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toXcel Professionals
- Alan C. Katz, M.S., DABT - President - Alan is a board-certified toxicologist with
over 40 years of experience in the agrochemical, industrial chemical, pharmaceutical, food ingredients, nutritional
supplements, and cosmetics 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 Pesticide Programs and has since spent over 20 years as a consultant in scientific
and regulatory affairs. Alan is past-president of the Society of Comparative Ophthalmology and currently serves 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. Alan serves 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 Mid-Atlantic Regional Chapter of SOT and the Neurotoxicology, Ocular Toxicology,
Biological Modeling, Carcinogenesis, and Risk Assessment Specialty Sections.
- J. Michael Kelley, Ph.D., Vice President - Mike has over 30 years of diversified management and technical experience in regulatory compliance strategy, microbiology, and toxicology related to the chemical industry. His experience includes serving as Director of Regulatory Affairs for an international Fortune 500 specialty chemical manufacturer, leading negotiations with regulatory authorities, and chairing industry panels. Mike's expertise includes obtaining and maintaining approvals under FIFRA and TSCA, which routinely require understanding and interpretation of the regulatory significance and utility of a wide variety of toxicological and microbiological data. He works closely with toXcel's European office, has led dossier submissions required under the EU's BPD, and works with clients on a regular basis to provide guidance and support to ensure compliance with REACh.
- Gary K. Whitmyre, MA, 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. As Principal of
risksciences, LLC, since 1997 and Whitmyre Research since 1999 and his previous experience on the staff
of other scientific consulting firms, he has been actively 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 for inclusion in applications for US federal and state marketing approvals, and international
dossiers supporting pesticides and antimicrobial products and other chemical registrations.
- Robert M. Sielaty, J.D., Executive Director of Product Registration and General Counsel - Bob is an accomplished Washington, D.C. consultant with over 40 years experience in regulatory positions in the federal government, national trade associations, private law practice, and consulting firms. With a background of studies in science and law, he assists chemical companies and the health care industry with government approval processes, legislative issues, and compliance programs for the marketing of pharmaceutical, agricultural, biochemical, and antimicrobial products. He advises companies on complex issues involving toxic substances and compliance. He is well-known by industry and government representatives as a reliable and knowledgeable regulatory expert, and has made numerous presentations at industry and government forums on topics involving the regulatory process. As General Counsel, he provides advice and guidance on the company's legal and business affairs.
- Christine McAlinden, DABT, UK and European Registered Toxicologist - 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 general toxicology where she gained a good practical understanding of toxicological studies and data. In 2001 Chris first joined toXcel as a consultant toxicologist gaining experience in the regulatory environment and giving support to 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 and is now a Panel member for the UK Register of Toxicologists. She has recently re-joined toXcel to establish their European office and develop their REACH services.
- Jane C. Eickhoff, M.S., Director of Strategic Services - Jane has over 30 years experience in environmental and dietary
exposure analysis and modeling, providing advice and assistance to agrochemical producers, the food industry and industrial 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. Jane's 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 coordinating
trade association working committees for crop protection and agricultural research. Jane has also been actively involved in training government
and industry staff in the use of dietary/drinking water residue exposure modeling.
- Angela M. Lynch, M.S.P.H, Ph. D., Staff Toxicologist - With a background as a researcher, academician and lecturer in Pharmaceutical
Science, Angela brings a Human/Public Health perspective to the toXcel team. She is experienced in interpreting federal policy and regulations for environmental and occupational exposures, conducting risk assessment, and assessing chemical studies.
Angela routinely interacts with state and federal agencies, including the US EPA, OSHA, and NIH to maintain compliance on all state and federal regulations. She is a member of the American Association for Pharmaceutical Sciences, the Society for Neuroscience, The PsychoNeuroImmunology Research Society, and the American Society of Neural Therapy and Repair, where she serves on the Education Committee.
