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CE Course Speakers

CE Courses

SR01 Basic Principles and Practices for Applying Epigenetics in Mechanistic Toxicology Basic
AM02 Advancing the Detection, Imaging, and Pitfalls in Monitoring Oxidative Stress in Health and Disease Advanced
AM03 Adverse Outcome Pathway (AOP) Development and Evaluation Basic
AM04 Contribution of Mitochondria to Drug-Induced Organ Toxicities Basic
AM05 Discovery and Validation of miRNA Biomarkers Bridging Preclinical and Clinical Toxicity: Lessons Learned from Hepatotoxicity Advanced
AM06 Embryology and Developmental Toxicity Testing Basic
AM07 Next-Generation Sequencing in Toxicogenomics Advanced
PM08 Approaches to Investigate and Assess Risks Associated with Drug-Induced Liver Injury (DILI) Advanced
PM09 Exploring Chemical Space in the New Toxicity Testing Paradigm: From Data Curation to Computational Simulations Basic
PM10 Genetics and Population Variability in Chemical Toxicity: The What, the How, and So What? Basic
PM11 Human Health Risk Assessment: A Case Study Application of Principles Advanced
PM12 Unique Approaches to Safety Assessment of Gene, Cell, and Nucleic Acid-Based Therapies Basic
PM13 Zebrafish As a Tool in Toxicology and Drug Discovery Screening Basic

Basic Principles and Practices for Applying Epigenetics in Mechanistic Toxicology

Sunrise Course (SR01) | CE Basic | 7:00 AM–7:45 AM

Theme:

Molecular Toxicology: Mechanistic Insights and Hazard Assessment

Chairperson(s): Shaun D. McCullough, US EPA, Chapel Hill, NC; and Ronald N. Hines, US EPA, Research Triangle Park, NC.

Part 1: Principles of Epigenetics: An Introduction to the Mechanisms of Gene Regulation. Ronald N. Hines, US EPA, Research Triangle Park, NC.

Dr. Hines serves as Associate Director for Health, US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory where he manages the laboratory health effects research and develops and implements strategies to assure an integrated, transdisciplinary research program responsive to the needs of the national research programs and offices. Prior to joining the Agency in 2012, Dr. Hines was Assistant Professor of Biochemistry and Investigator, Eppley Institute for Research in Cancer and Allied Diseases, University of Nebraska Medical Center from 1983 to 1989; Associate Professor (1989 to 1995) and Professor (1995 to 1999) of Pharmacology, Wayne State University School of Medicine; and Professor of Pediatrics and Pharmacology and Toxicology and Co-Section Chief, Clinical Pharmacology, Pharmacogenetics, and Teratology, Medical College of Wisconsin from 1999 to 2012, and Associate Director of the Children’s Research Institute, Children’s Hospital and Health Systems from 2005 to 2011.

Part 2: Experimental Techniques for Incorporating Chromatin and DNA Methylation Analysis into Mechanistic Toxicology. Shaun D. McCullough, US EPA, Chapel Hill, NC.

Dr. Shaun D. McCullough is a Principal Investigator in the Clinical Research Branch of the US Environmental Protection Agency’s Environmental Public Health Division in Chapel Hill, North Carolina. Dr. McCullough completed his postdoctoral training at the US EPA where he identified novel pathways of single and multi-toxicant mediated stress, for which he received the Molecular and Systems Biology Specialty Section Postdoctoral Fellow Award, the US EPA Superior Achievement Award, and the Gabriel L. Plaa Education Award. Dr. McCullough’s research is focused on investigating the role of the epigenome as a mediator of inter-individual variability in toxicant-induced health effects and susceptibility using in vitro and human exposure models. Dr. McCullough is the Chairman of the US EPA’s National Health and Environmental Effects Research Laboratory Epigenetics Workgroup, a founding member of the University of North Carolina’s Program in Chromatin and Epigenetics, and is on the Board of Directors for the American Society for Cellular and Computational Toxicology.

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Advancing the Detection, Imaging, and Pitfalls in Monitoring Oxidative Stress in Health and Disease

Morning Course (AM02) | CE Advanced | 8:15 AM–12:00 Noon

Theme:

Health and Environmental Impacts of Manmade and Naturally Released Toxicants
Molecular Toxicology: Mechanistic Insights and Hazard Assessment

Chairperson(s): Maria B. Kadiiska, NIEHS/NIH, Research Triangle Park, NC; and Ronald P. Mason, NIEHS/NIH, Research Triangle Park, NC.

We Detect Free Radicals Not Because It Is Easy but Because It Is Hard. Ronald P. Mason, NIH/NIEHS, Research Triangle Park, NC.

Ronald P. Mason received his BA in Chemistry, Cum Laude, from the University of California at Riverside, his PhD in Chemistry (physical), from the University of Wisconsin-Madison and was a Postdoctoral Fellow at Cornell University, Ithaca. New York. At present, he is a Senior Investigator and Head of the Free Radical Metabolite group in the Immunity, Inflammation, and Disease laboratory at the National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina. Dr. Mason has devoted his career to studying free radicals formed by metabolism of environmental pollutants, drugs, and biomolecules. In the last decade, Dr. Mason invented anti-DMPO immunoassays that bring the power of immunology to bear on detection of protein and DNA free radicals. Dr. Mason has made major contributions to the field of free radical biology and molecular toxicology. He is an accomplished professional, a dedicated scientist, and an effective mentor. Dr. Mason has received numerous accolades and also received the SFRBM Discovery Award in 2015.

In Vivo, In Situ Imaging of Free Radical Adducts in Animal Disease Models. Rheal A. Towner, Oklahoma Medical Research Foundation, Oklahoma City, OK.

Rheal A. Towner is currently an Associate Professor (since 2011) in the Department of Veterinary Pathobiology, Oklahoma State University, Stillwater, OK as well as Associate Professor, University of Oklahoma Health Sciences Center, Oklahoma City in the Department of Pharmaceutical Sciences (since 2005) and in the Department of Pathology (since 2003), Dr. Towner is an Associate Member and Director for the Advanced Magnetic Resonance Center, Oklahoma Medical Research Foundation, Oklahoma City (since 2002) as well as the Oklahoma Center for Neurosciences, University of Oklahoma Health Sciences Center, Oklahoma City (since 2003), Dr. Towner previously served as Manager for the Magnetic Resonance Imaging Facility, University of Guelph, Canada (1990–1992), NHMRC Research Officer (1993), Centre for Magnetic Resonance, University of Queensland, Australia, and
Senior Lecturer (1994–2002), Department of Physiology and Pharmacology, James Cook University, Australia.

Oxidative Damage Detection in Macromolecules: Free Radical-Innate Immune Crosstalk in Liver Disease. Saurabh Chatterjee, University of South Carolina, Columbia, SC.

Dr. Chatterjee is a human physiologist with specialized training in immunology. He completed his PhD while working as a research scientist at Bhabha Atomic Research Center, Mumbai India, a premier research institute of the Department of Atomic Energy, Government of India and affiliated to the University of Mumbai. He has made significant contributions to the field of immunotoxicology especially in pro-inflammatory disease processes like heat stroke, sepsis and inflammatory liver disease, especially nonalcoholic steatohepatitis.

Dr. Saurabh Chatterjee is currently an assistant professor at the Departments of Environmental Health Sciences and Department of Cell Biology and Anatomy, University of South Carolina (USC). He directs the Environmental Health and Disease Laboratory within USC. Dr. Chatterjee’s laboratory studies the environmental toxin potentiatiation of chronic liver and kidney diseases in obesity. His research experiences at the National Institute of Environmental Health Sciences (Laboratory of Pharmacology and Toxicology, and Duke University School of Medicine (Gastroenterology) as a postdoctoral researcher greatly enhanced his expertise in inflammatory liver disease in obesity and how the oxidative stress of environmental toxicants cause obesity-induced disease. He received the prestigious NIH pathway to independence (K99-R00) funding from NIEHS in 2011.

Xenobiotic Free Radical Detection in Biological Systems Using HPLC: A Technique for All. Arno G. Siraki, University of Alberta, Edmonton, AB, Canada.

Arno Siraki is an Associate Professor in the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta. Arno received his Honorary BSc with a specialization in toxicology in 1998 from the University of Toronto. Arno continued his graduate studies in the Department of Pharmacology (under the supervision of Dr. Peter J. O’Brien) and was conferred the degree of MSc in 2000 while working at the same time in a Quebec lab at GSK (then GlaxoWellcome). He selected a research path and continued graduate studies in the same laboratory as a PhD student. He was awarded an NSERC graduate fellowship for his thesis work (“Development of quantitative structure-activity relationships for metabolic activation of drugs and xenobiotics to reactive metabolites”) and was conferred his PhD in 2004 from the Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto. Arno’s postdoctoral studies were carried out at the National Institute of Environmental Health Sciences (NIH), located in Research Triangle Park, North Carolina, USA from 2004 to 2008. Under the guidance of Dr. Ronald P. Mason, Head of the Free Radical Metabolite Group, Arno developed methods to detect protein free radicals through xenobiotic metabolism. Arno was recruited to the Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta in 2008. His current research interests involve the association of free radicals with adverse drug reactions, identification of novel electron transfer intermediates (antioxidants), and the biological role of xenobiotic-induced protein free radicals.

Oxidative Modification of Proteins: Detection and Role in Autoimmunity. M. Firoze Khan, University of Texas Medical Branch, Galveston, TX.

