Greenleaf Publishing - Routledge. Greenleaf Publishing, a leading publisher in the areas of responsible management, ethics and social responsibility has recently joined Routledge, enabling the further development and strengthening of the list and improved international impact. Greenleaf Publishing has published many important titles in the areas of corporate governance and social responsibility. We gather and disseminate research and best practice in these fields via our Sustainable Organization Library (SOL) and Greenleaf Online Library (GOL) collections, and our printed books and ebooks. We support environmentally sound, socially just, ethical and sustainable growth. Introduction. Public health embraces a holistic, “cell-to-society” approach to understanding both the direct and underlying causes of disease and the conditions. Related Book Ebook Pdf The Ultimate Guide To Oldfashioned Country Skills : - Home - Practical Numerical Methods For Chemical Engineers Using Excel With Vba. Experience the Best Toxicology Research. Join Us in Baltimore in 2017. Register today to attend the Society of Toxicology 56th Annual Meeting and ToxExpo. George Mateljan founder of Health Valley Foods author of the best- selling The World’s Healthiest Foods: Essential Guide for the Healthiest Way of Eating. The world's leading online source of ebooks, with a vast range of ebooks from academic, popular and professional publishers. I recently heard a researcher from the University of Washington describe crows as "monkeys with wings" because of their relative brain to body mass ratio. Now that you know what lucid dreaming is, and you know the benefits and risks, it’s time to give it a solid try. Get ready, oneironauts—we’re about to take off. The Good Clinical Practice Guide covers the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use. Automatically formats, alphabetize, and prints bibliographies for free. Society of Toxicology - Annual Meeting 2. Share this page. Featured Sessions. Daily Plenary Session: Data Science. Monday, March 1. 3, 8: 0. AM to 9: 2. 0 AMView this Plenary Presentation Systems Approaches to Drug Efficacy and Toxicity in an Era of Big Data. Lecturer: Peter Sorger, Harvard Medical School, Boston, MA. The development of new therapeutic drugs is fundamental to improving human health, but the process is challenged by rising costs and a high rate of failure. New and better technology and big data are often put forward as the solutions to these problems. However, I will discuss laboratory and clinical studies showing that some of the fundamental concepts in pharmacology and toxicology are ripe for reinvention. Increasing data on the impact of cell- to- cell variability and temporal variation in cellular physiology motivates new ways of thinking about seemingly simple concepts such as drug dose- response. Better understanding of sources of variation in laboratory and clinical data should also improve our ability to identify robust biomarkers of therapeutic and adverse effects. I will argue that big data and data science are essential but insufficient: correct interpretation of empirical data in biomedicine hinges on theories about mechanism. I will discuss these theories, with reference to cytotoxic and targeted anti- cancer therapies, and studies of drug response in cell culture, animal models, and human clinical trials. New pharmacological principles derived from such studies are being developed into practical algorithms and open- source software as a means to improve target qualification, lead molecule optimization, and early phase clinical trials. The hoped for outcome: better drugs at a cost society can afford. Open Ecosystems for Understanding Toxicities and Adverse Events. Lecturer: Lara Mangravite, Sage Bionetworks, Seattle, WA. The presentation will address the use of collaborative approaches for the gathering, sharing and interpretation of health data. This will include the use of remote sensor- based data collection approaches to capture fluctuations in health relative to medication and disease—and the consideration of how these could be used to track adverse events. Merit Award Lecture. Monday, March 1. 3, 1. PM to 1: 2. 0 PMCell Proliferation and Carcinogenesis: Bad Luck and the Environment. Lecturer: Samuel M. Cohen, University of Nebraska Medical Center, Omaha, NE. Cancer develops because of multiple permanent genetic errors arising in a single stem cell, a clonal disease. Every time DNA replicates, spontaneous mistakes can occur. Thus, the risk of cancer can be increased by either directly damaging DNA each time it replicates (DNA reactive) or increasing the number of DNA replications (cell proliferation), or both. Some have indicated that the “spontaneous” errors that occur during DNA replication are the basis for cancer being due to “bad luck,” and are the cause of most cancers. However, it is well- known that numerous environmental factors can increase the risk of cancer. This dilemma is readily resolved by realizing that the number of stem cells and the rate of their proliferation can be markedly influenced by the environment. Over the course of more than a 5. I have been actively involved in research on DNA reactive carcinogens (nitrofurans, aromatic amines, nitrosamines) and non- DNA reactive carcinogens (saccharin, PPARγ agonists, arsenicals, others). Based on the fundamentals of carcinogenesis, a mode of action (MOA) approach, and the accumulated knowledge of carcinogenesis in animals and humans, carcinogenic risk can be readily evaluated today without utilizing the two- year bioassay. Meet the Directors: A Conversation with Linda S. Birnbaum and Robert J. Kavlock. Monday, March 1. PM to 2: 3. 