Meet us and Hear Our Expert Present at Formulation and Delivery 2024

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

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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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