Dr. Firoze Khan, after completing his postdoctoral training at NIEHS and University of Ottawa, joined University of Texas Medical Branch at Galveston in 1989 where he is Professor and Vice-Chair for Research in the Department of Pathology. Dr. Khan’s major research interest has been chemical-induced autoimmunity, with a major focus on contribution of oxidative stress in the pathogenesis of autoimmune diseases. His research has been supported by NIH for more than 20 years. He has published extensively in toxicology-related journals and received several academic awards. He is an Associate Editor of Toxicology and Applied Pharmacology and also serves on the editorial board of more than a dozen journals.

 

Validation of Best Detection Methods for Oxidative Stress Biomarkers in Biological Fluids. Maria B. Kadiiska, NIEHS/NIH, Research Triangle Park, NC.

Dr. Kadiiska’s dual and integrated grounding as both a physician and as a scientist has enabled her to develop unique and sophisticated research at NIEHS with two major foci:1) detection, identification and mechanisms of in vivo free radical generation by using electron spin resonance (ESR) spectroscopy in conjunction with spin-trapping techniques and 2) the validation, identification and assessment of accurate and noninvasive biomarkers to measure oxidative stress in vivo. She undertook considerable responsibility as project leader for the Biomarkers of Oxidative Stress Study (BOSS) since its inception more than a decade ago. BOSS is a major undertaking at the NIEHS Division of Intramural Research level. With Dr. Kadiiska’s leadership and her high level of scientific and technical expertise and significant organizational and personal communication abilities, BOSS became a large international collaborative study that has identified both accurate and inaccurate biomarkers of oxidative stress. With her successful leadership and very strong reputation, the study has evolved over the years and is now highly regarded as the benchmark for the measurement of oxidative stress in health and disease.

Reinterpreting the Best Biomarker of Oxidative Stress: The 8-iso-PGF2α/PGF2α Ratio Distinguishes Chemical from Enzymatic Lipid Peroxidation. Thomas J. van ‘t Erve, NIEHS/NIH, Research Triangle Park, NC.

T. Joost van ‘t Erve, PhD is a postdoctoral fellow with the National Institute of Environmental Health Sciences (NIEHS) in North Carolina, United States. Joost received his PhD in Human Toxicology from the University of Iowa. His research focuses on quantitatively elucidating the role of free radicals in health and toxicity. He published on new paradigms of the heritability of antioxidants in human red blood cells, as well as a new dosing metric to improve the information and reproducibility of toxicological cell culture experiments. Joost is currently working on accurately quantitating biomarkers of oxidative stress. He co-invented a method to reduce misinterpretation of the popular biomarker 8-iso-prostaglandin F2α and is applying this technique to better understand oxidative stress in several human and animal diseases and exposures. His contributions to the field of oxidative stress were recognized with a young investigator award from the Society of Redox Biology and Medicine in 2014.

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Adverse Outcome Pathway (AOP) Development and Evaluation

Morning Course (AM03) | CE Basic | 8:15 AM–12:00 Noon

Theme:

Molecular Toxicology: Mechanistic Insights and Hazard Assessment
Recent Advances in Safety Assessment

Chairperson(s): Stephen Edwards, US EPA, Research Triangle Park, NC; and Andrea Terron, EFSA (European Food Safety Agency), Parma, Italy.

Introduction. Stephen Edwards, US EPA, Research Triangle Park, NC.

Stephen Edwards is a Systems Biologist within the US Environmental Protection Agency’s (EPA) National Health and Environmental Effects Research Laboratory. Dr. Edwards is the US EPA lead for an international effort to develop an Adverse Outcome Pathway (AOP) Knowledgebase, which is designed to house descriptions of the biological mechanisms underlying chemical toxicity in a structured manner. He serves as a senior advisor in the Office of Research and Development on issues regarding the development of AOP-based predictive toxicology models of disease using genomics, proteomics, and metabolomics. With a combination of experimental and computational experience, Dr. Edwards also serves as a liaison with the US EPA’s National Center for Computational Toxicology and works on web-based tools to support systems biology research within the US EPA. Before joining the US EPA, he served as a research fellow at Rosetta Inpharmatics (Merck & Co.), a recognized leader in computational and systems approaches to drug development.

Introduction to Adverse Outcome Pathways and International Activities Guiding AOP Development. Kristie Sullivan, Physicians Committee for Responsible Medicine, Washington, DC.

Kristie Sullivan promotes the development and adoption of non-animal toxicology test methods through collaboration with industry, academic, and government stakeholders. Ms. Sullivan coordinates the International Council on Animal Protection in OECD Programmes (ICAPO), a coalition of NGOs participating in OECD programs, and has served on advisory committees including the Pesticide Program Dialog Committee. Ms. Sullivan has given presentations to a variety of audiences and has co-authored publications with industry and government colleagues. She has organized workshops and meetings on topics such as acute toxicity, skin and eye irritation, and respiratory toxicity, including several specifically for regulators. Ms. Sullivan is Secretary of the ASCCT and a member of the SOT, ESTIV, and the Society for Advancement of Adverse Outcome Pathways. Previously, Ms. Sullivan was an analyst in the UM OSEH Environmental Laboratory, and worked on the Staten Island Lung Cancer Research Project with the NYC Department of Health and Mental Hygiene.

Principles and Best Practices for AOP Development. Dan Villeneuve, US EPA, Duluth, MN.

Dr. Daniel L. Villeneuve is a research toxicologist at the US EPA Mid-Continent Ecology Division (MED) in Duluth, Minnesota. Dr. Villeneuve serves as a project lead for laboratory and field research aimed at the development adverse outcome pathway (AOP) knowledge and application of that knowledge to support regulatory toxicology. Dr. Villeneuve’s research is focused on the use of systems biology approaches and application of the AOP framework to extend fundamental understanding of the ways in which chemical stressors can interact with the hypothalamic-pituitary-gonadal (HPG)-axis to produce reproductive toxicity in fish and other vertebrates.

 

Weight of Evidence/Confidence Analysis in the Development and Documentation of AOPs. Bette Meek, University of Ottawa, Ottawa, ON, Canada.

Bette is currently the Associate Director of Chemical Risk Assessment at the McLaughlin Centre for Risk Science, Faculty of Medicine, University of Ottawa. She previously managed several chemical risk assessment programs within Health Canada. With colleagues internationally, she has contributed to or led initiatives in areas such as weight of evidence analysis for mode of action, chemical specific adjustment factors, physiologically-based pharmacokinetic modeling, combined exposures and predictive modeling.

 

 

Assembling AOP Information in the International AOP Knowledgebase. Carole Yauk, Health Canada, Ottawa, ON, Canada.

Carole Yauk is currently a Research Scientist for Health Canada located in Ottawa, ON, Canada, Adjunct Professor in the Department of Biology, Carleton University, Ottawa, ON, Associate Editor for Environmental and Molecular Mutagenesis, and on the Editorial Board for Mutation Research/Fundamental and Molecular Mechanisms.

 

 

 

 

Applying AOPs to the Development of Integrated Approaches on Testing and Assessment (IATA). Gavin Maxwell, Unilever, Sharnbrook, United Kingdom.

Gavin has over 11 years experience within Unilever and is currently a Science Leader specialising in Immunology/Skin Allergy within Unilever’s Safety & Environmental Assurance Centre (SEAC) predominantly working on the development, evaluation and application of non-animal approaches for risk assessment (with a focus on Skin Sensitisation). He previously chaired the Cosmetics Europe (European Cosmetics Industry Trade Association) Skin Tolerance taskforce for 5 years (2008–2013) and is currently involved in developing guidance for documenting IATA within the OECD Skin Sensitisation IATA working group.

 

 

Implementing the AOP Framework at EFSA. Andrea Terron, EFSA (European Food Safety Agency), Parma, Italy.

The professional background of Andrea Terron in the field of toxicology includes toxicologic pathology, nonclinical safety assessment for drug development (1986–2000), serving as the Director of Pathology in nonclinical safety assessment for drug development (2000–2012), and as Senior Scientific Officer, EFSA, for pesticides risk assessment (actual).

 

 

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Contribution of Mitochondria to Drug-Induced Organ Toxicities

Morning Course (AM04) | CE Basic | 8:15 AM–12:00 Noon

Theme:

Molecular Toxicology: Mechanistic Insights and Hazard Assessment

Chairperson(s): Varsha G. Desai, National Center for Toxicological Research, US FDA, Jefferson, AR; and Yvonne Will, Pfizer R&D, Groton, CT.

Contribution of Mitochondria to Drug-Induced Organ Toxicities: An Overview. Varsha G. Desai, National Center for Toxicological Research, US FDA, Jefferson, AR.

Dr. Desai is currently working as a Research Biologist at the US Food and Drug Administration’s National Center for Toxicological Research and is extensively involved in investigating mitochondrial role in organ toxicities induced by various therapeutic drugs including, anti-HIV and anti-cancer drugs in different animal models. Dr. Desai is the first to design and develop mitochondria-specific gene expression microarrays consisting of approximately 800 genes for rodent models to understand the mechanisms of various drug toxicities and degenerative diseases associated with mitochondrial dysfunction. This genomic tool is also expanded to nonhuman primates and humans to enhance our understanding of the mechanisms underlying species-specific differences in drug toxicities and disease susceptibilities associated with mitochondrial dysfunction. Dr. Desai has also developed a mouse model of chronic cardiotoxicity induced by an anti-cancer drug, doxorubicin, to identify early biomarkers of cardiac injury which may help in preventing toxic effects of doxorubicin in hearts of cancer patients.

