Now Available On Demand: Preventing Advanced Therapy Program Delays with Early Supply Chain Strategy
Advanced therapy programs move through development under intense pressure. Teams are working to reach the clinic, generate data, satisfy regulatory expectations, scale operations, and ultimately deliver therapies to patients who may have limited or no other options. In that environment of competing priorities, all of which are important at the same time, supply chain decisions can become easy to defer.
But as a recent roundtable webinar with XTalks made clear, decisions around cryopreservation, logistics, packaging qualification, site readiness, and documentation are not just operational details that can be solved later. The supply chain decisions made in the early stages of development can shape a program’s regulatory path, the scalability and cost of therapies, and the ability of the program to progress into commercialization and effectively serve a wider patient population.
Featuring perspectives from Gwendolyn Erskine, Senior Director of Consulting Services at Cryoport Systems, Dominic Clarke, Associate Chief Scientific Officer of Cryoport, Inc. and Vice President of IntegriCell® Technical Operations at Cryoport Systems, and Lorraine Hicks, an industry expert with extensive experience supporting cell and gene therapy programs across global regulatory pathways, the roundtable explored how early planning can help advanced therapy developers avoid late-stage friction.
The on-demand session explores practical questions that advanced therapy teams should be asking earlier, including:
- When should logistics considerations become part of site feasibility?
- How can teams balance phase-appropriate rigor without over-engineering too early?
- What are the risks of starting with fresh material, and when might that approach still make sense?
- How can cryopreservation decisions affect scalability and comparability?
- What documentation should teams capture before regulatory scrutiny increases?
- How long do shipping qualifications really take?
- Which internal and external stakeholders need to be aligned before a program advances?
The discussion also addresses common pitfalls, including underestimating shipping qualification timelines, assuming a process can be fixed later, failing to involve commercial teams early enough, and overlooking the real-world complexity of moving critical materials across sites, regions, or borders.
The full webinar, “Prevent Advanced Therapy Program Delays with Early Supply Chain Strategy,” is now available for on-demand viewing.
Watch the replay to hear the complete roundtable discussion and learn how early supply chain strategy can help advanced therapy teams reduce risk, support regulatory readiness, and prepare for scalable clinical and commercial execution.
