Drug Development Readiness: Interactive Checklist And RACI

Drug development is a complex, multidisciplinary process where scientific excellence alone is not enough to ensure success. Achieving robust development plans requires timely, coordinated input from experts across research, clinical, regulatory, CMC, project management, intellectual property, and commercial functions.

This resource helps organizations identify the right expertise, at the right stage, to make informed decisions that reduce risk, avoid costly delays, and improve the likelihood of success. The RACI Matrix provides a structured framework for defining cross-functional roles and responsibilities, while the Readiness Checklist helps assess whether the necessary expertise is engaged, aligned, and contributing effectively throughout development. Together, these practical tools promote integrated planning, minimize downstream rework, and strengthen collaboration from early discovery through late-stage development.

Developed with antibody programs as a reference and in collaboration with Marta Kijanka, Ph.D., they provide adaptable guidance to support successful drug development programs and informed decision-making across multidisciplinary teams.