Featured Insights

  1. Cell And Gene Therapy Commercialization Handbook 11/24/2025

    Bringing advanced therapeutics to market requires overcoming hurdles in regulation, logistics, and reimbursement. Learn how to coordinate supply chains and implement adaptive strategies for long-term commercial success.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  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. 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.

  9. Sterility Assurance With Louise Ui Fhatharta 1/17/2025

    This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.

  10. Navigating The Cell And Gene Regulatory Landscape 10/3/2024

    Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.