NIEHS SBIR/STTR Town Hall: April 2020

Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing

This webinar was presented by the NIEHS SBIR/STTR program in coordination with NICEATM.

A key component of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is early interaction between developers of NAMs and end-users, to ensure that the proposed NAMs will meet testing requirements for agency and industry stakeholders. This webinar-based town hall meeting was presented to facilitate improved communication between method developers, including small business applicants, and end-users, providing an opportunity for assay developers to hear from ICCVAM stakeholders on the desired characteristics and requirements for NAMs.

Presentations

• Agenda
• ICCVAM Activities Under the U.S. Strategic Roadmap
  Nicole Kleinstreuer - Acting Director, NICEATM
• FDA/CDER Considerations on NAMs for Pharmaceutical Development
  Paul Brown - FDA Center for Drug Evaluation and Research
• Qualification of In Vitro Alternatives for Biocompatibility Assessment of Medical Devices: Use of Medical Device Development Tools (MDDTs)
  Hilda Scharen and Jennifer Goode - FDA Center for Devices and Radiological Health
• Technical Considerations for Building Predictive Toxicological Tools in Support of the Chem/Bio Defense Mission
  Kyle Glover - U.S. Army Combat Capabilities Development Command Chemical Biological Center
• Reduction of Testing on Vertebrates Under the Amended Toxic Substances Control Act
  Edwin Arauz, William Irwin, Martin Phillips, and Todd Stedeford - EPA Office of Pollution Prevention and Toxics
• Evaluation and Implementation of New Approach Methodologies for Evaluation of Pesticide Chemicals
  Monique Perron - EPA Office of Pesticide Programs
• Pesticides: Invention to Market
  Douglas Wolf - Syngenta Crop Protection
• Two Current Gaps for Incorporation of NAMs into Toxicity Testing and Risk Assessment
  Lawrence Milchak - 3M Corporation
• IQ MPS Affiliate Perspective on Characteristics and Requirements for New Approach Methodologies (NAMs)
  Szczepan Baran - Novartis Institutes for BioMedical Research