This session will serve as an introduction to current issues and opportunities in regulatory toxicology for graduate students and early-career scientists, as well as to motivate them to seek training experiences that will increase their knowledge of the approaches to and challenges of bringing modern-day toxicology into a risk or safety assessment process. The SOT Graduate Education Subcommittee, via its Awareness of Regulatory Toxicology (ART) Working Group, has assembled experts in regulatory toxicology to discuss opportunities available for toxicology trainees and others interested in pursuing careers in regulatory toxicology. Resources developed by ART for trainees interested in these careers also will be presented to attendees. Regulatory bodies within the United States and other countries use scientific data from various sources to assess the safety of chemicals and drug candidates in order to inform regulatory policy and determine approvals for use. In turn, industry uses scientific data to meet regulatory requirements and to achieve product stewardship and sustainability goals. Training in and application of modern, laboratory-based science must be married to the legislative and regulatory processes in order to inform decisions that are understandable and benefit the public. Many toxicology and postdoctoral training programs do not cover regulatory toxicology or regulatory processes to a significant degree. In addition, scientists who engage in the regulatory process through advisory boards or public comment on specific issues may not be fully aware of the regulatory process and/or impacts of regulatory decisions. Although toxicologists often gain experience while on the job, accessing training or internships in regulatory toxicology early in a scientist’s career benefits trainees by increasing knowledge of how scientific data can be used in the public domain, as well as by increasing awareness of available job opportunities. In addition, knowledge of the regulatory use of toxicology information also benefits toxicologists considering service in an advisory capacity to government or industry.
Introduction. Angela Lynch, ToxPlus Consulting and Roosevelt University College of Pharmacy, Haymarket, VA.
Training in Regulatory Toxicology: Understanding Opportunities and Present-Day Challenges. James Klaunig, Indiana University, Bloomington, IN.
The Role of Regulatory Toxicology in Drug Development. Tao Wang, Achaogen, San Francisco, CA.
Generating Toxicology Data to Meet the Needs of Regulatory Agencies. Allison Greminger, ExxonMobil Biomedical Sciences Inc., New York, NY.
Evolving Approaches in Regulatory Toxicology: Integrating Pathway-Based Screening and Testing to Support Modern Chemical Safety Assessments and Harmonize International Approaches. David Dix, US EPA, Washington, DC.
Panel Discussion/Q&A. William Farland, Colorado State University and William H. Farland Consulting, LLC, Rockport, ME.