RapidFACT® – Overcoming the Poor Predictability of Preclinical Models to Accelerate Formulation Optimisation

Conventional formulation development uses preclinical models to assess formulation performance to select prototypes to study in humans. It is well understood that there is often a disconnect between preclinical and human bioavailability, hence relying on animal data carries risk of selecting suboptimal formulations. 

Translational Pharmaceutics platform integrates formulation development, on-demand GMP manufacture and clinical testing to accelerate drug development programs. It enables clinical assessment with GMP manufacturing, release and dosing possible in less than seven days, allowing clinical assessment to proceed with only short term stability data, and significantly reduced batch sizes. 

Flexible formulation design spaces can also be evaluated to enable critical formulation attributes to be studied allowing multiple formulation variables to be assessed and optimized based on emerging clinical PK data. Current talk describes the Translational pharmaceutics platform, its applications within the development cycle during first in human (FiH) studies giving an overview of a case study covering integrated formulation development, compounding and a FiH study with a novel synthetic peptide compound and also formulation platform selection within a FiH study. 

The presentation also covers RapidFACT® (rapid formulation development and clinical testing) application for solubility enhancement for DCS class 2 compounds, modified release and gastroretentive formulation optimization.  

Learning objectives 

• Gain and understanding of how exposure in preclinical species doesn’t not always predict human performance, and hence risks misleading development activity.
• See how integration of GMP manufacturing (CDMO) and clinical testing (CRO) industrial silos via Translational Pharmaceutics can accelerate drug development
• Develop an understanding of how Translational Pharmaceutics can be applied to perform Rapid Formulation development And Clinical Testing (RapidFACT®) to facilitate formulation selection and optimization within a clinical study increasing chances of success and delivering better outcomes

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