Mitochondrial Function and Dysfunction in Disease and Drug-Induced Toxicity. James A. Dykens, EyeCyte Therapeutics, San Diego, CA.

Dr. Dykens was on the Biology faculty at Grinnell College for five years where his research was supported by the National Science Foundation, the Mt. Desert Island Biological Lab, and the Marine Biological Lab in Woods Hole. He then joined the Immunopathology Department at Parke-Davis Pharmaceuticals where he used electron paramagnetic resonance spectroscopy to study mitochondrial free radical production. In 1996, Dr. Dykens joined MitoKor, a company focusing on the mitochondrial etiology of degenerative diseases, and in 2006 moved to Pfizer to focus on drug-induced mitochondrial dysfunction. For two and half years, he led Pfizer’s Investigative Cellular Toxicity group in Sandwich, United Kingdom. Dr. Dykens is currently the Founder of EyeCyte Therapeutics, a start-up developing mitochondrial therapeutics for progressive blinding diseases.

 

Mitochondrial Toxicity: A Decade of Technology Development, a Decade of Learnings. Yvonne Will, Pfizer R&D, Groton, CT.

Dr. Yvonne Will was born and raised in Germany where she conducted her undergraduate studies in Human Nutrition at the University of Bonn, while working as a full time position in the Department of Equine Exercise Physiology. In 1992, Dr Will conducted an internship at the College of Veterinaty Medicine at Oregon State University, where she enrolled the same year to obtain her MS degree. Her work was focused on the bioremediation of explosives using ruminant bacteria and analytical chemistry approaches. In 2000, Dr. Will obtained her PhD in Biochemsitry and Biophysics from Oregon State University, where her thesis focused on the relationships between glutathione deficiency and cellular and mitochondrial function/dysfunction. During her years at the biotechnology company MitoKor, San Diego (2000–2003) she was involved in drug discovery aimed on improving mitochondrial function or preventing mitochondrial dysfunction in obesity, diabetes, and CNS related diseases.

From 2003 until 2007, Dr. Will was a group leader in Drug Safety at Pfizer La Jolla, pioneering a screening paradigm for drug induced mitochondrial toxicity, supporting many therapeutic areas. This platform has been adapted throughout all major pharmaceutical companies. During that time she also held an adjunct faculty position at San Diego State University in the Toxicology program where she conducted lectures, taught laboratory courses and mentored MS students. In the fall of 2007 Dr. Will transferred to Pfizer Groton to lead a group of scientists in the Compound Safety Prediction Group within Medicinal Chemistry. This group was set out to conduct in vitro safety assessment as early as possible within the drug discovery process to reduce late stage attrition. Dr. Will’s group has pioneered many new technologies throughout the years. Dr Will has published a book on drug induced mitochondrial toxicity is currently on a new book on drug discovery toxicology. Dr. Will has given many national and international lectures, conducted workshops and seminars and continues to publish numerous papers each year in peer reviewed journals. In 2012, Dr. Will was honored with the Connecticut Technology Council’s Woman Research Innovation and Leadership Award. Dr. Will’s passion is to develop young scientists through external influence such as publications and participations in national meetings. In September of 2014, Dr. Will became the Head of Science and Technology for Drug Safety within Pfizer. As such she works on strategy as well as innovation and developing the next generation of scientists through a postdoctoral program as well as mentoring efforts. Dr. Will also practices a life-work balance by spending time with her family, in particular her 11 year old daughter Natalia and riding dressage on her horse Mocca.

Mitochondrial Dysfunction in Acute Kidney Injury. Rick G. Schnellmann, Medical University of South Carolina, Charleston, SC.

Dr. Rick Schnellmann is an Eminent Scholar and Distinguished University Professor in the Department of Drug Discovery and Biomedical Sciences at the Medical University of South Carolina, Charleston, South Carolina. He has received his PhD in Pharmacology and Toxicology from the University of Arizona and my postdoctoral training in renal physiology at Duke University.

His longstanding research interests are in the mechanisms of renal injury and regeneration, and the treatment thereof. Much of his previous and current research has been focused on the role of mitochondrial injury in renal cell death. In particular, they characterized the role of a mitochondrial protease (i.e. calpain 10) and a mitochondrial phospholipase (iPLA2γ) in mediating and protecting mitochondria and renal cells from diverse insults. More recently, they have focused on 1) mitochondrial homeostasis and novel approaches to promote mitochondrial biogenesis to treat acute and chronic kidney injury, 2) on the development of urinary biomarkers of mitochondrial dysfunction.

Doxorubicin-Induced Mitochondrial Cardiomyopathy. Kendall B. Wallace, University of Minnesota Medical School Duluth, Duluth, MN.

Dr. Kendall Wallace received his PhD in Physiology from Michigan State University in 1979 and his Postdoc work was done at the University of Iowa Toxicology Center. Dr. Wallace is currently Asst., Assoc., Full Professor in the Pharmacology & Biochemistry and Molecular Biology Departments at the University of Minnesota Medical School Duluth, Minnesota.

 

 

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Discovery and Validation of miRNA Biomarkers Bridging Preclinical and Clinical Toxicity: Lessons Learned from Hepatotoxicity

Morning Course (AM05) | CE Advanced | 8:15 AM–12:00 Noon

Theme:

Molecular Toxicology: Mechanistic Insights and Hazard Assessment
Recent Advances in Safety Assessment

Chairperson(s): Alison Harrill, University of Arkansas for Medical Sciences, Little Rock, AR; and Brian Chorley, US EPA, Research Triangle Park, NC.

Introduction. Brian Chorley, US EPA, Research Triangle Park, NC.

Dr. Brian Chorley is molecular biologist with training in cellular biology and genomics. Dr. Chorley completed his PhD in 2005 from North Carolina State University where he studied the signaling mechanisms of inflammation and mucin production in airway epithelial cells. He continued his research as a postdoctoral fellow at the National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, where he studied the genetic influences on NRF2 antioxidant signaling pathway activation. In 2010, he began his current position as Principal Investigator in the National Health and Environmental Effects Research Laboratory (NHEERL) at the US Environmental Protection Agency where he currently studies genetic and epigenetic biomarkers of adverse human health outcomes after chemical exposure. He also leads US EPA task groups which study Adverse Outcome Pathway development of liver steatosis and high-throughput assay design to test for CYP-mediated biotransformation of environmental chemical toxicity.

Utilizing miRNAs to Assess Organ Specificity: Using miR-122 to Distinguish between Liver and Muscle Injury. Warren Glaab, Merck Research Laboratories, West Point, PA.

Dr. Warren Glaab has worked within Safety Assessment at Merck Research Laboratories for 18 years. Most recently he has served as Director of Systems Toxicology, involved with providing biomarker development support to Safety Assessment, incorporating new model systems and technologies including genomics and proteomics, and investigative toxicology research solutions. Previous experience within the Department of Molecular and Investigative Toxicology group in Safety Assessment included novel assay development and investigational studies to better understand toxicity mechanisms. He earned his PhD in Toxicology at the University of North Carolina at Chapel Hill, conducted research at the National Institute of Environmental Health Sciences in Research Triangle Park, and completed two postdoctoral positions at National Institute of Environmental Health Sciences and at Merck Research Laboratories in West Point, Pennsylvania.

Emerging Biomarkers of Liver Injury: From miR-122 to Liquid Biopsies in the Clinic. Jiri Aubrecht, Pfizer Inc., Groton, CT.

Jiri Aubrecht is a Senior Director and Group Lead of Safety Biomarker Laboratories at Pfizer, Groton, Connecticut. His research interests are development and application of translational strategies with emphasis on qualification of novel biomarkers for risk assessment. Dr. Aubrecht completed postdoc fellowship in molecular toxicology at Harvard School of Public Health, has experience in biotech an pharmaceutical industry, and authored over 55 peer-review publications in leading biomedical journals, six book chapters, has one issued patent and several patent applications. Dr. Aubrecht serves as a co-director of Predictive Safety Consortium at the Critical Path Institute, is a member of the Society of Toxicology and a vice president of Clinical and Translational Toxicology Specialty Section. Dr. Aubrecht served as chair of the HESI Technical Committee on Application of Genomics to Mechanism-Based Risk Assessment and was a member of the scientific advisory board of the EU project CarcinoGenomics.

Clinical Qualification of a miRNA Biomarker in a Hospital Setting: miR-122 in Acute Liver Failure Patients. Daniel Antoine, University of Liverpool, Liverpool, United Kingdom.

Dr. Daniel Antoine is currently a Wellcome Trust funded research fellow at the MRC Centre for Drug Safety Science (CDSS) and lecturer in Pharmacology at the University of Liverpool, United Kingdom. Dan completed his PhD in 2009 in Pharmacology. Prior to his PhD, Dan completed his BSc (Hons) in Biochemistry (first class) and worked in research posts within Molecular Toxicology at AstraZeneca. He undertook postdoctoral training at the CDSS with Prof. B.K. Park and Prof. M. Pirmohamed as well as Royal Society International Travelling Fellowships at the Harvard Medical School, United States, with Prof. J.V. Bonventre and at the Karolinska Institute, Sweden, with Prof. U. Andersson. Dan is currently the coordinator of the safety biomarker research group at the CDSS, Liverpool, United Kingdom. His research is mainly focused on the understanding of fundamental mechanisms related to adverse drug reactions and the prediction of drug toxicity through the development of translational biomarkers of drug-induced liver and kidney injury. He is a member of the DILI (drug-induced liver injury) project team for the SAFE-T (Safer And Evidence based Translation) IMI consortium to develop and qualify safety biomarkers. He also sits on the British Toxicology Society’s (BTS) Education, Training and Early Career Toxicologists Subcommittee and is the co-chair of the British Pharmacological Society (BPS) Toxicology Affinity Group. In 2014, Dr. Antoine was elected to serve as a Councillor for the International Union of Basic and Clinical Pharmacology (IUPHAR) Drug Metabolism and Drug Transport Section Executive Board. In 2013, Dr. Antoine received the British Toxicology Society’s Early Career Investigator Award and in 2015 received the European New Investigator Award from the International Society for the Study of Xenobiotics (ISSX), the 2015 Bill Bowman Travelling Lectureship from the British Pharmacological Society and the 2015 Young Investigator Award in Translational Pharmacology jointly from The Federation of European Pharmacological Societies (EPHAR) and the European Association for Clinical Pharmacology and Therapeutics (EACPT). Dan is an editorial board member for the journals Pharmacology Research & Perspectives and Biomarkers. His academic research is currently funded by grants awarded from the European Commission, Medical Research Council, Wellcome Trust, The Royal Society and the pharmaceutical industry.

