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...
When the single biggest reason for patient dropout is the burden of travel, continuing to design every trial around a physical clinic isn’t just inefficient—it represents a systemic failure to meet patients where they are. Decentralized Clinical Trials (DCTs) are often discussed as a technology trend, but this view misses the point entirely. DCT is...
Biotech companies are increasingly turning to specialized contract research organizations (CROs) to handle their clinical trials, especially for complex and innovative therapies like allogeneic CAR-T. While large, traditional CROs have long been the industry standard, their one-size-fits-all model often creates significant risks for the unique needs of biotech firms. The high-stakes nature of groundbreaking research...
Many clinical trials today treat patient burden with kid gloves—offering comforts and courtesies to soften the blow of a fundamentally flawed process. But what if we stopped trying to soften the blow and instead focused on removing the barrier entirely? This is the critical difference between accommodation and re-engineering. Accommodation (The “Kid Gloves” Approach): This...
CAR-T therapies have already redefined treatment options in hematologic cancers, and today the same innovation is beginning to transform the way we approach autoimmune diseases such as systemic lupus erythematosus (SLE) and myasthenia gravis. The industry’s pivot from autologous to allogeneic, “off-the-shelf” CAR-T therapies represents more than just a scientific breakthrough—it’s a new paradigm in...
Nearly 80% of clinical trials fail to enroll on time. Behind this number are delayed treatments and missed opportunities for patients. Too often, the terms friendly and patient-centric are used interchangeably. Friendliness—kind staff, a welcoming waiting room, simplified language—makes participation more pleasant, but true patient-centricity is something far deeper. It is a paradigm shift that...
Navigating the regulatory landscape is one of the most crucial, and often most complex, steps in bringing innovative allogeneic CAR-T therapies to market. For biotech companies pioneering the next wave of off-the-shelf treatments, having a dedicated, expert-led regulatory team—your “dream team”—can be the decisive factor that determines whether your therapy reaches patients swiftly or faces...
In the rapidly evolving landscape of cell therapy, particularly with the rise of allogeneic (“off-the-shelf”) CAR-T treatments, agility and expertise are no longer optional—they are essential. Traditional large CROs, while proven at scale, often fall short when it comes to the nuanced, high-stakes demands of pioneering therapies that are redefining medicine. That’s where CRO flexibility...
