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

*full transcript below

In part 2 of our 5-part interview series on the current CDMO landscape, Dave Miller, PhD, chief scientific officer at AustinPx, discusses how his organization’s evolution from a drug sponsor to a contract development and manufacturing organization (CDMO) shapes its approach to client partnerships. Initially founded to develop novel medicines, the company went on to reforumulate drug products to address unmet therapeutic needs. Once those assets were ready, they were partnered out, leaving behind a fully integrated infrastructure encompassing drug product development, CMC, clinical operations, and regulatory capabilities. This shift allowed the team to apply its expertise not just to its own assets, but across the industry.

Miller describes this as a “by developers for developers” mindset: “We were developers, we’re working with developers, so we are walking in step with them as we move forward.” This perspective means viewing each client’s molecule through the lens of a sponsor—tailoring development strategies as if the product were their own. That includes addressing complex formulation challenges, such as bioavailability issues in small molecules, and extending support beyond standard CDMO services into preclinical, clinical, and regulatory advice.

Miller sees differentiation in the CDMO market as requiring more than technical capabilities; companies must offer something unique and demonstrably useful, backed by a strong scientific and engineering foundation. Trust, he emphasizes, is a critical differentiator. A longstanding track record with regulatory agencies and intellectual property protection builds client confidence, particularly compared to some overseas markets where concerns about IP security persist. For Miller, the goal is long-term partnership, guiding a molecule from formulation through manufacturing tech transfer, while safeguarding client assets and enabling successful regulatory filings. This blend of technical depth, sponsor mindset, and trust-based collaboration, he argues, positions the company as an uncommon partner in a crowded CDMO landscape.

Check out part 1 (Collaborative Innovation in CDMOs: Dave Miller, PhD, on Early Engagement, IP Strategy, and Advanced Formulation), 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're really unique and I've already touched on it a couple times in our previous questions in that we evolved from a sponsor ourselves. So we started with our novel KinetiSol platform. We had this unique tool that differentiated us from any other developers, and we utilized that tool to reformulate drug products to address specific unmet therapy needs.

So that was the evolution. Had a drug, we developed a tool and started utilizing that tool to create differentiated medicines and developed those for almost a decade ourselves. And then at the point that we had developed those assets to a place where they could be partnered, we partnered those assets off.

But what remained as the company was a fully integrated company that was really focused on drug product development as well as, you know, your standard sort of CMC, clinical operations, regulatory activities. So we had this infrastructure, and we realized that whereas before we were sort of leveraging one tool in KinetiSol to develop products, now we had all sorts of tools. And rather than just focus those on our own assets, we could open those to the entire industry, let the whole industry leverage our tools, our expertise towards advancing molecules. So that's kind of where our “by developers for developers” mindset comes from. Like we still feel, we still carry in our DNA that sponsor perspective. So when a client approaches us with their molecule and their problem statement and their target product profile, we view it through their lens. And so we want to develop that product as if it were our own asset. We were developers, we're working with developers, so we are walking in step with them as we move forward.

We've developed all sorts of novel products for our own pipeline. Like I said, with compounds like deferasirox and abiraterone and rivaroxaban and nintedanib, looking at the problem statements for those molecules and tailoring a development program and ultimately an end product to address the deficiencies of those drug products.

And so that framework is exactly how we interact with our clients. We understand their molecule, the challenges, the target product profile, the clinical development plan, and we implement the same sort of development strategies and approaches we took to our own pipeline. So, you know, even though we're an oral development, oral drug product development CDMO, and those are the tangible services we provide, there's a whole host of intangible services where we'll advise a client, on, say, their preclinical strategy, their clinical strategy, regulatory strategy, sort of just as sort of bonus we say, look, we've been here before. We've done this in the way that you're proposing and here's the issues they're going to face, and here's what we would suggest.

So it's sort of these intangible, soft services that our clients get that you don't get anywhere else because we once were a sponsor, we were developers ourselves, and now we work in tandem with other sponsors and other developers, not only to provide innovative formulation solutions that are tailored to their molecule, but also to be a partner, sort of an advisor at the various stages, just based on our own history.

That sort of mentality of a CDMO is becoming more common. But I think we're really unique as you look at CDMOs in the US and around the world. Not too many CDMOs that are fee for service now have a history of developing their own products and are able to apply that history to their clients' assets.

So I think we stand out in that regard. And, like I said, we still very much carry in our DNA that sponsor mentality and we bring that to the table when we start working with clients. And they feel that sort of partnership approach, that intangible advisor, they sign up for pharmaceutical development services, but they get so much more.

And I think that's the feedback we get from our clients. It's a unique experience in working with, Austin Pharmaceuticals.

Again, I think what we are leveraging is scientific expertise. So high science, we have, coming out of our history, we're focused primarily on enabling formulations, bioavailability and for very challenging small molecules that had various issues that impacted bioavailability.

So we developed a deep expertise and a wide array of tools for addressing bioavailability and issues, and creating enabled formulations. We have world class in that regard, but also carry a ton of knowledge in terms of just conventional pharmaceuticals, developing conventional dosage forms, manufacturing efficiency, GMP manufacturing, release, regulatory strategy.

So, we've got the high science approach, but also with a well-rounded experience in general. I think the high science is key, offering novel platforms that differentiate your company against what's out there in the landscape. There’s a lot of noise in the CDMO space.

I think what companies need to be differentiated is offering something different, something useful, and something that has a depth of history like we do with our bioavailability platform, but as I said, it's also about, again, co-development, not putting a client's compound through sort of a decision tree type structured development, but developing a tailored approach and tailored solution specifically for that molecule and demonstrating the scientific expertise and depth, as well as the engineering expertise and depth to take that molecule through formulation development, onto manufacturing tech transfer, to ensure that you're going to be the development and manufacturing partner for your client from start to finish.

The foundation of all of that, what underlies all of that, is having a robust quality system, a history with regulatory agencies, a history with IP generation and maintenance and retention that creates a feeling of trust among your clients that I think still, in comparison to Eastern markets, there's still some uncertainty there with respect to trustworthiness in terms of regulatory and IP, and I think that's still some… there's a natural sort of trustworthiness for domestic CDMOs and particularly CDMOs like us who have such an extensive regulatory and IP history that we will be trustworthy, will protect their asset, not only in terms of the services we provide, but also retaining their IP, generating new IP. And we can be a partner for them in providing what's needed for regulatory filing and standing behind it.