= Members Only
ACT eLearning Series
Special Topics Speakers
Mary Jeanne Kallman, PhD, DSP
Mary Jeanne Kallman earned a PhD from the University of Georgia in Neuroscience and completed a postdoctoral fellowship in pharmacology and toxicology at Virginia Commonwealth University. She was a tenured Associate Professor and Director of the PhD Experimental Graduate Program at the University of Mississippi for 9 years. She worked for Lilly Research Labs for 17 years as the Group Leader for Safety Pharmacology in their Toxicology Group where she provided drug develop solutions in rodents, primates, and dogs as needed. She also worked for Covance Laboratories, a large CRO, as the Global Director of Neuroscience. Dr. Kallman is currently managing a consulting business which provides input on CNS issue resolution and abuse liability strategies for drugs in development. She holds diplomate status (DSP) in the Safety Pharmacology Society and she has held several professional leadership positions including President of the Safety Pharmacology Society, Co-Leader of the Scientific Liaison Coalition (SLC) of SOT, and co-leader of the Cross Company Abuse Liability Council (CCALC). In 2019 Dr. Kallman co-edited a book on issue resolution in safety pharmacology. She frequently publishes scientific papers, book chapters, and presents on various CNS issues. Dr. Kallman received EPA and NIH funding for her research and support of her academic laboratory.
Joanne Kilgour, MSc, PhD, ERT
Dr. Kilgour is a Consultant Toxicologist at Regulatory Science Associates. She has been an Independent Consultant since 2016, focusing on inhaled and oncology projects. She provides strategic nonclinical toxicology advice to small, medium, and large Pharma on product development from Phase 1 through to marketing authorization. Dr. Kilgour also supports development via program design and management, regulatory document preparation, and representation at regulatory meetings. She has 28 years of product development experience in both Pharma and Agrochemicals (including 10 years at both Syngenta Central Toxicology Laboratory and AstraZeneca). Dr. Kilgour is the Chair of the Association of Inhalation Toxicologists (AIT) and previous Scientific Meetings and the Secretary and Chair of the Education Subcommittee of the British Toxicology Society. She was previously involved in a cross-industry Working Group on challenges of Alveolar Macrophage findings in Inhaled Drug Development (Forbes, et al, 2014) and is currently leading a Pharma-wide Working Group on Inhaled Biologics, aiming to publish two papers in Toxicologic Pathology in 2020. She is an invited speaker on Inhalation Toxicology at the Birmingham MSc Toxicology Course, ACT Course, Educational Workshop for Regulators at FDA in 2013, and European Chemicals Agency (ECHA) in 2017.
Naomi Kruhlak, PhD
Dr. Naomi Kruhlak has worked for US FDA’s Center for Drug Evaluation and Research (CDER) as a computational toxicologist for 18 years, developing and applying (quantitative) structure-activity relationship ((Q)SAR) models to support the regulatory review of pharmaceuticals. She is the Scientific Lead for CDER’s Computational Toxicology Consultation Service and is the Principal Investigator on three FDA/CDER Research Collaboration Agreements with commercial (Q)SAR software vendors, as well as an Inter-Agency Agreement with NIH generating in silico-based drug safety predictions. Dr. Kruhlak has published 42 peer-reviewed articles describing data standardization, transformation, and classification for modeling purposes, and the creation and application of (Q)SAR models with chemical interpretability. Dr. Kruhlak holds B.Sc. and Ph.D. degrees in chemistry from the University of Salford, England, and the University of Calgary, Canada, respectively.
Susan Laffan, PhD
Susan Laffan is currently a Head of the Nonclinical Global Investigative Safety group at GlaxoSmithKline, she is a toxicologist with over 18 years of pharmaceutical industry experience. Susan is the nonclinical chair of the GSK’s pediatric advisory network providing advice to drug development teams on their pediatric development plans. Dr. Laffan represented PhRMA on the ICH S11 Working Group. She is an expert in reproductive and developmental toxicology and has been directly involved on the drug development teams supporting the safety assessment of compounds from discovery through post marketing. Susan earned a PhD in toxicology from the University of North Carolina and Chapel Hill, conducting her dissertation at the USEPA, Research Triangle Park, NC. In addition to being a BDRP member, she is a member of the Society of Toxicology and the ILSI/HESI DART Technical Committee.
