Learn how an integrated program design can simplify development processes for complex molecules and reduce overall costs.
Drug development for any molecule type is challenging, however complex molecules requiring solubility enhancement or specialized formulation expertise like modified release or pediatrics, have even greater challenges achieving clinical and commercial success. These types of molecules require a development program that advances these challenging molecules rapidly to the next milestone while keeping an eye on downstream process development and commercialization.
With the ultimate goal being to get treatments to patients faster, drug developers can leverage an integrated approach to 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 they can flag developability problems that could impact the downstream success of the program. This approach is essential before quickly transitioning drug candidates into first-in-human (FIH) clinical studies to understand a molecule’s full potential.
There are also many benefits of employing an integrated approach when expediting complex molecules from FIH into proof-of-concept (POC) trials. The seamless integration of formulation development, drug product manufacturing and clinical testing capabilities enables real-time clinical data to help guide dosage form design, ensuring better decision making; and supporting a more streamlined approach to outsourcing.
Fill out the form below to access this on-demand webinar, Overcoming formulation challenges for complex programs: Integrated strategies for Poor Solubility, Modified Release & Pediatrics, with John McDermott, Executive Director of Drug Development Consulting at Quotient Sciences.
You'll learn how an integrated program design can simplify drug development processes for complex molecules, reduce overall costs, and improve the likelihood of clinical & commercial success.