Governance

2022 HESI Board of Trustees Nominees

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  Myrtle Davis, DVM, PhD, ATS

  Bristol Myers Squibb

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  Dr. Myrtle Davis is the Vice President for Discovery Toxicology in the Pharmaceutical Candidate Optimization (PCO) organization. Dr. Davis joined BMS from the National Cancer Institute where she was the Chief of the Toxicology and Pharmacology Branch of the Developmental Therapeutics Program. Myrtle has previous experience as a Research Advisor in the Drug Safety group of Lilly Research Laboratories. In both roles, she contributed critical expertise to the advancement of several drugs candidates and to the understanding of toxicological mechanisms. She also has several years of academic experience as an Associate Professor in the Department of Pathology in the School of Medicine at the University of Maryland.

  Dr. Davis is currently responsible for leading the scientific efforts in Discovery Toxicology to provide target and molecular hazard identification and risk assessments for issues identified in discovery research. She also leads and oversees the investigative toxicology efforts needed to support mechanistic understanding of compound- or target-mediated toxicities in discovery and development.

  Dr. Davis is a Fellow of the Academy of Toxicological Sciences, an active member of the Society of Toxicology (and serves as the current President), and a member of the Society of Toxicologic Pathology. She served on the Board of Scientific Councilors of the National Toxicology Program, and the Board of HESI. She served as a reviewer for the Assay Development and Screening Technologies Laboratory of the National Center for Advancing Translational Sciences (NCATS). Myrtle also served as an Associate Editor for Toxicological Sciences and Toxicologic Pathology, and served as Editor-in-Chief of the ILAR Journal (Institute for Laboratory Animal Research of the National Academy of Sciences). She has authored several book chapters and co-authored peer-reviewed publications on a range of topics including apoptosis, toxicant-induced cell signaling, and biomarkers of tissue injury. She has also developed course content and lectures for medical and graduate student education.

  A native New Yorker, Dr. Davis completed a postdoctoral fellowship in Toxicologic Pathology at the University of Maryland. She earned a PhD in Toxicology from the University of Illinois Champaign-Urbana and obtained her Doctor of Veterinary Medicine degree from Tuskegee University School of Veterinary Medicine. She also completed undergraduate work in Chemistry and Math at Tuskegee University. Myrtle attended Tuskegee University where she pursued a BS degree in Chemistry and Mathematics followed by a Doctorate of Veterinary Medicine.

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  Nina Hallmark, PhD

  Vice Chair of Board

  Bayer Crop Science

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  Dr. Nina Hallmark is currently working in the Environment Safety organisation of Bayer AG Crop Science Division in Germany. This role includes investigating the potential risk to terrestrial vertebrates, such as birds and mammals, to pesticides used in the landscapes where these wild creatures live and feed. Previously, Nina worked as a Human Safety expert for Bayer In France, using her interest and experiences in human toxicology to explore potential developmental, reproductive or endocrine-mediated toxicity from pesticides using laboratory mammalian test systems. This built on similar work with industrial chemicals during 8 years with ExxonMobil in Brussels, Belgium and Houston, Texas, USA. This opportunity followed her PhD in reproductive and developmental toxicology from the University of Edinburgh, Scotland. Originally Nina studied Biochemistry at the University of Birmingham, England which led to a MSc in Forensic Science at the University of Edinburgh in bonny Scotland. This course revealed the science and art of regulatory toxicology, leading to her becoming an in vivo Study Director for a CRO (today known as Charles River), before embarking on the PhD program and subsequent roles within the global chemical and pesticide industries. This fusion of academic, industry and CRO experiences have shaped Nina’s interests in safety sciences. These have matured into a focus on the potential inter-play between human and environment protection testing and assessment approaches. She is also curious about and fascinated by the changing technologies available to investigate potential hazard and exposure profiles which can enable effective, realistic safety profiling and assessment of the different chemistries which are integral to our 21st century lifestyles. Nina believes in cross-disciplinary collaboration to identify and address the key safety science questions we face today and is greatly looking forward to supporting HESI with their mission as the Health and Environmental Sciences Institute to engage with diverse scientific minds of the HESI strategic partners to bring their many different experiences and perspectives into the discussions and together, to foster collaborative, holistic, science-based solutions.

