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 optimisation 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.
Key topics covered included:
1. 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.
2. 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.
3. How an integrated approach conserves the active pharmaceutical ingredient (API) by removing drug product scale-up from the critical path.
4. How this unique approach can increase the potential for downstream success in patient trials by facilitating decisions based on clinical data.
About John McDermott
John McDermott has over 20 years of industry experience in roles in pharmaceutical sciences with Rhone Poulenc Rorer, Covance and Quotient Sciences, which he joined in 2001. He has been central to the development of Quotient Sciences' Translational Pharmaceutics platform, which integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human studies and fast development. In addition, John has a significant body of experience in scintigraphy imaging studies for oral and inhaled dosage forms, including the development and validation of radiolabeling methods.
About Dr. Andrew Parker
Dr. Andrew Parker has two decades of experience in the pharmaceutical industry, spanning from preclinical development, through early clinical formulation development into late-stage development, scale up and commercialization. Andrew has a particular interest in enabling technologies for bioavailability enhancement, characterization of all delivery formats, innovative technologies and understanding drug product structure – drug product function relationships. Prior to Quotient Sciences, Andrew worked at Cooper Surgical and Healthcare as a Program Director and at Catalent as an Open Innovation Director covering two business units. Andrew holds a PhD in physical chemistry from the University of Bristol.