This week, FDA released guidance for sponsors conducting clinical trials on how to manage ongoing and planned activities. This guidance emphasizes patient safety and communication.   FDA noted that the decisions about continuing with patient recruitment and treatment, implementing alternative options for patient monitoring or visits, or discontinuing a trial may depend on specific, individual circumstances. Changes or missing information with regard to COVID-19 should be well documented, and the clinical study report should describe contingency measures, a list of all participants affected, and the analyses and corresponding discussions that address the impact.

The complete guidance document can be found here.

Job Description

ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 3 years in biopharmaceutical/pharmaceutical experience, in industry, government [FDA], or Contract Research Organizations [CROs]), to join our expanding Biopharmaceutical/Pharmaceutical consulting practice. ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Biopharmaceutical/Pharmaceutical Practice provide consulting services to pharmaceutical companies in all phases of the drug development process. This includes providing clients with scientific, strategic, and regulatory expertise in the nonclinical safety assessment of biopharmaceutical/pharmaceutical products. This position requires understanding the scientific and regulatory process for the development of biopharmaceutical/pharmaceutical products for a variety of therapeutic indications.  The candidate must be familiar with current ICH and regulatory guidelines for drug development, as well as industry trends and new techniques and methods used in safety assessment studies.

This position will involve designing and overseeing nonclinical safety assessment programs for drug candidates, developing study protocols and reports, and interpreting data from various studies for the client and regulatory authorities. The candidate will be responsible for writing various regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures), as well as risk assessments/monographs for drug components (e.g., impurities, solvents).  Within ToxStrategies you will work alongside toxicologists, epidemiologists, engineers, and biostatisticians who are recognized as leaders in their respective fields. This position offers a stimulating and challenging work environment, opportunities for professional development and leadership, and competitive compensation and benefits.

Responsibilities May Include:

• Oversee the study design, data interpretation, and monitoring of toxicology studies in different animal species, and interpret and incorporate safety, TK/PK, and PK/PD data, and anti-drug antibody responses
• Serve as the toxicology representative on project teams
• Write pharmacology and toxicology sections of regulatory submissions (pre-INDs, INDs)
• Address scientific, regulatory, and business challenges associated with development of pharmaceutical/biopharmaceutical products
  • Prepare toxicology risk assessments/monographs for drug components, solvents, or impurities
• Develop study documents, including proposals, study protocols and reports, and presentations
• Attend and present at toxicology meetings (e.g., ACT, SOT), serve on professional scientific committees, and publish journal papers and book chapters
• Participate in due diligence meetings for in- and out-licensing
• Travel may be required (approximately 20% of the time)

Essential Qualifications:

• BS, MS, or Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is highly desired but not required
• Minimum of 3 years’ experience in the biopharmaceutical/pharmaceutical industry, government (FDA), and/or Contract Research Organizations (CROs) (postdoctoral work is not applicable to the required 3 years)
• Comprehensive understanding of ICH and regional regulatory guidance documents for toxicology studies of drug products
• Experience working with drug development teams
• Project management experience and attention to detail
• Strong organizational skills and ability to manage multiple assignments
• Excellent written and verbal communication skills
• Ability to work independently or in multidisciplinary teams
• Member of and actively involved in scientific/toxicology professional organizations (e.g., BioSafe, SOT, ACT), including recent presentations and publications

For more information on ToxStrategies’ practice areas and team, please visit www.toxstrategies.com. To apply, please submit a cover letter and resume to hr@toxstrategies.com.

ToxStrategies is an Equal Opportunity Employer and a Woman-Owned Business.

The USEPA has released their draft Risk Evaluation for Trichloroethylene (TCE) for public comment.  TCE is the eighth of the first ten chemicals to undergo risk evaluation under amended TSCA. The TCE draft risk evaluation and supporting documents can be found at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/draft-risk-evaluation-trichloroethylene.

The Environmental Protection Agency has finalized low-priority designations for 20 substances under the Toxic Substances Control Act, and will not subject them to risk evaluations. “This final list of low-priority chemicals will allow EPA to focus its risk evaluation efforts on the chemicals that could significantly impact public health and the environment,” said the EPA. For more information, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemical-substances-undergoing-prioritization-low.

ToxStrategies scientists attended the 44^th Annual Winter Meeting of the Toxicology Forum January 27–29, where they presented on a wide range of topics, including the use of New Approach Methods (NAMs) in the risk characterization of PFAS; advances, opportunities, and challenges in using NAMs in toxicological evaluations; expanding the use and chemical space of the TTC; and challenges and opportunities in assessing the safety of sunscreen active ingredients. The following ToxStrategies scientists were participants at the meeting:

These scientists are all active in The Center of Excellence for 21^st Century Toxicology, a division of ToxStrategies, Inc.

For nearly six decades, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) have served as scientific advisory bodies to the Codex Alimentarius Commission. In light of the increasingly complex nature of chemical assessments in food since publication of the latest guidance in 2009, JECFA/JMPR have initiated multiple efforts to update subchapters in EHC 240 (Principles and methods for the risk assessment of chemicals in food, Environmental Health Criteria 240).

In particular, an updated Chapter 5 in EHC reflects new scientific developments and contributes to international harmonization in the application of dose-response modeling and derivation of acute and chronic health-based guidance values, considering toxicological, microbiological, and pharmacological effects. WHO has opened a public consultation on the updated chapter (and annex), to ensure its transparency and that it contains sufficient detail on the methods, assumptions, and scientific assessment.

Interested parties are invited to submit written comments by January 31, 2020.

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.