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.
Traditional drug product optimization processes take 12-18 months to complete, and places significant emphasis upon 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.
Join Quotient Sciences’, VP of Scientific Consulting, John McDermott and Senior Drug Development Consultant, 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 optimisation process using real-world case studies to get new medicines to patients in need faster.
Key topics covered include:
- How an integrated drug product and clinical testing approach can be applied to design, manufacture, and obtain clinical data on new formulations in an accelerated timeframe.
- How a formulation design space can be used to optimize the quantitative composition of critical-to-performance excipients and dosage strengths relative to clinical performance.
- How an integrated approach conserves the active pharmaceutical ingredient (API) by removing drug product scale-up from the critical path.
- How this unique approach can increase the potential for downstream success in patient trials by facilitating decisions based on clinical data.
About Quotient Sciences:
Quotient Sciences is a drug development and manufacturing accelerator supporting customers across the entire development pathway from candidate selection to commercial launch. We deliver uniquely integrated programs and a range of tailored services that dramatically shorten drug development times. We’re driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.