Author: jacob

A newly launched Phase I trial from the University of Oxford illustrates how rapid vaccine trial delivery can move at speed while meeting the same regulatory and safety standards, with clear relevance to outbreak response. The trial, conducted in Oxford, will assess the safety and immune response of the ChAdOx1 BDBV vaccine candidate in 50…

Cancer drug development has evolved rapidly over the past decade. Advances in immunotherapy, precision medicine, cell therapies, and targeted treatments have created new opportunities for improving patient outcomes, but they have also increased the complexity of clinical development. Demonstrating whether a treatment delivers meaningful clinical benefit is a fundamental part of oncology research and drug…

2 million people worldwide are diagnosed with breast cancer each year. As the world’s most prevalent form of the disease, treatment has previously focused on rounds of chemotherapy to shrink the tumours. While in many cases chemotherapy has been found to be highly effective at eliminating cancer cells and reducing the risk of recurrence, its…

Clinical research is evolving rapidly. While randomised controlled trials (RCTs) remain the gold standard for establishing the safety and efficacy of new therapies, there is increasing recognition that understanding how treatments perform in real-world clinical settings is equally important. This shift has accelerated the use of real-world evidence (RWE) in drug development. Regulatory bodies, including…

Selecting a Contract Research Organisation (CRO) is one of the most consequential decisions a sponsor will make during clinical development. Whether you are a biotech entering First-in-Human studies or a pharmaceutical company progressing into Phase III, the right CRO can improve operational control and reduce development risk. Understanding how to choose a CRO requires more…

Cancer remains one of the most complex and challenging areas of modern medicine, driving continuous innovation in drug development. At the heart of this progress are oncology clinical trials, which play a critical role in advancing new therapies and improving patient outcomes. For biotech and pharmaceutical companies, these trials are not only a regulatory requirement…

Phase 1 trials are the first clinical trials to include humans. They are essential in determining the safety and tolerability of a drug in development. A well-designed phase 1 clinical trial is heavily dependent on clinical pharmacology, the medical discipline that bridges preclinical science into data-driven decisions. Without thorough clinical pharmacology, Phase 1 clinical trials…

What is a primary immunodeficiency? A primary immunodeficiency is an umbrella term for a group of conditions that hinder the body’s ability to fight infection. Sometimes referred to as a primary immune disorder, primary immunodeficiency is a group of over 550 chronic, inborn genetic conditions. Whilst in most circumstances they are genetically inherited, some symptoms…