INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

  • Cost Of Healthcare And Biopharma Implications
    Cost Of Healthcare And Biopharma Implications

    The pharmaceutical industry’s success has become something of a double-edged sword, and our healthcare systems are burdened with the costs of lifestyle challenges. Everyday businesses and healthcare professionals must work diligently to improve our quality of life, but pricing and access will continue to be a battle globally that the industry must take note of.

  • Virtual Patient Registries: Real-World Evidence For Cell And Gene Therapies
    Virtual Patient Registries: Real-World Evidence For Cell And Gene Therapies

    In recent years, cell and gene therapies have been generating highly promising results in clinical studies, advancing them toward the market. However, the small number of products launched to date have not been proven commercial successes, with a number of advanced therapies being withdrawn from the EU market and limited sales of CAR-T therapies in the U.S.

  • Establishing Data Models To Support Cell And Gene Therapy Adoption
    Establishing Data Models To Support Cell And Gene Therapy Adoption

    Cell and gene therapy offers extended-term relief from disease states but comes at high cost with a complex reimbursement model. What proportion of intervention costs should be levied up front, and what proportion can be phased into the future (when the patient benefits accrue and are proven)? Separating the payment timeline from the treatment schedule is often referred to as outcome-based costing.

  • 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.

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