505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, And Controls With Clinical Trial Phases

By Marianthi Karakatsani, Ph.D., Director, Regulatory Affairs, CMC

All pharmaceutical companies share a common goal, regardless of their size or history: for their products to achieve commercial status and success through the most time- and cost-efficient development path. The 505(b)(2) regulatory pathway was established to offer efficiency benefits for clinical, nonclinical, and chemistry, manufacturing, and controls (CMC) product development. Often sponsors, particularly start-ups and mid-size companies, concentrate their limited resources, expertise, and funding on clinical development, while deprioritizing the CMC development strategy. While the successful completion of clinical trials can certainly help to invite and maintain funding, those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.

We’ll answer questions like:

• How can you ensure phase-appropriate CMC documentation?
• What are some key CMC considerations for Phases 1, 2, and 3?
• What CMC strategy challenges can you expect when supporting clinical trials in 505(b)(2) ?