Understanding Formulation Challenges Early to Accelerate Timelines for FIH Trials

Monday, October 17, 2022

9:00 AM – 10:00 AM ET

Location:360 Stage #1, Exhibit Hall A&B

Presented By Charles River

Partner Presentation Speaker(s)

Russell Scammell

Director Small Molecule Drug Discovery
Charles River Laboratories
Harlow, England, United Kingdom
Darren Matthews

Research Leader
Charles River Laboratories
Greater Brighton, England, United Kingdom

Description: Preformulation and formulation development are traditionally prioritized at the later stages of the drug discovery process, which can present downstream challenges in the developability of an API. This can have a significant impact on the API performance, resulting in delays and higher development costs.
This presentation provides an overview of how integrating key disciplines and assays into the early preclinical development process and collaboration in the CMC space can accelerate timelines while reducing white space in the journey from preclinical to clinical studies.

Learning Objectives:

How early-stage collaboration between the pharmaceutics, DMPK, and TOX scientists can help select the right development compound and reduce later stage timelines.
How early-stage pharmaceutics assessment of the compound can ensure the right studies are carried out early.
How combining these early learnings with expert formulation development in the preclinical phase can reduce timelines, minimize risk, and provide key information for progressing into late-stage development.