Rationalizing the Preclinical-Clinical Hurdle – How to Overcome the Toxicology Exposure Challenge

Join our speaker, Dr. Andrew Parker as he delves into the regulatory framework and the needs of enabling technologies for poorly soluble molecules.  

In this presentation, Dr. Andrew Parker, Senior Drug Development Consultant, will discuss considerations when navigating the pre-clinical to clinical transition, exploring regulatory expectations, enabling technologies for poorly soluble molecules, and other topics.

He will review the solutions that our team have developed to help customers successfully navigate through development milestones, leveraging the Quotient Sciences Translational Pharmaceutics® platform. He will share the rationale for assessing amorphous solid dispersions when compared with lipidics and size reduction and show how these can be easily translated into fit-for-purpose, first-in-human (FIH) presentations suitable for oral administration and enabling dose escalation.

Key learning objectives:

• How to identify the best development strategy, technology(s) and candidate(s), demonstrate solubility improvement and stability
• Justify the selection of prototypes as suitable for animal testing and potentially improving exposure to meet toxicology multiples required to justify entering an FIH study
• Where to invest from the early stage, modularity of the preclinical screen, and how it can be refined based on your needs

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*We reserve the right, at our sole discretion, to deny registration or remove any individual who is not a confirmed current or potential client/partner of Quotient Sciences.