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Maryann R Cooper,1 Chelsea Binkowski,2,3 Jessica Hartung,2,4 Jennifer Towle1 1Department of Pharmacy Practice, School of Pharmacy – Worcester/Manchester, MCPHS University, Manchester, NH, 2School of Pharmacy – Boston, MCPHS University, Boston, MA, 3North America Medical Affairs, 4Global Medical Affairs, Sanofi Oncology, Cambridge, MA, USA Abstract: The interaction between vascular endothelial growth factor and its receptor is an important therapeutic target due to the importance of this pathway in carcinogenesis. In particular, this pathway promotes and regulates angiogenesis as well as increases endothelial cell proliferation, permeability, and survival. Ramucirumab is a fully human monoclonal antibody that specifically targets the vascular endothelial growth factor receptor-2, the key receptor implicated in angiogenesis. Currently, ramucirumab is approved for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC) in combination with docetaxel. In a Phase III clinical trial, ramucirumab was shown to improve the overall survival in patients with disease progression, despite platinum-based chemotherapy for advanced NSCLC. This review describes the pharmacology, pharmacokinetics and dynamics, adverse event profile, and the clinical activity of ramucirumab observed in Phase II and III trials in NSCLC. Keywords: NSCLC, antiangiogenesis, VEGF-targeted therapy

This paper describes the overall achievements of the Animal Health and Welfare (AHAW) Panel of EFSA and its support unit since 2003. The AHAW Panel deals with animal health and animal welfare issues, primarily related to food-producing animals, at the human–animal–environment interface. Scientific opinions adopted by the AHAW Panel are comprehensive scientific reviews and risk assessments and provide the scientific grounds for the identification of control options, most of them being reflected in European Union legislation on animal health and welfare. Between 2004 and 2012, the AHAW Panel delivered 47 scientific opinions related to animal health and 38 scientific opinions on animal welfare on a wide variety of issues. The welfare of animals is a matter of much public concern and has an overall impact on the condition of the animals, with consequences for productivity, disease and food safety. A major achievement of the AHAW Panel has been to establish a unique multidisciplinary capacity, combining expertise in addressing animal health and welfare issues. The AHAW Panel has also demonstrated its capacity to respond rapidly to urgent requests, thus becoming a prominent partner of risk managers in response to crises. Over time, the AHAW Panel has become internationally recognised as a leader in risk assessment in the field of animal health and welfare, based on EFSA core values of scientific excellence, independence and transparency. The development of robust methodological frameworks for the assessment of risks related to animal health and welfare is a continuing process for the AHAW Panel. Over the past ten years, EFSA has achieved greater participation from the scientific community, stakeholders and interested parties, and fostered cooperation with relevant organisations in the EU Member States in the area of animal health and welfare. The AHAW Panel has demonstrated that evaluating health and welfare and assessing risk in animal populations serves to protect public health, the environment and the economic benefit we derive from animals.