Can Regulatory Affairs Personnel Add Value When the Goal is Increasing Speed of Drug Development?

Abstract

Regulatory affairs professionals must contribute to higher speed drug development. This contribution is essential for competitive reasons and is fully consistent with meeting the needs of the technical professionals (both inside sponsor organizations and inside the Food and Drug Administration [FDA]) who are served by regulatory affairs professionals. Regulatory affairs personnel must actively seek and recognize opportunities to speed up development programs, especially at the pre-investigational new drug (IND) and early IND stages. In these early stages of investigation, enhanced speed and improved decision making can enable sponsors to make judicious choices and only proceed to invest in Phase III (ie, the most expensive phase of development) for the most promising drugs. This paper presents a discussion of the major approaches to enhancing speed, including watchful observation of the interdependencies among technical disciplines, careful assessment and periodic reassessment of the assumptions as the program evolves, and active contingency planning.