The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. Continue reading
REACH a Better Solution: in vitro Skin Sensitization Assays as Animal Testing Alternatives
Skin sensitization testing is a major gap for many companies addressing the 2018 REACH substance registration deadline. Join us for a Q&A session with our Covance experts as we review REACH requirements and focus on a better solution for skin sensitization studies: in vitro assays as new alternatives to animal testing.
Q: What do REACH regulations hope to achieve?
A: The European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) places responsibility on companies to assess and manage risks posed by chemicals. They also have to provide appropriate safety information to users. The first purpose is to ensure protection of human health and the environment. Next, the regulation promotes using alternatives to animal test methods. Third, it seeks free circulation of substances to the market, with enhanced competitiveness and innovation. Continue reading
In recent years many researchers have focused on the analysis of circulating soluble cancer biomarkers as an indicator of the host immune response to oncogenesis.1,2,3 Multiple biomarkers can be quantified in order to fully characterize changes in homeostasis brought on by tumor growth and metastasis. The ability to multiplex tumor-type specific antigens and general immune response biomarkers in a small plasma or serum sample can provide the researcher a broad picture of test agent efficacy.
The drug industry is evolving and clinical trials are becoming more complex. How do CRAs in a large global company keep their skills up to date? Recognizing that large group meetings are costly and virtual training feels impersonal, Covance decided to address this challenge with an innovative model called CLIK: Country Leadership Imparting Knowledge.
With selected leaders identified from each of the 70+ countries that Covance serves, the CLIK program brings CRAs face-to-face to share their experiences, gain new knowledge and then serve as training representatives for peers in their own regional teams. Continue reading