Intellectual Property as a Core Strategy in Drug Formulation and Development

*full transcript beneath

In this remaining a part of our 5-part interview collection on the present CDMO panorama, Dave Miller, PhD, chief scientific officer at AustinPx, discusses the rising significance of mental property (IP) technique in formulation growth, emphasizing the way it has change into inseparable from fixing conventional drug supply challenges. Miller, who brings each sponsor and CDMO views to the desk, highlights how IP concerns should be constructed into the earliest levels of formulation planning, significantly as many compounds coming into the market are already late of their patent lifecycles.

As Miller explains, “It’s not just about solving the drug delivery problems but also generating additional IP to protect the asset beyond loss of exclusivity.” For shoppers creating molecules with patents near expiration, composition-of-matter IP tied to the drug product itself is more and more relied upon as a strategy to lengthen safety. By designing tailor-made formulations that handle points corresponding to bioavailability, stability, and manufacturability, corporations can typically create distinctive, patentable compositions that concurrently meet therapeutic and industrial wants.

Miller additionally underscores the position of proprietary platforms in offering what he calls “perpetual protection against generic competition.” Even when generics try to work round a formulation, they typically lack entry to the specialised processing applied sciences required to copy the efficiency of the innovator product. This technological barrier, he notes, can present a long-lasting aggressive edge past conventional regulatory exclusivity.

Ultimately, Miller frames the position of a CDMO not as a transactional service supplier, however as a real growth companion. From the earliest design of a formulation by to commercialization, the aim is to ship therapeutic profit whereas making certain long-term safety of the asset.

Check out earlier elements of the interview collection 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

Part 3 – Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience

Part 4 – Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

About the Interviewee

Dr. Miller brings over 20 years of pharmaceutical growth expertise and has spent his profession investigating methods to enhance the bioavailability of poorly soluble molecules. As CSO of AustinPx, Dr. Miller leads the pharmaceutics and analytical growth groups and oversees the appliance of the KinetiSol Technology. Prior to his present place, Dr. Miller served as Vice President of Research and Development at DisperSol Technologies and Senior Principal Scientist at Hoffmann-La Roche. Dr. Miller makes a speciality of formulation and processing applied sciences for bettering oral bioavailability of insoluble small molecules. He has utilized his experience towards advancing quite a few drug candidates by all levels of growth from early discovery to line extension. Dr. Miller is a co-inventor of the pharmaceutical functions of the KinetiSol expertise and continues to be a key modern driver for utility and growth of the platform. He has revealed over 40 analysis articles in peer-reviewed journals, authored 8 e-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 quite a few 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 unique audio/video content material. It might comprise errors, casual language, or omissions as spoken within the authentic recording.

We take care of lots of shoppers which have IP within the forefront as they’re creating the supply system for his or her molecule. So now the IP technique is a part of the formulation technique. It’s not nearly fixing the drug supply issues but additionally producing further IP to guard the asset past lack of exclusivity. And among the shoppers that come to us have molecules which have been in medical growth for a very long time. And, and so by the point they attain market, the IP defending the molecule itself will likely be close to expired.

So then we actually depend on the drug product composition of matter IP to guard the asset past lack of regulatory exclusivity. So we do lots of entrance finish analysis of the formulation growth plan with IP in thoughts. But as I stated, it isn’t about creating a formulation simply to attain IP.

When you develop a tailor-made formulation growth program and a tailor-made composition particular to the problems of that molecule, and also you do it proper and also you do it properly, you remedy the bioavailability, stability, manufacturability points concurrently. A pure facet impact of that’s the composition that you’ve got generated particular to that molecule is novel. It’s distinctive, it is patentable. And so IP is attainable once you take that method, but additionally even with out the IP, if you find yourself utilizing novel platforms like we have now that are not accessible to generics, even when they may formulate round, they nonetheless haven’t got the underlying processing instruments to create that composition, to generate these efficiency metrics. Without entry to our platforms they’ve generics that may’t copy the efficiency of the product. They would possibly be capable of circumvent the formulation, however they cannot obtain the identical efficiency metrics. So that finally finally ends up being what I wish to name perpetual safety in opposition to generic competitors.

As lengthy because the generic cannot entry the device that makes it doable, that might by no means duplicate your product, and that is very engaging for quite a few our shoppers for which drug product IP is important to the event. Again, it isn’t nearly, as a CDMO, transactional companies, offering the capsules on time for the medical examine. It’s about co-development, beginning on the entrance finish with the complete growth pathway in thoughts, all the way in which to the industrial way forward for the molecule. And IP is true there on the forefront of these early concerns. So, that is the method we take. And, once more, being a sponsor ourselves, each time we initiated a brand new program, particularly once you’re engaged on 505(b)(2) molecules, creating the formulation that not solely checks the bins by way of offering therapeutic profit after which assembly form of the usual standards of stability manufacturability, but additionally, as soon as we show the therapeutic profit within the clinic, are we going to have a length of exclusivity that enables the traders to recoup their funding?

Those have been the important thing necessities after we began creating our personal merchandise. And so we simply naturally carry that to the desk that we are able to design a supply system that gives extra than simply assembly the usual necessities of a dosage type, but additionally offering IP that might defend the asset for, you recognize, a decade after lack of exclusivity. So, it is turning into vital to a big majority of our shoppers and packages.