By Abigail Hisler, Global Director of Strategic Marketing, Biologics
Emerging companies are often disadvantaged compared to established drug manufacturers, taking two years longer to get to market and receiving complete response letters (CRL) at 38% higher rates.1 Longer development times and higher CRL rates can have significant negative repercussions such as additional clinical trials, rework, and delays, resulting in increased costs and potential lost future business.
With countless activities to manage, new companies may underestimate the complexity of selecting the most suitable packaging system or may not have the available resources. Packaging development may be deprioritized or delayed until Phase II or III or maybe deferred to an outsourcing supplier such as a CDMO. Regardless of a company’s size, recognizing the importance of packaging development and prioritizing its role in drug development early on can help you proactively identify events that could delay your timelines and prepare you to develop strategies to overcome these risks.