Blogs

  1. Essential Strategies For Mastering CMC And Avoiding CRLs For CGTs 10/16/2025

    CGT developers face rising regulatory challenges around potency, stability, and process control. Find out how proactive planning, expert guidance, and early FDA engagement are key to avoiding delays.

  2. Why CMC Is A Key Sticking Point For CGTs And How To Meet FDA Expectations 10/2/2025

    FDA scrutiny of CMC for cell and gene therapies is high. Learn common pitfalls—like issues with potency and comparability—and gain actionable strategies to meet regulatory expectations and reduce risk.

  3. Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success 9/24/2025

    The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.

  4. Navigating Commercial Logistics: Key Considerations For Emerging CGT Manufacturers 8/27/2025

    A successful cell and gene therapy launch requires a logistics strategy that keeps patients at the center, plans for disruptions, and prepares for future growth and global expansion.

  5. Discover The Path To Oncology Success 8/22/2025

    The oncology landscape is brimming with innovative therapies and new treatment approaches. Successful commercialization requires a well-orchestrated strategy to bring these complex products to market.

  6. Don't Let Distribution Derail Your CGT Launch 8/7/2025

    Overcoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access.

  7. Optimizing Commercial Distribution As You Prepare To Launch Your CGT 7/29/2025

    An effective commercial distribution strategy is crucial for new cell and gene therapies, helping manufacturers navigate challenges and ensure patient access.

  8. Navigating The CGT Supply Chain: Key Logistical Challenges And Solutions 7/16/2025

    Commercializing cell and gene therapies requires overcoming complex logistical hurdles. Customized strategies for temperature control, compliance, and end-to-end delivery are crucial to prevent supply chain issues.

  9. Creating A Compliant And Scalable CGT Logistics Launch Plan 6/12/2025

    As cell and gene therapies advance to commercialization, biopharma companies face immense logistical hurdles. A customized, end-to-end strategy is crucial for ensuring product integrity and market success.

  10. ThinkLive Cell and Gene Therapy Summit 2025 Summary 6/11/2025

    From patient support to intricate logistics, ThinkLive CGT Summit 2025 leaders tackled the essential commercial strategies needed to deliver these innovative therapies to patients globally.