Richard C. Pleus, PhD
Founder and CEO
RICHARD C. PLEUS, PhD, heads Intertox Inc., the scientific research and consulting company he founded in 1995. Within Intertox, he brings his deep knowledge of toxicology to aid in the legal and business side of toxicity assessment. To date, he has performed more than 400 toxicological assessments and has tested the impact of hundreds of chemicals in medicine, medical products, consumer products, air, soil, water, food, and waste.
Dr. Pleus has particular experience in:
- Determining effects of chemicals on the human body, including nanomaterials, pharmaceuticals, hydrocarbons, pesticides, and volatile and non-volatile organic compounds;
- Serving as either an expert witness or a consulting expert on toxicology and pharmacology in litigation;
- Developing and maintaining high-level Environmental Health and Safety compliance processes, including workplace standard operating procedures, collection of appropriate scientific data, and, as appropriate, hazard and/or exposure analyses of chemical and biological agents;
- Conducting toxicological product safety assessments and workplace safety assessments;
- Briefing governmental agencies and serving as a delegate to international scientific conferences;
- Conducting health assessments of chemical effects on fetal development, reproductive development, and nervous and endocrine disruption;
- Lecturing and presenting on diverse topics in toxicology and their applications in the private and public sector.
Dr. Pleus has conducted extensive scientific research at Intertox, as an individual researcher, and with his global network of colleagues. He has won 6 grants for research in the last 10 years, has published numerous peer-reviewed articles, and written and edited books and book chapters on diverse subjects in toxicology and nanotechnology. He has served as a US delegate for national and international scientific conferences, including the US-Russia Bilateral Presidential Commission on Science and Technology, and the International Organization for Standardization (ICO) Technical Committee (TC) 229. His ability to present scientific information in clear, layman’s terms, have made him a sought-after expert witness in litigation and a featured presenter for businesses, trade organizations, and universities across North America, Europe, Asia, and the Middle East.
Dr. Pleus earned a PhD in environmental toxicology from the University of Minnesota, where he had earlier completed his Masters in environmental health. Dr. Pleus’ undergraduate work was at Michigan State University, where he graduated with honors in physiology. He conducted his post-doctoral training in neuropharmacology at the University of Nebraska Medical Center.
Michael C. Maloney, RAC
Executive Vice President, Regulatory Affairs
MICHAEL C. MALONEY, RAC, works with Intertox clients who need to gain Food and Drug Administration (FDA) approval for drugs and medical devices. Mr. Maloney has helped medical device and drug companies bring products to market for more than 30 years. He has regularly provided hands-on management of companies in these fields. Both as a consultant and as an employee, he has led new product development step-by-step from approval process to launch.
Mr. Maloney has particular experience in:
- Developing consultancy programs for medical device companies seeking to establish regulatory compliance;
- Crafting and overseeing national and international product regulatory dossiers;
- Submitting dossiers in compliance with electronic Common Technical Document (eCTD) specifications;
- Directing successful negotiations with FDA (CDRH, CDER, CBER);
- Managing nonclinical safety and biological activity programs;
- Overseeing clinical investigations to establish safety, proof-of-concept, and efficacy;
- Negotiating with regulators over product classification, labeling, advertising, and promotional materials;
- Managing prior approval supplements for CMC;
- Acting as regulatory liaison in cases involving 510(k), PMA, NDA and BLA approvals.
Mr. Maloney has an extensive experience as a regulatory affairs subject matter expert. He co-founded the Novent Group in 1991, providing regulatory consultation for a broad range of medical products leading to numerous marketing authorization successes. He has also provided regulatory consultation as the president of LaHaye Laboratories (1996-2001) and the Head of Regulatory Affairs at ZymoGenetics (2005-2009), he shepherded numerous products to FDA approval, including the clotting solution Recothrom. As an expert in regulatory affairs, Mr. Maloney serves as a liaison on major cases, working with clients to create strategies to win regulatory approval, craft the appropriate dossiers for submittal to regulators, negotiate with regulators, and maintain post-approval commitments to ensure continued regulatory compliance.
Mr. Maloney earned a degree in Biological Sciences from San Jose State University. He holds Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society, which is the only certification in this field recognized worldwide.
Gretchen M. Bruce, DABT
Director of Toxicology
GRETCHEN M. BRUCE, DABT, is Director of Toxicology at Intertox, where she began in 1999. She has over 20 years of experience in conducting toxicological risk assessments in a variety of settings. These include human health impact analyses, regulatory compliance assessments, and workplace exposure hazard assessments. Her expertise in data analysis and modeling allows her to conduct these assessments with unique skill.
Ms. Bruce has particular experience in:
- Developing risk assessment models and data analyses for a broad range of human health risks in industrial facilities and workplace environments;
- Conducting toxicological evaluations to support extractable/leachable chemicals (E&T) assessment, including developing analytical evaluation thresholds (AETs);
- Conducting risk assessments to consumers of allegedly biologically and chemically contaminated air, water, food, and soil;
- Evaluating human health impacts from chemicals in pharmaceutical medical devices, consumer products, water, and the environment;
- Developing acceptable dose levels and human health impacts for pharmaceuticals, personal care products, and endocrine disrupters in water;
- Providing scientific litigation support;
- Assessing compliance with toxicity standards in accordance with federal CERCLA, RCRA, TSCA, state (e.g. Prop. 65), and local regulations.
Ms. Bruce has particular expertise in developing and implementing data analysis methods and risk assessments. She is well-versed in the process of litigation, and provides expert toxicological analyses to support legal cases. Ms. Bruce’s expertise allows her to assist clients in maintaining compliance with local, state, and federal toxicological regulations.
