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...
The idea of using CAR-T cell therapy for multiple sclerosis has moved from speculation to practical testing in the clinic. Early reports show that this therapeutic can be delivered safely, can reach the cerebrospinal fluid, and can produce changes in immune biomarkers that matter in progressive disease. This matters because B cells and antibody-producing cells...
In business, the adage is simple: what gets measured gets managed. We apply this rigor to our financial performance and operational efficiency, so why not to our patient-centricity efforts? For too long, the success of a clinical trial has been measured by a set of purely operational KPIs—enrollment rates, query rates, site activation times. While...
Anti-CD20 monoclonal antibodies like ocrelizumab have advanced MS treatment significantly and offered real hope to many patients. Yet, over time, their limitations have become harder to ignore, particularly when it comes to progressive forms of MS, where patients continue to accumulate disability despite treatment. Why Anti-CD20 Falls Short These therapies are highly effective at depleting...
For decades, the clinical trial industry has asked patients for their data, their time, and their bodies. It’s time we started asking for their expertise. True patient-centricity means shifting from passively collecting patient “input” to actively seeking patient “partnership.” This is most powerfully realized in protocol co-creation, where patients are given a seat at the...
For decades, patients with multiple sclerosis (MS) and other autoimmune diseases have relied on therapies that manage symptoms but rarely alter the long-term trajectory of disease. The arrival of Chimeric Antigen Receptor (CAR) T-cell therapy could change that paradigm. This advanced approach is demonstrating its potential to re-engineer the immune system, targeting the underlying causes...
