Featured Insights

  1. A Thoughtful Copay Program Design That Increased Patient Engagement 11/26/2024

    Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.

  2. A Year Of Reflection And Preparation 1/3/2025

    The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

  3. Unlock The Future Of Market Access In 2026: A Guide To Navigating A Shifting Healthcare Landscape 11/24/2025

    Navigating the future healthcare landscape requires early strategic planning and organizational agility to manage policy shifts. From AI implementation to global pricing dynamics, understanding these trends is essential for ensuring timely patient access.

  4. Pre-Launch Checklist - A Roadmap To Success 6/21/2024

    The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.

  5. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

    The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

  6. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

    Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

  7. Strategic Management Of The Mature Product Portfolio 4/7/2024

    Explore a new outsourcing paradigm that integrates expertise, regulatory knowledge, efficiency, and cost containment, moving beyond traditional low-cost offshore staffing models.

  8. Unraveling The Complexity Of Cell Therapy: Advancements And Challenges 11/26/2024

    Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

  9. 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.

  10. Evolving And Expanding Global Consulting With Local Expertise 2/3/2025

    Experts discuss global market expansion, emphasizing regulatory complexities, product lifecycle investments, and integrating local expertise to ensure successful product launches and long-term market sustainability.