INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• How To Leverage RWE To Facilitate Access To Cell & Gene Therapies

  As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.

• A Shared Opportunity: The Future Of Cell And Gene Therapy

  Find out why the commercialization of cell and gene therapies raises several complex conversations and questions for employers and payers. 

• Gene Therapy Competitive Dynamics: Winner Takes All?

  A one-time gene therapy treatment with the potential to cure patients could create a “winner takes all” dynamic, whereby second and later entrants for the same indication would have significantly smaller patient populations. The extent to this dynamic will occur will depend on how similar gene therapy treatments are considered by payers, KOLs, and physicians to be comparable.

• Cell & Gene Therapy Investment Outlook In 2022 & Beyond

  Cell and gene therapies are one of the most active areas of research and investment in the development of medicine. This article examines the current state of clinical development, investment, and financial performance of companies developing cell and gene therapies, and whether these conditions support the next wave of life sciences advancement or are indications of a biotech bubble.

• Scale Up And Process Development: Ask The Experts

  In this eBook, a panel of key thought leaders share their perspectives on current obstacles and future developments in scale up and process development.

• The 4 Trends Affecting Blockbuster Drug Status

  Although the billion-dollar mark will remain one of the principal benchmarks to define the success of pharmaceutical products, new indicators are emerging. This article looks at the drugs identified in Clarivate's Drugs to Watch series from 2015 and 2016, analyzing the trends and challenges that occurred over the past five years. The analysis identified these 4 key trends.

• Are You Leveraging KOLs For Biopharma Market Access As Much As You Could Be?

  Pharmaceutical companies spend a lot of time and effort engaging and collaborating with key opinion leaders (KOLs), an exercise typically owned by medical affairs. But few take advantage of network mapping tools and relationship-building principles from a market access lens to help inform and shape coverage strategies and identify access champions for their products.

• Cell And Gene Therapies: Solving Six Challenges

  This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

• 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.