Cell and Gene Commercialization

  1. Arcellx On Designing A Dynamic CAR-T 3/13/2025

    Arcellx's CMO and CTO talk about the company's platform technology, its partnership with Kite, and preparing its lead asset, anito-cel, for commercial launch.

  2. Navigating Patient Access Challenges In Commercializing Your CGT Product 3/10/2025

    Learn how to effectively break down barriers to patient access in cell and gene therapy by enhancing provider education, streamlining coordination, and expanding patient support.

  3. 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.

  4. The United States' Pioneering Role in Cell and Gene Therapy 2/10/2025

    The United States has been a pioneer in cell and gene therapy and continues to dominate it, driven by its public and private institutions, research advancements, and strong investor support.

  5. Reflecting On A Milestone Year For Cell And Gene Therapies 2/3/2025

    Examine the significant CGT advancements in 2024, including new approvals for solid tumors and diabetes treatments, as well as the role of AI and logistical improvements in scaling these therapies.

  6. The Evolution Of Cell And Gene Therapy: Pioneering Breakthroughs For A New Era In Medicine 1/30/2025

    This article explores the rapid evolution of cell and gene therapy (CGT), highlighting its expansion beyond hematology and oncology into autoimmune and metabolic diseases, emphasizing the need for safety, patient access, and a collaborative, knowledge-sharing approach to accelerate innovation and ensure broader therapeutic impact via the "Knowledge Research Organization."

  7. Catalysts of Change: How the Cell and Gene Therapy Market Has Evolved 1/28/2025

    Since 2021, the CGT market has continued to grow, but challenges remain, especially with regard to regulatory compliance.

  8. Know Your Product, Know Your Path: A Primer On Advanced Therapy Development 1/16/2025

    To prevent path-to-market setbacks, it is critical to develop a CMC strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

  9. New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings 1/15/2025

    To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

  10. 2025 Forecast For Advanced Therapies 1/8/2025

    As we reflect on the lessons from 2024, it’s time to consider what 2025 may hold for the industry. Special attention is given to oligos, mRNA, cell therapies, and AAV.