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.

Job Description

ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 7–10 years experience in in biopharmaceutical/pharmaceutical consulting and/or industry or government [e.g., FDA]) 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 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 an understanding of 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 endpoints and methods being used in safety assessment.

This position will involve designing and overseeing (monitoring) nonclinical safety assessment programs for drug candidates, as well as interpreting and integrating data from various studies for the client and regulatory authorities. Additional responsibilities will include overseeing development of study protocols and reports, and writing various regulatory documents (e.g., pre-IND packages, IND/CTAs, BLAs/NDAs, Investigator Brochures), as well as presenting to and interacting with regulatory agencies (e.g., FDA or EMA). 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, 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 or oversee writing of the pharmacology/toxicology sections of pre-IND, IND/CTA, and NDA/BLA submissions
  • Balance the demands of multiple complex, high-priority programs, and work under stringent timelines
• Participate in meetings with FDA and international regulatory authorities such as EMA
• Address scientific, regulatory, and business challenges associated with development of pharmaceutical/biopharmaceutical products
• Provide comments and develop positions on draft guidance issued by regulatory authorities worldwide
• Prepare study documents, including proposals, reports, and presentations
• Attend and present at toxicology meetings (e.g., ACT, SOT), serve on professional/scientific committees, and publish (papers, book chapters)
• Conduct business development activities to attract and develop new projects and clients
• Participate in due diligence meetings for in- and out-licensing
• Travel may be required (approximately 20% of the time)

Essential Qualifications:

• MS or Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is highly desired but not required
• Prior pharmaceutical consulting and/or biopharmaceutical/pharmaceutical industry and/or government experience (FDA) required (minimum 7–10 years)
• Comprehensive understanding of ICH and regional regulatory guidance documents for toxicology studies of drug products
• Experience working with drug development teams (may require educating inexperienced teams on the purpose of toxicology testing)
  • Experience overseeing the entire nonclinical safety assessment program for drug candidates through all drug development phases (e.g., pre-IND to marketing)
• Experience performing gap analyses for drug development programs and identifying studies that are necessary to support clinical development
• Experience in writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs), and presenting to and interacting with regulatory agencies
• Experience managing project-related and toxicology and/or clinical-hold issues, and ability to resolve situations and develop strategic options
• Project management experience
• Ability to manage multiple assignments and balance the demands of overseeing complex, high-priority programs
• Demonstrated 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/or 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.

Engineer/Exposure Assessor

ToxStrategies, Inc., is seeking a chemical or environmental engineer with experience conducting quantitative chemical exposure assessments to join our expanding Exposure Sciences consulting practice. The position involves data-driven assessments of human and environmental exposure to chemicals to support risk-based evaluations related to foods, manufacturing of chemical substances, use of commercial and consumer products and contaminated sites. The successful candidate will have a working knowledge of statistical approaches for evaluation of environmental data (including Bayesian methods), chemical fate and transport mechanisms, mathematical exposure modeling, and environmental sampling. Mastery of data presentation and visualization as well as computer programming in R language is preferred.  Working knowledge of physiologically based pharmacokinetic (PBPK) modeling is also considered a plus.

This position offers a dynamic and challenging work environment, opportunities for professional development and leadership, and competitive compensation and benefits. On a daily basis, responsibilities will involve designing and conducting scientific projects that may include generation, critical review, analysis, and/or synthesis of scientific data. A significant component of the position will involve technical writing in the form of proposals, protocols, reports, and scientific manuscripts, as well as verbal communication via presentations and teleconferences. The position involves regular collaboration on multidisciplinary teams that may include toxicologists, epidemiologists, industrial hygienists, engineers, and biostatisticians, many of whom are recognized as leaders in their respective fields. Active participation in the scientific community such as presenting at professional meetings (e.g., AIHCE, ISES, SOT, SRA), serving on committees, and publishing scientific manuscripts is strongly encouraged.

ToxStrategies is a multidisciplinary scientific consulting firm that develops innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Exposure Assessment Practice provide consulting services to public and private-sector clients around the world. Our work involves providing clients with scientific, strategic, and regulatory expertise in the assessment of chemicals in the environment, food and food ingredients, and consumer products.

Essential Qualifications

• B.S or M.S in chemical or environmental engineering.
• Minimum of 4+ years’ experience in human health risk assessment, specializing within a particular field (e.g., industrial hygiene) or across disciplines.
• Experience with multi-media mathematical modeling programs and screening level models such as those in OECD Toolbox and EPA’s ToxCast and ExpoCast databases
• Experience leading project tasks or teams.
• Strong organizational skills and ability to manage multiple assignments with attention to detail and effective time management skills.
• Excellent written and verbal communication skills.
• Ability to work independently or in multidisciplinary teams.

Ability to travel (may be required approximately 5%–10% of the time).

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

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.