INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• CAR T-Cell Therapy In Non-Hodgkin’s Lymphoma: Where Do We Go From Here?

  Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, many key players are now pursuing development of therapies in earlier treatment settings and in other non-Hodgkin’s lymphoma subtypes, such as mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.

• Planning For Commercial Success – Best Practices For Designing Cell & Gene Therapy Clinical Trials

  Cell and gene therapy applications have, in the last three years, made the jump from pure research products to commercialized products with high clinical efficacy, particularly for hematologic malignancies. This webinar elaborates on how to design early development programs and clinical trials for CGTs to ensure that the product can be commercialized successfully in all target markets i.e. can be reimbursed and adopted successfully despite small patient numbers, rare diseases, complex administration etc.

• Mandatory Hub For Orphan-Designated Pediatric Therapy

  UBC successfully provided Hub services to ease the barriers to access and simplify a very complex treatment initiation in pediatric patients suffering from SMA.

• Pricing Reimbursement Recap From Meeting On The Mesa

  At last month’s Meeting on the Mesa, ARM’s annual can’t-miss event, attendees were treated to insightful keynotes, panel discussions, and breakout sessions that covered all the major topics impacting the cell and gene sector. One such plenary discussion, moderated by Audentes’ Chairman and CEO, Matt Patterson, was particularly valuable in that the panelists offered insight on their companies’ path to commercialization.

• 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

  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

  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

  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

   

  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

  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.