Author Archives: ToxStrategies

Concerns about potential health risks associated with low-level exposures to PFAS, along with their widespread uses and reported detections in various environmental media and products, are triggering regulation, litigation, and an urgent need to apply the best available science in evaluating the exposure, toxicology, and epidemiology to characterize potential human health risks. ToxStrategies and EpidStrategies have scientific expertise and advanced technical resources to assist clients in navigating the scientific environment and growing regulatory labyrinth associated with PFAS.

ToxStrategies’ and EpidStrategies’ capabilities include (but are not limited to) protocol development for PFAS extraction and migration from products, articles, and containers; assessment of fate and transport of PFAS; exposure and risk assessment of PFAS in environmental media; exposure and safety assessment of PFAS contained in wide variety of products, including foods, packaging, personal care products, cosmetics, health and beauty care products, and commercial/industrial products; in-depth PFAS toxicology knowledge; development of PFAS toxicity criteria and toxicokinetic modeling; critical assessment and systematic reviews of PFAS epidemiological studies and evidence to understand impact on health outcomes; and critical evaluation and systematic reviews of PFAS literature.

Learn more about ToxStrategies PFAS capabilities here.

EpidStrategies scientists Dr. Jon Fryzek, Ms. Lauren Bylsma, and colleagues, have published a paper assessing one of the key elements of chemotherapy for cancer patients. Chemotherapy-induced toxicity is a constant challenge that is often addressed by reducing the dosage, which can be a factor in treatment failure for patients with likely curable malignancies. The study authors conducted a meta-analysis of scientific literature to assess the impact of relative dose intensity (RDI) on survival in adult patients. They concluded that maintaining an RDI of ≥80% or ≥85% for two regimens studied resulted in higher overall survival, stating that “management of toxicities across treatment modalities may contribute to maintenance of higher RDI and benefit survival for patients with advanced solid tumors.” The study appears in the “early view” posted online at The Oncologist.

ToxStrategies scientist Kara Franke presented a session on optimizing industrial hygiene data collection and management to inform the US EPA in the TSCA risk evaluation process at the 2021 AIHce EXP virtual conference. The presentation highlighted issues that included:

• Ensuring appropriate analytical limits of detection
• Best practices for record-keeping
• Collecting robust, high-quality data that represent not just high-risk workers but all workers with potential exposure.

The talk was titled “Updating your Exposure Assessment Strategy to Better Inform the TSCA Risk Reviews”. Contact Kara Franke with questions.

Cannabidiol (CBD) and other hemp-derived products continue to gain attention from the FDA and consumers. A ToxStrategies team led by Dr. Rayetta Henderson is continuing work on a systematic mapping of published literature related to CBD and safety. Studies will be categorized by CBD or related substance type, route of exposure, study model, and health outcome(s) (e.g., neurological, reproductive, etc.), and classified as beneficial or adverse. A preliminary analysis of the data was presented at the 2020 Society of Toxicology annual meeting; currently the team is updating that effort by mapping data published through the end of 2020. The resulting assessment will provide an overview of the current landscape of available CBD data, as well as identify outcomes or other sub-topics that may be suitable for further research and could support future work for systemic reviews, Generally Recognized as Safe (GRAS) assessments, and New Dietary Ingredient Notifications (NDINs).

Read more on CBD from ToxStrategies.

Dr. John M. Rogers, ToxStrategies Senior Consultant, has been awarded the 2021 Edward W. Carney Distinguished Service Award by the Society for Birth Defects Research and Prevention (BDRP, established in 1960 as the Teratology Society). This award honors Dr. Edward W. Carney, Past President of BDRP, for his exemplary dedication and service to the Society and the field of teratology. The Edward W. Carney Distinguished Service Award recognizes an individual who has provided distinguished service to BDRP. Dr. Rogers has served as BDRP’s President, Treasurer, and chair of several committees; was the Society’s inaugural Robert L. Brent Lecturer; and is Co-Editor of the Society’s journal, Birth Defects Research. He is the author of the chapter on Developmental Toxicology for Casarett and Doull’s Toxicology, the Basic Science of Poisons, has mentored many graduate students and postdoctoral fellows, is a frequent lecturer in BDRP’s Continuing Education Courses, and teaches developmental toxicology at the University of North Carolina, Chapel Hill. Dr. Rogers recently retired from the U.S. Environmental Protection Agency after 36 years as a scientist and director.

