WEBINAR ON DEMAND
Duration: 1 hour​

Navigating the complex pathway of preclinical drug development often involves encountering significant hurdles, such as low bioavailability of promising drug candidates and constraints on resources (time, cost, and API). Lipid-based formulation (LBF) presents a proven solution for enhancing the oral bioavailability of challenging molecules while allowing for a swift transition to clinical trials with reduced API and cost requirements. Despite its advantages, LBF remains underutilized, largely due to misconceptions about its complexity and a perceived lack of experience, particularly during the critical transition from preclinical toxicology studies to clinical trials.

In this webinar, experts will discuss the barriers to developing LBFs and share strategies for translating them into clinically and commercially viable drug products. The speakers will also examine lipid excipients from the perspective of dosing in preclinical models for toxicology studies and their safety profile. Additionally, the experts will explore preformulation techniques and modeling tools to gain insights into LBF-mediated oral bioavailability. Finally, case studies will be presented on transitioning LBFs from preclinical toxicology to a viable formulation suitable for an accelerated pathway in the clinic.

Key learning objectives

• Understand how to improve bioavailability through a lipid-based formulation.
• Gain insights into critical considerations and strategies for dosing lipid formulations in preclinical models.
• Learn about the regulatory and technical nuances involved in transitioning preclinical LBF to viable clinical dosage forms.

SPEAKERS

Grace M. Furman, PhD
CEO/President
Paracelsus, Inc
 

Ellie Au, Ph.D.
Manager, Product Development
Catalent