INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

  • Developing Novel Policy Proposals To Support Access To Gene And Cell Therapies
    Developing Novel Policy Proposals To Support Access To Gene And Cell Therapies

    The decades-long focus on more “personalized” medicines has paved the way for the recent and anticipated advances in gene and cell therapies and progress in many other areas. The first generation of gene and cell therapies has the potential to transform the way we treat some diseases and can bring new hope to patients with many rare and serious conditions.

  • CAR T-Cell Therapies: Current Limitations & Future Opportunities
    CAR T-Cell Therapies: Current Limitations & Future Opportunities

    Novel technologies to address areas left unaddressed by Kymriah and Yescarta have started streaming into the research arena. This article focuses on the barriers to widespread commercial adoption of the currently available CAR T cell therapies, and opportunities for developers of next-generation treatments.

  • A Strategy to Drive Down Therapy Costs: Manufacturing Improvements
    A Strategy to Drive Down Therapy Costs: Manufacturing Improvements

    Indeed, earlier this year at World Advanced Therapies & Regenerative Medicine (WATRM) Congress in London, it was predicted that manufacturing will be a major future differentiator between therapy companies. I spoke to Dr. Paul Lammers, MD, MSc, president, CEO, and Director of Triumvira Immunologics about the therapy pricing and manufacturing’s role in it.

  • 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.

More On Commercialization Issues