   

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  Dale J. Hoff, PhD

  US Environmental Protection Agency

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  Dr. Hoff currently serves as Director in EPA’s Great Lakes Toxicology and Ecology Division, Center for Computational Toxicology and Exposure in Duluth, Minnesota. Dr. Hoff’s area of expertise is in the field of environmental toxicology and the assessment of effects of chemicals in terrestrial plants and wildlife, semi-aquatic wildlife, and aquatic organisms. While he has a multidisciplinary background in ecological risk assessment, recent work has focused on the systematic review and curation of scientific data used in the ecological risk assessment of chemicals. Dr. Hoff has been an ecological risk assessor in USEPA’s Superfund program and has worked directly with EPA’s Office of Water and Office of Chemical Safety and Pollution Prevention in the research and development of tools to be used for assessment of chemicals in ecological receptors.

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  Anthony Holmes, PhD

  Past President of Assembly

  NC3Rs UK

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  Dr. Anthony Holmes is Director of Science and Technology at the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs; www.nc3rs.org.uk). He has strategic oversight of the science and technology supported through NC3Rs, ensuring that the NC3Rs has a long-term and sustainable strategy for supporting the best science and technology and its use in practice to achieve 3Rs and wider scientific and economic benefits. He also leads the CRACK IT open innovation program. Anthony is a member of the UK BioIndustry Association (BIA) Science and Innovation Advisory Committee, and a member of the iGEM Foundation’s Safety and Security Committee. Anthony has a PhD from the University of Cambridge and worked as a postdoctoral researcher at the Babraham Institute, Cambridge, exploring the molecular mechanisms behind calcium signaling pathways and their role in human health and disease.

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  Adam Lillicrap, PhD

  Norwegian Institute for Water Research (NIVA)

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  Dr. Adam Lillicrap is the Research Manager for the section of Ecotoxicology and Risk Assessment which employs 24 dedicated research scientists and several PhD students and post-Doctoral scientists. He is also NIVA’s GLP Manager and has been project managing and study directing regulatory ecotoxicity tests according to Good Laboratory Practice (GLP) for over 20 years. Adam is a EUROTOX Registered Toxicologist (ERT) and is involved in numerous international committees and expert working groups. Adam is the Norwegian representative at the OECD validation management group for ecotoxicity test methods (VMGEco). Adam is also the Norwegian expert for fish within the OECD and the Norwegian representative for ISO Water Quality test standards. Adam has been working with zebrafish embryos for ecotoxicity assessments for over 20 years and was an industry nominated expert to the OECD regarding the implementation of the Fish Embryo Toxicity (FET) test guideline. Subsequently, Adam was elected as an independent advisor for the validation management group of the ring trial of the FET test. Over the years, Adam has been very active in the field of animal alternatives for ecotoxicity testing, chairing many sessions at SETAC and currently chairs the SETAC global animal alternatives interest group. He has been actively promoting the use of alternative methods for hazard assessments of chemicals at a regulatory level and was the project lead for the newly adopted ISO standard and OECD test guideline for a cytotoxicity assay (RT-gill W1 cell line). Adam was also the chairperson for the Cefic LRi Research Liaison Team for the project CELLSens and is currently leading the Cefic LRi project (ECO 51) entitled Strengthening Weight of evidence for FET data to replace acute Fish Toxicity (SWiFT). Adam was also the coordinator for a JPI Oceans Knowledge Hub for contaminants of emerging concern in the marine environment. Adam has a thorough understanding of the regulatory complexities regarding the adoption of alternative test methods and the need for a weight of evidence approach to gain regulatory acceptance. Adams main interests involve understanding how chemicals are regulated within an environmental context, and how to influence policy making decisions for regulatory frameworks.

