Join us during AAPS for our breakfast seminar at the Hyatt on October 24.
'How To Accelerate Drug Product Optimization: Integrated Program Delivery Using Translational Pharmaceutics®'
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 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.
Join Quotient Sciences’, Senior Drug Development Consultant as she critically evaluates the existing reformulation paradigm, describes the Translational Pharmaceutics approach and shares 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.
Space is limited! Register your interest to attend our seminar using the form below.
October 24, 2023
Hyatt Hotel, Orlando, Florida, Plaza K Ballroom
Key topics covered include:
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 Dr. Aruna Railkar
Senior Drug Development Consultant, Aruna has over 25 years of experience in the pharmaceutical industry working at the discovery–development interface, providing critical input for progressing compounds into clinical development, prodrug evaluation, understanding challenges in absorption/exposure of lead molecules, and development of formulation strategies (conventional or enabling) based on compound properties.
During her career at Hoffmann-La Roche, she led the group characterizing compounds' physicochemical and biopharmaceutic properties to inform NCE selection and provided stage-appropriate formulation development for preclinical and clinical studies collaborating with discovery and development teams in multiple therapeutic areas. Her area of interest is the development of novel dosage forms for existing drugs (as an alternate route of administration or improved delivery, which can use the 505(b)(2) development pathway). She joined Quotient Sciences as a Senior Research Fellow in the Scientific consulting group.