Featured Sessions

New Investigator Lunch

Tuesday, March 8, 12:00 NOON–1:15 PM

Chairperson(s): Joel G. Pounds, Pacific Northwest National Laboratory, Richland, WA, and Nancy Kerkvliet, Oregon State University, Corvallis, OR

Sponsor: Research Funding Committee

This event is focused on new investigators such as new assistant professors on tenure track. Participants will be able to speak informally with federal funding agency proram officers and more senior investigators, including members of the Research Funding Committee. After a brief grantsmanship talk by Sally J. Rockey, Ph.D., NIH Deputy Director for Extramural Research, discussion will continue with the program officers at each table. Ask your questions and benefit from conversation resulting from the questions of others. You can also arange at this time to meet these representatives later in the Research Funding Resource Room for an individual discussions. A limited number of box lunches and seats will be available.

Plenary Lectures

Plenary Opening Lecture: NIH Vision

Monday, March 7, 8:00 AM–9:00 AM

Lecturer: Lawrence Tabak, Principal Deputy Director, National Institutes of Health (Invited)

View Dr. Tabak’s Presentation

Keynote Plenary Lecture: Increasing the Prestige of Regulatory Sciences

Tuesday, March 8, 8:00 AM–9:00 AM

Lecturer: Margaret Hamburg, U.S. Food and Drug Administration, Washington, D.C.

Described as, “an inspiring public health leader with broad experience in infectious disease, bioterrorism, and health policy,” by HHS Secretary Kathleen Sebelius we are delighted to have Dr. Margaret A. Hamburg, the 21st U.S. FDA Commissioner present a keynote plenary lecture at the Society’s 50th anniversary meeting. Dr. Hamburg is exceptionally qualified by her training and experience as a medical doctor, scientist, and public health executive.

Dr. Hamburg graduated from Harvard Medical School, and completed her residency in internal medicine at what is now New York Presbyterian Hospital-Weill Cornell Medical Center, one of the top-ten hospitals in the nation. She conducted research on neuroscience at Rockefeller University in New York, studied neuro-pharmacology at the National Institute of Mental Health on the National Institutes of Health campus in Bethesda, Md., and later focused on AIDS research as Assistant Director of the National Institute of Allergy and Infectious Diseases.

During her career she has been widely praised for her initiatives, decisive leadership, and significant public health measures. As a public health officiall she is credited with improving services for women and children, a needle-exchange program to reduce the spread of HIV (the AIDS virus), and the initiation the first public health bio-terrorism defense program in the nation. Her most celebrated achievement, however, was curbing the spread of tuberculosis in the 1990s.

In 1994, Dr. Hamburg was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored. Three years later, at the request of President Clinton, she accepted the position of Assistant Secretary for Policy and Evaluation in the U.S. Department of Health and Human Services.

View Dr. Hamburg’s Presentation

Keynote Medical Research Council (MRC) Lecture: Cellular Responses to DNA Damage: New Molecular Insights and New Approaches for Cancer Therapy

Wednesday, March 9, 8:00 AM–9:00 AM

Lecturer: Stephen P. Jackson, The Gurdon Institute and Department of Biochemistry, University of Cambridge, Cambridge, United Kingdom

Inherited or acquired defects in detecting, signal-ling or repairing DNA damage are associated with various human pathologies, including immuno-deficiencies, neurodegenerative diseases and various forms of cancer1. Our increasing knowledge of cellular DNA-damage responses (DDR) is therefore providing new insights into the aetiology of such diseases and, moreover, is presenting opportunities for novel diagnostic and therapeutic strategies. Work in Dr. Jackson’s laboratory aims to decipher the mechanisms by which cells detect DNA damage and signal its presence to the DNA-repair and cell-cycle machineries. In particular, much of the work focuses on DNA double-strand breaks (DSBs) that are generated by ionizing radiation and radiomimetic chemicals, and which can also arise when the DNA replication apparatus encounters other DNA lesions.

In this talk, Dr. Jackson will first provide an overview of how cells respond to DNA damage and will describe the key protein players in these events. Next, he will discuss some of our recent work that has identified new proteins that mediate DSB responses, control DSB processing or modulate chromatin structure at DNA damage sites. He will then explain how this type of work identified therapeutic opportunities that led to me founding KuDOS Pharmaceuticals Ltd, whose mission was to develop DDR inhibitors for cancer therapy. Finally, He will use the example of the KuDOS drug olaparib (now owned by and being developed by AstraZeneca) to highlight the exciting potential for DDR inhibitors in treating many cancers.

