Bringing a therapy from clinical development to commercial reality is one of the most complex (and least forgiving) transitions in the product. What begins as a highly controlled, often manual clinical supply chain must evolve into a scalable, globally coordinated operation capable of consistent patient delivery under strict regulatory expectations.

For emerging and established biopharma companies alike, the challenge is to build the operational discipline, infrastructure, and cross-functional alignment required to sustain that growth. From establishing standardized processes and real-time visibility to managing global logistics networks and performance metrics, commercialization demands a different approach.

According to Bianca Gustafson, Senior Director of Program Management at Cryoport Systems, success in this transition hinges on treating commercialization as a strategic, program-driven effort that begins early in development. With extensive experience overseeing clinical and commercial programs, Gustafson brings a practical perspective on how disciplined program management and scalable partnerships can help organizations navigate increasing complexity and deliver reliably at scale.

In this Q&A, Gustafson shares insights on how companies can bridge the gap from clinical proof of concept to commercial readiness and the critical role that structured program management plays in making that transition successful.

Contract Pharma: What are the most common supply chain risks companies underestimate when moving from early-phase trials to commercial readiness?

Bianca Gustafson: From a program management standpoint, the most underestimated risk is the shift…