Why do so many drug development programs lose momentum as they transition from product development into clinical manufacturing?

This white paper explores the often-overlooked disconnect between formulation development and GMP execution that can lead to delays, inefficiencies, and frustration for sponsors. Drawing on industry observations and conversations with sponsors, it highlights how these challenges are frequently rooted not in science, but in organizational structure, communication, and operational handoffs.

By comparing traditional task-based operating models with integrated program-based approaches, the paper examines how cross-functional alignment, early GMP planning, continuous knowledge management, and technical continuity can dramatically improve clinical readiness and manufacturing success.