- Nicola D. Cowen, B.S., Senior Associate Scientist – Niki coordinates and manages
project efforts between senior and junior staff. She evaluates and summarizes toxicology
studies required to support regulatory actions on agricultural chemicals, antimicrobials, and
inert ingredients. She also leads efforts to prepare FIFRA and state submissions in support
of pesticide products and interacts directly with EPA and clients to resolve labeling issues.
Niki closely monitors the US Environmental Protection Agency's global harmonization
efforts. In addition to maintaining the company’s database of international CRO study
capabilities and costs, she places and monitors studies. Niki is proficient in both conducting
NPIRS searches and interpreting the findings to confirm data compensation requirements for
specific products and to provide clients with valuable competitive intelligence. She holds
current memberships in the American College of Toxicology (ACT) and the Society of
Environmental Toxicology and Chemistry (SETAC), and is furthering her graduate studies in
the field of Environmental Science and Policy at George Mason University.
- Jennifer L. Wagar, B.S., Senior Associate Scientist – Jennifer is experienced with
preparing dossiers, including IUCLID documentation, required for the registration of products
for Annex I listing under the European Union’s Biocidal Products Directive (BPD; 98/9/EC)
as well as the Plant Protection Products Directive (91/414/EEC) and is also knowledgeable
with regard to the Canadian registration processes through Health Canada’s Pest Management
Regulatory Agency (PMRA). She has experience in preparing state registration applications and supporting data compilations for
submission to California, New York, and Florida. She is proficient in conducting literature
searches, scientific research, data evaluation, and summarization of data. Jennifer plays a
key role in all aspects of preparation of regulatory submissions to the US EPA regarding
pesticide active ingredients and products and interacts directly with EPA on behalf of clients
to resolve issues. Jennifer is trained in the use of the National Pesticide Information
Retrieval System (NPIRS) and is toXcel’s primary contact for the Accepted Labels State
Tracking and Repository (ALSTAR). She is an active member of the Regulatory
Affairs Professional Society (RAPS).
- Nicole F. Perkinson, B.S., Associate Scientist – Nicole joined the toXcel team
immediately after graduating from college with a degree in Biology. During her college
career, she interned with the US Department of Agriculture and gained practical experience in risk assessment
methods and risk management policies. Nicole is experienced in the preparation of US EPA/FIFRA
applications, including reduced-risk pesticide applications and compiling associated data
waiver justifications. She has experience in preparing state registrations for submission to
multiple state pesticide regulatory authorities and is trained in the use of NPIRS. She also
prepares dossiers required for the registration of products for Annex I listing under the
European Union’s Plant Protection Products Directive and prepares applications for
submission to Canada’s Pest Management Regulatory Agency (PMRA). She has
experience with the FDA regulatory process, including OTC drug product listing. Nicole has
demonstrated proficiency for data compilation, evaluation, and technical writing as well as indepth
label reviews for regulatory compliance. She is an active member of the Regulatory
Affairs Professional Society (RAPS).
- Christopher J. Burnside, B.S., Associate Scientist - Chris first began his work with toXcel
as an intern during college. Rejoining the toXcel team immediately after graduation, he
applies practical experience as an analytical and environmental chemist to the evaluation
and development of environmental fate and product chemistry studies. Chris integrates a
working knowledge of the chemical realm into the detailed preparation of scientific and
regulatory documents required for federal and state registrations of pesticide products
(insect repellents, agrochemicals, and antimicrobials) under FIFRA and Pre-manufacture
Notices (PMNs) under TSCA for EPA acceptance of new chemical substances.
- Crystal A. Turner, Office Administrator – Crystal is an experienced administrative
associate and a member of the International Association of Administrative Professionals. In
addition to her function as the office manager, she handles accounting matters and
maintains financial records, conducts NPIRS and other on-line data searches, and
consistently resolves complex document production issues in a timely and efficient manner.
Crystal has valuable experience with the formatting of regulatory submissions and oversees
document quality assurance with great attention to detail.
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