Exosomes and Their miRNA Cargos: Potential Biomarkers for Liver Diseases. Banishree Saha, University of Massachusetts Medical School, Worcester, MA.

During her research associateship, at Institute of Liver and Biliary Sciences, Dr. Saha, studied the immune mechanisms and the host response during Hepatitis C Virus (HCV)-HIV co-infection. She collaborated with Hannover Medical School, Germany, and studied the effects of HCV-HIV co-infection on memory T cell phenotype and functions. After joining the department of medicine, University of Massachusetts Medical School as a postdoctoral fellow, she has been studying the effects of HCV infection and alcohol on the host innate immune system. She has published several journal articles and book chapters and has presented her research work at various national and international meetings in the field of immunology and hepatology.

 

 

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Embryology and Developmental Toxicity Testing

Morning Course (AM06) | CE Basic | 8:15 AM–12:00 Noon

Theme:

Developmental Toxicity: Mechanisms and Evaluation

Chairperson(s): John M. DeSesso, Exponent, Alexandria, VA; and Anthony R. Scialli, Scialli Consulting LLC, Arlington, VA.

Introduction and Principles of Validation. Anthony R. Scialli, Scialli Consulting LLC, Arlington, VA.

Anthony Scialli is a specialist in reproductive and developmental toxicology and in obstetrics and gynecology. He is Clinical Professor of Obstetrics and Gynecology at George Washington University School of Medicine and Health Sciences and Adjunct Professor of Obstetrics and Gynecology and of Pharmacology and Physiology at Georgetown University School of Medicine. Dr. Scialli directs the Reproductive Toxicology Center, a nonprofit foundation in Washington, DC, which maintains Reprotox®, an online data base on the effects on reproduction of drugs, chemicals, biologicals, and physical agents. He founded and was editor-in-chief of the journal Reproductive Toxicology for 17 years and is a past president of the Teratology Society.

 

Comparative Embryological Development, Gestational Landmarks, and Their Influence on Test Designs. John M. DeSesso, Exponent, Alexandria, VA.

Dr. DeSesso has 40 years of experience specializing in the areas of developmental and reproductive toxicology, general toxicology, risk assessment, and human health effects of environmental agents and pharmaceuticals. His research interests include normal and abnormal development, with emphasis on the mechanisms by which chemical and physical agents influence developing organisms. He has worked on projects including assessing the potential for inorganic arsenic contamination to cause human birth defects, investigating the possible reproductive toxicity of trichloroethylene, assessing the possible teratogenicity of atrazine and glyphosate, and demonstrating the mode of teratogenic action for an artificial blood substitute that is absent in humans. He has provided key expertise in human health risk assessment, including negotiation of risk assessment protocols on a site-specific basis. He is an adjunct professor of Biochemistry and Cellular & Molecular Biology at Georgetown University School of Medicine where he has taught embryology and anatomy for over 30 years.

Details of Skeletal Development and How this Matters When Interpreting Results. John M. Rogers, US EPA, Research Triangle Park, NC.

Dr. John Rogers is the Director of the Toxicity Assessment Division, National Health and Environmental Effects Research Laboratory, US Environmental Protection Agency, Research Triangle Park, North Carolina. Prior to that he served as Chief of the Developmental Biology Branch, and he has been with US EPA for over 30 years. Dr. Rogers is a graduate faculty affiliate in the Curriculum in Toxicology, University of North Carolina, Chapel Hill, and an Adjunct Professor at North Carolina State University College of Veterinary Medicine. He received his PhD in Biology from the University of Miami (Florida), and was a National Eye Institute postdoctoral fellow at the University of California, Davis. Dr. Rogers’s research addresses mechanisms of abnormal development, including maternally-mediated developmental toxicity, maternal nutrition, and the developmental origins of health and disease. Dr. Rogers is a past president of the Teratology Society, a member of the Society of Toxicology (SOT), past president of the Reproductive and Developmental Toxicity Specialty Section of SOT, and a member of the International Society for Developmental Origins of Health and Disease. Dr. Rogers has published over 125 peer-reviewed papers, invited reviews and book chapters, and has edited 2 books. Dr. Rogers has received 13 US EPA Scientific and Technical Achievement Awards for his published works and 3 Bronze Medals for service to US EPA.

 

Normal and Abnormal Development of Heart and Great Vessels: Understanding the Problem and Interpreting the Findings. H. Scott Baldwin, Vanderbilt University School of Medicine, Nashville, TN.

Dr. H. Scott Baldwin currently serves as the Chief of Pediatric Cardiology and Co-Director of the Pediatric Heart Institute at the Monroe Carell Jr., Children’s Hospital in Nashville, Tennessee and as Professor of Cell and Developmental Biology at the Vanderbilt University School of Medicine in Nashville, Tennessee.

 

 

 

 

Developmental Toxicity Testing without Animals: The Big Slippery Mountain. Robert E. Chapin, Pfizer Inc., Groton, CT.

Dr. Robert E. Chapin is currently a Senior Research Fellow and a member of the Developmental and Reproductive Toxicology Center of Expertise at Pfizer Global Research and Development in Groton, Connecticut. He received his PhD degree in 1980 from UNC-Chapel Hill in Pharmacology, and then postdoc’d for 2 years at the Chemical Industry Institute of Toxicology. This was followed by 18 years at the National Institute of Environmental Health Sciences, first as a Senior Staff Fellow in the National Toxicology Program, then as a Principal Investigator and then Lab head. His area of expertise is reproductive toxicology, primarily in the male, but lately has been working hard in the area of in vitro predictive toxicology. He has developed advanced in vitro culture methods for exploring mechanisms of reproductive toxicology, and helped pioneer the integrated use of molecular, biochemical, histologic, and in vitro methods to address mechanistic questions in reproductive toxicology. For his work in this area, he won the NIH Director’s Award for Science in 1995 and the Achievement Award at Pfizer in 2010. He was named the Young Andrologist of the Year in 1993 by the American Andrology Society, and is a co-recipient of the Alice B Hamilton Award for leadership in science from NIOSH. He has more than 150 peer-reviewed publicatons, a couple dozen books and book chapters, sat as an ad hoc member on several Scientific Advisory Panels for the EPA, worked on numerous ILSI committees and publications, consulted with the WHO and Japanese Ministry of Health, and been actively involved with the NIEHS Center for the Evaluation of Risks to Human Reproduction. He is a member of the American Society of Andrology, and the Society of Toxicology, where he has organized workshops, Continuing Education Courses, and been elected to all the available offices in the Reproductive and Developmental Specialty Section. He has served as an Associate Editor for Fundamental and Applied Toxicology and Associate Editor for Birth Defects Research Part B, and is currently on the editorial board of Toxicological Sciences and BDRB.

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Next-Generation Sequencing in Toxicogenomics

Morning Course (AM07) | CE Advanced | 8:15 AM–12:00 Noon

Theme:

Molecular Toxicology: Mechanistic Insights and Hazard Assessment
Recent Advances in Safety Assessment

Chairperson(s): Weida Tong, National Center for Toxicological Research, US FDA, Jefferson, Jefferson, AR; and Jos Kleinjans, Maastricht University, Maastricht, The Netherlands.

Next-Generation Sequencing: Next Wave of Opportunities, Challenges, and Anxiety. Jos Kleinjans, Maastricht University, Maastricht, The Netherlands.

Prof. Jos Kleinjans is professor of Environmental Health Science at Maastricht University where in 1991, he started the Department of Health Risk Analysis & Toxicology, and as of January 1, 2011, he is chairing the new Department of Toxicogenomics (currently ~ 35 fte, comprising chairs on environmental health science, population toxicogenomics, and immunotoxicology). He has over 25 years experience in toxicology and biomarker research, and has contributed over 300 scientific articles on toxicology and environmental health sciences, mainly focused on genetic toxicology and toxicogenomics.

Prof. Kleinjans has been the scientific director of the Netherlands Toxicogenomics Centre, which was committed to developing ‘omics-based alternatives for current animal models for chemical safety testing, and he coordinates/has coordinated major toxicogenomics-related projects funded by national public funding bodies (Netherlands Genomics Initiative and the Foundation of Technological Sciences) and by the EU (FP6 Integrated Projects NewGeneris and carcinoGENOMICS, as well as FP7 Coordinated Actions diXa and—currently—FP7 Collaborative Project HeCaToS).

Prof. Kleinjans is a member of the Dutch Health Council.

Next-Generation Sequencing: Technology and Bioinformatics. Wenming Xiao, NCTR/US FDA, Jefferson, AR.

