A Bright Tomorrow for Therapeutic Orphans: The Potential for New Approach Methodologies to Bridge Data Gaps for Pregnant Patients
Paul Locke Paul Locke

A Bright Tomorrow for Therapeutic Orphans: The Potential for New Approach Methodologies to Bridge Data Gaps for Pregnant Patients

By Matthew Durthaler | July 24th, 2025

As caution often precludes pregnant humans from serving as models of their own physiology, various non-human animal models have been employed. While these models have displayed some value, they are severely limited by interspecies variation and thus serve as subpar predictors of gravid human physiology.”

Sonogram captured by Matthew Durthaler, used with permission

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Advancing NAMs for Risk Assessment: Perspectives from SOT 2025 
Paul Locke Paul Locke

Advancing NAMs for Risk Assessment: Perspectives from SOT 2025 

By Breanne Kincaid | April 17th, 2025

Together, these presentations illustrate a clear shift towards integrated, mechanistically informed risk assessment strategies that reduce the number of animals required to generate toxicity data—paving the way for regulatory frameworks that are both scientifically robust and economically sustainable.”

Image by Breanne Kincaid

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Organoid’s Potential to Advance Low Dose Research
Paul Locke Paul Locke

Organoid’s Potential to Advance Low Dose Research

By Loza Taye | April 3rd, 2025

Organoids will have an increasingly important role in shaping our understanding of radiation biology and in the development of policies and medical practices concerning radiation exposure.”

Image by aislan13

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The Utility of an Intra-Agency NAM Office
Paul Locke Paul Locke

The Utility of an Intra-Agency NAM Office

By Breanne Kincaid | January 10th, 2025

“…the FDA’s NAM office represents a strategic evolution in integrating innovative methodologies into regulatory science. While it complements ICCVAM’s mission, its intra-agency focus and regulatory authority position it to drive faster, more context-specific advancements in risk assessment.“

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Regulation Updates in China
Paul Locke Paul Locke

Regulation Updates in China

By Yiguang Zhu and Zachary Leibowitz | August 22nd, 2024

“A wave of regulatory updates in China is reshaping the landscape of the field of animal testing, challenging long-standing practices and opening doors to innovative non-animal alternatives.”

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MPS World Summit 2024 Recap
Paul Locke Paul Locke

MPS World Summit 2024 Recap

By Breanne Kincaid & Yiguang Zhu | July 11th, 2024

“In attending the MPS World Summit and other conferences and webinars, it is increasingly clear that MPS developers and end-users would all benefit from clearly enumerated regulatory requirements describing what benchmarks must be met in order for MPS data to be accepted for particular use contexts.”

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ICCVAM 2024 Public Forum Highlights
Paul Locke Paul Locke

ICCVAM 2024 Public Forum Highlights

By Loza Taye | June 13th, 2024

“The 2024 ICCVAM Public Forum highlighted progress and future directions in alternative testing methods and how that work is proceeding in federal agencies and some partners. The presentations and discussions underscored a shared commitment to reducing animal testing while improving regulatory science and maintaining rigorous safety standards.”

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