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  Gary Minsavage, PhD, DABT, MBA

  President of Assembly

  ExxonMobil Corporation

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  Dr. Gary Minsavage is the Senior Environmental Health Advisor for ExxonMobil Corporation, where he provides corporate leadership and strategic direction regarding environmental health matters. Minsavage is involved in identifying emerging challenges and opportunities, leading collaborative networks and research projects, and contributing to the advancement of risk assessment methods development. Minsavage received his PhD in toxicology from the University of Rochester and Masters of Business Administration from Rutgers University. He completed postdoctoral training as a US National Research Council Fellow at the US Army Medical Research Institute of Chemical Defense before joining ExxonMobil Biomedical Sciences, Inc. (EMBSI). Minsavage is a Diplomate of the American Board of Toxicology and an active member of the US Society of Toxicology where he serves on the Risk Assessment Specialty Section Executive Committee, and also serves on the Board of the Health and Environmental Sciences Institute. Minsavage serves as a Liaison for the National Academies’ Environmental Health Matters Initiative where he helps the world’s leading scientists prioritize and tackle complex environmental health challenges and opportunities. He held a number of leadership roles at ExxonMobil, including Division Manager for the Global Product Stewardship Services Division at EMBSI, responsible for supporting product stewardship issues and opportunities, as well as safety data sheet authoring for all of ExxonMobil; Section Head for the Epidemiology, Health Surveillance, and Quality Assurance Section at EMBSI, responsible for coordinating epidemiology and QA programs for ExxonMobil global business units and external collaborations; and Section Head for the Toxicology Section at EMBSI, where he led toxicology research programs and initiatives. From 2008 to 2011, Minsavage was on assignment in Brussels, Belgium, as the Science Executive for Health Programs at the European refining industry’s technical association for health, safety, and the environment (CONCAWE). In this role, he was the EU REACH Project Manager responsible to deliver all petroleum product risk assessments for the 2010 registration period and was responsible to coordinate research in various areas including community health impact of air pollution and epidemiologic assessments of industry workers. Minsavage enjoys driving strategic thinking at work and hanging out with his family on and off sports fields.

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  Graeme Moffat, PhD

  Amgen, Inc.

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  Dr. Moffat is currently Vice President of Amgen’s Translational Safety and Bioanalytical Sciences (TS&BA) function, located in Thousand Oaks, CA. Within that role, Dr. Moffat is accountable for the scientific and operational excellence of TS&BA across 5 global locations to enable effective end-to-end pipeline decision making and robust human risk assessments that ensure patient safety.

  TS&BA provides translational safety sciences expertise including exploratory and regulatory toxicology, pathology, laboratory and animal sciences to support programs from discovery through post‐marketing and bioanalytical assessment of nonclinical and clinical studies encompassing the full spectrum of Amgen’s multi-modality pipeline.

  In addition to these functional leadership roles, Dr. Moffat is the co-chair of Amgen’s Research Safety Governance Board and is responsible for leading by example and setting the highest standards possible for workplace safety for all Global Research staff. Previously, Dr. Moffat has also served as Amgen’s Institutional Official, accountable for upholding the highest ethical and scientific standards for all animal research conducted at Amgen.

  Externally, Dr. Moffat co-chaired the Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology (DART) Technical Committee from 2015-2018 and was elected to the HESI Board of Trustees in 2019. Dr. Moffat has also represented Amgen on the Preclinical Development Expert groups at both the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

  Prior to joining Amgen in 2007, Dr. Moffat spent 12 years at Syngenta (formerly AstraZeneca) in the UK where he held several positions of increasing responsibility including the Head of Developmental and Reproductive Toxicology. Dr. Moffat received his PhD in the fields of molecular biology and immunology from the University of Glasgow, Scotland and was a Postdoctoral Fellow at Scripps Clinic, La Jolla CA and the Imperial Cancer Research Fund Biomedical Research Centre in Dundee, Scotland. Dr. Moffat has served on numerous external scientific committees and has published over 30 peer-reviewed research articles.

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  Ruth Roberts, PhD, FRSB, FRCPath

  Chair of Board

  ApconiX, Ltd.

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  Ruth Roberts, PhD, FRSB, FRCPath

  Dr. Ruth A. Roberts is Chair and Director of Drug Discovery at Birmingham University, UK, and Cofounder of ApconiX, an integrated toxicology and ion channel company that brings together a team of world-renowned nonclinical safety experts with over 300 years of drug discovery and development experience. Before that, Ruth was Global Head of Regulatory Safety at AstraZeneca and Director of Toxicology for Aventis in Paris, France. She is currently Vice Chair of HESI. She chaired the HESI Emerging Issues Committee from 2015 to 2016, joined the HESI Board in 2019, and has co-chaired the HESI Biomarkers of Neurotoxicity scientific committee since its inception in 2015.

