Speed Without Compromise: CRO Flexibility

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...

The High Stakes of Picking the Wrong CRO in Allogeneic Development

Choosing an adequate CRO for an allogeneic cell therapy trial is a critical decision that can determine the success or failure of a program. Allogeneic cell therapy is one of the most exciting frontiers in medicine, offering the promise of “off-the-shelf” treatments that could transform oncology and beyond, but this promise comes with an exceptionally...

Why Agility is the New Gold Standard in Allogeneic CAR-T Trials

The field of oncology is undergoing a dramatic transformation, driven by the rise of cell therapies. For years, the gold standard was autologous CAR-T therapy, a groundbreaking approach that uses a patient’s own modified immune cells to fight cancer. But while incredibly effective, this method is plagued by logistical and manufacturing hurdles. It’s a slow,...

The Festival of Biologics in San Diego – through our Accelsiors lens

This year, Accelsiors had the unique opportunity to participate in the Festival of Biologics USA, held at the San Diego Convention Center on April 23–24. With over 1,500 participants and exhibitors from around the world, the Festival was an inspiring experience, offering opportunities for growth, raising Accelsiors’ visibility, and establishing many valuable new connections. The...

Biomarkers in Drug Development: Transforming Clinical Trials for Neurodegenerative Diseases

The Role of Biomarkers in Accelerating Drug Development Imagine developing a new drug for Alzheimer’s disease (AD)—only to discover halfway through clinical trials that many participants didn’t actually have the (right) disease pathology. This costly mistake is exactly why biomarkers are reshaping neurodegenerative disease drug development.  Biomarkers in clinical trials help researchers:  Identify the right...

Biosimilars on the Brink of Transformation: What EMA’s 2025 Vision and FDA Insights Mean for You

Are you ready for the next big shift in biosimilar development?  The biosimilar landscape is evolving at lightning speed, driven by groundbreaking regulatory updates from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The EMA’s 2025 reflection paper introduces a tailored clinical approach that promises to streamline biosimilar development, while...