When disaster strikes, the safety of your en-route patient samples depends upon the contingency planning that was done in anticipation of the emergency. While many emergencies happen in an instant, immediately impacting our logistics infrastructure – earthquakes, tornados or volcanic eruptions, for example – some, such as the recent series of severe hurricanes and typhoons, have longer lead times.”
When events of this nature occur, our global logistics team is behind the scenes preparing for such events. With more than 25 full-time staff, this team monitors shipments, coordinates with couriers, and oversees all of the operations that are critical to ensuring that patient samples are received at our labs within stability. Even factoring in emergencies, transportation failures impact only about 0.1% of all specimens. Continue reading
The American Cancer Society estimates that in 2017 over 1.6 million people will be diagnosed with non-skin cancers in the United States. It is known that more than 50% of all cancer patients will receive some sort of radiation therapy as part of their treatment plan. Why is it then that preclinical evaluation of drugs in combination with radiation is not mainstay in the industry?
Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint
stiffness and loss of function, ultimately leading to disability if untreated. RA also has significant systemic features in many patients that appreciably impact upon their quality of life, including fatigue and depression. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1
Modern RA treatment paradigms (i.e. “treat to target”) focus on achieving remission/low disease activity to minimize joint damage and disability. Biologic agents targeting key inflammatory mediators (TNF-alpha, IL-1, IL-6), key cells and activation pathways of the adaptive immune system such as B cells and T cell co-stimulation pathways, have revolutionized the treatment of RA and many other immune-mediated inflammatory diseases (IMIDs), and have rapidly been introduced into accepted treatment paradigms2,3 when earlier disease modifying anti rheumatic disease (DMARD) agents such as methotrexate (and others) are insufficient to reach these target goals. Continue reading
Diabetic kidney disease (DKD) patients have an increased cardiovascular (CV) risk in addition to their increased risk of progression to end-stage renal disease. Recognizing that the FDA and other regulatory agencies have great interest in both the CV and renal safety and efficacy of compounds under development, pharmaceutical companies should consider inclusion of an appropriate approach to adjudication of potential CV events early in the course of planning for development of drugs to treat DKD.
Adapting current regulatory perspectives
From the regulatory perspective, there is a lot of emphasis focused on looking at both CV and renal risks during the development of type 2 diabetes treatments.1 However, no specific guidance exists for clinically-evident endpoints in DKD. Continue reading
Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint stiffness and loss of function, ultimately leading to disability if untreated. RA also produces significant systemic affects such as fatigue and depression that may appreciably impact quality of life for many patients. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1
The immune system is the body’s main defense against foreign materials and biologic agents such as bacteria, viruses, chemicals, and foreign cells and tissues. The immune response includes specific action of lymphocytes (one type of white blood cell) and is facilitated by other white blood cells, including neutrophils, monocytes, macrophages, eosinophils and basophils. The immune system can be viewed as a system controlled by negative feedback, meaning that normally it must reduce the effects of disturbance or invaders through self-regulation. Continue reading
Identification of new medicines for kidney disease remains an ongoing challenge in drug development. This challenge includes establishing new biochemical measurements (biomarkers) which can sensitively and accurately reflect the status of renal health and any associated changes in renal function. Sponsors are exploring many options to improve the application of biomarkers in preclinical use in order to better inform early phase safety studies and downstream clinical trials.
Katherine Landschulz, PhD, associate director of the translational biomarker solutions laboratory, and veterinarian pathologist Laura Boone, DVM, PhD, recently shared their experiences working on renal disease studies at Covance. They discussed their insights on how biomarkers are being used in preclinical studies to predict safety and advance translational medicine in drug development.