HESI Framework for Intelligent Non-Animal Methods for Safety Assessment Workshop

Background: The need to develop new tools and increased capacity to test chemicals and pharmaceuticals for potential adverse impact on human health and the environment is an active area of development. A series of NRC reports in 2007 and 2009 recognized and recommended that effective implementation of new technologies in risk assessment requires interdisciplinary and inter-sector dialogue, as well as a consistent and coherent strategy for validating and then integrating new technologies into the existing risk assessment framework.

The response to these challenges for a “paradigm shift” toward using newer alternative non-animal methods for safety assessment has resulted in multiple initiatives by numerous organizations, which for the most part, are independent and uncoordinated. Having numerous uncoordinated efforts attempting to reach the same goal can have serious unintended consequences. A lack of broad agreement on objectives for determining the credibility of non-animal testing can lead to confusion by regulators and the public and to slow implementation. This runs the risk of eroding public confidence/ trust in regulatory evaluations and product stewardship programs. Uncoordinated efforts can also result in increased costs and time to market to meet multiple different regulatory requirements for acceptance.

Scientific confidence in the final recommendations of independent groups working on alternative non-animal methods would be strengthened by a consistent set of criteria against which to assess the reliability of a new method. These criteria for approaches to new method verification would be instrumental in determining whether a method is suitable for its intended application (“fit-for-purpose”) in similar regulatory decisions across agencies and geographies.

In 2014, ILSI Health and Environmental Sciences Institute (HESI) adopted the subcommittee on “Framework for Intelligent Non-Animal Methods for Safety Assessment” with a goal of providing a framework outlining the criteria for those scientists and institutions engaged in the development of non-animal alternative methods for safety assessment purposes. Over the past 2 years, the work has been carried out under 3 distinct subgroups with the following objectives and goals:

Performance Characterization: This subteam will develop criteria against which assay performance can be assessed. The objective here is not formal validation, but rather a set of information/characteristics that would reasonably be expected to be obtained for any method being developed.

Model Predictive Performance: This subteam will develop criteria whereby it is possible to assess how well the method performs in providing information that would be relevant in chemical risk assessment, i.e. assessment of a prediction model derived from the method.

Utilization: This subteam will develop criteria for determining the “Fitness-for-Purpose” of a method for real world/ regulatory application.

Objectives and Output

The workshop will convene participants (both internal and external) from stakeholder groups working on non-animal alternative methods for safety assessment. This includes academic research organizations, NGOs, government and other risk assessment bodies, and industry to gather input and perspective on the committee’s work product to date. Convening these participants will increase the chances for reaching consensus among the participating organizations, thereby creating a consistent approach across the organizations.

The objectives of this workshop are to:
• Present the outlined criteria and case studies developed to date and seek input from all participants
• Receive weigh in and perspective from outside stakeholders
• Identify any gaps or considerations to be incorporated into a framework
• Discuss future direction and path forward for this initiative and potential impact to the larger community