Navigating CMC Regulatory requirements for accelerated commercialization

Presented by Jacqueline Hargis, PhD (Head of Supply Chain and Program Management, Tampa Drug Product Site) and Jakob Bonde, MSc (Head of Regulatory Affairs Small Molecules (DS & DP) / Associate Director Regulatory Affairs)

An increasing number of therapies obtain designations with accelerated and priority reviews. The need to streamline the pathway from development to commercialization path for these drug products is of crucial importance. Lonza will share practical Chemistry, Manufacturing, and Controls (CMC) experience on how to navigate regulatory, development, manufacturing and packaging requirements critical for accelerated clinical pathways and commercialization.

Key Learning Objectives:

• Process, timing, practical aspects and execution requirements necessary for accelerated and priority reviews;
• The designation benefits for manufacturing development supporting clinical trials and registration applications;
• Considerations for effective interface with a CDMO partner including CPP / CQA identification.