The North Highland Life Sciences team recently attended the Advanced Therapies USA Conference in Philadelphia, where industry leaders explored the operational, regulatory, and strategic challenges shaping the future of cell and gene therapy. Across sessions, speakers emphasized a shared priority: translating breakthrough science into scalable, reliable delivery that reaches more patients.
Key Takeaways from Advanced Therapies USA 2025:
Across discussions on regulatory strategy, manufacturing innovation, and workforce development, several consistent themes emerged from the conference:
- Regulatory pathways are expanding, but expectations for evidence and manufacturing maturity remain high
- Manufacturing scalability is achievable, but supply chain infrastructure and workforce readiness remain significant constraints
- Cross-functional alignment between clinical development, regulatory planning, and operational strategy accelerates patient access
- Real-time quality systems and AI-enabled verification reduce bottlenecks and delays
- Transformation, not optimization, is required to scale from thousands to millions of patients
Scaling to One Million Patients: Cross-Industry Lessons for Cell & Gene Therapy
A standout session featured North Highland’s Frank Orlowski, Managing Director, and Erik Singleton, Senior Director, who challenged the industry to rethink how scale is achieved. Drawing inspiration from proven strategies from retail, automotive and agriculture, they demonstrated how approaches from other sectors can help the field move from roughly 40,000 patients treated to the million-plus needed in the next decade.
While scientific progress has been remarkable, gene-modified cell therapies remain constrained by high-cost, low-throughput operational models. Orlowski and Singleton emphasized that solving this challenge requires borrowing playbooks from industries that have already mastered personalized production at scale.
Their session outlined three core strategies:
- Build modular manufacturing systems. Postpone customization by producing pre-kits at scale and adding patient-specific cellsonly when treatment is confirmed. Borrowed from one of the top Fortune 500 retail brands this approach can reduce vein-to-vein time.
- Plan from one integrated forecast. Align patient authorization data, hospital bed availability, and raw material supply into a single planning rhythm. Thiseliminates silos and can cut planning cycles in half.
- Make quality instantaneous. AI-enabled vision systems allow verification in real time instead of after productionwhich can reduce QA release time.
Orlowski and Singleton stressed that incremental optimization will not close the gap between 40,000 patients and one million. Achieving meaningful scale requires transformation. Companies serious about owning this market need to redesign their value chains, not just improve existing processes.
Scaling cell and gene therapy depends on more than scientific innovation. It requires operational transformation, integrated planning, and proven strategies drawn from industries with experience in personalized production at scale.
North Highland’s Supply Chain and Life Sciences teams partner with cell and gene therapy organizations to design scalable value chains and build systems that help turn breakthrough science into accessible treatment.
Ready to scale your cell and gene therapy operations? Explore our Cell Therapy expertise or connect with our Testing Excellence team.
