INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

  • What’s A Cure Worth? ICER Publishes Value Assessment Framework For Curative Therapies
    What’s A Cure Worth? ICER Publishes Value Assessment Framework For Curative Therapies

    The Institute for Clinical and Economic Review (ICER) recently conducted a study of value assessment methods considered for “cures” or “potential cures” and solicited input from international HTA bodies. The research will form the basis of a value framework that will be applied in the assessment of potential cures and other treatments that qualify as what ICER refers to as “single or short-term transformative therapies.”

  • Cell and Gene Therapy Commercialization Considerations
    Cell and Gene Therapy Commercialization Considerations

     

    As the cell and gene therapy landscape continues to mature, so too do the intricacies of commercialization. Inside the pages of this free collection of articles, you’ll find insightful data addressing the challenges critical for the sustainability of cell and gene therapy business models.

  • Establishing And Maintaining A Treatment Network For Your Cell And Gene Therapy Product
    Establishing And Maintaining A Treatment Network For Your Cell And Gene Therapy Product

    Delivering cell and gene therapies is an expensive and highly complex process, and there are a number of critical metrics that manufacturers should consider when selecting treatment sites. Subsequent activities — preparing sites to receive and initiate therapy, and managing site training and ongoing certification — can be equally, if not more, challenging.

  • 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.

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