On Tuesday April 27, Kirk Hartley of ToxicoGenomica presented a webinar hosted by the American Society for Cellular and Computational Toxicology (ASCCT). The topic was: Legal and Policy Considerations in the Use of New Approach Methodologies (NAMs) in Chemical Risk Assessment. A recording of the webinar can be accessed here and a complimentary copy of Kirk Hartley’s presentation can be downloaded below.

Webinar Summary

It has been over a decade since the National Research Council described the vision for toxicity testing in the 21st century. Since that time, numerous initiatives have risen to the challenge resulting in high-throughput in vitro and computational new approach methodologies (NAMs) generating toxicity and exposure data, as well as predictive models, in chemical testing. These efforts have outlined guidance aimed at modernizing risk assessment to utilize data from NAMs; however, despite the advances of the last decade, few have actually been adopted by the risk assessment community. One of the challenges facing the use of NAMs in chemical risk assessment and regulation is their consideration in, and resilience to, legal challenges. Thus, their successful development and implementation in regulatory decision making relies on an underlying knowledge of the public health policy implications and legal precedents involved in the use of new and emerging technologies for regulatory decision making and product liability.

Kirk Hartley served as one of two legal experts to discuss the balance between precedent and novel science in litigation, ranging from regulatory policy to personal injury cases. During this discussion, he explored the specifics surrounding ‘Focus on “Common Law,” Meaning Decisions by Judges’ and the implications of the use of NAMs moving forward. A brief outline of his presentation is provided below:

• Overview and resource materials on common law courts and process
• Comparative database search results – big picture evidence of how far law lags
science–links to handful of opinions where advanced methods mentioned or applied
• Example of “sealed” records from recent case (Vanda) in which drug maker sued
FDA for requiring extended animal studies for a new drug
• Comments from senior justices on handling with science and law challenges
• Overview of US federal and state legal rules and standards for scientific evidence
• Update of federal court Reference Manual on Scientific Evidence, 3rd Ed
• Selected cases and events that reflect use of methods beyond epidemiology
• Citations to articles on use of genomics in litigation

We are pleased to offer our readers a complimentary copy of Kirk Hartley’s presentation (slide deck). Complete the form below to download your copy now.