As the year draws to a close, many clinical development and operations teams are stepping away from day‑to‑day delivery and taking a longer view of what lies ahead. Pipelines are being reviewed, protocols revisited, and assumptions quietly questioned. In steatotic liver disease (SLD) development, one shift has moved during 2024–2025 from terminology debate to operational...
After exploring the complex legal, financial, and operational barriers stalling European clinical trials, the natural question is: What’s being done about it? Fortunately, the response is not silence. The EU-X-CT initiative, a multi-stakeholder consortium of industry leaders, patient advocates, and academic experts, has developed a pragmatic and targeted 6-Point Action Plan. This is the official blueprint designed to dismantle the barriers...
After six weeks of examining the role of CAR-T cell therapies in autoimmune disease, one thing is clear: this therapy is far more than an incremental step. It has the potential to reshape how we treat progressive MS and other difficult-to-manage conditions, offering possibilities that once felt out of reach. The Scientific Promise CAR-T cell...
In the first two parts of our series, we established the business risks and the profound human cost of Europe’s fragmented clinical trial landscape. Now, we look under the hood at the specific legal and regulatory gears that have seized up, creating this challenging environment for biotech innovators. The core of the problem is a...
Autologous CAR-T cell therapies have shown remarkable proof of concept, but a pressing question remains: can they ever be scaled to treat widespread diseases like MS? While the science is compelling, today’s manufacturing models come with steep challenges in cost, complexity, and time. To bring CAR-T cell therapies into a broader future, innovation will be...
Imagine a patient in Lisbon diagnosed with a rare form of melanoma. Their local treatment options have been exhausted. Their physician discovers a promising Phase I trial, a potential lifeline, but the site is in Munich, nearly 3,000 kilometers away. Last week, we discussed the clinical trial statistics that keep biotech executives awake at night....
The European Union presents a frustrating paradox. It is a global powerhouse of scientific intellect, advanced healthcare, and pharmaceutical investment, yet it is steadily losing its footing as a leader in clinical research. For the agile, emerging biotech companies on the front lines of innovation, this isn’t just an academic observation—it’s a clear and present...
CAR T therapy has immense potential in autoimmune diseases like multiple sclerosis, but safety remains the central concern that guides every decision. The objective is to build a development pathway that anticipates risk, manages complications promptly, and maintains therapeutic intent. Real progress depends on disciplined planning, clear decision rules, and consistent measurement that allow teams...
The clinical research industry stands at an inflection point, facing a choice between two distinct futures. The first path is “friendliness.” It’s the continuation of the status quo, softened by cosmetic improvements and well-intentioned gestures. This path accepts the underlying drivers of failure—burdensome protocols that lead to an average 30% patient dropout rate—as unavoidable costs...
