Human Health and the Environment: Global is Local is Personal
Linda S. Birnbaum, PhD, DABT, ATS, National Institute of Environmental Health Sciences and National Toxicology Program
Monday, July 15, 6:00pm–7:00pm
Human health is inextricably linked to the environments in which we live. Global trends in environmental health are an aggregate of environmental health at the local or community level, and those trends and impacts we see at the local community level are the result of personal health outcomes. By researching opportunities to increase the health and wellness of the individuals, and engagement with communities, we can affect global shifts in health outcomes. To be successful the toxicology community must look for new ways to investigate the cumulative effects of exposures from air, water, chemical toxins, radiation, pest control. In addition, we must look more broadly and partner with other disciplines to address cross-cutting areas, including such topics as building design, urban and regional planning, energy, transportation, disaster preparedness and response, climate change, and environmental stress. To fulfill our mission of reducing the burden of human illness and disability associated with environmental exposures, scientific research must lead to public health action. This means that we have an obligation not only to produce the best science possible, including the exploration of precision approaches, but also to communicate science in ways that further public health protection.
Linda S. Birnbaum, PhD, is director of the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health, and the National Toxicology Program (NTP). A board-certified toxicologist, Birnbaum has served as a federal scientist for nearly 39 years. Prior to her appointment as NIEHS and NTP Director in 2009, she spent 19 years at the U.S. Environmental Protection Agency (EPA), where she directed the largest division focusing on environmental health research.
Birnbaum has received many awards and recognitions. In 2016, she was awarded the North Carolina Award in Science. She was elected to the Institute of Medicine of the National Academies, one of the highest honors in the fields of medicine and health. She was also elected to the Collegium Ramazzini and to the Institute of Medicine of the National Academies of Science, and received an honorary Doctor of Science from the University of Rochester and a Distinguished Alumna Award from the University of Illinois. She also received an Honorary Doctorate from Ben-Gurion University, Israel; the Surgeon General’s Medallion 2014; and 14 Scientific and Technological Achievement Awards, which reflect the recommendations of EPA’s external Science Advisory Board, for specific publications.
Birnbaum is an active member of the scientific community. She was vice president of the International Union of Toxicology, the umbrella organization for toxicology societies in more than 50 countries, and former president of the Society of Toxicology, the largest professional organization of toxicologists in the world. She is the author of more than 800 peer-reviewed publications, book chapters, and reports. Birnbaum’s own research focuses on the pharmacokinetic behavior of environmental chemicals, mechanisms of action of toxicants including endocrine disruption, and linking of real-world exposures to health effects. She is also an adjunct professor in the Gillings School of Global Public Health, the Curriculum in Toxicology, and the Department of Environmental Sciences and Engineering at the University of North Carolina at Chapel Hill, as well as in the Integrated Toxicology and Environmental Health Program at Duke University.
A native of New Jersey, Birnbaum received her M.S. and Ph.D. in microbiology from the University of Illinois at Urbana-Champaign.
Challenges in Global Health: Innovative Discovery and Translational Strategies
Peter Warner, MA, DPhil, Bill & Melinda Gates Foundation
Tuesday, July 16, 8:00am–8:50am
Millions of people suffer and die from diseases that disproportionately affect the poor. These include malaria and tuberculosis as well as a long list of other tropical diseases such as onchocerciasis and lymphatic filariasis. The Bill & Melinda Gates foundation (BMGF) is driven by the belief that every life has equal value. Providing the tools to improve the health of the poorest is a critical aspect of our work and this includes the discovery and development of drugs which will have the most impact on the lives of the poor. Often pharmaceutical companies cannot easily justify the significant investments needed to discover and develop drugs for these diseases. The BMGF can help to build partnerships and provide resources and expertise to de-risk drug discovery and development projects. The BMGF works with Product Development Partners including Medicines for Malaria Venture, The TB Alliance and Drugs for Neglected Diseases Initiative to harness the best academic research and couple it with research institute and pharmaceutical company partners to generate new drugs. A network led by the BMGF is the TB Drug Accelerator and this is as an example of what can be achieved when world leading disease knowledge and biology is coupled with excellence in drug discovery. This lecture will provide examples of how the challenges in developing drugs for neglected diseases can be overcome.
Peter Warner, MA, DPhil is the Senior Program Officer in Discovery and Translational Sciences. Peter joined the Bill and Melinda Gates Foundation (BMGF) in 2013 after a 28-year career in the Pharmaceutical industry. Trained as a medicinal chemist, he has worked across a broad range of therapy areas delivering drug candidates to the clinic. Immediately prior to joining the BMGF he led the AstraZeneca Neglected Diseases Research Unit in Bangalore. Within the BMGF he manages a portfolio of drug discovery grants, projects and partnerships focused primarily on tuberculosis, malaria and filarial disease drug discovery. He is the co-leader of the TB Drug Accelerator consortium which brings together multiple partners to discovery new TB drugs and treatment regimens through a unique collaborative model.
The National Center for Advancing Translational Sciences: Catalyzing Translational Innovation in Rare Disease Research
Christopher P. Austin, MD, National Center for Advancing Translational Sciences
Wednesday, July 17, 8:00am–8:50am
The process by which observations in the laboratory or the clinic are transformed into useful interventions that tangibly improve human health is frequently termed “translation.” This multi-stage and multifaceted process is poorly understood scientifically, and the current research ecosystem is operationally not well suited to the distinct needs of translation. As a result, biomedical science is in an era of unprecedented accomplishment without a corresponding improvement in meaningful health outcomes.
