The Value Of Agile Project Management In Pharma's Race To Market

By Andrea Oro, Vice President and Head of Business Development, and Rui Teixeira, Director of Operations, UQUIFA

Flexibility and agility in the face of uncertainty and complexity have become hallmarks of companies able to survive and thrive in today’s pharmaceutical industry. The increased focus on the unmet needs of smaller, targeted patient populations over the last decade has driven a paradigm shift toward novel drugs that must be produced in faster, more efficient facilities. As a result, drug companies must explore innovative technologies, methodologies, and business models in order to stay a step ahead of their opponents. Compounding this is the pressure on regulatory authorities to maintain proper oversight while not impeding progress and speed, especially in a post-COVID era where the entire world is waiting for effective treatments. Therefore, as regulatory policies for new drug development tighten and competition grows fierce, manufacturers must identify organizational strategies that can increase their flexibility, so they can keep pace with today’s market.

One such approach is agile project management, where the various planning stages of developing a drug substance and/or drug product are executed using a repeated cycle of operations. It focuses on continuous releases and incorporates customer engagement and feedback at every step along the way. Through cross-functional collaboration with integrated project teams, innovative solutions can be explored while simultaneously strengthening productivity, removing non-value added tasks, and reducing processes’ timelines.