Right from the Start: Drug Product Design for Rapid Clinical Development

In this talk, we highlight the importance of flexible and advanceable drug product design, right from the start, to enable rapid clinical development without the need for time-, material-, and cost-intensive reformulation and subsequent bridging studies. Leveraging scalable parameters based on material properties and a depth of experience in drug product formulation, we demonstrate how bench-scale techniques and platform formulations allow for rapid development and scale-up of tablets comprised of spray dried dispersions.

First, we present a case study to illustrate the use of material-sparing approaches and rational drug product design to efficiently bring an enabled formulation into the clinic, allowing the dose flexibility required for early-phase studies without sacrificing the robust product design expected for a commercial product.  We then demonstrate how to leverage scalable parameters determined with bench-scale techniques for process scale-up to support a rapidly advanceable product from FIH through commercial launch.

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ABOUT THE SPEAKER:

Micah Tuttle is a Senior Engineer in the Product and Process Development group at Serán Bioscience.  He leads a team of engineers and scientists in formulating and manufacturing tablets – first for in vitro testing, then scaling to demonstrate process robustness and product stability, transferring knowledge for GMP operations, and supporting the manufacture of FIH and later-stage clinical supplies.  His deep knowledge around material properties and behaviors gives him a unique perspective on pharmaceutical powder processing, and applying that to the development of dozens of NCEs has made him a subject-matter expert on manufacturing processes including powder blending, dry granulation, and tablet compression.

Micah holds Bachelor’s (Materials Engineering) and Master’s degrees (Materials Science) from Arizona State University, and has over a decade of experience in industrial process development, high-tech manufacturing, and failure analysis across a range of industries including automotive, semiconductor equipment, and energy storage.

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