Framework for Intelligent Non-Animal Methods for Safety Assessment Subcommittee

 

Framework for Intelligent  Non-Animal Methods for Safety Assessment Subcommittee

Mission Statement

The Issue

The response to challenges for a “paradigm shift” toward using newer alternative non-animal methods for safety assessment has resulted in an explosion of independent initiatives by numerous organizations, and a lack of broad agreement on objectives for determining the credibility of non-animal testing.

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. Such criteria will likely need to be context sensitive, i.e., specific to the intended regulatory decision under consideration (e.g., prioritization, classification, hazard prediction). 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.

The HESI Subcommittee, formed in the fall of 2014, has the following objectives:

  • Create a tripartite forum to discuss non-animal methods / approaches independent of any regulatory, policy, or participant restrictions imposed by specific agencies or organizations.
  • Determine criteria to be used in assessing fitness-for-purpose of methods and approaches for decision-making, i.e., what are the minimum requirements or criteria for demonstrating that a method or approach can be used for risk assessment, regulation, etc.?
  • Provide guidance and general criteria (not specifics) for each type of major decision (e.g., prioritization / screening, read-across, hazard assessment, risk assessment).
  • Ensure peer engagement to assess the acceptability of the group’s proposals.
  • Develop a white paper/publication that reflects the consensus of the group on the points above.

This HESI program is not intended as a mechanism to develop assays, develop criteria for specific assays or methods, or certify or provide a “seal of approval” to specific assays.

It is envisioned that the resulting criteria developed by this tripartite group would be used by independent organizations to guide development of organization-specific guidelines and new non-animal methods for safety assessment. The benefits of developing these criteria via the tripartite HESI approach include the following:

Establishes an umbrella framework of criteria which are consistent, transparent, and generally accepted, and that can be used by different institutions for different decision-making purposes.
Promotes harmonization and uniformity across and among organizations.

Committee Contacts

HESI Staff

Stanley Parish, PhD 
sparish@hesiglobal.org

Leadership Team

Prof. Alan Boobis, OBE, PhD
Imperial College London

Doug Wolf, DVM, PhD, FIATP, ATS  
Syngenta

 

Members and Fact Sheet

Committee Events

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

Rockville, MD, USA

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.

Read more

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Committee Publications

All Publications

An Evaluation Framework for New Approach Methodologies (NAMs) for Human Health Safety Assessment

The need to develop new tools and increase capacity to test pharmaceuticals and other chemicals for potential adverse impacts on human health and the environment is an active area of development. The response to these challenges for a “paradigm shift” toward using new approach methodologies (NAMS) for safety assessment has resulted in an explosion of initiatives by numerous organizations, but, for the most part, these have been carried out independently and are not coordinated in any meaningful way. To help remedy this situation, a framework that presents a consistent set of criteria, universal across initiatives, to evaluate a NAM’s fit-for-purpose was developed by a multi-stakeholder group of industry, academic, and regulatory experts.

Read more

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