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

Regulatory Toxicology and Pharmacology, 2020

Stanley T. Parish, Michael Aschner, Warren Casey, Marco Corvaro, Michelle R. Embry, Suzanne Fitzpatrick, Darren Kidd, Nicole C. Kleinstreuer, Beatriz Silva Lima, Raja S. Settivari, Douglas C. Wolf, Daiju Yamazaki, Alan Boobis

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.

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Application of New Statistical Distribution Approaches for Environmental Mixture Risk Assessment: A Case Study

Science of the Total Environment, 2019

Aude Kienzler, Stephanie Bopp, Marlies Halder, Michelle Embry, Andrew Worth

There is growing evidence that single substances present below their individual thresholds of effect may still contribute to combined effects. Here, the possible use of ecotoxicological threshold concentrations of no concern (i.e. 5th percentile of statistical distribution of ecotoxicological values) is investigated to fill data gaps in MRA.

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Tumorigenicity Assessment of Cell Therapy Products: The Need for Global Consensus and Points to Consider

Cytotherapy, 2019

Y. Sato, H. Bando, M. Di Piazza, G. Gowing, C. Herberts, S. Jackman, G. Leoni, S. Libertini, T. MacLachlan, J.W. McBlane, L. Pereira Mouriès, M. Sharpe, W. Shingleton, B. Surmacz-Cordle, K. Yamamoto, J.W. van der Laan

Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated cells or transformed cells. Here, we critically review currently available in vivo and in vitro testing methods for tumorigenicity evaluation against expectations in international regulatory guidelines.

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A Cross-Sector Call to Improve Carcinogenicity Risk Assessment Through Use of Genomic Methodologies

Regulatory Toxicology and Pharmacology, 2019

Carole L. Yauk, Alison H. Harrill, Heidrun Ellinger-Ziegelbauer, Jan Willem van der Laan, Jonathan Moggs, Roland Froetschl, Frank Sistare, Syril Pettit

Robust genomic approaches are now available to realize improvements in efficiencies and translational relevance of cancer risk assessments for drugs and chemicals. The authors propose a path for implementation of innovative cancer risk assessment including incorporating genomic signatures to assess mechanistic relevance of carcinogenicity and enhanced use of genomics in benchmark dose and point of departure evaluations.

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Electrophysiological Characterization of Drug Response in hSC-Derived Cardiomyocytes Using Voltage-Sensitive Optical Platforms

Journal of Pharmacological and Toxicological Methods, 2019

Emily R. Pfeiffer-Kaushik, Godfrey L. Smith, Beibei Cai, Graham T. Dempsey, Maria P. Hortigon-Vinagre, Victor Zamora, Shuyun Feng, Randall Ingermanson, Renjun Zhu, Venkatesh Hariharan, Cuong Nguyen, Jennifer Pierson, Gary A. Gintant, Leslie Tung

Voltage-sensitive optical (VSO) sensors offer a minimally invasive method to study the time course of repolarization of the cardiac action potential (AP). This Comprehensive in vitro Proarrhythmia Assay (CiPA) cross-platform study investigates protocol design and measurement variability of VSO sensors for preclinical cardiac electrophysiology assays.

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