Featured Insights

  1. Navigating Regulatory Complexity In CGT Development, Commercialization 5/28/2025

    To successfully commercialize cell and gene therapies, understanding evolving US regulatory mandates is key. Consider these strategies to avoid delays and ensure compliance.

  2. Addressing Market Access Challenges As CGTs Expand To Larger Patient Populations 5/1/2025

    Navigating market access for advanced therapies requires new strategies. Explore ways to boost payer understanding, innovate pricing, and adapt treatment settings as these therapies expand.

  3. The Future Promise Of Advanced Therapies In Ophthalmology 3/17/2025

    Six years after the first approved gene therapy in ophthalmology, the field is experiencing a surge of activity. Delve into the exciting potential of advanced therapies for eye diseases.

  4. Navigating Patient Access Challenges When Bringing Your CGT Product To Market 2/24/2025

    Bringing cell and gene therapies to market requires more than scientific breakthroughs; manufacturers must navigate complex patient access challenges to ensure these innovations reach those in need.

  5. Optimizing The Channel Strategy To Expand Patient Access 1/17/2025

    Patient access depends on a well-planned channel strategy. Explore key considerations for optimizing distribution, logistics, and patient support in the evolving cell and gene therapy landscape.

  6. Insights From The FDA's New FAQ 12/17/2024

    The FDA's new FAQ offers crucial insights into best practices, from regulatory meetings to quality control and preclinical studies. Dive in for expert guidance.