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Pivotal Strategy: How to navigate regulatory landscape and operational considerations for pivotal readiness

18 Sep 2025
Cell Therapy Development
  • Are your processes and methods pivotal ready? What does readiness mean?
  • Do you have a regulatory strategy? Is it aligned with your development strategy?
  • Have you defined a Target Product Profile for commercial? What are the operational/cost considerations for pivotal? 
Industry Expert
Faraz Siddiqui, Senior Vice President, Technical Operations - Senti Bio