Dr. Xiao received his bachelor in biology from Xiamen University in 1989 and master in genetics from the Institute of Microbiology, Chinese Academy of Science in 1992. Later on, he moved to United States and finished PhD program in molecular genetics form the Medical College of Wisconsin in 1997 and master program in computer science from Marquette University in 1998. From 1998 to 2005, Dr. Xiao was bioinformatics scientist in GeneLogic, MetriGenix, and Celera Genomics. Since 2005, he joined the National Institute of Health as a contractor and then as a staff scientist at Center for Cancer Research, National Institute of Cancer. In December 2014, Dr. Xiao joined Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration (FDA). Dr. Xiao has numerous publications in peer-reviewed journals such as Nature, PNAS, New England Journal of Medicine, and Cancer Cell. In 2010, he received the NIH director award and NIH merit award for his contribution in Lymphoma Leukemia Molecular Profiling Program.

In his early career in industry, Dr. Xiao defined and developed IT infrastructure and software/database solutions for genomics and microarray data. During his tenure at NIH, Dr. Xiao developed informatics tools in supporting next generation sequencing (NGS) technology for intramural research at the NIH for various applications such as, genome assembly, ChIP-Seq, RNA-Seq, Exome-Seq and digital gene expression.

DNA-Seq: Toxicant-Induced Mutation Analysis. Florian Caiment, Maastricht University, Maastricht, The Netherlands.

After a PhD in the lab on miRNA studies, Florian Caiment opted for a full bioinformatics postdoc position at Maastricht University (Toxicogenomics department). He started on the ASAT knowledge base (Assuring Safety without Animal Testing) project followed by the FP7 EU project diXa (Data Infrastructure for Chemical Safety), where he could develop high end programming and database skills. He also collaborated in several international consortia such as the SEQC (SEquencing Quality Control) project initiated by the US FDA (Food and Drug Agency) or the Rat miRNA HTS Atlas by the US HESI consortium (Health and Environmental Sciences Institute). Two years ago, he moved to the FP7 EU project HeCaTos project (Hepatic and Cardiac Toxicity Systems modelling), which enabled him to apply both his molecular biology and bioinformatics skills to study heart and liver toxicity, with a particular focus on HTS data and its cross integration with other omics datasets.

Epigenomics: A New Opportunity in Toxicogenomics. Ralf Herwig, Max-Planck-Institute for Molecular Genetics, Berlin, Germany.

Ralf Herwig studied mathematics and computer science and heads a bioinformatics group at the Max-Planck-Institute for Molecular Genetics in Berlin since 2001. The group develops methods, tools and resources for genome analysis in order to interpret genome data in the context of human diseases and to build predictive computational models for the underlying disease processes. Herwig is member of large sequencing consortia such as the 1,000 Genomes Project. Recent developments include the molecular interaction resource ConsensusPathDB, methods for high-throughput sequencing, e.g., ARH-seq for the detection of splice variations or MEDIPS for the analysis of genome-wide methylation. In toxicogenomics, Ralf Herwig has developed a systems biology approach for analyzing high-throughput data at the pathway level in order to identify molecular processes in vitro that are predictive for chemical carcinogenesis and drug-induced toxicity. This approach was awarded with the 31st Animal Protection Research Prize of the German Ministry of Education in 2012.

RNA-Seq: Mechanistic and Predictive Toxicology. Weida Tong, NCTR/US FDA, Jefferson, AR.

Since 2012, Dr. Weida Tong has served as the Director for the Division of Bioinformatics and Biostatistics at the National Center for Toxicological Research (NCTR), US FDA located in Jefferson, Arkansas. Previously, Dr. Tong served as Director for the Center of Excellence for Bioinformatics (formerly Toxicoinformatics (2002–2012), Manager of the Computational Science Group, on-site IT contractor at NCTR (1998–2002), and as Senior Computational Chemist, Computational Science Group, on-site IT contractor at NCTR (1996–1998). Dr. Tong began his career at the University of Missouri St. Louis as a Computational Chemist from 1991 to 1996.

 

RNA-Seq As a Way to Access Transcriptomic Information in Archival Tissues. Susan Hester, National Health and Environmental Effects Research Laboratory, US EPA, Research Triangle Park, NC.

Dr. Susan Hester is a research scientist within the Systems Biology Branch of the National Health and Environmental Research Laboratory, US Environmental Protection Agency (EPA). After joining the US EPA in 1997, she developed genomics as a research tool to investigate the molecular effects of carcinogenesis. She serves as a faculty adjunct at the School of Medicine at University of North Carolina at Chapel Hill. She has received numerous Scientific and Technological Achievement Awards for her research efforts. She has authored more than 100 peer-reviewed publications and abstracts. She has served as the Chair of the Microarray Research Group, ABRF, as well as participating in several other research committees including an appointment to the OECD’s Extended Advisory Group on Molecular Screening and Toxicogenomics. She has received many invitations to speak internationally and presented her Toxicogenomics research throughout her career. She is developing RNA-Seq approaches and tools using FFPE samples.

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Approaches to Investigate and Assess Risks Associated with Drug-Induced Liver Injury (DILI)

Afternoon Course (PM08) | CE Advanced | 1:15 PM–5:00 PM

Theme:

Health and Environmental Impacts of Manmade and Naturally Released Toxicants
Recent Advances in Safety Assessment

Chairperson(s): Monicah Otieno, Janssen Pharmaceuticals, Spring House, PA; and Paul Watkins, The UNC Institute for Drug Safety Sciences, Research Triangle Park, NC.

Overview of DILI and Associated Risk Hazards. Monicah Otieno, Janssen Pharmaceuticals, Spring House, PA.

Monicah Otieno received her PhD in Pharmacology from University of Rochester in Rochester, New York, where she studied mechanisms of bioactivation of halogenated alkenes. She subsequently took a position as a postdoctoral fellow at Johns Hopkins University in Baltimore, Maryland, studying mechanisms of carcinogenesis. Monicah has since worked in the pharmaceutical industry for 14 years as a Discovery/Mechanistic Toxicologist with positions at AstraZeneca, Bristol-Myers Squibb, and currently at Janssen Pharmaceuticals (Johnson & Johnson) where she is the Director of Mechanistic & Investigative Toxicology at the Pennsylvania site. She has been involved in addressing several toxicology issues for projects in her career including drug-induced liver injury.

 

Clinical Perspective Including Risk Identification and Management. Paul Watkins, The UNC Institute for Drug Safety Sciences, Research Triangle Park, NC.

Dr. Paul B. Watkins is director of the University of North Carolina Institute for Drug Safety Sciences. He is also Professor of Medicine, Pharmacy, and Public Health at the University of North Carolina, Chapel Hill.  Dr. Watkins is a trained clinical hepatologist and also an accomplished basic and translational investigator in the fields of drug metabolism and hepatotoxicity. He serves as the chair of both the Steering and Genetics Committees for the US Drug-Induced Liver Injury Network (DILIN) (U01DK065201). He also directs the DILIsim Initiative, which is a public-private partnership involving scientists from 13 major pharmaceutical companies and the US FDA. Dr. Watkins is one of the most frequently cited authors in the field of pharmacology according to www.isihighlycited.com. He is the recipient of numerous honors and awards including the 2009 Therapeutic Frontiers Award from the American College of Clinical Pharmacy, the 2013 Agilent Thought Leader Award, and the 2015 Rawls-Palmer Award for Progress in Medicine from the American Society for Clinical Pharmacology and Therapeutics. 

 

Role of Reactive Metabolites in Immune DILI. Jack Uetrecht, University of Toronto, Toronto, ON, Canada.

Dr. Jack Uetrecht served his internal medicine residency at Kansas University Medical Center from 1975–1978; followed by a Clinical Pharmacology Fellowship at Vanderbilt University from 1978–1981. He was an Assistant Professor of Pharmacology and Medicine at Vanderbilt University from 1981–1985 and Associate Professor of Pharmacy and Medicine, University of Toronto, 1985–1993. Since 1993, Dr. Uetrecht has served as a Professor of Pharmacy and Medicine at the University of Toronto and was Associate Dean of Pharmacy at the University of Toronto from 1994–1998. Dr. Uetrecht was the Canada Research Chair in Adverse Drug Reactions from 2001 to 2015.

 

 

Role of Hepatic Transporters in DILI. Kim Brouwer, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Dr. Brouwer is the William R. Kenan Jr., Distinguished Professor and Associate Dean for Research and Graduate Education, UNC Eshelman School of Pharmacy. Dr. Brouwer directs an NIH-funded research program focused on hepatobiliary drug disposition, hepatic transport proteins, and development/refinement of in vitro models to predict in vivo hepatic drug disposition, drug interactions, and hepatotoxicity. She has mentored 58 postdoctoral fellows/visiting scholars, 30 doctoral students, 23 undergraduate/honors students, and has published 200 research papers, reviews and book chapters. Dr. Brouwer is co-inventor of B-CLEAR®, an in vitro method to assess hepatic uptake, excretion and biliary clearance that correlates with in vivo data, and is co-founder of Qualyst Transporter Solutions. Professional Service: International Transporter Consortium Steering Committee; ASCPT Board of Directors; Clinical Pharmacology & Therapeutics and CPT Pharmacometrics & Systems Pharmacology Editorial Advisory Boards. Honors and Awards: NIH Pharmacology Study Section (1998–2002); NIH Quantitative and Systems Pharmacology Working Group (2010–2012); AAPS Fellow; PHRMA Foundation Award in Excellence in Pharmaceutics. Dr. Brouwer is the 2016 Chair of the Drug Metabolism Gordon Research Conference.