  Dr. Roberts received her BSc in biochemistry and her PhD in medical oncology from the University of Manchester, UK. She is former president of EUROTOX, former president of the British Toxicology Society (BTS), and a Fellow and past president of the Academy of Toxicological Sciences (ATS) and was elected Fellow of the Royal College of Pathologists in 2012 and of the Royal Society of Biology in 2014.

  Dr. Roberts was the recipient of the SOT Achievement Award in 2002, the EUROTOX Bo Holmstedt Award in 2009, and the SOT 2018 Founders Award, given in recognition of outstanding leadership in fostering the role of toxicological sciences in safety decision making. With over 150 publications in peer-reviewed journals, she is interested in developing and implementing innovative models in drug discovery and development.

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  Hans Sanderson, PhD

  Aarhus University

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  Dr. Sanderson has been employed both in industry as the Director for Environmental Safety, with Washington DC chemicals trade association (ACI formerly SDA), as well as in academia as a post-doctoral fellow in Canada – and currently as a senior researcher in Denmark. He has a broad background in environmental and public health of bioactive chemical risk assessment over the past two decades. He has served on NAS and WHO panels reviewing public health risks from trace level exposures to pharmaceuticals in drinking water. Dr. Sanderson currently serves on the WHO Chemical Risk Assessment Network – with a focus on developing countries capacity and needs to assess public risks of chemicals exposures. He has completed a 4 yr project exposure pathway modelling and cancer risk screening on Vieques. He has worked on projects from many different international organizations including WHO; NATO; EU; Cefic and produced several peer-reviewed publications from each project. Dr. Sanderson was the National Expert for Denmark to the EU Commission H2020 and now Horizon Europe Programme Committee Environment and Climate, Danish Research Council 2017- present. Since 2016, he has worked with the Danish EPA on projects related to Environmental Quality Standards of chemicals including pesticides and pesticide metabolites and developed and reviewed several EQS reports to the DK-EPA.

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  Pamela Spencer, PhD

  Secretary

  Angus Chemical Company

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  Dr. Pamela “Pam” Spencer is the Vice President of Regulatory, Product Stewardship & Quality at ANGUS Chemical Company, in Chicago, Illinois. Prior to this role, she worked for the Dow Chemical Company for 30 years, retiring as the Scientific Director of Dow’s Toxicology Environmental Research & Consulting function. Dr. Spencer actively works to promote the concepts of safer product design with regulatory agencies, industry, academia, and nongovernmental organizations particularly as it relates to the application of New Approach Methods (NAMs). She is the inaugural President of the Association for the Advancement of Alternatives Assessment (A4), serves on the Board of Directors for the Center for Contemporary Science (CCS), and is a Diplomate of the American Board of Toxicology. She received her doctorate from the Department of Toxicology, School of Public Health, University of Michigan and her Master of Science in biology from Central Michigan University. She has extensive experience in regulatory toxicity testing and research to define human health risks, with numerous publications to date in the areas of neurotoxicology, genetic toxicology, carcinogenicity, and green chemistry.

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  Jean-Pierre Valentin, PhD, HDR, ERT, FRSB, FRCPath, DSP

  UCB

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  Jean-Pierre holds a Ph.D. in Physiology & Pharmacology 1990, from the University of Montpellier, France. Following a post-doc at UCSF, Jean-Pierre joined the Pierre Fabre Research Centre (1992-98) where he contributed to the discovery and progression into development of 3 candidate drugs. He joined AstraZeneca to build from inception, develop and lead the Department of Safety Pharmacology where he contributed to the safety evaluation of ~200 candidate drugs across a wide range of therapy areas, leading to the development and successful registration of several marketed products. In February 2014 he joined UCB-Biopharma as Senior Director Head of Investigative Toxicology, based in Belgium supporting the entire portfolio across several therapy areas and modalities. He is an active member of several scientific societies; former President of the Safety Pharmacology Society; current co-chair of the HESI subcommittee on Proarrhythmia, and of the HESI Cardiac Steering Team. He is also Chair of the IQ-DruSafe Secondary Pharmacology Working Group; and he is representing the EFPIA on the ICH E14-S7B Implementation Working Group. He is involved in training, education and mentoring programs associated with several scientific societies, universities, and trade associations. He is author/co-author of several patents and >200 peer review publications and book chapters.