John Lipscomb, PhD, DABT, ATS
Dr. Lipscomb began his career as a biologist at the National Center for Toxicological Research in Jefferson, Arkansas. He later served as a Captain (research toxicologist) in the U.S. Air Force, where he earned the Air Force Achievement Medal for his pioneering work on the military’s first large-scale investigation of human metabolic variability. He completed his federal career as a toxicologist and risk assessor in EPA’s National Center for Environmental Assessment and National Homeland Security Research Center in Ohio, where he was a chemical manager for three different risk assessment programs and led the development of EPA guidance for quantitative risk assessment and emergency exposure guidance values. Dr. Lipscomb has over 100 peer-reviewed publications, book chapters and government technical reports. His interests include quantitative risk assessments of single chemicals and chemical mixtures, in vitro to in vivo extrapolation, toxicokinetics and non-default extrapolations of dosimetry among and between species. Dr. Lipscomb is a Diplomate of the American Board of Toxicology and Fellow of the Academy of Toxicological Sciences. He serves on the Health Advisory Board for NSF International and American Industrial Hygiene Association’s Emergency Response Planning Committee. He is past president of the Society for Risk Analysis’s Ohio chapter, the Society of Toxicology’s Risk Assessment Specialty Section and Ohio Valley regional chapter, as well as the American Board of Toxicology. He serves on the Editorial Board for Toxicological Sciences and is an Associate Editor for Toxicology Mechanisms and Methods, and Toxicology Reports. Dr. Lipscomb holds bachelor’s and master’s degrees in biology from the University of Central Arkansas and a PhD in interdisciplinary toxicology from the University of Arkansas for Medical Sciences and is an adjunct professor of Toxicology and course director for Human Health Risk Assessment in the Department of Pharmacology and Toxicology at the University of Louisville.
Andrew Makin, MSc
Andrew Makin has almost 40 years of practical, hands-on experience in design, management, conduct and overview of preclinical programmes and individual studies. He has a first degree in biology and psychology from the University of Keele in England and an MSc in applied zoology from the University of Wales. He is a Member of the Royal Society of Biology and is a Registered Toxicologist. Dr. Makin’s experience in toxicology is in the areas of preclinical pharmaceutical development, and related subjects. He has a significant understanding of the scientific and regulatory requirements in these fields. Working in Contract Research, first in the UK with HLS from 1980 to 2001, and subsequently in Denmark from 2002 until 2019 with Scantox, LAB Research and Citoxlab, he has gained a very broad understanding of the needs of customers from a wide variety of different companies and approaches, from small (virtual) companies all the way up to Big Pharma. Dr. Makin’s work has involved all aspects of the process from identifying the needs of the customer through to execution of projects and interpretation of study results. During this time, he worked with most animal species and with most study types, and naturally, during his time at Scantox, this included a significant focus on the Göttingen minipig and projects involving the development of dermal and topical drugs and devices. Having worked with projects in all the major regions of the world, he has a fundamental understanding of the needs of drug development companies globally. Since 2019 he has taken this experience into the world of consulting, establishing his own company.
Mark Powley, PhD
Mark W. Powley received a PhD in toxicology from Purdue University and completed postdoctoral training at the University of North Carolina – Chapel Hill. From 2004 to 2009 he worked in the general toxicology, biochemical toxicology, and genetic toxicology groups at Merck Research Laboratories. In 2009 Mark moved to the US FDA Center for Drug Evaluation and Research (CDER), Office of New Drugs. In addition to reviewing nonclinical data, Mark co-chaired several CDER pharmacology/toxicology subcommittees including those focused on genetic toxicology and computational toxicology. Mark rejoined Merck Research Laboratories in 2017 and currently works in the genetic toxicology group. His primary role involves supporting both mutagenic and non-mutagenic impurity safety assessment.