Role of Mitochondrial Toxicity in DILI. Yvonne Will, Pfizer Inc., Groton, CT.

Dr. Yvonne Will was born and raised in Germany where she conducted her undergraduate studies in Human Nutrition at the University of Bonn, while working as a full time position in the Department of Equine Exercise Physiology. In 1992, Dr Will conducted an internship at the College of Veterinaty Medicine at Oregon State University, where she enrolled the same year to obtain her MS degree. Her work was focused on the bioremediation of explosives using ruminant bacteria and analytical chemistry approaches. In 2000, Dr. Will obtained her PhD in Biochemsitry and Biophysics from Oregon State University, where her thesis focused on the relationships between glutathione deficiency and cellular and mitochondrial function/dysfunction. During her years at the biotechnology company MitoKor, San Diego (2000–2003) she was involved in drug discovery aimed on improving mitochondrial function or preventing mitochondrial dysfunction in obesity, diabetes, and CNS related diseases.

From 2003 until 2007, Dr. Will was a group leader in Drug Safety at Pfizer La Jolla, pioneering a screening paradigm for drug induced mitochondrial toxicity, supporting many therapeutic areas. This platform has been adapted throughout all major pharmaceutical companies. During that time she also held an adjunct faculty position at San Diego State University in the Toxicology program where she conducted lectures, taught laboratory courses and mentored MS students. In the fall of 2007 Dr. Will transferred to Pfizer Groton to lead a group of scientists in the Compound Safety Prediction Group within Medicinal Chemistry. This group was set out to conduct in vitro safety assessment as early as possible within the drug discovery process to reduce late stage attrition. Dr. Will’s group has pioneered many new technologies throughout the years. Dr Will has published a book on drug induced mitochondrial toxicity is currently on a new book on drug discovery toxicology. Dr. Will has given many national and international lectures, conducted workshops and seminars and continues to publish numerous papers each year in peer reviewed journals. In 2012, Dr. Will was honored with the Connecticut Technology Council’s Woman Research Innovation and Leadership Award. Dr. Will’s passion is to develop young scientists through external influence such as publications and participations in national meetings. In September of 2014, Dr. Will became the Head of Science and Technology for Drug Safety within Pfizer. As such she works on strategy as well as innovation and developing the next generation of scientists through a postdoctoral program as well as mentoring efforts. Dr. Will also practices a life-work balance by spending time with her family, in particular her 11 year old daughter Natalia and riding dressage on her horse Mocca.

Computational Approaches to Integrate DILI Hazards and Predict DILI Potential. Brett Howell, The UNC Institute for Drug Safety Sciences, Research Triangle Park, NC.

Dr. Howell’s research experience has focused on the use of mathematical modeling techniques to solve interesting biological problems. He has published in a variety of areas including the use of physiological modeling to optimize drug overdose treatment, the use of liposomes to test chemicals for ocular toxicity without animals, basic principles associated with lipid-membrane interactions, and modeling of drug-induced liver injury. Dr. Howell, along with Dr. Scott Siler, leads the modeling effort for the DILI-sim Initiative and acts as a technical contributor.

 

 

 

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Exploring Chemical Space in the New Toxicity Testing Paradigm: From Data Curation to Computational Simulations

Afternoon Course (PM09) | CE Basic | 1:15 PM–5:00 PM

Theme:

Recent Advances in Safety Assessment

Chairperson(s): Cecilia Tan, US EPA, Research Triangle Park, NC; and Daniel Chang, Chemical Computing Group, Inc., Montreal, QC, Canada.

Computational Chemistry in Toxicity Testing, Hazard and Risk Assessments. Daniel Chang, Chemical Computing Group, Inc., Montreal, QC, Canada.

Daniel Chang is a computational chemist with Chemical Computing Group (CCG), a leading software company in the area of bioinformatics, cheminformatics and molecular simulations. His area of research includes the application and development of high throughput computational methods used in the pharmaceutical, biotechnology and environmental health sectors pertaining to chemical screening, AOPs, exposure, metabolism and toxicology. He has extensive experience in the development and application of computational chemistry theory within the human health and environmental sciences—with an emphasis on predicting stereoselective metabolism, providing in silico parameter estimates for PBPK/PD models, and interpreting high throughput in vivo assay data. Prior to joining CCG in 2014, Daniel was a researcher and branch chief of the Exposure Dose Research Branch within the US EPA National Exposure Research Laboratory where he led an interdisciplinary team of investigators evaluating the influence of in silico molecular property predictions on computational exposure and toxicity estimates. Prior to the US EPA, he worked at Pacific Northwest National Laboratory as a postdoctoral researcher with Drs. Bruce Garrett and Greg Schenter developing a hybrid classical/quantum mechanics method amenable to large-scale atomistic simulations of reaction rate constants under aqueous conditions. Dan received his PhD in Chemical Physics for work on using electronic structure theory as well as classical and quantum dynamics to understand the subtle quantum effects of low-lying energetically degenerate states on molecular recombination processes.

Applications of Cheminformatics in the Regulatory Assessment of Chemicals. Andrew Worth, European Commission—Joint Research Centre, Ispra, Italy.

Dr. Andrew Worth is a senior scientific officer at the European Commission’s Joint Research Centre (JRC), where he leads the Predictive Toxicology Group within the Systems Toxicology Unit of the JRC’s Institute for Health & Consumer Protection (IHCP). The Unit also hosts the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Dr. Worth has degrees in Physiological Sciences and in Linguistics from Oxford University, and a PhD in Computational Toxicology from Liverpool John Moores University. He has over 150 publications in the area of predictive toxicology. From January–June 2012, Dr. Worth was a visiting scientist at the US Food and Drug Administration (FDA) within the US FDA Center for Food Safety and Applied Nutrition (CFSAN). Dr. Worth is a member of the editorial boards of Alternatives to Laboratory Animals (ATLA) and SAR and QSAR in Environmental Research (SQER).

Progress towards Predicting Potential Hazards and Assessing Risk in the Early Stage of Drug Discovery. BinQing Wei, Genentech Inc., South San Francisco, CA.

As a computational chemist, Dr. Wei enjoys solving critical but difficult problems in drug discovery using innovative computational approaches and by working closely with experimental scientists. In the past 7 years, he has worked on over 10 projects spanning oncology, immunology, neurodegeneration and infectious disease, including smallmolecule drugs as well as antibody-drug-conjugates. Previously, his graduate research entailed modeling of proteinligand interactions and virtual screening. During his postdoctoral fellowship, he worked on chemical proteomic profiling technology and studied enzyme activities underlying tumor metastasis.

 

Advancements in Applying Predictive Computational Tools to Prioritize Environmental Chemicals Investigated in High-Throughput Screening Assays. Jeremy Leonard, North Carolina State University, Raleigh, NC.

Dr. Jeremy Leonard is a postdoctoral scholar at Oak Ridge Institute for Science and Education since 2014 . He was an adjunct instructor in biology at Meredith College in 2014; Postdoctoral scholar at North Carolina State University from 2013 to 2014; and adjunct instructor in biology and environmental science at Carteret Community College in 2009. Dr. Leonard has also been a research technician at the UNC Institute of Marine Science from 2008 to 2010; research technician at Duke Marine Laboratory from 2003 to 2008; and laboratory technician at the University of Georgia from 1997 to 1998.

 

 

The Contributions of Chemistry Standards and Database Tools at the Chemical-Biology Interface. Antony Williams, US EPA, Durham, NC.

Antony is a Computational Chemist in the National Center of Computational Toxicology at the US Environmental Protection Agency (EPA). Prior to joining the US EPA he worked at the Royal Society of Chemistry as their Vice president of Strategic Development focused on the development of the ChemSpider database, that he originally developed as a hobby project, and managing the cheminformatics team. The team were involved with delivering chemistry support to a number of major European projects including the Open PHACTS project meshing open chemistry and biology data to deliver an open platform supporting the pharmaceutical sciences. He is classically trained as an NMR spectroscopist and has a personal passion for Computer-Assisted Structure Elucidation from complex analytical data. He is widely published with over 160 papers and book chapters and is actively engaged in the social networks at the ChemConnector.

Conquering Chemical Space with Cheminformatics Workflow and In Silico Profiling to Complement High-Throughput Screening. Rocky Goldsmith, Chemical Computing Group, Inc., Montreal, QC, Canada.

Dr. Michael-Rock (“Rocky”) Goldsmith is an Applications Scientist working at Chemical Computing Group Inc., a Montreal-based life-science informatics and modeling software company that produces the Molecular operating Environment (MOE); a fully integrated molecular-discovery platform. Prior to this position Dr. Goldsmith was a principal investigator at the US EPA, where he also performed postdoctoral research at the National Center for Computational Toxicology in the field of in silico chemical genomics methods and virtual high-throughput screening. During his undergraduate studies at Concordia University in Montreal he worked in pharmaceutical, tobacco and explosives industries in both R&D and product development and subsequently completed his PhD in theoretical chemistry and molecular biophysics at Duke University (Durham, North Carolina) working on theoretical optical activity of molecular assemblies and aggregates, theory-assisted determination of absolute stereochemistry of chiral natural products, and elucidating the molecular mechanisms of biological sequestration and in vivo distribution of the food contaminant Ochratoxin.

 

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Genetics and Population Variability in Chemical Toxicity: The What, the How, and So What?