Specifically, Dr. Jackson will explain the molecular basis for how olaparib is exquisitely cytotoxic to cancer cells bearing DSB repair defects because of inherited mutations in BRCA1 or BRCA2 but is well tolerated by normal cells of cancer patients. In closing, he will explain how this and related mechanisms of “synthetic lethality” might be applied to a wider range of cancers that bear DDR defects.

View Dr. Jackson’s Presentation

Keynote Plenary Lecture: U.S. Environmental Protection Agency (U.S. EPA) Vision

Thursday, March 10, 8:00 AM–9:00 AM

Lecturer: Bob Perciasepe, Deputy Administrator, U.S. EPA (Invited)

View Dr. Perciasepe’s Presentation

Meet the Directors Series

The Meet the Director program is a special 60-minute session that provides an opportunity for the series of leaders of major federal agencies to engage in discussions of emerging trends in toxicology research and its funding.

NIEHS Director

Wednesday, March 9, 9:30 AM–10:30 AM

Chairperson(s): Jon C. Cook, Pfizer, Groton, CT

Lecturer: Linda S. Birnbaum, NIEHS, Rearch Park Triangle, NC

The National Institute of Environmental Health Sciences (NIEHS) seeks to understand how the environment infuences the development and progression of human disease. This session will be a particularly valuable opportunity to update SOT members on the future directions of the NIEHS and the National Toxicology Program (NTP). Dr. Birnbaum will talk about her plans for leading NIEHS and NTP in promoting the environmental public health of the United States and the world through research directed at preventing and treating disease.

CDC/NIOSH Director

Wednesday, March 9, 10:45–11:45 AM

Chairperson(s): William Slikker, Jr., U.S. FDA, Jefferson, AR

Lecturer: John Howard, CDC/NIOSH, Washington D.C.

The National Institute for Occupational Safety and Health (NIOSH) is a component of the Centers for Disease Control and Prevention in the U.S. Department of Health and Human Services. NIOSH’s mission is to generate new knowledge in the field of occupational safety and health and transfer that knowledge globally. NIOSH was established along with the the Occupational Safety and Health Administration (OSHA) by the Occupational Safety and Health Act of 1970. NIOSH is a founding member of the National Toxicology Program (NTP) along with the Food and Drug Administration and the National Institute for Environmental Health Sciences.

Highlights of NIOSH’s current activities in the area of toxicology include two major programs. First, the National Occupational Research Agenda (NORA) is a partnership program to stimulate inno-vative research and improved workplace practices. NORA has become a research framework for NIOSH and the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing these needs. Participation in NORA is broad, including stakeholders from universities, large and small businesses, profes-sional societies, government agencies, and worker organizations.

The program entered its second decade with a new sector based structure to better move research to practice within workplaces. The national agenda will be developed and implemented through the NORA Sector Councils. NIOSH is the steward of NORA and facilitates the work of the Sector Councils, which develop and implement research agendas for the occupational safety and health community. Second, the Nanotechnology Research Center (NRC) developed a Strategic Plan, published Progress Reports, provided guidance of good handling practices for nanomaterials, and produced CIBs for nano TiO2 and carbon nanotubes. Currently, there are 52 projects in the NTRC. Projects are in the areas of toxicology and internal dose, measurement methods, exposure assessment, epidemiology and surveillance, risk assessment, engineering controls and PPE, fire and explosivity, recommendations and guidance, communication and information, and applications.

Finally, during the Deepwater Horizon Response—Gulf of Mexico Oil Cleanup NIOSH was involved in several activities including rostering efforts, exposure assessments using health hazard evaluations (HHEs), toxicity testing, and worker health surveillance. NIOSH’s efforts in assessing the toxicity of the oil spill have focused on the dispersant designed to break up the oil. There has been a lot of concern about the chemicals within the dispersant, as well as the mixture of the crude and the dispersant together. The toxicology studies are currently ongoing and are looking at pulmonary, cardiovascular, and central nervous system effects after inhalation of dispersant or oil as well as dermal and immune effects after topical exposure to dispersant or oil. Also, on May 28, 2010, BP requested a health hazard evalua-tion of Deepwater Horizon Response workers. The sixth in a series of interim reports from this health hazard evaluation was issued September 13, 2010. These reports can be found by clicking on the NIOSH Web site. In addition, you will also find at this site current spreadsheets containing quantitative industrial hygiene sampling data available to date from NIOSH’s health hazard evaluation of the Deepwater Horizon Response.

Center for Scientific Review Director

Wednesday, March 9, 1:15 PM–2:14 PM

Chairperson(s): Cheryl Lyn Walker, University of Texas MD Anderson Cancer Center, Smithville, TX

Lecturer: Sy Garte, Center for Scientific Review, Bethesda, MD

The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for Scientific merit. The recent history of the peer review process for toxicology and environmental health sciences grant applications will be discussed, including the experience of the pilot Special Emphasis Panel (SEP) on Systemic Injury from Environmental Exposure (SIEE). Analysis of data, and lessons learned from this pilot will be presented. Alternative approaches, geared toward ensuring the optimum quality and fairness of review for toxicology grants will be described, and preliminary results from recent review cycles will be shared.

