Cancer is one of the most scientifically complex and dynamic diseases. Even with significant advances in our understanding of the genetic and molecular mechanisms that lead to cancer, only 10 percent of approved oncology drugs demonstrate an overall survival benefit.1 In recent years, there has been a shift in how early-phase oncology studies are conducted...
Leveraging Rare Disease Insights Powered by the CENTOGENE Biodatabank and Centralized Multiomic Laboratories in Clinical Trials MORRISVILLE, N.C., and CAMBRIDGE, Mass., ROSTOCK, Germany, and BERLIN, January 9, 2023 — Premier Research, whose mission is to help the most innovative biotech and medtech companies take their best ideas from concept to commercialization, and Centogene N.V. [Nasdaq:...
Radiation therapy was first used to treat cancer more than a century ago, and nearly half of all cancer patients still receive it at some point during their treatment.1 Historically, most radiation therapy was given by delivering ionizing beams of radiation from outside the body, but with advances in the field of nuclear medicine, radionuclides...
In this era of precision medicine, biomarkers play a critical role in the rational development of novel therapies. With advances in both our understanding of cancer pathophysiology and tumor profiling technology, biomarkers can now be used to provide important insights at every stage of drug discovery and development. In this article, we explore the common...
Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of improvement in tumor response rates showed only 10 percent of these therapies...
Introduction Over the past decade, immune-oncology (IO) has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be attributed to an explosion of research in this area in recent years, leading to a paradigm shift in the understanding of cancer. Until the late 1990s...
Antibody-drug conjugates (ADCs) are an active area of oncology research, partly due to advances in synthetic biochemistry that may help improve the tissue specificity and cytotoxicity of these complex therapeutics. In recent years, the pace of development for this class of cancer therapeutics has been increasing, with 12 ADCs approved by the FDA since June...
Background Cervical cancer is the fourth most common cancer in women. Despite being highly preventable, over 600,000 women were diagnosed and more than 340,000 died from the disease worldwide in 2020. The majority of cervical cancers are caused by infection with human papillomavirus (HPV) and the implementation of HPV vaccines has been shown to reduce...
The FDA is committed to increasing sponsor opportunities to apply RWD and RWE to support regulatory decision-making.1 The goal is to use quantities of available data, streamline the drug development process, and learn how interventions perform in real-world use, outside the strictly controlled limits of a clinical trial. According to legal and scientific standards, the...
Increasing emphasis on rare diseases has led to a greater need to accurately define the profile, characteristics, and outcomes of patients living with those conditions. The development of safe and effective treatments of rare diseases requires a deep understanding of the disease of interest, including its frequency, clinical features, risk factors, outcomes, burden, and evolution....