Scientific innovation and advances in ligand targeting have spurred the development of many different types of radiopharmaceutical (RPs) – radioisotopes bound to biological molecules to target specific organs, tissues, or cells within the body — with a wide range of clinical uses. As those uses have proliferated, and as research has continued to yield novel...
Today there are over 10,000 rare diseases affecting more than 30 million people in the U.S.1 Many of these disorders are life-threatening, and more than 90% do not have a U.S. FDA-approved treatment2. Novel gene therapies offer hope for improving the health of patients afflicted with these conditions. Securing clearance for these treatments is...
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 participants with studies that align with their specific medical condition and characteristics. In precision oncology,...
We’re currently experiencing breakthrough times for clinical research in gene therapies. These complex treatments offer much-needed hope to more than 30 million U.S. patients affected by over 1000 rare diseases1, many of which are life-threatening and the vast majority of which have no available treatment. Gene therapy products must meet the same key regulatory...
Development of liquid biopsies for early cancer detection requires careful planning. Understanding the regulatory environment and the challenges of conducting the studies needed for approval is integral to success. Here, we review the regulatory pathways for in vitro diagnostics (IVDs) in both the US and the EU and offer strategies for designing and operationalizing large-scale...
Cancer is the leading cause of death worldwide, accounting for nearly one in every six deaths. According to a recent paper, an estimated 15% of cancer-related deaths could be avoided by early disease detection.1 However, there are currently very few population-based screening programs and, even where a screening test does exist, compliance is relatively low....
Digital medicines and digital therapeutics (DTx) are changing the future of healthcare by empowering patients to participate in—and influence—their treatment, health, and well-being. These technologies can support various stages of the healthcare journey, addressing unmet needs and bridging gaps in the market for traditional medicine. This convergence of software and healthcare creates opportunities, but the...
Data-driven solutions for your most difficult CGT hurdles Cell and gene therapy research is often a high-stakes undertaking, involving incredibly complex science and constantly shifting regulatory terrain. We work diligently to minimize your development risks through our insightful regulatory support, expert-led chemistry, manufacturing and controls (CMC) strategies, and data-driven clinical execution. To read more, download...
Infant formula is an essential food product that serves as the sole source of nutrition for many babies in North America and Europe during their first year of life, supporting health, growth, and development.1,2 More than a year since the shutdown of the largest infant formula plant in the US in February 2022, the country...
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. In this guide, we explore key steps in executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention. We also discuss the critical role of...