The presentation will include an interactive segment, whereby audi-ence members will be encouraged to share their experiences with the peer review process, and contribute ideas for improvement.

U.S. FDA Director

Wednesday, March 9, 2:30 PM–3:30 PM

Chairperson(s): Michael P. Holsapple, International Life Sciences Institute, Washinton, D.C.

Lecturer: Jesse Goodman, U.S. FDA, Silver Spring, MD

U.S. FDA has defined regulatory science as the science of devel-oping new tools, standards and approaches to assess the safety, effcacy, quality and performance of U.S. FDA-regulated products (see Advancing Regulatory Science for Public Health, 2010). No area of science is more important to our ability to predict a product’s safety, or assess the potential significance of chemical substances in products, than toxicology. Well performed toxicology studies have undoubtedly protected consumers from many unsafe products and from contaminants that pose true threats to health. Yet most of the toxicology tools in use for regulatory assess-ment have as of yet been essentially unchanged by the molecular and cellular revolutions of the last 40 years. A wealth of innovation based on application of genomic, proteomic, metabolic, cell based and modeling tools is being applied, largely in the research community, to assessing the e?ects of novel and existing compounds. These tools, if and as they are validated for their predictive capabilities, o?er the potential to revolutionize toxicology and its use in safety assessments, dramatically improving our ability to detect, understand and manage potential risks. Improvements should occur both in sensitivity and in specificity—the goal should be to detect true risks, but to not reject products that are safe due to false positive signals that may not be predictive of target e?ects in humans (or, for that matter, in other parts of the ecosystem). In addition, there are compelling reasons to limit animal testing where other methods may either replace or improve prediction. In recognition of this potential, U.S. FDA has made “Transforming Toxicology” one of its broad strategic priorities in its Advancing Regulatory Science Initiative. U.S. FDA is including support for new approaches to toxicology in its joint NIH/FDA regu-latory science grants, as well as in e?orts in both its product centers and at the National Center for Toxicological Research. Enhancing toxicology studies for nanoparticles would receive enhanced support at U.S. FDA, and through collaborative studies, under the President’s 2011 budget proposal currently before Congress, which includes the first dedicated budget support line for regulatory science at U.S. FDA. The Offce of the Chief Scientist recently formed a new U.S. FDA-wide Chemical and Environmental Science Council (CESC) to serve as a focus for more proactively managing the growing U.S. FDA portfolio of cross-cutting chemical and toxicology issues, and to enhance scien-tific and policy communication, collaboration and training across U.S. FDA and with external partners. U.S. FDA has been increasingly engaged with colleagues in diverse agencies such as NIEHS (including through the NTP), U.S. EPA (including through the Tox-21 initiative and multiple specific issues), CDC and CPSC, among others. Such collaboration has, for example, been critical in the scientific response to potential health threats from the Gulf Oil Spill. Through these and other e?orts, U.S. FDA has raised the profile of toxicology within the Agency and signaled its support for collaboration to advance the science needed to inform the best possible decisions.

U.S. EPA Director

Wednesday, March 9, 3:45 PM–4:45 PM

Chairperson(s): Michael P. Holsapple, International Life Sciences Institute, Washinton, D.C.

Lecturer: Kevin Teichman, Deputy Assistant Administrator for Science, Office of Research and Development (Invited)

Award Lectures

Merit Award Lecture: Neurotoxicology Goes Global: Scientific Collaboration and Mentorship

Monday, March 7, 12:15 PM–1:05 PM

Lecturer: Michael Aschner, Vanderbilt University, Nashville, TN

Leading Edge in Basic Science Award Lecture: Roles of Keap 1-Nrf2 in Environmental Response

Tuesday, March 8, 7:00 AM–7:50 AM

Lecturer: Masayuki Yamamoto, Ph.D., Tohoku University Graduate School of Medicine, Japan

Distinguished Toxicology Scholar Award Lecture: Cloning and Functional Analysis of the Aryl Hydrocarbon Nuclear Translocator (ARNT)

Tuesday, March 8, 12:15 PM–1:05 PM

Lecturer: Oliver Hankinson, Ph.D.,University of California, Los Angeles, CA

Translational Impact Award Lecture: Integration of Bioinformatics into Regulatory Decision Making

Wednesday, March 9, 12:15 PM–1:05 PM

Lecturer:Weida Tong, Ph.D., U.S. FDA—National Center for Toxicological Research (NCTR)