How to Accelerate Drug Product Optimization Using Translational Pharmaceutics®5 October 2023
Drug product optimization is a critical development step that is common for most drugs that are progressing through today’s development pipelines.
Most new drugs require some form of formulation change during their development, whether to respond to suboptimal exposure profiles, to transition from an early development formulation to one suitable for chronic administration in patients, or as part of a life-cycle management strategy.
Watch Quotient Sciences’, VP of Scientific Consulting, John McDermott and Senior Drug Development Consultant and Dr. Andrew Parker, as they critically evaluate the existing reformulation paradigm, describe the Translational Pharmaceutics approach and share insights gained from 15 years of experience in accelerating the drug product optimization process using real-world case studies to get new medicines to patients in need faster.
Traditional drug product optimization processes take 12-18 months to complete and place significant emphasis on the predictive power of laboratory and preclinical assessments. This approach is a non-optimal working model necessitated by the multiple disciplines required to develop, make and test new formulations in humans.
Quotient Sciences’ integrated development platform, Translational Pharmaceutics®, was first applied in 2008 to re-engineer and streamline the drug product optimization process, using clinical data to improve decision-making and halve development timelines. Over the past 15 years, Translational Pharmaceutics has now been applied to over 250 drug product optimization programs, for applications including solubility enhancement, modified release and pediatric formulation development activities.