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

Join us for an insightful seminar taking place at the Princeton Innovation Center. 

At Quotient Sciences, we strive to deliver a full-service drug development offering that meets the needs of the industry and our customers. The purpose of this event is to connect with you to ensure that we are aligned and aware of the challenges that you are facing and to get your input on the needs, drivers and service gaps that exist in the CDMO/CRO sector to better support you.

In this presentation, Dr. Valeria Ciarnelli, Senior Director of Product Development will discuss considerations when navigating the pre-clinical to clinical transition, delving into the regulatory expectations and the needs of enabling technologies for poorly soluble molecules, among other topics.

Valeria will review the solutions that our team have developed to help customers successfully navigate through development milestones, leveraging the Quotient Sciences Translational Pharmaceutics® platform. They will share 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 selection of prototypes as being suitable for testing in animals and potentially improving exposure to meet toxicology multiples required to justify entering a FIH study.
• Where to invest from early stage, modularity of the preclinical screen and how it can be refined based on your needs.

Register now

 *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.