Immunotherapy, which engages and harness the body’s own immune system to fight cancer, has revolutionized the field of oncology. Among the most promising immunotherapy approaches are immune checkpoint blockade, adoptive cell therapies, therapeutic vaccines, oncolytic viruses, and mono, bi and...
Hematological malignancies are a diverse group of cancers that affect the blood, bone marrow, lymph nodes, and spleen. The complexity and variability of these diseases demand innovative and personalized approaches to treatment that traditional clinical trial methodologies often lack. Designing...
In the field of oncology, as we got better at understanding the changes that occur in cancers at a molecular level, we have seen a shift towards precision medicine. Biomarkers are central to this change and can be leveraged to...
Advances in genomic and proteomic technologies have led to the identification of numerous biomarkers with potential clinical utility in oncology, including gene mutations, gene amplifications, gene expression signatures, and altered proteins. To date, more than 1,500 potential oncology biomarkers have...
The success of clinical trials is contingent upon finding participants who meet certain criteria, ensuring that the resulting study data are meaningful and relevant to the target patient population. Clinical trial matching is the process of identifying and connecting potential...
Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies. Key considerations for developing early-phase trials that can more accurately define...
Cell therapy clinical trials are complex and successfully operationalizing these studies requires careful consideration of the interplay between the patient journey and vein-to-vein logistics workflow.
Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant...