OUR PEOPLE

Alan C. Katz, DABT, ERT, FRSB, President– Alan has a master’s degree in Human Physiology and is a board-certified toxicologist with over 40 years of experience in the pharmaceutical, chemical, food ingredients and supplements, cosmetic, and agrochemical fields.  He is broadly experienced in the public and private sectors, including management of toxicology, product chemistry, risk assessment, and regulatory affairs programs in industry, government, and consulting.  Following an extensive career in industrial research in chemistry, toxicology, and pharmacology, he served as a senior toxicologist with the US EPA Office of Prevention, Pesticides and Toxic Substances and has since spent over 30 years as a consultant in scientific and regulatory affairs.  Following his service at EPA, Alan played a key role in working with industry to address chemical safety and hazard reporting issues under the TSCA Section 8(e) Compliance Audit Program.  Alan is past-president of the Society of Comparative Ophthalmology and previously served a dual role on the editorial staff of the Journal of Applied Toxicology as a member of the Editorial Advisory Board and Editor of the Toxicology Updates feature. He is currently on the Editorial Advisory Board of the Food and Drug Law Journal.  Alan also served as an elected member of the Awards Committee of the American College of Toxicology and is an active participant in the Society of Toxicology, where he is a member of the national Society and the Mid-Atlantic Chapter, and the Drug Discovery, Regulatory and Safety Evaluation, Neurotoxicology, Ocular Toxicology, and Risk Assessment Specialty Sections.  He also holds membership in the American Chemical Society where he has contributed to several research presentations over the years.  In addition to his status as a Diplomate of the American Board of Toxicology since 1980, Alan is a European Registered Toxicologist (through the UK Registry) and he was recently elected as a Fellow of the Royal Society of Biology.

Christine McAlinden, DABT, UK and European Registered Toxicologist, Associate Director – Chris is a board-certified toxicologist with over 20 years’ experience within the industry. She began her career with a UK CRO as a Study Director in toxicology where she gained a solid practical understanding of toxicological studies and data evaluation.  In 2001 Chris first joined toXcel International Ltd as a consultant toxicologist, gaining added experience in the regulatory environment and advising and supporting clients on the safety assessment of animal food additives (EFSA and FDA), agrochemicals and pharmaceuticals (MHRA and EU).  Between 2007 and 2011 she continued with consultancy work and also gave toxicological support to an Indian CRO, including training and protocol/report reviewing.  She has been actively involved with REACH, providing only-representative services, consortium representation, dossier and CSR compilation and dossier submission.  Chris has served on the education committee of the British Toxicology Society, as a Panel member for the UK Register of Toxicologists, and is currently serving as the toxicologist for the Food Standards Agency’s Advisory Committee on Amials Foodstuff (ACAF). In early 2011, Chris re-joined toXcel to establish our new European office in Ledbury, England and to further develop our comprehensive REACH services.  In her role as Associate Director, Chris provides leadership in business and scientific affairs on behalf of our European operations, registered in England and Wales.   Chris has an honors degree Bachelor of Science in Applied Biology, specializing in Biomedical Sciences, is a European Registered Toxicologist, and is a Diplomate of the American Board of Toxicology.

Bryan J. Katz, PE, PTOE, PMP, Vice President of Engineering – Bryan holds a Ph.D., as well as graduate and undergraduate degrees, in Civil Engineering from Virginia Tech and is a registered Professional Engineer in the Commonwealth of Virginia and a certified Professional Traffic Operations Engineer who brings over 15 years of experience in transportation safety, operations, and construction engineering and inspection. He is also an Associate Professor of Practice at Virginia Tech, where he teaches transportation engineering courses in the Civil and Environmental Engineering Department. Since 2002, he has supported research projects for the Federal Highway Administration (FHWA) at the Turner-Fairbank Highway Research Center in McLean, Virginia. He is a voting member on the National Committee on Uniform Traffic Control Devices and serves as the Secretary of the Research Committee. In addition, he is an active member of the Transportation Research Board, serving on two technical committees, and is also an active member of the Institute of Transportation Engineers. He serves as a paper reviewer for Accident Analysis and Prevention, Traffic Injury Prevention, and for three volumes of the Transportation Research Record. Prior to joining toXcel, Bryan worked for Leidos (formerly SAIC) and HNTB Corporation.

Connie Welch-DuJardin, Vice President – An expert in environmental laws and regulations, Connie enjoyed great success as founder and principal of Connie Welch and Associates.  Her background includes a 17 year distinguished career within the US EPA’s Office of Pesticide Programs (OPP), where she held prominent leadership positions dealing with conventional pesticides, antimicrobial pesticides, and inert ingredients. During the last eight years of her tenure at EPA. Connie served as Chief of Regulatory Management Branch II in the Antimicrobial Division, Office of Pesticide Programs. This position also afforded Connie the opportunity to work with other offices within the EPA (i.e., the Office of Pollution Prevention and Toxics, the Office of Drinking Water, and the Office of Solid Waste) and other federal agencies (the Food and Drug Administration, the Consumer Products Safety Commission, and the US Department of Agriculture).  Because of Connie’s extensive EPA career and previous experience as a leading regulatory consultant to industry, she is ideally suited to providing clients with a wealth of pesticide knowledge and expertise.   Connie started her career with a bachelor’s degree in Chemistry and holds advanced degrees in Ministry.

Raluca E. Kubaszky, DVM, PhD, DABT,  Executive Director of Nonclinical Development – A veterinarian by training and a board-certified toxicologist, Dr. Kubaszky has over 20 years of laboratory and academic experience in nonclinical study design and management of complex projects.  She obtained a doctorate in Veterinary Medicine from the University of Agronomical Sciences Bucharest, Romania, then specialized in nonclinical research after completing a Ph.D. in Veterinary Medicine, Endocrinology of Reproduction. In 2011, she became a Diplomate of the American Board of Toxicology. Prior to joining toXcel, Raluca participated in the design, conduct, and reporting of toxicology studies to support a wide variety of development programs at major contract research organizations.  As a Principal Scientist/Study Director specialized in nonclinical research for IND, BLA, and NDA filing or chemical/agrochemical registration, Dr. Kubaszky performed GLP and non-GLP studies including validations of new methods and procedures. Dr. Kubaszky’s role at toXcel is to expand  the pharmaceutical, biotechnology and radiation safety services within the company’s global portfolio, and to implement toXcel’s presence in Canada, in addition to its USA and European-based offices. Dr. Kubaszky provides strategic scientific, regulatory and hands-on expertise to support development of a wide variety of products for pharmaceutical, medical device, biotech, chemical and agrochemical companies. She has nonclinical experience with cell and gene therapies, biologic, biosimilar, and small-molecule products for a wide variety of indications and special expertise in radiation safety programs.

Jennifer Symoun, PMP, Business Manager/Director of Communications and Outreach – Jennifer holds an undergraduate degree in Commerce, with concentrations in Management and Management Information Systems from the University of Virginia and has over 15 years of experience in project management, outreach and communications, web development, web conferencing, and research and analysis support for the Federal Highway Administration (FHWA) and National Highway Traffic Safety Administration (NHTSA). Jennifer has focused on a diverse range of transportation topic areas, including impaired driving enforcement, freight management and operations, work zone safety and mobility, and congestion pricing. She specializes in research and writing guidance documents and outreach materials that educate and inform practitioners about relevant transportation topics. Prior to joining toXcel, Jennifer worked for Leidos (formerly SAIC).

Melba S. Morrow, DVM, Director of Toxicology –  Melba holds a Doctorate of Veterinary Medicine degree and has over 35 years of government regulatory experience, having worked at the Food and Drug Administration’s Center for Veterinary Medicine and the Environmental Protection Agency’s Office of Pesticide Programs. At EPA, she held several positions including team leader and senior scientist in the Health Effects Division and special assistant positions at the branch and division levels in the Antimicrobials Division. During her government career, she developed testing guidelines for domestic animal safety, wrote position papers and conducted numerous toxicity reviews for food use and antimicrobial chemicals.  She has served on hazard and risk assessment committees within the Office of Pesticide Programs and has worked with FDA on issues involving dual regulatory jurisdiction.   Melba also served as an expert panelist with the World Health Organization’s International Programme on Chemical Safety. During her tenure at the EPA, she received bronze medals for her work on endocrine disruption, anthrax remediation and programmatic issues.   

Gary K. Whitmyre, DABT, Senior Director of Exposure and Risk Assessment – Gary is a board certified toxicologist with over thirty years of technical experience focused on residential, occupational, and consumer exposure analysis, risk assessment, and toxicology of environmental chemicals.  He holds a master’s degree in Biochemistry.  As Principal of risk sciences, LLC and Whitmyre Research and his previous experience on the staff of other scientific consulting firms, he has been engaged in a wide variety of risk assessment projects.   His experience includes probabilistic modeling of human exposure to chemicals in indoor and outdoor environments, development of expert opinions for litigation cases, regulatory compliance through product-specific exposure assessments under California Proposition 65, preparation of human health risk assessments to include in applications for US federal and state marketing approvals, and international dossiers supporting pesticides and antimicrobial products and other chemical registrations.

Nicholas Kehoe, Director of Transportation Technology – Nicholas received both his undergraduate and graduate degrees in Civil Engineering from Virginia Tech with his graduate degree concentrating on transportation systems. He has nearly 10 years of experience providing technical support to Federal and State transportation agencies covering a range of activities that include project management, performance measurement, program oversight, data collection and analysis, education, outreach, and professional development. His experience focuses on transportation safety, operations, and freight transportation. Recently, Nicholas spent more than two years providing on-site support to the Federal Highway Administration at the United State Department of Transportation headquarters where he analyzed freight-related data to assist in policy development and producing communications and educational materials for freight professionals.

