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Annual Report for Fiscal Year 2015

Annual Report for Fiscal Year 2015
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NICEATM FY 2015 Workshops

Nanomaterials

NICEATM and the PETA International Science Consortium (PISC) co-organized a Technical Discussion on In Vitro Testing Strategies to Assess Inhalation Toxicity of Nanomaterials Feb. 24-25, 2015, at the EPA in Washington, D.C. At this meeting, specifications were defined for the development and evaluation of an in vitro system to assess inhalation toxicity of multiwalled carbon nanotubes. Recommendations were made for the system to include a variety of lung cells cocultured at an air-liquid interface, and relevant human dosimetry and nanomaterial lifecycle transformations were considered. These recommendations were central to a subsequent request for research proposals, issued by PISC, to develop an appropriate testing system, and funding was awarded in September 2015. A workshop report is in preparation.

Pertussis vaccines

NICEATM supported a workshop to review data from a multilaboratory study to evaluate an in vitro alternative to the murine histamine sensitization test for safety testing of acellular pertussis vaccines. The In Search of Acceptable Alternatives to the HIST: What is Possible and Practical? workshop was held in London March 4-5, 2015, and organized in collaboration with the U.K. National Centre for the 3Rs (replacement, reduction, or refinement of animal use in testing and research). Workshop participants concluded that the relevance and reliability of the in vitro test were sufficient, and recommended that vaccine manufacturers begin using the in vitro test, alongside current mouse tests, to demonstrate its validity for their specific products. Participants also discussed implementing an approach that would allow manufacturers to waive testing entirely under certain circumstances. A report on the workshop is in preparation for publication in FY 2016.

Induced Pluripotent Stem Cells

NICEATM co-organized the Workshop on Good Cell Culture Practices for Induced Pluripotent Stem Cells held in Baltimore June 1-3, 2015. Its goal was to develop consensus standards and foster international standardization on the use of induced pluripotent stem cells. Existing standards on the use for cell and tissue culture systems served as a guide, as attendees considered the unique properties and challenges of pluripotent stem cells compared to traditional in vitro systems. Attendees developed a framework for a guidance document specific to pluripotent stem cells that addresses quality of materials and methods, documentation, protection of workers and the environment from hazards, compliance with laws and ethical principles, and education and training. The guidance document is planned for publication in FY 2016.

Acute Systemic Toxicity

The workshop Alternative Approaches for Identifying Acute Systemic Toxicity: Moving From Research to Regulatory Testing brought together representatives from regulatory agencies, academia, and industries to develop strategies for advancing alternative methods for product safety testing that meet the needs of regulatory agencies. The workshop, co-organized by NICEATM, PISC, and the Physicians Committee for Responsible Medicine, was held Sept. 24-25, 2015, at NIH in Bethesda, Maryland. During the workshop, several resources were identified as necessary for meaningful progress in identifying and implementing alternatives to animal use: high quality reference data, training on use and interpretation of computational approaches, and global harmonization of testing requirements. Breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, and each group crafted a roadmap and a strategy for implementation within a three-year timeframe. NICEATM will coordinate the creation of, and provide support for, a working group of workshop participants charged with implementing the strategies. Workshop proceedings are being prepared for submission for publication in FY 2016.

Related Annual Report Pages:

nanomaterials image
pertussis bacterium
Gold colored animal cells
worker handling chemicals