Overcoming Formulation Challenges for Complex Programs: Integrated Strategies for Poor Solubility, Modified Release & Pediatrics
Drug development for any molecule type is challenging, given the numerous stages an active lead molecule or new chemical entity (NCE) must transition through to gain regulatory approval and reach patients to demonstrate its benefits. For more complex molecules that may require having solubility enhancement or specialized formulation expertise like modified release or a pediatric program, the challenges in achieving clinical and commercial success are even greater. These types of molecules require a development programs to be constructed in a way that advances these challenging molecules rapidly to the next milestone whilst keeping an eye on the downstream process development and commercialization.
By leveraging an integrated approach, drug developers can rapidly screen formulation technologies and dosage forms in as early as the preclinical stage, using biorelevant in-vitro screening tools and physiologically based in-silico models to flag developability problems. This approach is essential before quickly transitioning drug candidates into clinical studies to understand a molecule’s full potential, with the ultimate goal of getting treatments to patients faster.
In this talk, John McDermott, Vice President of Scientific Consulting, will outline how an integrated program design can simplify development processes for complex molecules and reduce overall costs. Using case studies on modified release, poor solubility, and pediatrics, he will demonstrate how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.