Sheryl Miller, PMP, Director of Human Performance and User Experience – Sheryl obtained her Ph.D. in Human Factors and Applied Cognition from George Mason University, where she focused on issues of interruption and multi-tasking, team workload and decision-making, human-computer interaction, and usability. She obtained her undergraduate degree in Psychology from the State University of New York (SUNY) College at Geneseo, minoring in Organizational and Occupational Behavior. Sheryl has over 12 years of experience providing project management, research skills, and human factors expertise to a diverse range of topics. These have included pedestrian safety, Intelligent Transportation Systems (ITS), connected vehicles, collision warning and avoidance systems, Transportation Management Centers (TMCs), and other safety or mobility techniques, technologies, and marketing approaches. As a Human Factors Psychologist, Sheryl has ensured that the user experience is included early and often in engineering projects. This has included conducting experimental studies in the laboratory and field; capturing and interpreting stakeholder perspectives with surveys, interviews, and focus group meetings; and assessing task flow and interface design with usability methods. Sheryl is a member of the Human Factors and Ergonomics Society (HFES) and User Experience Professionals Association (UXPA).

Carrie Redden, Director of Health and Planning – Carrie has dual master’s degrees in Public Health and City Planning (specializing in transportation planning). She has over 15 years of experience working to support community and individual behavior change accomplished through understanding and addressing the individual, interpersonal, infrastructure, societal, and practical factors that influence decision-making at the individual, community and policy level. Ms. Redden has strong research and facilitation skills. She has provided leadership in guiding, facilitating, and implementing a variety of community health assessments required qualitative and quantitative data analysis, including key stakeholder interviews, focus groups, and data indicator analyses. Carrie has worked to identify and delineate the health impacts of changes within the transportation and planned environment, including issues such as walk to school policies, complete streets, and pedestrian and cyclist infrastructure.

Jane C. Eickhoff, Director of Strategic Services – Jane has over 30 years’ experience in the environmental field, providing advice and assistance to the food industry and chemical manufacturers concerning compliance with environmental and agrochemical regulations and registration requirements.  She evaluates potential exposure and health risks of chemical contaminants, crop residues and additives in foods by conducting refined dietary and aggregate risk analyses using non-proprietary models including CARES, DEEM, and LifeLine^® software.  Her experience also includes obtaining tolerance and exemption from tolerance petition approvals, effective interaction with European, Canadian, and US regulatory authorities, ensuring compliance with regulations, evaluating data compensation issues, serving as facilitator for an industry task force, and coordination of trade association working committees for crop protection and agricultural research.  Jane holds a Master’s degree in Biology.

Jennifer L. Fulford, Manager of Scientific Projects – Jennifer has over 12 years of experience in the field and uses her strong organizational and management skills as the manager and coordinator of numerous complex projects, providing comprehensive scientific and regulatory compliance services.  She acts as coordinator of toXcel’s Assistant staff.  Jennifer plays a key role in all aspects of preparation of international dossiers, as well as regulatory submissions to the US EPA (FIFRA) and US FDA regarding pesticide active ingredients and products, and interacts directly with the Agency staff on behalf of clients to resolve issues during the registration process.  Jennifer has extensive experience reviewing laboratory study reports, principally toxicology reports, and has participated in auditing laboratories on behalf of study sponsors.  Proficient in conducting literature searches, scientific research, data evaluation, and summarization of data, Jennifer has also received training at the National Library of Medicine (NLM) for the TOXNET^® databases.  Jennifer is trained in the use and interpretation of the National Pesticide Information Retrieval System (NPIRS) and regularly uses the database to assist clients in all aspects of data review and competitive intelligence.  Jennifer has a Bachelor of Science degree in Biology and is a member of the  Society of Toxicology (SOT).   Jennifer is on the Food and Drug Law Institute‘s (FDLI) Publications Peer Review Committee.

Nicole F. Perkinson, RAC, Manager of Regulatory Affairs – Nicole has a master’s degree in Environmental Policy and Management with over 11 years of experience with Federal and State pesticide regulations.  She is also Regulatory Affairs Certified with experience in the areas of pharmaceutical, medical device, and food ingredient regulation.  Nicole manages a wide variety of projects including the preparation and submission of product applications to Federal and State regulatory authorities.  She interacts directly with regulatory Agencies on behalf of clients to identify and resolve regulatory issues and assists clients in updating and maintaining registrations and ensuring their products meet regulatory requirements.  She is proficient in the areas of data compilation, evaluation, technical writing, and regulatory compliance reviews and has practical experience in risk assessment methods and risk management policies. 

Trudy L. Knight, Senior Scientist – Trudy is a highly qualified toxicologist and pharmacist, with a PhD focusing on the mechanism of drug-induced liver injury (DILI).  She is passionate for the safety of drugs and chemicals, and has maintained a wide perspective in the field; her experience spans the diverse sectors of academia, pharmaceutical industry, National Health Service and UK government.  In academia, Trudy pursued research and teaching in several aspects of toxicology.  She has also participated as an invited member of the working group of the International Agency for Research on Cancer (IARC).  Trudy is an active member of the Royal Society of Chemistry, British Pharmacological Society, and British Toxicology Society (BTS).  In the latter capacity, she has served as member, then Secretary, of the BTS Communications Subcommittee.  Trudy maintains particular interest in the elucidation of mechanisms of toxicity and the development of nanomedicines and biologics.