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  Martin van den Berg, PhD, ERT

  Past Chair of Board

  Utrecht University

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  Martin van den Berg, PhD, ERT

  Prof. Dr. Martin van den Berg is an Emeritus Professor in Toxicology, former deputy director of the Institute of Risk Assessment Sciences of the University of Utrecht, and a European Registered Toxicologist (ERT). He is currently Chair of HESI.

  He is an honorary professor in environmental toxicology at the University of Queensland (Brisbane) and a visiting professor at the Royal Chulabhorn Research Institute and Graduate School in Bangkok. In 2006 he received an honorary doctorate from the University of Umea, Sweden, for his research on mixture toxicity of dioxin-like compounds. He has published over approximately 375 peer-reviewed scientific articles, short papers, and conference proceedings.

  Prof. van den Berg has been and is an advisor to many national and international organizations (Dutch National Health Council, WHO, FAO, IARC, EU, and US) involved with (eco)toxicological risk assessment of environmental and food contaminants and pesticides.

  He is Co-Editor-in-Chief of Regulatory Toxicology and Pharmacology and Current Opinion in Toxicology (Elsevier). From 2008 to 2018 he served as a member of the Dutch Committee of Appeal from the Board of Authorisation of Plant Protection Products and Biocidal Products. During the last decades he was also an advisor to the chemical and pharmaceutical industry for the registration and sustainable use of new products.

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  Douglas Wolf, DVM, PhD, FIATP, ATS

  Syngenta

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  Douglas Wolf, DVM, PhD, FIATP, ATS

  Dr. Wolf graduated in 1981 from the University of Missouri with a Doctor of Veterinary Medicine degree (D.V.M.) and, after 6 years in clinical veterinary practice, attended Purdue University where, in 1991, he completed a pathology residency and received a research PhD in Veterinary Pathology. Dr. Wolf was a staff scientist for 6 years at the Chemical Industry Institute of Toxicology (CIIT) where he studied chemical carcinogenesis. From 1997 until 2013 Dr. Wolf held various positions with the U.S. Environmental Protection Agency, initially as a Principal Investigator at the National Health and Environmental Effects Research Laboratory (NHEERL), where he continued research in chemical carcinogenesis and molecular pathology. Dr. Wolf held several formal leadership roles at EPA as a Branch Chief in the Environmental Carcinogenesis Division, as Director of the Toxicology Assessment Division, as Assistant Laboratory Director in NHEERL and as Director of the Endocrine Disruptor Screening Program in the Office of Chemical Safety and Pollution Prevention. He received numerous awards for innovative work at the US EPA to provide solutions to improve regulatory science and decision-making. In November 2013 he joined Syngenta Crop Protection as Regional Lead for Toxicology and Health Sciences in North America. Dr. Wolf is currently a Senior Syngenta Fellow where he leads international efforts to advance science-based risk assessment focusing on crop protection chemicals and progressing the development and qualification of new approach methods in the service of decreasing the use of animals in chemical evaluation. Dr. Wolf has authored or coauthored over 155 journal articles, book chapters, and technical reports and has presented at numerous national and international scientific meetings. In 2004 he was elected a Fellow of the International Academy of Toxicologic Pathologists and in 2007 a Fellow of the Academy of Toxicological Sciences.

2022 HESI Emerging Issues Committee Nominees

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  Anthony Bahinski, PhD, MBA, FAHA

  Vivodyne, Inc.

