Stefanie Walther | VP Immunology, Cell and Gene Therapy
Novartis

Festival of Biologics Day 2 @ 14:30

Commercial Considerations for CAR-T Therapy: Lessons Learned from Recent Blockbusters

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• Key barriers for commercialization on a global level: CAR-T Manufacturing complexity, vein-to-vein logistics infrastructure, treatment centre qualification requirements, and multi-dimensional market access challenges that extend beyond traditional reimbursement

• Success factors: Strategic early investments in quality operations and supply chain excellence, creation of new customer-facing roles (cell therapy coordinators, specialized medical liaisons), and cross-functional integration from manufacturing to patient support

• Core elements for launch roadmap: Scalable manufacturing capacity with built-in redundancy, centre of excellence network development 18-24 months pre-launch, flexible payer contracting models, and operational excellence systems for real-time cell tracking and patient journey management

Stefanie Walther, VP Immunology, Cell and Gene Therapy, Novartis

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Stefanie Walther / Commercial Considerations for CAR-T Therapy: Lessons Learned from Recent Blockbusters

Stefanie Walther, VP Immunology, Cell and Gene Therapy,
Novartis

Dr. Stefanie Walther is VP, Disease Area Head for Immunology, Cell & Gene Therapy at Novartis, leading commercial strategy for innovative therapies including CAR-T in severe autoimmune conditions on a global level. With 20+ years in pharmaceutical commercialization and medical, she previously...

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