To meet the opportunities and needs in translational science, NCATS was created as NIH’s newest component in December 2011. NCATS is scientifically and organizationally different from other NIH Institutes and Centers. It focuses on what is common to diseases and the translational process, and acts as a catalyst to bring together the teams necessary to develop new technologies and paradigms to improve the efficiency and effectiveness of the translational process. This talk will provide an overview of NCATS mission and programs, with a view toward future developments in rare disease research.
Christopher Austin is Director of the National Center for Advancing Translational Sciences (NCATS) at the US National Institutes of Health. NCATS’ mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Before becoming NCATS Director in September 2012, he was Director of the NCATS Division of Preclinical Innovation, which focuses on translating basic science discoveries into new treatments, particularly for rare and neglected diseases, and developing new technologies and paradigms to improve the efficiency of therapeutic and diagnostic development. In this role, he founded and directed numerous initiatives including the NIH Chemical Genomics Center (NCGC), the Therapeutics for Rare and Neglected Diseases (TRND) program, and the Toxicology in the 21st Century (Tox21) program. In 2016, Dr. Austin was elected chair of the International Rare Disease Research Consortium (IRDiRC). Before joining NIH in 2002, Dr. Austin directed research programs genomics-based target discovery, pharmacogenomics, and neuropsychiatric drug development at Merck, with a particular focus on schizophrenia. Austin earned an A.B. in biology from Princeton University and an MD from Harvard Medical School. He completed clinical training in internal medicine and neurology at Massachusetts General Hospital, and a research fellowship in genetics at Harvard.
Mechanisms vs AOP: Does It Matter for the Use of the Mechanistic Data in Decision-Making?
Kate Z. Guyton, International Agency for Research on Cancer, Lyon, France; and Maurice P. Whelan, European Commission Joint Research Centre (JRC), Ispra (VA), Italy
Thursday, July 18, 8:00am–9:15am
Chairperson: Ivan Rusyn, Texas A&M University, College Station, TX, USA
Following in a spirit of very successful sessions that occur annually at several major national toxicology meetings since the early 1990s in which leading toxicologists advocate opposing sides of an issue of significant toxicological importance, the ICT XV Scientific Program will includes a debate that will address the question: Mechanisms vs AOP: Does it matter for the use of the mechanistic data in decision-making?
This session will debate the future prospects for using mechanistic data to bridge important gaps in assessing new and existing chemicals. Attention will be given to lessons learned from the various approaches developed over the years by toxicologists and risk assessors for identifying, evaluating and applying mechanistic knowledge and data in a variety of assessment contexts. Prominent examples include pathway-based approaches such as the Mode of Action (MoA) framework developed by the WHO's International Program on Chemical Safety (IPSC), and the Adverse Outcome Pathway (AOP) framework, initially described by the ecotoxicology community and now brought forward by the Organisation for Economic Co-operation and Development (OECD). Another recent approach has been to interrogate, assemble and evaluate the relevant evidence on various cancer mechanisms, facilitated by the definition of the Key Characteristics (KC) of carcinogens by the WHO's International Agency for Research on Cancer (IARC). All of these approaches are designed to facilitate the optimal use of mechanistic knowledge and data in decision-making, but they differ in many ways, including how the underpinning data and knowledge are assembled and how they are applied in practice. But do these differences really matter? Are there better ways out there? Should different approaches develop independently or is there a need for more consensus and convergence? What gaps in evidence and other challenges have these approaches revealed so far? Moreover, irrespective of the actual approach one might favor, how far can we actually go with basing hazard and risk conclusions on mechanistic data?
Regardless of the differences and personal convictions, each scientific debate delegate will present relevant evidence and compelling scientific arguments to persuade and appeal to the response of the audience in order to obtain the approval or refusal of the motion.
Dr. Kate Guyton is a Senior Toxicologist at the International Agency for Research on Cancer (IARC), World Health Organization in Lyon, France. Prior to joining IARC, she served as a Toxicologist in the Office of Research and Development at the US Environmental Protection Agency (2005–2014). She also has experience, as the Director of Scientific Affairs at CCS Associates (1998–2005), working with the US National Cancer Institute in cancer screening, prevention, treatment and imaging. Dr. Guyton received her BA (cum laude) from Johns Hopkins University, her PhD from the Johns Hopkins Bloomberg School of Public Health, and her postdoctoral training at the US National Institutes of Health. Dr. Guyton has been certified as a Diplomate of the American Board of Toxicology since 1998. She has authored more than 75 scientific articles in her area of expertise.
Prof. Maurice Whelan is head of the Chemical Safety and Alternative Methods Unit of the Directorate for Health, Consumers and Reference Materials of the European Commission's Joint Research Centre (JRC), based in Ispra, Italy. He also heads the JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM). Priorities of his work include the advancement of in vitro and computational methods for regulatory safety assessment of chemicals and for application in basic and applied research. Whelan is the EU co-chair of the OECD Advisory Group on Molecular Screening and Toxicogenomics that is responsible for the OECD programme on Adverse Outcome Pathways, and he is a member of the Steering Committee of the European Partnership for Alternative Approaches to Animal Testing (EPAA). In 1993 he was awarded his Ph.D. by the University of Limerick (Ireland) in Mechanical Engineering based on his research into the design of orthopaedic knee prostheses. Publications include over 200 scientific papers and a recent book on the validation of alternative methods for toxicity testing. He holds a number of external appointments including the 2017–2018 Francqui Chair for alternative methods at the Vrije Universiteit Brussel (VUB, Belgium) and visiting Professor of Bioengineering at the University of Liverpool (UK).