INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

  • Gene Therapy: Commercial Challenges And Strategic Choices
    Gene Therapy: Commercial Challenges And Strategic Choices

    Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

  • What Risks Do Annuity Pricing Models Present To Cell & Gene Therapy Developers?
    What Risks Do Annuity Pricing Models Present To Cell & Gene Therapy Developers?

    Over the past four decades, and especially in recent years, progress in the development of cell and gene therapies has reached unprecedented levels. In gene therapy alone, between 1989 and 2015 there were more than 2,330 clinical research programs targeting almost 50 different indications.1,2 As more cell and gene therapies reach commercial stage, industry insiders expect research in the sector to continue to expand in the coming years. For patients, clinicians, and health systems, new cell and gene therapies bring the promise of historic and transformative advances in the treatment of many serious diseases. 

  • Translating Biopharma Knowledge To Cell And Gene Therapies
    Translating Biopharma Knowledge To Cell And Gene Therapies

    Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

  • Cell Therapy Manufacturing Under GMP - How And When To Get Started
    Cell Therapy Manufacturing Under GMP - How And When To Get Started

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

  • Demonstrating Value And Securing Patient Access For Cell And Gene Therapies
    Demonstrating Value And Securing Patient Access For Cell And Gene Therapies

    Because the parameters for ex vivo cell and gene therapy manufacturing differ considerably from chemical drug production, life sciences companies are likely to encounter challenges along key stages of the product life cycle.

  • ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes
    ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  • 6 Regulatory Changes Affecting Bioprocessing In China
    6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  • Critical Considerations About The Future Of Global Cell Culture Bioprocessing
    Critical Considerations About The Future Of Global Cell Culture Bioprocessing

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  • 4 Strategies For Success In The CAR-T 2.0 Marketplace
    4 Strategies For Success In The CAR-T 2.0 Marketplace

    As the second wave of CAR-T therapies begins coming to market in the next five years, their manufacturers will need to anticipate and prepare to address many of the same commercial challenges as their predecessors, as well as several additional ones.

  • Designing Gene Therapy Trials For Access: What Payers & Health Systems Want To See
    Designing Gene Therapy Trials For Access: What Payers & Health Systems Want To See

    Gene therapy may be the next revolution in healthcare. The opportunity to cure diseases through the modification of the genome was once considered science fiction, but no longer. The United States has seen a few approvals in this area, including the approval of voretigene neparvovec for a rare form of blindness. In addition, CAR-T agents, two of which are available, have demonstrated alternative ways to treat disease by manipulating genes of different cells.

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