New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening
NIEHS - National Institute of Environmental Health Sciences
About This Grant
Proposal Abstract Traditionally, live animals have been used to assess the toxicity of candidate chemicals in pharmaceutical drug development. However, animal tests are increasingly scrutinized for being time- consuming, costly, and ethically challenging. This has driven demand for non-animal alternative tests, or new approach methodologies (NAMs). The recent FDA Modernization Act 2.0 supports this shift by permitting the adoption of validated NAMs in place of animal tests for safety assessments and regulatory approval of human trials. NAMs can serve as first-tier screening tools to identify potentially toxic drugs, allowing only those with no apparent toxicity to proceed to animal testing if necessary. This tiered approach could significantly reduce live animal use. To achieve this goal, rigorous validation of individual NAMs according to international standards is essential to ensure regulatory acceptance. The proposed project aims to establish validated NAMs for developmental and reproductive toxicity (DART) assessment using morphogenesis models derived from pluripotent stem cells. My lab has previously developed these morphogenesis models from mouse and human stem cells, which recapitulate key morphological and molecular events of early embryogenesis in vitro. In published studies, we showed that these models exhibit significant morphological and gene expression changes in response to chemicals known to cause birth defects or miscarriages. To validate these models as NAMs for DART assessment, we will apply the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline, which provides a list of reference drugs with comprehensive in vivo toxicokinetics data, such as rodent plasma concentrations linked to embryotoxicity and non-embryotoxicity. These data can serve as benchmarks to evaluate the effectiveness of NAMs in predicting embryotoxic drug concentrations in alignment with in vivo results. To accomplish our objective, we propose three Specific Aims. Aim 1 is to examine the impact of embryotoxic drug exposures on the gene expression profiles in the mouse morphogenesis model. Aim 2 is to enhance detection capabilities through molecular augmentation of the mouse morphogenesis model. Aim 3 is to examine the response of a human stem cell-based morphogenesis model in reference to available rodent toxicokinetics data. This project is significant in its potential to establish validated NAMs as non-animal alternatives for preclinical DART assessments. It is innovative in its use of advanced stem cell technology to model embryological processes, facilitating precise concentration-specific analyses aligned with high international standards.
Grant Summary
New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening is a NIEHS - National Institute of Environmental Health Sciences grant providing up to $157K for university, nonprofit, healthcare org. Applications are due 2028-04-08 (open). Check eligibility and apply with FindGrants.
Focus Areas
Eligibility
How to Apply
Up to $157K
2028-04-08
- 1Confirm your organization is eligible for New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening from NIEHS - National Institute of Environmental Health Sciences, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to NIEHS - National Institute of Environmental Health Sciences before the deadline.
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New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening: Frequently Asked Questions
Who is eligible for the New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening?
New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening is offered by NIEHS - National Institute of Environmental Health Sciences and is generally open to university, nonprofit, healthcare org. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening provide?
New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening provides up to $157K per award from NIEHS - National Institute of Environmental Health Sciences. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening deadline?
Applications for New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening are due 2028-04-08 (open). Because deadlines can change, verify the date with the funder, NIEHS - National Institute of Environmental Health Sciences, and give yourself enough time to prepare a complete, competitive application before the close date.
How do you apply for the New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening?
To apply for New approach methodologies using stem cell morphogenesis models for preclinical developmental toxicity screening, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from NIEHS - National Institute of Environmental Health Sciences.