Services

Richard C. Pleus, Ph.D., M.S.

Founder, CEO, Chief Toxicologist

RICHARD C. PLEUS, Ph.D., heads Intertox Inc., the scientific research and consulting company he founded in 1995. Within Intertox, he brings deep knowledge of toxicology to assist in protecting public health. To date, he has performed more than 600 toxicological assessments and has analyzed the impact of hundreds of chemicals on human health for aviation and space travel, medicine, medical products, consumer products, air, soil, water, food and waste.

Dr. Pleus has particular experience and expertise in:

  • Aerospace, reproductive and endocrinological toxicology and neuro- and neurodevelopmental toxicology.
  • Determining effects of chemicals on the human body, including chemical warfare agents, metals, nanomaterials, pharmaceuticals, chlorinated hydrocarbons, pesticides, volatile and non-volatile organic compounds and mycotoxins.
  • He is known for his ability to synthesize complex scientific information and to present accessibly for diverse audiences.
  • Developing Environmental Health and Safety compliance processes for workplaces and industries.
  • Developing and implementing experimental study designs for product-based health research.
  • Conducting toxicological assessments for residents residing near industrial facilities.
  • Conducting toxicological product and workplace safety assessments.
  • Discussing science and presenting to state, federal and foreign governmental agencies.
  • Communicating toxicological risks.
  • Serving as expert witness for attorneys representing both plaintiff and defense cases or as a consulting expert on toxicology and pharmacology in litigation.

Expertise

Dr. Pleus has conducted extensive scientific research at Intertox as an individual and with his global network of colleagues. He has won 6 grants for research in the last 10 years, published numerous peer-reviewed articles and written and edited books and chapters on diverse subjects in toxicology and nanotechnology. He has served as a U.S. delegate for national and international scientific conferences, including the U.S.-Russia Bilateral Presidential Commission on Science and Technology. His consistent presentation of scientific information in clear, layman’s terms, has made him a sought-after expert and presenter for businesses, trade organizations and universities across North America, Europe, Asia, Africa, South America and the Middle East.

Education

Dr. Pleus earned a Ph.D. in environmental toxicology from the University of Minnesota, where he had earlier completed his Masters of Science in environmental public 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.

Pro Bono Work

Dr. Pleus currently leads the U.S. delegation for Environmental Health and Safety (Working Group 3) to the International Organization for Standardization (ICO) Technical Committee (TC) 229’s.

Dr. Pleus provides scientific expertise on a matter for the Innocence Project Northwest; University of Washington School of Law.



Services

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.

Expertise

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.

Education

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.



Services

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.

Expertise

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.

Education

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).



Services

Lisa M. Corey, PhD, DABT

Senior Toxicologist

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.

Expertise

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.

Education

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).



Services

Jesse A. Port, PhD

Toxicologist

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.

Expertise

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.

Education

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.



Anne Galyean, PhD

Staff Scientist

ANNE GALYEAN, PhD, is a Staff Scientist at Intertox, Inc. with 13 years of experience. Arriving at Intertox in 2017, she offers a unique interdisciplinary perspective through her background in analytical chemistry, environmental fate and transport, biomedical research and engineered nanoparticles. Her technical contributions ensure that assessments are delivered in accordance with exacting quality-control standards, and that complex analytical information is communicated effectively to any intended audiences.

Dr. Galyean has particular experience in:

  • Evaluating laboratory procedures and analyzing data;
  • Providing critical toxicology assessment and project management support;
  • Providing support on compliance with the state of California’s Proposition 65;
  • Writing technical reports involving complex toxicological subjects.

Expertise

As an interdisciplinary scientist, Dr. Galyean brings a unique perspective to multi-disciplinary and cross-collaboration efforts, including project coordination and technical writing expertise. She provides support for a number of service lines at Intertox, including aviation/aerospace, worker’s compensation and product stewardship.

Education

Dr. Galyean earned her Ph.D. in Aquatic Analytical Chemistry from the University of North Carolina, Chapel Hill. She received her Bachelor of Science degree in Chemistry from the University of Richmond.



Mallory Little

Staff Scientist

MALLORY LITTLE began her work as a Staff Scientist at Intertox, Inc. in 2019. With a background in environmental and occupational health sciences, her work at Intertox spans areas from extractables and leachables to water quality. Her work includes assisting with risk assessments and researching health effects resulting from chemical exposures.

Ms. Little has particular proficiency in:

  • Providing support on risk assessments including extractables and leachables, water quality and more;
  • Evaluating human health impacts from chemicals in water, products and the environment;
  • Assisting clients with chemical regulations including PFAS and perchlorate.

Expertise

Ms. Little has significant experience studying the nuclear receptors PXR and CAR as well as the microbiome, a community of bacteria, fungi, viruses, and protozoa living primarily in the intestines. Through her graduate studies, she investigated how environmental chemicals can affect the microbiome and in turn, the human body. Her paper, “Gut Microbiome: An Intermediary to Neurotoxicity,” is published in the journal Neurotoxicology. Her upcoming paper, “Understanding the Physiological Functions of the Xenobiotic-sensing Nuclear Receptors PXR and CAR on the Gut Microbiome using Genetically-modified Mice” will be published in the journal Microbiome. Ms. Little also previously worked for the Centers for Disease Control and Prevention in Atlanta, Georgia, as part of the Division of Tuberculosis Elimination.

Education

Ms. Little earned her Master of Public Health in Environmental and Occupational Health Sciences from the University of Washington, Seattle. During her program, she focused on toxicology and risk assessment. She conducted her undergraduate work at the University of Georgia in Athens, Georgia, where she earned her Bachelors of Science in Genetics and Microbiology.