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  Dr. Anthony Bahinski is Chief Technology Officer at Vivodyne, where he leads the translation of Vivodyne’s automated platform for massively scalable safety and efficacy testing on lifelike lab-grown human tissues to pharmaceutical and regulatory partners. Prior to joining Vivodyne, he served as the Global Head of Safety Pharmacology at GlaxoSmithKline. At GlaxoSmithKline, his responsibilities were focused on coordinating a global strategy to investigate safety risks of drugs on the cardiovascular, respiratory, CNS, renal, and other specialized tissues, both in vitro and in vivo. Dr. Bahinski’s career spans academic research and large Pharma, with more than 20 years’ experience in the pharmaceutical industry. He served as Lead Senior Staff Scientist on the Advanced Technology Team at Harvard’s Wyss Institute, leading DARPA and FDA collaborative efforts in development of organ chip systems. Dr. Bahinski has served on several advisory boards and is a current member of the Science Board of the US FDA, US EPA Board of Scientific Counselors (BOSC), and the Industrial Advisory Board for Dutch Research Council awarded SMART Organ on Chip (OoC) project. He is a member of the Editorial Board of the journals, Applied In Vitro Toxicology and Frontiers in Pharmacology of Ion Channels and Channelopathies. He has served on Peer Review Panels at the NIH, US EPA and NCI SBIR. Dr. Bahinski is author/co-author of over 40 publications including peer-reviewed articles and book chapters.

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  Suzanne Fitzpatrick, PhD, DABT

  US Food and Drug Administration

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  Dr. Suzanne Fitzpatrick is a board certified toxicologist here and in Europe and is an internationally recognized expert in alternative methods. She is the Senior Advisor for Toxicology at FDA/CFSAN. She is the FDA lead to ICCVAM and Tox 21 and chairs the FDA Alternative Methods Work Group. Dr. Fitzpatrick is the FDA representative to the International Regulatory Committee for the European Research Projects under ASPIS (Rik Hunter, ONTOX and Precision Tox) and she cochairs the EFSA and CFSAN Work Group on NAMS.

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  Jacquelin MacDonald Gibson, PhD, MSCE

  Indiana University

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  Dr. MacDonald Gibson is Professor and Department Chair in the Environmental and Occupational Health Department of the School of Public Health at Indiana University in Bloomington, IN. She earned two PhDs in 2007 in Engineering and Public Policy and Civil and Environmental Engineering at the Carnegie Mellon University in Pittsburgh, PA.

  Her research addresses news stories of health risks from toxic waste spills, polluted water supplies, hazy air, contaminated foods, and other environmental problems abound. It also involves sorting through the headlines to figure out what environmental risks really might be important to our health or our community’s health and figuring out how to decrease those risks can seem an insurmountable task. She seeks to illuminate what individuals, communities, and policymakers can do to make the biggest and most lasting improvements in public health by improving the quality of our environment.

  Her students and she parse complicated environmental problems into manageable elements that can be modeled mathematically and re-integrated to inform environmental and public health policy decisions. They have worked across the globe, from the US to the United Arab Emirates. Their work examines environmental risks to health at the scale of communities, building models that integrate knowledge of how pollutants are distributed through communities, how people become exposed to pollutants and other environmental risks factors, and how these exposures, in turn, increase risks of illness or premature death. Their main tools are drawn from applied mathematics and statistics, but they also conduct field research. Her students have collected and analyzed water and air samples, administered surveys, and conducted focus group interviews, in order to develop the knowledge needed to understand environmental risks to public health and advance policies to reduce those risks. Given an important environmental policy question, they find the tools needed to analyze potential solutions.

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  Misti Ushio, PhD

  ValoHealth

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  Misti Ushio is formerly the CEO of TARA Biosystems which was acquired by ValoHealth in 2022.

  TARA Biosystems develops physiologically relevant 3D tissue models for drug discovery and development applications. The company’s Biowire™ II platform enables generation of large amounts of human relevant data for predictive drug development. TARA accelerates discovery efforts for novel heart medicines via its disease modeling and phenotypic screening capabilities, and also evaluates early cardiac risk assessment of drug discovery candidates.

  Dr. Ushio has over 20 years of experience in the biotechnology and pharmaceutical industry, and early stage life science company building. Dr. Ushio has served most recently as Chief Strategy Officer and Managing Director of Harris & Harris Group, where she advised and invested in life science companies to help them translate their transformational science into commercially successful companies.

  Earlier in her career, Dr. Ushio held management roles at Merck & Company, where she developed vaccines and biologics products, and Columbia University, where she managed the intellectual property of several scientific and engineering portfolios.

  She was graduated from Johns Hopkins University (B.S., Chemical Engineering), Lehigh University (M.S., Chemical Engineering) and University College London (Ph.D., Biochemical Engineering). She also serves as a Director on the boards of private and public life science companies. In 2018, she was named to Fast Company’s Top 100 Most Creative people in Business.