ADC, Gene Therapy, Cell Therapy, Oligonucleotides & Toxicology & Multi Organ & Liver
A comprehensive review of emerging drug- discovery approaches that leverage complex in vitro and in silico models to shift from animal- based toxicity to human- relevant predictive systems.
Liver & Multi Organ & Toxicology
A blinded, multisite study shows hiPSC-cardiomyocytes can stratify torsades de pointes risk across 28 drugs with reproducible electrophysiologic readouts, supporting use in proarrhythmia assessment.
Multi Organ & Toxicology
The review argues that MPS hold promise to improve drug safety prediction by offering more physiologically relevant preclinical models for key organs (liver, heart), while outlining existing technical and translational challenges to their adoption
Heart, liver & Toxicology
Outlines how iPSC-derived cardiac/hepatic microsystems model drug adverse effects and proposes qualification paths for regulatory-grade use.
Multi Organ & ADME
Frames pharma needs and cross-cutting concepts for characterizing MPS toward defined contexts of use.
Skin & Toxicology
Maps current complex skin models, highlights missing immune/appendage/flow features, and recommends steps toward assay qualification.
Liver & Toxicology
Provides staged benchmarking, key performance metrics, and a 20-compound test set to standardize liver MPS for safety assessment.
Kidney & Toxicology
Specifies attributes and context-of-use criteria to evaluate nephrotoxicity with kidney MPS in drug development.
Multi Organ & ADME
Overview of MPS platforms for ADME: highlights progress in single- and multi-organ systems, outlines key design/validation criteria and urges industry adoption to reduce animal reliance
GI & Toxicology
Proposes assay strategies and readouts to transform gastrointestinal safety testing, positioning GI-MPS as enabling tools.
Liver & Toxicology & ADME
Demonstrates that a liver MPS yields reproducible toxicity, metabolism, and intracellular accumulation data across runs and labs.
Cardiovascular & Toxicology
Synthesizes how heart and vascular MPS can be integrated for CV safety, outlining practical adoption considerations.
Heart & Toxicology
A review of how human-iPSC-derived cardiomyocytes (hiPSC-CMs) are increasingly used in nonclinical regulatory submissions for cardiac safety assessment, highlighting their utility and limitations.
Multi Organ & Toxicology
A comprehensive review of in-vitro-to-in-vivo extrapolation (IVIVE) methods that outlines definitions, regulatory implications and the path to reducing animal testing in toxicity risk assessment.
Liver & Toxicology & ADME
A review of liver-on-chip (LoC) technologies highlighting their promise for improved hepatic clearance and toxicity prediction in drug development, while pinpointing translational and implementation challenges for widespread industrial use.
Multi Organ & Toxicology
Industry survey reveals that pharmaceutical companies are increasingly using new approach methodologies (NAMs) to replace animal studies in nonclinical safety assessment—but adoption is hindered by regulatory harmonisation and translational-confidence gaps
Multi Organ & Oligonucleotides
The review discusses how microphysiological systems (MPS) can help overcome key challenges in the development of oligonucleotide therapeutics (ONTs)—such as delivery, species selectivity, ADME, and toxicity- by providing human-relevant models tailored for ONTs.
Multi Organ & Cell Therapy
The review examines how microphysiological systems (MPS) can be applied to nonclinical evaluation of cell therapies, outlining opportunities (efficacy, safety, mechanistic insight) and challenges in qualification and adoption.
Multi Organ & Gene Therapy
A review exploring how combining CRISPR- based genome editing with microphysiological systems (MPS) enhances both gene therapy modelling and safety assessment by improving human relevance and reducing animal use.
Liver
Reviews how liver MPS recapitulate 3D, multicellular, flow-exposed microenvironments to improve prediction of metabolism, DDI, and toxicity relevant to clinical pharmacology.
Liver
A review of liver-on-chip (LoC) technologies highlighting their promise for improved hepatic clearance and toxicity prediction in drug development, while pinpointing translational and implementation challenges for widespread industrial use.
Lung
Defines qualification elements and practical needs to deploy lung MPS for biopharma safety testing and de-risking new modalities.
Immune System
Summarizes status and recommendations for incorporating immune-competent MPS into pipelines, including qualification needs.
Multi Organ
FDA–IQ MPS workshop consensus on evaluation, standardization, and adoption frameworks for complex in vitro models in drug development.
Multi Organ
Reviews how disease-relevant MPS are used in industry and the hurdles to broader deployment and regulatory acceptance.
Multi Organ
Captures FDA–IQ MPS workshop outcomes on standardizing complex in vitro models and pathways for regulatory use.
Multi Organ
Pharma authors argue for in vitro model adoption to reduce animal use while pinpointing advances needed to raise readiness levels.
Multi Organ
Industry survey details how MPS are resourced and applied (safety/PK/PD/ADME) and flags barriers to broader internal adoption and regulatory inclusion.
Multi Organ
Discusses roles for animal cell-based MPS in 3Rs strategies and how they might complement human MPS in development pipelines.
Multi Organ
Presents a pharma perspective on when animal MPS can be decision-supportive for human programs and how they fit alongside human MPS.
Multi Organ
Animal-derived microphysiological systems (MPS) can help bridge species gaps, support regulatory decision-making and advance the 3Rs by mimicking organ function across species.
Multi Organ
FDA outlines a strategic framework for accelerating qualification and regulatory adoption of new-approach methodologies (NAMs) to reduce reliance on animal testing.
Multi Organ
FDA/CDER identifies key gaps in current nonclinical testing and advocates for context-defined new approach methodologies (NAMs) to bolster regulatory safety evaluations.
Multi Organ
Human organ-chip devices replicate organ-level human physiology and inter-organ interactions to improve disease modelling, drug development and personalised medicine.
Multi Organ
This Primer systematically maps the design, fabrication, operation and applications of organ-on-chip (OoC) systems, enabling researchers to match device architecture to biological function efficiently.
Multi Organ
This editorial frames the transition of organ-on-chip systems from concept to practice by highlighting commercialization milestones and practical implementation challenges.
Multi Organ
A pharma-industry review defining model-omics and context-of-use frameworks to evaluate where complex in vitro models (CIVMs) like organoids and Organ-Chips are ready for impact in drug development.