Navigating CMC Requirements For Accelerated Development

By Jakob Bonde, Head of Regulatory Affairs, Small Molecules, and Jacqueline Hargis, Ph.D., Head of Supply Chain and Program Management, Lonza

INTRODUCTION

In pharmaceuticals, time is money, particularly when it comes to product launch. Experts estimate that launch delays can cost companies an average of $15 million per drug per day.1 Given the high stakes and competitive landscape, companies need to develop strategies early in the development process to minimize the possibility of launch delays and maximize speed to market, so crucial new therapies can reach patients quickly, patent life can be maximized, and market share can be enhanced.

Chemistry, manufacturing, and control (CMC) activities are critical to the effort of moving promising new drug products to market quickly and efficiently. This summary addresses how careful planning and early integration of an effective CMC strategy, plus choice of the right partner, contributes to project success. A case study is provided to show the results of effective use of these CMC strategies.