EpidStrategies, a division of ToxStrategies, Inc., is excited to be participating in the European Hematology Association Virtual Congress, which will be held virtually from June 9^th through 17^th, 2021.

Jon Fryzek, Naushin Hooda, Xiaohui Jiang, and Gina Nicholson will present two virtual posters during the congress, on Friday, June 11, at 09:00 CEST. The posters are titled, “Healthcare resource utilization among patients with cold agglutinin disease in Denmark” and “Increased antidepressant use among newly diagnosed patients with cold agglutinin disease compared with other patients in a large US healthcare system.”

The abstracts will be published in the online Abstract Book, a supplement of HemaSphere (EHA’s official journal), the EHA Library, and the Virtual Congress platform. The abstracts are currently accessible on ehaweb.org, and will be available on the Virtual Congress platform at the time of the presentation. Registration is required to access the platform.

The EpidStrategies team, along with colleagues in industry and academia, have been deeply engaged in ongoing research on cold agglutinin disease (CAD), a rare, chronic type of autoimmune hemolytic anemia. In addition to the CAD work being presented at EHA 2021, our group has presented abstracts at the ISPOR Europe 2020 Virtual Conference (2020) and the Society of Thrombosis and Haemostasis Research Annual Meeting (2020), and has published our work in the peer-reviewed publications Journal of Medical Economics, Research and Practice in Thrombosis and Haemostasis, and Blood Advances.

EpidStrategies scientists are committed to assisting clients in developing therapies for rare diseases and have extensive experience supporting orphan product development and regulatory submissions by estimating target population size, characterizing rare patient populations, and identifying relevant clinical endpoints and potential safety concerns. For more information about our rare disease services, please see our website

ToxStrategies is pleased to announce that John M. Rogers, Ph.D., has joined our Health Sciences Practice, following a distinguished career with the U.S. EPA. Dr. Rogers brings more than 40 years of experience in the areas of developmental and reproductive toxicology, further strengthening the body of expertise that we offer our clients.

Dr. Rogers’ experience includes evaluating and advising on animal and in vitro toxicology research to support U.S. EPA decision-making. He also brings a wealth of teaching experience at Duke University, the University of North Carolina, North Carolina State University, and the University of Miami. In addition, he has held several positions with the Society of Toxicology, in their Reproductive and Developmental Toxicology Special Section, and the Teratology Society (now the Society for Birth Defects Research and Prevention).

Dr. Rogers has served on the editorial boards of The Journal of Toxicology and Environmental Health, Mutation Research – Reviews and The Journal of Developmental Origins of Health and Disease, and also served as an Associate Editor for Environmental Health Research and Birth Defects Research (BDR). He is currently Co-Editor of BDR. He is a recognized expert in developmental and reproductive toxicology, with more than 100 peer-reviewed publications and 40 book chapters, including  writing the chapter “Developmental Toxicology” in Casarett and Doull’s Toxicology (now in it’s ninth edition).

During his distinguished career, Dr. Rogers has won fourteen Scientific and Technical Achievement Awards and three Bronze Medals for his research at EPA, including research on the developmental toxicity of per- and polyfluoroalkyl substances (PFOA) and methanol, maternal toxicity and adverse outcome pathways.

Learn more about Dr. Rogers here .

ToxStrategies Information Specialist Ms. Seneca Fitch is among a group of scientists from the regulatory community, academia, the pharmaceutical industry, and consulting who have published an article in Scientific Reports (an open-access publication of the journal Nature). The paper investigates why some new drugs, having survived the rigorous process of animal and human testing necessary to bring them to market, end up causing unexpected, and sometimes severe, adverse drug reactions in the wider patient population (killing more than 10,000 patients annually in the United States). The authors point out that a battery of new tests and techniques have emerged in the last few decades (referred to as new approach methods [NAMs]) to study the mechanisms of toxicity of chemicals and identify endpoints of concern. Pursuing three separate evidence streams for specific drugs associated with drug-induced liver injury, they propose a “paired-compound approach” to comparing various tests, to reach a systematic, transparent, and evidence-based approach to drug development.