Today’s precision medicine and targeted therapeutics encompass fairly complex formulations involving biologics and Long-acting Injectables. The device design needs to not only incorporate the challenging needs of the formulation, address patient optimized administration and also deliver consistent PK. The success of the clinical outcome is dependent on the delivery optimization in these situations. The presentation will highlight characterization methodologies for various types of formulations, drug delivery optimization, and empirical simulator to assess pharmacokinetics / pharmacodynamics towards successful path to device and clinical trials with reduced time to market. Enabling technologies for delivery optimization will be showcased for biologics, suspensions and challenging formulations.
Talking points as listed below. - Pharmaceutical Landscape – Biologics, Combination Product trends - Drug Formulation Considerations - Approach to “Drug Delivery Optimization” Device Considerations - Unmet Needs and Challenging applications involving novel Bio-therapies and Long-acting Injectables, require “enabling” device solutions - Combination Product Integrated Development - Methodologies, Technologies and Empirical Data – Path to device - Reduced time to Clinic - Consistent PKs – Successful clinicals outcomes
Learning Objectives:
Understand Delivery Optimization for specific requirements of formulations such as bio therapeutics or long acting injectables and effects of Delivery Parameters
Develop empirical data in preclinical models for PK and establish parameter optimization for consistent PKs
Develop Integrated approach for drug and device in parallel towards successful combination products