Afternoon Course (PM10) | CE Basic | 1:15 PM–5:00 PM

Theme:

Health and Environmental Impacts of Manmade and Naturally Released Toxicants
Molecular Toxicology: Mechanistic Insights and Hazard Assessment

Chairperson(s): Ivan Rusyn, Texas A&M University, College Station, TX; and Barbara A. Wetmore, ScitoVation, LLC, Research Triangle Park, NC.

Genetics for Toxicologists: Why Should We Care? Ivan Rusyn, Texas A&M University, College Station, TX.

Dr. Rusyn is Professor in the Department of Veterinary Integrative Biosciences in the College of Veterinary Medicine & Biomedical Sciences at Texas A&M University in College Station, Texas. Prior to joining A&M, he was Professor at the University of North Carolina at Chapel Hill. His laboratory has an active research portfolio with a focus on the mechanisms of chemical toxicity, the genetic determinants of susceptibility to toxicant-induced disease, and computational toxicology. His studies on health effects of chemicals resulted in over 160 peer-reviewed publications. He served on many US National Academy of Sciences/National Research Council committees. He participated in World Health Organization/International Agency for Research on Cancer monographs 96, 100, 101, 106, and 112. His other service commitments include membership on the Board of the Scientific Councilors NIEHS, the Science Advisory Board for the North Carolina Department of Environment and Natural Resources, and a Research Committee of the Health Effects Institute.

Basic Concepts in Genetics, Heritability, Genome-Wide Association, and Related Toxicology Study Designs. Fred A. Wright, North Carolina State University, Raleigh, NC.

Fred A. Wright, PhD, is a Professor in the Departments of Statistics and Biological Sciences North Carolina State University and Director of the NCSU Bioinformatics Research Center. Dr. Wright’s interests include expression quantitative trait locus (eQTL) analysis, gene mapping, and toxicogenomics.

 

 

 

 

Pharmacogenomics Tools to Unravel the Genetic Basis of Toxicodynamic Variability. Nancy J. Cox, Vanderbilt University, Nashville, TN.

Nancy Cox earned a BS in Biology from the University of Notre Dame in 1978 and a PhD in Human Genetics from Yale University in 1982. After conducting post-doctoral research at Washington University and the University of Pennsylvania, she joined the University of Chicago, where she spent 28 years as a faculty member in the Departments of Medicine and Human Genetics. She left her position as Professor and Section Chief of Genetic Medicine to join Vanderbilt in January, 2015 to become the Mary Phillips Edmonds Gray Professor of Genetics and inaugural Director of the Vanderbilt Genetics Institute, and Director of the Division of Genetic Medicine. Dr. Cox is a quantitative human geneticist with a computational laboratory focused on developing novel methods for the analysis of genomics (and other -omits) data and applying these methods to common human diseases and pharmacogenomic phenotypes to identify and characterize the genetic component to these phenotypes. She currently funded research in methods development for the GTEx project, as well as for studies in diabetes and its complications, pharmacogenomics, autism, schizophrenia, and bipolar disorder. Since coming to Vanderbilt she has worked with colleagues here to develop funded projects in research on health disparities and also on the analysis of whole genome sequence data for the NHGRI funded sequencing centers.

Strategies to Quantitate Chemical-Specific Toxicokinetic Variability Due to Genetics and Other Factors. Barbara A. Wetmore, ScitoVation, LLC, Research Triangle Park, NC.

Dr. Wetmore is a Senior Research Investigator at ScitoVation, LLC. Her research interests focus on the development and assessment of in vitro experimental and modeling tools that can be utilized to inform toxicity testing and risk assessment. Specifically, she has extensive expertise in vitro–in vivo extrapolation (IVIVE) modeling, pharmacokinetics, in vitro and high-throughput screening HTS approaches, chemical mode of action assessments, and life-stage based modeling to assess population variability. Her recent publications in IVIVE and life-stage based modeling received international awards (Simcyp Academic Awards: 2012, 2015; Outstanding Paper Advancing the Science of Risk Assessment (SOT Risk Assessment Specialty Section: 2014). Other research interests have focused on the application of genomic and proteomic tools to inform chemical mode of action assessments and biomarker discovery. She has served in various capacities as an expert or peer reviewer for organizations including the National Academy of Sciences, European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM), US EPA, and Health Canada. She is currently serving as Vice President-elect for the In Vitro and Alternative Methods Specialty Section.

Advancing Risk Assessment with Genetic and Population Variability Data. Weihsueh A. Chiu, Texas A&M University, College Station, TX.

Weihsueh Chiu is a Professor in the Department of Veterinary Integrative Biosciences in the College of Veterinary Medicine and Biomedical Sciences at Texas A&M University. Prior to joining Texas A&M University, Dr. Chiu worked at the US Environmental Protection Agency (EPA) for over 14 years, most recently as Chief of the Toxicity Pathways Branch in the Office of Research and Development. His research has focused on human health risk assessment of environmental chemicals, particularly with respect to toxicokinetics, mechanisms of toxicity, physiologically-based pharmacokinetic modeling, dose-response assessment, and characterizing uncertainty and variability. He has a particular interest in the use of probabilistic and Bayesian methods. He has also served on multiple committees and workgroups of the World Health Organization and the US National Academies of Sciences on risk assessment.

 

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Human Health Risk Assessment: A Case Study Application of Principles

Afternoon Course (PM11) | CE Advanced | 1:15 PM–5:00 PM

Theme:

Health and Environmental Impacts of Manmade and Naturally Released Toxicants

Chairperson(s): John C. Lipscomb, US EPA, Cincinnati, OH; and Bette Meek, University of Ottawa, Ottawa, ON, Canada.

Introduction. Bette Meek, University of Ottawa, Ottawa, ON, Canada.

Bette is currently the Associate Director of Chemical Risk Assessment at the McLaughlin Centre for Risk Science, Faculty of Medicine, University of Ottawa. She previously managed several chemical risk assessment programs within Health Canada. With colleagues internationally, she has contributed to or led initiatives in areas such as weight of evidence analysis for mode of action, chemical specific adjustment factors, physiologically-based pharmacokinetic modeling, combined exposures and predictive modeling.

 

 

Hazard Characterization. Zhongyu (June) Yan, Dow AgroSciences, Indianapolis, IN.

Zhongyu (June) Yan is a Toxicologist and Risk Assessor within Dow AgroSciences R&D global headquarters in Indianapolis, Indiana. She has led a cancer risk assessment team and has human health global responsibilities for various crop protection products. She received her MD from Tianjin Medical School and her PhD in Biomedical Sciences from Wright State University. Prior to joining Dow AgroSciences she was Human Health Risk Assessment Follow at the National Center for Environmental Assessment at the US EPA where she developed multiple comprehensive chemical risk assessment documents. June has been actively involved in risk assessment societies including the Risk Assessment Specialty Section (SOT) and the Society for Risk Analysis and has served as an invited reviewer for journals and books.

Dose-Response Assessment. Q. Jay Zhao, US EPA, Cincinnati, OH.

Dr. Zhao is a board certified toxicologist with US EPA, Office of Research and Development, National Center for Environmental Assessment (NCEA). He is specialized in dose-response analysis and human health risk assessment, and is responsible for developing US EPA’s chemical risk assessment documents such as Toxicological Reviews for Integrated Risk Information System (IRIS) and Provisional Peer Reviewed Toxicity Values (PPRTV). Before he joined US EPA in 2007, he worked in Toxicology Excellence for Risk Assessment (TERA) for 10 years and served as the program manager leading TERA’s chemical assessment program, and organized all the chemical assessment activities within the organization.

 

Exposure Assessment. Robinan Gentry, Ramboll ENVIRON, Monroe, LA.

Robinan Gentry, PhD, DABT, and a Principal Consultant with Ramboll ENVIRON, has over 25 years of experience in toxicological issues relevant in the determination of the potential safety or risk associated with exposure to chemicals in consumer products, pharmaceuticals or the environment. Over her career, she has been a principal investigator or contributing author for numerous safety and risk assessments for both government and industry. The purpose for a number of these assessments has been to incorporate both standard and innovative quantitative approaches in the determination of acceptable levels of exposure of humans to chemicals in the environment, in pharmaceuticals, and in consumer products. Her recent work includes projects that are aimed at understanding the mode of action of adverse effects in animals and the implications to human health, as well as the development of innovative approaches that rely upon in vitro data and incorporation of these data into the risk assessment paradigm.

Risk Characterization. John C. Lipscomb, US EPA, Cincinnati, OH.

Dr. Lipscomb is a Toxicologist and Risk Assessor for the US EPA. He is certified in General Toxicology by the American Board of Toxicology, is a Fellow of the Academy of Toxicological Sciences, and a Twenty-Five Year member of the Society of Toxicology. He conducts technical risk assessments on environmental contaminants and develops quantitative methods for health risk assessments. He has chaired and lectured in several SOT CE Courses and edited a text on Toxicokinetics and Risk Assessment (Informa, 2007).

 

 

 

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Unique Approaches to Safety Assessment of Gene, Cell, and Nucleic Acid-Based Therapies

Afternoon Course (PM12) | CE Basic | 1:15 PM–5:00 PM

Theme:

Recent Advances in Safety Assessment

Chairperson(s): Timothy MacLachlan, Novartis, Cambridge, MA; and Joy Cavagnaro, AccessBio, Boyce, VA.

Toxicological Approaches to Gene Therapy. Joy Cavagnaro, AccessBio, Boyce, VA.