0 PMChairperson(s): Patricia E. Ganey, Society of Toxicology Vice President; Michigan State University, East Lansing, MI. Panelists: Linda S. Birnbaum, NIEHS, Research Triangle Park, NC; and Robert J. Kavlock, US EPA, Washington, DC. This important session will provide an informal venue for meeting attendees to have a candid and open discussion with two key leaders of federal organizations with missions to protect and improve public health: Dr. Birnbaum, Director, National Institute of Environmental Health Sciences (NIEHS), NIH, and Dr. Kavlock, Deputy Assistant Administrator for Science at the Office of Research and Development for the US EPA. The entire session will be devoted to a question- and- answer format concerning scientific directions and priorities for NIEHS and EPA including funding priorities and outlooks, and training opportunities. SOT/EUROTOX Debate. Monday, March 1. 3, 4: 4. PM to 6: 0. 0 PMToxicology Testing of Drug Combinations Does Not Add Significant Value to Human Risk Evaluation Beyond What Is Known for the Individual Agents. Chairperson(s): Leigh Ann Burns Naas, Gilead Sciences Inc., Foster City, CA; and Heather Wallace, University of Aberdeen, Aberdeen, United Kingdom. SOT Debater: Kenneth L. Hastings, Hastings Toxicology Consulting LLC, Mount Airy, MD. EUROTOX Debater: Phil Bentley, Toxicodynamix International LLC, Hendersonville, NC, and Basel, Switzerland. Endorser(s): Society of Toxicology (SOT)European Societies of Toxicology (EUROTOX)Each year the SOT Annual Meeting includes a debate that continues a tradition that originated in the early 1. This year, our debaters will address the proposition: Toxicology Testing of Drug Combinations Does Not Add Significant Value to Human Risk Evaluation Beyond What is Known for the Individual Agents. The use of innovative drug combinations—both large and small molecule—in clinical development is increasing. The objective is often to increase efficacy by targeting multiple pathways for the same disease, to improve safety by being able to lower doses of one or more drugs, or to provide more convenient/acceptable therapies to patients. As the number of these clinical combinations rises, there is an increasing need to evaluate their nonclinical safety. At the heart of this evaluation is the question regarding the need for actual animal testing. Global regulatory guidance has provided a framework for the nonclinical safety evaluation of combination products, which considers the need for testing based on such things as the potential for PK or PD interactions, overlapping toxicology profiles, extent of toxicology characterization of the individual agents and their margins of safety, human clinical experience with the individual agents, and the stage of clinical development of each agent. The guidance applies not only to fixed dose combinations but co- packaged and co- use as well. Unless there is clinical experience with the combination and that combination involves two late stage (Phase 3, Marketed) entities, nonclinical repeat dose toxicity studies up to 9. This broad recommendation is inconsistent with the principles of the 3. Rs for reduction, refinement, and replacement in animal experimentation. Conversely, the potential for unexpected safety events with novel, targeted therapies is a clear clinical concern. The debaters will discuss the evidence regarding whether the information gathered in nonclinical combination studies provides clear benefit in the overall risk evaluation for clinical combinations. Regardless of framework differences and personal convictions, each scientific debate delegate will present relevant evidence and compelling scientific arguments to persuade and appeal to the audience in order to obtain the approval or rejection of the motion. In addition to being a featured session at the SOT Annual Meeting in Baltimore, Maryland, this debate will again take place (with the debaters taking the reverse positions) in Bratislava, Slovak Republic, during the 5. Congress of the European Societies of Toxicology (2. EUROTOX Annual Congress), September 1. Daily Plenary Session: Precision Medicine. Tuesday, March 1. AM to 9: 2. 0 AMView this Plenary Presentation Pharmacogenomics of Drug Toxicity in Cancer: Making the Case for Precision Medicine. Lecturer: Jun J. Yang, St. Jude Children’s Research Hospital, Memphis, TN. Elucidation of the genetic basis for inter- patient variability in drug toxicity not only reveals important biology of a drug’s mechanism of action but also provides critical knowledge that enables risk- adapted treatment individualization. This is particularly relevant in cancer where chemotherapy is often associated with severe acute toxicities and debilitating long- term side effects. Therefore, the narrow therapeutic index of anti- leukemic drugs provides a compelling rationale for improvements in evidence- based precision medicine approaches. Focusing on acute lymphoblastic leukemia as a model disease, our pharmacogenomics research identifies genetic factors associated with response and toxicity of a wide range of common anti- cancer drugs, from which we then develop genetics- guided individualized therapy. For example, inherited deficiency in detoxification enzymes TPMT and NUDT1. In fact, there is a rapidly- growing number of medications for which pharmacogenomic variants can directly guide treatment choice and/or dosing strategy. At the forefront of precision medicine, pharmacogenomics hold particularly great promise to transform medical practice with more efficacious and safer therapies across diseases. The Role of Precision Medicine in Closing the Innovation Gap. Lecturer: Richard Barker, University of Oxford, Oxford, United Kingdom. The tremendous recent advances in basic bioscience are not translating as effectively and affordably as they should into health benefit for patients and positive change in healthcare delivery. The presentation will analyze and illustrate this phenomenon and the threat it represents to the long- term sustainability of biomedical innovation.
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