Ms. Bruce earned her Bachelor of Science in Environmental Toxicology from the University of California at Davis and is a certified Diplomate of the American Board of Toxicology (DABT).
Chris E. Mackay, MSc, PhD, CPM
Senior Managing Toxicologist
CHRIS MACKAY, MSc, PhD, CPM, joined Intertox in 2016 as a Senior Managing Toxicologist. He has over 20 years of experience conducting site, product, and chemical safety assessments. In his career Dr. Mackay he has worked extensively to support occupational, public, and consumer safety in diverse industries: manufacturing, electronics, chemicals, pesticides, pharmaceuticals, agriculture, and others.
Dr. Mackay has particular experience in:
- Conducting toxicity assessments in humans, animals, and plants;
- Conducting life cycle analyses for chemicals and processes;
- Performing Quantitative evaluations for the interactions between products and consumer populations for application in toxicology studies;
- Providing litigation support as a consultant/expert witness in cases of toxic trespass, personal injury, occupational hygiene, product liability, as well as compliance under REACH, FIFRA, TSCA, and CA Proposition 65;
- Conducting and developing product-safety analyses measuring human health and environmental impacts;
- Conducting exposure and toxicity evaluations of nanomaterials.
Dr. Mackay has extensive experience conducting both quantitative and qualitative toxicological impact analyses from molecular to global domains. He has supported over 150 clients in both state actions and litigation as an expert consult and witness. Dr. Mackay is especially adept at navigating national and international regulatory requirements for consumer, product, and environmental situations, as well as clearly presenting his toxicological and regulatory assessments in terms understandable by lay jurists. In the field of business, he has worked to ensure safety and compliance, thus limiting potential liability held by his clients.
Dr. Mackay earned his PhD in pharmacology and toxicology at the University of California, Davis. He earned his MSc in environmental biology at the University of Guelph, Ontario, where he also completed his undergraduate work in environmental toxicology with honors. He performed postdoctoral training at the University of Florida’s Center for Environmental and Human Toxicology.
Lisa M. Corey, PhD, DABT
LISA M. COREY, PhD, DABT, joined Intertox in 2004, and currently works as a senior toxicologist. She has studied the effects of chemicals that may pose a threat to human health for more than 10 years. Her knowledge of human health risks in air, water, and the workplace enables her to have a significant impact in all areas of environmental health and human toxicology.
Dr. Corey has particular experience in:
- Evaluating the health risks of metals, halogenated compounds, organophosphates, pesticides, solvents, and nanomaterials;
- Evaluating risk with special consideration towards sensitive populations;
- Conducting product assessments for chemical compounds;
- Preparing labels and Safety Data Sheets (SDS) for industrial chemicals in accordance with OSHA guidelines;
- Ensuring compliance with governmental toxicity regulations including REACH, EPA Maximum Contaminant Levels (MCL), and State of California standards;
- Developing company-wide hazard/safety plans to manage human health risks to a broad range of chemicals;
- Providing litigation support and expert testimony for cases involving human health risk and exposures to hazardous chemicals.
Dr. Corey is adept at evaluating human health risks from exposure to chemical and biological agents in air, water, soil, and food. She has provided scientific comments and Maximum Contaminant Level (MCL) of perchlorates in water in accordance with California Public Health Goal (PHG) criteria. She has also conducted assessments of jet engine oil and hydraulic fluid in aircraft cabin air. Dr. Corey’s extensive knowledge of human health risks from chemicals allows her to promote her clients’ compliance with local, state, federal, and international Environmental Health and Safety (EHS) regulations, provide litigation support as either a consultant or an expert witness, and develop new toxicological assessments for measuring chemical impacts on human health.
Dr. Corey earned her PhD in Environmental Toxicology from the University of Washington, where she also earned her Master of Science in Environmental Toxicology. She conducted her undergraduate studies in biology at the University of Washington. Dr. Corey is also certified as a Diplomate of the American Board of Toxicology (DABT).
Jesse A. Port, PhD
JESSE A. PORT, PhD, began his work as a toxicologist at Intertox in early 2016. His work primarily focuses on conducting exposure, toxicity, and human health risk assessments of exposures to chemical and biological agents in water, soil, and food.
Dr. Port has particular experience in:
- Conducting health hazard assessments of substances for carcinogenicity, genomic toxicity, and reproductive and developmental toxicity;
- Risk assessments of possible contaminants in consumer and medical products including deriving acceptable intake levels;
- Biological monitoring for microbial pathogens and antibiotic resistant genes in aquatic environments;
- Employing genomics and DNA sequencing to survey the composition and distribution of microbial and fish communities in marine environments;
- Toxicological evaluation of Material Safety Data Sheets (MSDSs) for industry products including classification of hazardous substances and/or mixtures based on OSHA and GHS standards.
Dr. Port is adept in evaluating health risks from exposure to chemicals in the environment and consumer products, as well as in the identification of pathogens and microbes in waste & seawater. He has conducted over a dozen assessments of human health hazards in pharmaceuticals, including developing maximum acceptable exposure levels for contaminants in an intravenous drug product.
Dr. Port earned his Ph.D. in Environmental Toxicology at the University of Washington, where he also received his masters in Marine & Environmental Affairs. He conducted his undergraduate work in Ecology & Environmental Biology at the University Colorado, Boulder. Dr. Port completed a 3-year post-graduate science fellowship at Stanford University’s Center for Ocean Solutions.