Dr. Joy Cavagnaro is the President of Access BIO, an internationally recognized consultant on development strategies enabling clinical translation of novel drugs and biologics. Her career spans academia, CRO and biotech industries and government. She has served as the principal study director for biotechnology products at Covance (Hazelton Labs). At CBER/FDA, she was appointed to the SBRS; US FDA’s safety topic lead and rapporteur for “ICH S6” advocating the “case-by-case” based approach. She is Past Chair of RAPS, a member of SACATM and President of NCAC-SOT. She is also a recipient of SOT’s Biotechnology SS first Career Achievement Award. Dr. Cavagnaro is the founder, Past Chair and current ex officio member of the leadership committee of BioSafe. She is the current R&D Liaison to the ACNA Executive Committee of DIA, Chair of Clinical and Regulatory Affairs Committee, and a member of Translational Science & Product Development Committee of the ASGCT. She serves as an advisor and member of the GWG for CIRM and Chair of CRRI IRB. She is also Editor for Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials, John Wiley & Sons, aka the “BioBible.”

Toxicological Approaches to T-Cell Immunotherapies. Timothy MacLachlan, Novartis, Cambridge, MA.

Tim MacLachlan is currently an executive director and head of Biologics Safety Assessment within the Department of Preclinical Safety at the Novartis Institutes of Biomedical Research. Prior to this Tim has held roles of increasing responsibility in pharmaceutical preclinical safety assessment including biotherapeutics, gene and cell therapies, at Novartis, Genzyme and Curagen. Tim has been involved in several external toxicology groups including chair of the preclinical leadership committee of the Biotechnology Industry Organization, “Biosafe.” Tim received his PhD from Thomas Jefferson University and performed his postdoctoral research at the University of Pennsylvania.

 

Toxicological Approaches to Cell Therapies. Cliff Sachs, MedImmune, Gaithersburg, MD.

Clifford Sachs is a Director, R&D-Toxicology at MedImmune. He has over 15 years of experience developing biological drugs including antibodies, fusion proteins, cell and gene therapies. He is a member of the Biotechnology Organization (BIO) BioSafe Leadership committee and served as Chair of both the BioSafe Cell Therapy Expert Working Group and the BioSafe Specialty Biologics Expert Working Group (SBEWG).  Before joining MedImmune Clifford worked at Janssen, Centocor, Biogen Idec, Abbott and Novartis Pharmaceuticals. Clifford was the toxicology leader for the registration of Stelara and provided non-clinical leadership to Johnson and Johnson’s cell therapy programs including a systemic cell based therapy and an ocular cell based therapy/device combination product through successful IND filings through Phase 2.

Toxicological Approaches to Genome Editing. Kathleen Meyer, Sangamo Biosciences Inc., Richmond, CA.

Kathleen Meyer is a Senior Director of Toxicology at Sangamo BioSciences, and supports nonclinical development of a variety of zinc finger protein-based gene therapy compounds. She has been responsible for the nonclinical safety evaluation strategy and implementation of small molecule, monoclonal antibody, peptide, enzyme replacement, and gene therapy projects in the biopharmaceutical industry. Kathleen is a member of the Society of Toxicology, American College of Toxicology, and is a Diplomat of the American Board of Toxicology.

 

 

Think Like a Regulator: US FDA Considerations for Preclinical Studies for Cell and Gene Therapy Products. Becky Robinson, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD.

Becky Robinson is a biomedical engineer and team leader in the Pharmacology/Toxicology Branch in the Office of Cellular, Tissue, and Gene Therapy in the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA). After receiving her PhD, she joined the US FDA in 2010 as a Regenerative Medicine Commissioner’s Fellow, where she conducted scientific review of regulatory applications for medical devices, and cell and gene therapy products. Upon completion of her fellowship in 2012, she joined the Center for Devices and Radiological Health (CDRH) as a scientific reviewer in the Division of Reproductive, Gastro-Renal, and Urological Devices. During her time at CDRH she was actively involved in Center-level projects and received several awards for her work. Dr. Robinson recently re-joined CBER where she supervises regulatory review of a diverse cell and gene therapy product portfolio, including: chimeric antigen receptor T cells, oncolytic viruses, gene editing products, human embryonic stem cells, and induced pluripotent stem cells.

 

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Zebrafish As a Tool in Toxicology and Drug Discovery Screening

Afternoon Course (PM13) | CE Basic | 1:15 PM–5:00 PM

Theme:

Health and Environmental Impacts of Manmade and Naturally Released Toxicants
Recent Advances in Safety Assessment

Chairperson(s): Mamta Behl, National Toxicology Program/NIEHS, Research Triangle Park, NC; and Arantza Muriana, BBD BioPhenix S.L.-Biobide, San Sebastián-Donostia, Spain.

Introduction and Course Goals. Mamta Behl, National Toxicology Program/NIEHS, Research Triangle Park, NC.

Mamta Behl, PhD, DABT is a toxicologist in the Toxicology Branch, which promotes, designs and administers research programs to understand how environmental exposures affect the public’s health. As a study scientist, Dr. Behl leads, designs, evaluates, and interprets rodent studies via the assembly and co-ordination of teams of scientists at the NTP in the disciplines of toxicology, pathology, statistics, chemistry, ADME, molecular biology and bioinformatics, and publishes findings as NTP technical reports and papers in scientific journals.

As a neurotoxicologist, Dr. Behl’s responsibilities include developing testing strategies to assess developmental neurotoxicity (DNT) and neurotoxicity (NT) using in vitro and in vivo models. She is interested in the development of in vitro and alternate animal models to identify toxicity pathways for DNT and NT using genomics, metabolomics, and bioinformatics technologies to screen and prioritize compounds for in vivo testing. She also mentors postdoctoral fellows on issues related to neurotoxicity.

The Ins and Outs of Using Zebrafish for Mechanistic Toxicology Studies. Antonio Planchart, Department of Biological Sciences, North Carolina State University, Raleigh, NC.

Dr. Antonio Planchart is an Assistant Professor in the Department of Biological Sciences at North Carolina State University. He is a member of the Center for Human Health and the Environment.  Research in the Planchart lab combines high throughput techniques, including proteomics and transcriptomics, to understand how environmental factors affect vertebrate embryonic development. His lab’s primary focus is identifying genetic modifiers of craniofacial development that can be modulated by changes in the environment during embryogenesis. Specifically, Dr. Planchart’s lab is interested in discovering regulatory genes that confer phenotypic plasticity and canalization, which buffer an organism from changes in its environment that could drastically alter its developmental program if left unchecked. 

Developmental Toxicology Research in Zebrafish. Kimberly Brannen, Merck, West Point, PA.

Dr. Brannen has worked with zebrafish and other alternative models in developmental toxicology research for much of her career and has experience in both regulatory and investigative developmental and reproductive toxicology (DART). She recently joined the Merck DART department as a Principal Scientist, and previously, she worked in DART at Charles River and Bristol-Myers Squibb.

 

 

 

Optimizing Multi-Dimensional Bioactivity Screening in Zebrafish. Robert Tanguay, Oregon State University, Sinnhuber Aquatic Research Laboratory, Corvallis, OR.

Robert Tanguay is a Distinguished Professor in the Department of Environmental and Molecular Toxicology and the Director of the Sinnhuber Aquatic Research Laboratory at Oregon State University. Over the past several years he has advanced the use of zebrafish as a toxicology model and recently developed automated high throughput instrumentation to accelerate phenotype discovery. Phenotypic anchoring coupled with the inherent molecular and genetic advantages of zebrafish are used to define the mechanisms by which chemicals, drugs and nanoparticles interact with and adversely affect vertebrate development and function. He received his BA in Biology from California State University-San Bernardino, his PhD in Biochemistry from the University of California-Riverside and postdoctoral training in Developmental Toxicology from the University of Wisconsin-Madison with Dr. Richard Peterson.

Innovative Zebrafish Hepatotoxicity, Cardiotoxicity, and Neurobehavioral Toxicity Assays for Drug Selection. Arantza Muriana, BBD BioPhenix S.L.-Biobide, San Sebastián-Donostia, Spain.

R&D Director. Bachelor of Pharmacy and Master degree in R+D+i of New Drugs at the Navarra University (Pamplona, Spain), also MBA from the San Pablo CEU University of Madrid (Spain), where she improved her project management and business development skills. She began working in Biobide in 2006, after a training period in zebrafish biology in the Salk Institute in California. She has experience been working in zebrafish for more than 10 years and has experience organizing and managing international projects such as FP/or Eureka.

 

 

Recent Developments and Recognition of Zebrafish for Use in Safety Evaluation by the Regulatory Agencies. Gopala Krishna, Supernus Pharmaceuticals, Inc., Rockville, MD.

Dr. Krishna worked as an NAS/NRC postdoctoral fellow at NIOSH (West Virginia) and Oak Ridge National Laboratories (Tennessee) from 1984–1986 studying molecular mechanisms of drug-induced toxicity. In the last 29 years, he has been with Pharma industry working for Pfizer, Abbott Labs, MGI Pharma, Enzon Pharma, and is currently at Supernus Pharma as the Executive Director and Head, Preclinical and Competitive Intelligence, and contributed to several marketed products. He is an expert in regulatory Pharm/Tox, served as Adjunct Professor of Toxicology—University of Michigan, reviewer of grants for NIH and NIEHS, published extensively and has been on the editorial board and Guest Editor of Mutation Research and Toxicology Mechanisms and Methods. He served as the President of SOT-ASIO-SIG. He is a Diplomate of ABT, a Fellow of ATS and recipient of multiple awards including the 2014 Academy of Distinguished Alumnus award of West Virginia University as a visionary.