parts 3-5 to drop in the coming days!

About the Interviewee

Dr. Miller brings over two decades of pharmaceutical development experience and has spent his career investigating ways to improve the bioavailability of poorly soluble molecules. As CSO of AustinPx, Dr. Miller leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol Technology. Prior to his current position, Dr. Miller served as Vice President of Research and Development at DisperSol Technologies and Senior Principal Scientist at Hoffmann-La Roche. Dr. Miller specializes in formulation and processing technologies for improving oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development from early discovery to line extension. Dr. Miller is a co-inventor of the pharmaceutical applications of the KinetiSol technology and continues to be a key innovative driver for application and expansion of the platform. He has published over 40 research articles in peer-reviewed journals, authored 8 book chapters, and is co-editor of the First, Second, and Third Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He is a co-inventor on numerous granted and pending patents worldwide. Dr. Miller holds a BS in Chemical Engineering and a PhD in Pharmaceutics from the University of Texas at Austin.

Transcript

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I think we are. We're seeing the effects of onshoring manufacturing. The geopolitical environment right now is uncertain. I think that it's a good strategy, you know, onshoring/ nearshoring either as a primary approach for developing and manufacturing drug products, as well as, the whole supply chain flowing into that drug product.

If not as a primary strategy, as a contingency, as a backup plan, you know, so that they can react to changes in the geopolitical environment, and it seems like they're changing every day. So I think in most of our sponsor companies that we work with and partners, I think it's a very wise strategy to start developing these contingency plans, if not just shifting completely to onshoring domestic development and manufacturing.

We have a number of clients who've begun shifting what they've done historically in China back to the US for those reasons. I think also, you know, what was driving a lot of that work towards the Eastern markets was, you know, speed and cost, right?

These other CDMOs abroad, they offer services for the price is very low. The speed is very high. But a number of our clients as a side effect of, you know, bringing stuff back to the US that they've done historically in China, are recognizing the inefficiencies even though it's on face faster and cheaper.

The issues that you deal with in terms of miscommunications, reiterating work, you know, data inconsistencies, manufacturing issues, the amount of work that needs to be reiterated or redone or the doubt that's created when the data or the documentation isn't complete be taken into account.

And so, these clients that have brought these activities back to the US that were traditionally done in China are starting to recognize the value in onshoring, just from a perspective of it may be more costly and slightly more time consuming on the front end, but you save on the back when you're avoiding these issues that I've just described.

So, what's been driven by the geopolitical environment and tariffs and uncertainty, creating this trend of onshoring, what started with that has, I think, evolved into becoming reacquainted with the value that's earned by working with high-quality domestic CDMOs, like us. It's been a pleasant side effect where a cost and time are at least on the front aren't quite as valued now as the quality of deliverable and the ultimate time saving in doing right the first time. That's been our perspective on the hot topic of conversation.