Skip to content

Stylized cells, blue

Category: Preclinical & Clinical


From Lab to Landmark: What Europe’s First Nonprofit Gene Therapy Approval Means for the CGT Community

Part 25 of our Bridging the Gap Series (Summary of the webinar session held in December 2025) Editor’s note: Since this webinar, Waskyra has also received approval from the U.S. Food and Drug Administration (FDA), expanding access beyond Europe. One of the hardest challenges in cell & gene therapy (CGT) is determining how programs for ultra-rare diseases […]

From Discovery to Delivery: Building Smarter Regulatory Pathways for Cell and Gene Therapy

Part 24 of our Bridging the Gap Series (Summary of the webinar session held in November 2025) Access to life-saving cell and gene therapies depends not only on scientific breakthroughs but also on the systems that bring those breakthroughs to patients. Regulations, infrastructure, and collaboration across borders determine whether a therapy moves from the lab to the […]

Connecting the Dots in Cell and Gene Therapy: The Power of Shared Purpose and Patient Hope

Part 23 of our Bridging the Gap Series (Summary of the webinar session held in October 2025) The last decade has seen a revolution in the way cell and gene therapies are developed, delivered, and accessed. What began as pioneering work in bone marrow transplantation has evolved into a global ecosystem advancing engineered cell therapies that offer […]

Decentralizing CAR-T in Europe: Inside and Beyond Hospital Clínic de Barcelona’s ARI Program

Part 22 of our Bridging the Gap Series (Summary of the webinar session held in September 2025) Access to advanced therapies is often framed as a challenge of resources and infrastructure. But in Europe, a bold new model is reshaping how patients receive life-saving CAR T-cell therapy. Instead of relying solely on commercial manufacturing and centralized approval […]

Creating Accessible Cell and Gene Therapies — The World Can’t Wait

Part 21 of our Bridging the Gap Series (Summary of the webinar session held in August 2025) Providing access to transformative cell and gene therapies is one of the most urgent challenges in modern healthcare. These treatments offer the possibility of curing conditions once thought untreatable—yet in the United States, only a fraction of eligible patients are […]

The Urgency of Now: Accelerating Access to Cell & Gene Therapies

Part 20 of our Bridging the Gap Series (Summary of the webinar session held in July 2025) Access to life-saving cell and gene therapies is one of the most critical challenges facing healthcare today. While these therapies offer remarkable hope for patients battling life-threatening conditions like cancer and rare genetic diseases, the reality is that only a […]

The Goldilocks Goal in Long-Term Follow-Up for Cell & Gene Therapies: Finding the “Just Right” Approach

Part 19 of our Bridging the Gap Series (Summary of the webinar session held in June 2025) In the rapidly advancing world of cell and gene therapy, a single treatment can alter a patient’s life trajectory. But what happens after the initial success? For many, the journey is just beginning. Long-term follow-up (LTFU) is not just a […]

It Takes a Team: Lessons from the Beautiful Game for Cell and Gene Therapy Access

Part 18 of our Bridging the Gap Series (Summary of the webinar session held in May 2025) Access to advanced therapies that can fundamentally alter disease trajectories is one of the most pressing frontiers in healthcare. Among them, cell and gene therapies offer unprecedented hope for millions, especially those grappling with rare, chronic, or previously untreatable conditions. […]

From Philly to Rio: International Collaboration on CAR T-Cell Manufacturing & Delivery Brings Costs Down

Part 17 of our Bridging the Gap Series (Summary of the webinar session held in April 2025) Across the globe, access to life-saving cell and gene therapies like chimeric antigen receptor (CAR) T-cell therapy remains largely limited to wealthier nations and well-resourced health systems. While the clinical outcomes of these therapies can be extraordinary—offering cures for certain […]

A New Era for Mesenchymal Stem Cell Therapies: What the FDA Approval of RYONCIL Means for the Field

Part 16 of our Bridging the Gap Series (Summary of the webinar session held in March 2025) Mesenchymal stem cells (MSCs) have long shown promise in regenerative medicine, with the potential to treat everything from heart disease to autoimmune conditions. But for decades, MSC therapies struggled to move beyond early-phase clinical trials and regional approvals. That changed […]