Author Archives: ToxStrategies

Dr. Susan Borghoff, Director of ToxStrategies’ Center of Excellence for 21^st Century Toxicology, was invited to participate in the inaugural Conference on Reducing Animal Testing for Chemical Safety, convened on December 17, 2019, by EPA’s Office of Pesticide Programs. Approximately 60 scientists from government, academia, and industry were present at the full-day meeting, and were joined by more than 600 individuals in the morning session via teleconference. The gathered experts in environmental and chemical safety research discussed advancements in New Approach Methods (NAMs), to assess the current state of chemical safety research and discuss scientifically valid alternatives to animal testing. According to EPA, “This event, which will take place annually, is a major step in implementing [the Agency’s vision] to aggressively pursue reductions in animal testing.”

Dr. Borghoff brought her expertise in study design and managing research and regulatory-driven toxicology to the breakout group that discussed “Variability and Relevance of Current Animal Tests and Expectations of NAMs.” In her 30-year career, Dr. Borghoff has managed diverse research programs for both industry and government clients. Recent efforts have been focused on the development and implementation of a framework to evaluate both in vitro and in vivo mechanistic data into hazard characterization.

A recently published article by ToxStrategies scientists and others presents the systematic identification, appraisal, and integration of mechanistic data in an assessment of potential carcinogenicity of the non-nutritive sweetener sucralose. Based on the evaluation of over 700 measurements/assay endpoints related to one or more key characteristics of carcinogens (KCC) reported in the literature and via high-throughput screening data, the authors found a lack of evidence for activity across the mechanistic database. These results align with the overall lack of tumor response to sucralose in rodent cancer bioassays, corroborating previous reports of a lack of carcinogenicity related to sucralose exposure. The open-access article can be found here: https://www.sciencedirect.com/science/article/pii/S027869151930688X.

EpidStrategies, a division of ToxStrategies Inc., is founded on rigorous scientific principles that guide our research on complex health conditions. We are scientists who provide consulting services to public and private sectors worldwide. With a focus on pharmaceuticals, medical devices, nutrition, and environmental chemicals, our scientists aid clients in the conduct, evaluation, and interpretation of epidemiologic studies. We are seeking an epidemiologist to join our team of epidemiologists and statisticians conducting systematic literature reviews and statistical analyses, and preparing manuscripts.  EpidStrategies offers a challenging and dynamic work environment, professional development opportunities, and competitive compensation and benefits.

Specific job responsibilities include:

• Perform systematic literature reviews following establishing guidelines such as PRISMA
• Conduct statistical analyses using SAS, STATA, or R
• Write project proposals and other technical documents
• Draft conference abstracts and manuscripts
• Develop new and maintain existing client relationships
• Project management including oversight of multiple project timelines, deliverables, and budgets

Ideal candidate will have:

• MPH, MS, or PhD in a relevant field such as epidemiology
• Approximately 3-5 years of work experience
• Strong writing and communication skills
• Experience conducting literature reviews
• Proficiency in at least one statistical computing package
• Familiarity with attending and presenting at professional conferences
• Existing authorization to work in the United States

Interested candidates should send a cover letter and CV to hr@toxstrategies.com.

ToxStrategies scientist Dr. Bill Rish is a co-author of a new article that demonstrates acceptably low doses of naturally occurring radiation (NORM) when using the waste from alumina production (APR, or alumina production residue) in producing and using cement. Putting APR to this beneficial use, instead of storing it indefinitely, has raised concerns about workers involved in cement production or use, or members of the public, being exposed to radiation. The findings of Dr. Rish and colleagues, however, demonstrate that workers or the public being exposed to radiation over the life cycle of APR reuse will not receive doses in excess of any current risk-based standards. The article is published in the Journal of Air & Waste Management Association.

A recently published article by ToxStrategies scientists, with Dr. Daniele Wikoff as lead author, presents the systematic identification, appraisal, and integration of mechanistic data in an assessment of potential carcinogenicity of the non-nutritive sweetener aspartame. Based on the evaluation of over 1300 measurements/assay endpoints related to one or more key characteristics of carcinogens (KCC) reported in the literature and via high-throughput screening data, the authors found a lack of evidence for activity across the mechanistic database. These results align with the overall lack of tumor response to aspartame in rodent cancer bioassays, corroborating previous reports of a lack of carcinogenicity related to aspartame exposure. The open access article can be found here: https://www.sciencedirect.com/science/article/pii/S0278691519306568

Following implementation of the Hemp Farming Act, part of the Agricultural Improvement Act of 2018 (aka, “2018 Farm Bill”), interest in hemp-derived products, especially cannabidiol (CBD), has outpaced the development of a legal pathway for their use. As the industry advocates for the US FDA to issue a regulation for lawful marketing of CBD in food and/or dietary supplements, ToxStrategies has been assisting clients in conducting systematic safety evaluations, including those to support future regulatory submissions. Specific experience includes assessment of CBD manufacturing conditions and toxicological safety that could support future Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) submissions, as well as the safety profile of naturally occurring CBD in hemp food products. ToxStrategies continues to monitor regulatory developments in the area of hemp-derived products and participates in relevant trade associations, such as the Council for Responsible Nutrition (CRN), where Dr. Rayetta Henderson (ToxStrategies Managing Scientist) is a member of the CBD Task Force.

ToxStrategies will be represented at the upcoming 31^st annual meeting of the British Society of Toxicologic Pathology (BSTP) held jointly with the Association of Inhalation Toxicologists (AIT) in Alderley Edge, Cheshire, UK (November 10-11, 2016) by Dr. Marcie Wood. Dr. Wood will be presenting a US regulatory perspective on determination of adversity in inhalation toxicology studies.

Dr. Wood is a Senior Scientist in ToxStrategies’ Biopharmaceutical/Pharmaceutical Practice and has expertise assisting clients with issues related to nonclinical safety assessment of small molecule and biologic products, including general toxicology and inhalation toxicology. ToxStrategies’ scientists have worked at the FDA, as well as in the biopharmaceutical and pharmaceutical industries, and are uniquely suited to assist clients with complicated scientific, regulatory, and strategic challenges that arise during the nonclinical development of drug candidates.

Please contact Dr. Wood (mwood@toxstrategies.com) if you would like to arrange to meet with her at BSTP/AIT.

Dr. Kirby Tyndall and Ms. Camarie Perry will be attending and exhibiting at the upcoming Society of Environmental Toxicology and Chemistry (SETAC) meeting in Orlando, Florida (November 6-10, 2016). This year marks the 7^th SETAC World Congress meeting, and the 37^th Annual SETAC North America meeting.

Dr. Tyndall and Ms. Perry are Senior Scientists at ToxStrategies.  They have extensive expertise assisting clients with a wide array of issues related to toxicology, complex environmental and human health risk assessments, and development of risk-based cleanup levels. ToxStrategies’ scientists have experience working at various regulatory agencies (state and federal), within industry, and consulting.  As a result, our scientists are uniquely suited to assist clients with complicated scientific, regulatory, and strategic challenges.

Dr. Tyndall and Ms. Perry are looking forward to seeing some familiar faces and meeting new people while in Orlando.  Please stop by and visit them at booth #706!