Drug Product Development: Preclinical To Commercial

Drug product (DP) development spans multiple stages, each with distinct requirements, yet developers often face a lack of clear, phase‑specific guidance outlining which studies are essential from preclinical work through commercialization. This webinar addresses that gap by introducing a high‑level roadmap designed to unify development activities across therapeutic modalities. The roadmap highlights foundational elements such as defining a Quality Target Product Profile (QTTP), establishing robust analytical and formulation strategies, conducting container–closure evaluations, and aligning process development with regulatory expectations set by agencies including the FDA, EMA, and ICH.

Speakers

Dr. Bruce Kerwin and Dr. Eva Keilhauer explore how DP development integrates with clinical progression, emphasizing how phase‑appropriate characterization ensures safety, potency, and product quality as a therapy advances through human trials. They also address common pitfalls—such as overlooking physical stability issues or delaying formulation refinement—that can lead to costly setbacks. Overall, the session provides a comprehensive framework to help teams more effectively plan, de‑risk, and execute drug product development from early studies to commercial readiness.