Leading by Example

In a video interview with Pharma Commerce, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been largely resolved, with organizations now demonstrating clear strategies, scalable capacity, and well-vetted supply chains. Regulatory hurdles have also been substantially addressed, and most companies are effectively engaging primary launch sites, especially major academic medical centers, ensuring they are trained and ready for product deployment.

However, several persistent challenges remain. Reimbursement, particularly in Europe, continues to be a major hurdle—even for mature companies with marketed therapies. Another notable issue is physician education, especially outside of large teaching hospitals. Many community-based physicians lack a deep understanding of cell and gene therapies, creating a barrier to broader adoption.

Sawicki also pointed to community care engagementas an area needing attention. While major centers are prepared, regional and community sites are lagging in terms of readiness and support. According to available market data, current therapies are reaching only about 20% of the addressable patient population in the United States and Europe, with even lower uptake globally.

Finally, standardization of processes, particularly across clinical sites and within supply chain systems, remains an issue. Inconsistent procedures and infrastructure gaps at these levels hinder the ability of sites to fully support these complex therapies. Addressing these shortcomings will be critical to expanding access and realizing the full potential of cell and gene therapy worldwide.

Sawicki also comments on how supply chain expectations have shifted amid tighter funding, FDA leadership changes and evolving CMC standards; the critical role of cryopreservation, real-time logistics data and AI-enabled fulfillment in protecting product integrity and patient outcomes; what pharma leaders can borrow from CGT’s operational playbook to improve resilience across therapeutic areas; and much more.

A transcript of his conversation with PC can be found below.

PC: What lessons can pharma leaders in traditional therapeutic areas learn from CGT’s highly specialized operational strategies, particularly in terms of supply chain resilience and adaptability?

Sawicki: Well, I think you have to take a step back and look at the broader pharmaceutical market. If you look at the trend in the active therapeutics that are in development, the vast majority of them have shifted into a temperature-controlled format, so biologics have had a huge expansion. You’ve got things like buy specifics, you've got all sorts of new modalities that are coming out, but almost all of them have a temperature-control requirement associated with them. With cell and gene, there's really extreme rigor around the temperature management and product management in the field because it's patient-specific material that's irreplaceable.

A lot of those learnings that have been gained over the last 10 years or so in the cell and gene space—as it relates to risk management, temperature-controlled considerations, qualification and validation of thermal packaging—all of those things are paying benefits back to the broader space today, in particular with reducing scrap rates, reducing risk, and also, the value of decentralized depots, so to speak. Instead of having one large depot that distributes all product out, they're going to more regional formats, which will help them, I think, over time, in expansion of those therapeutic classes into lesser developed areas/emerging markets. I think all of those things will pay benefits over time to the broader market.