INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• C&GT's : A Roadmap To Solving 6 Challenges Over The Next Decades

  This past year has seen remarkable progress in the growth of C&GT's. Advances in cell reprogramming, genetic editing, and manufacturing mean affordable C&GT's will be available for a range of diseases and uses. However, the pathway ahead will need planning. This article reviews six major issues affecting the C&GT space and provides recommendations for companies to be successful.

• CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward

  In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.

• Guide To Transitioning Clinical Cell Therapy Manufacturing To Commercial Scale

  More and more CGT manufacturers are focusing on automating and closing unit processes earlier in the developmental cycle. This saves significant time, increases efficiency and reduces cost. In this paper, we discuss the automation strategies that CGT manufacturers should consider during this transition. We also provide a manufacturing roadmap that can improve manufacturing efficiencies along the developmental journey.

• Shaping A System That Enables Patients To Access High-Cost Cell & Gene Therapies

  The health and life sciences industry needs to create an effective financial system to support the complex new payment structures being adopted for cell and gene therapies.

• Gene Therapy For Rare Disorders Panel Summary

  A panel of industry experts share updates on their current pipelines, development process, and discuss of their unique experiences and lessons learned in leading early-stage gene therapy companies.

• Payers Create CAR-T Approval Systems As Adoption Increases

  Spurred by CMS’s decision to cover CAR-T cell therapies under Medicare, commercial payers are beginning to systematize approvals for CAR-T treatment as use of these breakthrough cancer therapies is beginning to ramp up. In this article experts weigh in on factors driving authorizations now and what to expect as more CAR-T therapies are approved.

• A Maverick Gene Therapy Manufacturing Strategy

  Sio Gene Therapies CEO Pavan Cheruvu explains the company’s rationale for migrating away from a hybrid in-house/CDMO manufacturing model to a fully insourced one. 

• Innovation: Shortening The Path To Commercialization In Advanced Therapies

  In this Precision ADVANCE panel, industry experts share perspectives on the current state of the cell and gene therapy industry and provide key insights in shortening time-to-market for advanced therapies.

• The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers)

  What's ahead for gene therapy in the next decade? This article highlights six key questions and recommendations for the future of the industry. For example, what technologies should gene therapy companies evaluate beyond delivery vehicles, and how should a gene therapy be priced?

• How Cell And Gene Therapies Are Reshaping Commercialization Strategies

  In this webinar, Carolyn Morgan of PRECISIONeffect moderates an expert panel exploring the challenges of commercializing a cell or gene therapy from industry trailblazers that share lessons learned from prior launches and discuss how cell and gene therapies are reshaping commercializing strategies. Some of the topics explored will be tensions between cost-effectiveness and affordability, evidence generation strategies and development, and communication to payers and health technology appraisal organizations.