The pharmaceutical industry faces mounting preclinical challenges, with many molecules exhibiting poor solubility, unstable solid forms, unpredictable bioavailability, and limited developability data. When the relationship between molecular structure, physical form, and process is not understood early, issues such as inappropriate salt choice or unworkable physical properties often surface too late—causing delays, rework, and costly changes to non clinical and early clinical plans. Early insight into solubility, stability, biopharmaceutics, and solid state behaviour is essential to avoid these pitfalls and keep development on track.
This webinar will show you how to overcome these risks using practical, science driven strategies. You’ll learn how early characterisation of physicochemical, biopharmaceutical, and stability properties can reduce uncertainty, support smarter formulation decisions, and accelerate progress toward the clinic.
We’ll also highlight the key red flags that can derail drug substance and proto formulation developability—and share actionable tools to address them before they impact your timelines. In addition, the session provides a holistic view of how molecular and bulk API properties influence formulation, manufacturability, in vivo performance, and the importance of integrating CMC early with clinical planning.
By investing in robust preformulation—from salt selection and polymorph screening to evaluating bulk properties and biopharmaceutic risks—developers can enhance manufacturability, strengthen regulatory readiness, and reduce programme risk from day one. Don’t miss this opportunity to learn how Arcinova and Charles River achieve first time right API form selection. Register today to secure your place and accelerate your path from lab to life with greater confidence.
Key Learning Objectives
- Discover the key challenges in preclinical development and how early insight into compound properties can reduce uncertainty and drive smoother study execution.
- Learn how physicochemical, biopharmaceutical, and stability data shape smarter formulation decisions and enable a faster, lower‑risk transition into the clinic.
- Recognise critical red flags in drug substance and proto‑formulation developability and understand how to optimise them for clinical and commercial success.
- Gain a holistic view of how molecular and bulk API properties influence formulation, manufacturability, in vivo performance, and the value of integrating CMC with clinical studies.