Sven, Senior Study Director, Toxicology at Covance, discovered his team’s work had unpredictably reached his home – and impacted his family’s life.
In January 2016, Sven’s 3-year-old daughter was complaining about pain in her legs. At first, it seemed like natural growing pains, but it then became difficult for her to walk in the mornings. An ultrasound with an orthopedic doctor revealed a high level of swelling in her knees and she received a diagnosis of juvenile rheumatoid arthritis – a disorder where the body’s immune system attacks its own cells and tissues. Continue reading →
“Affinity” is defined as, “a spontaneous or natural liking or sympathy for someone or or something.” This concept applies also to the biologics (large molecules) we help to develop. Drugs like monoclonal antibodies (mAb) or bispecific antibodies are ideal drug candidates since they have very high affinity to bind to their target substance or site. Given the variability of the targets, safety profiles, and therapeutic windows, it is important to understand the characteristics of the affinity of the target and how to translate phenomena such as target mediated drug disposition (TMDD). Continue reading →
Nonalcoholic fatty liver disease (NAFLD) is the accumulation of fat or lipids in the liver in the absence of significant alcohol uptake or viral infection. Within NAFLD there is a spectrum of disease ranging from excess storage of fat in the liver (NAFL) to fat plus inflammation (called nonalcoholic steatohepatitis or NASH), to liver fibrosis and cirrhosis, or end stage liver disease with loss of liver function. NASH is the most common cause of liver disease in developed countries, largely due to the increased prevalence of obesity and type 2 diabetes. A percentage of patients with NASH and liver fibrosis will progress to liver failure or hepatocellular carcinoma or liver cancer. In fact, NASH is expected to be the number one cause for liver transplantation in a few years, making it critical to identify high-risk patients early. Continue reading →
Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.
How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study. Continue reading →
With evolving medical knowledge, there is an ever-increasing need to effectively facilitate knowledge transfer to key target audiences, especially patients and caregivers. Medical writing for patients must not only meet stringent good clinical practice standards and good publication practices but it must also communicate specific information in a clear, relevant and compelling manner. Patient-friendly writing is centered on generating content that engages, instructs and presents medical evidence, which is truly informative and is visually impactful—with use of graphs, figures and images.