References

Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trials

10.1038/s41416-020-01033-x · 2020 · External reference

Trends in clinical success rates and therapeutic focus

10.1038/d41573-019-00074-z · 2019 · External reference

Comprehensive measurement of biopharmaceutical R&D investment

10.1038/d41573-024-00131-2 · 2024 · External reference

Costs of drug development and research and development intensity in the US, 2000-2018

10.1001/jamanetworkopen.2024.15445 · 2024 · External reference

Clinical development success rates for investigational drugs

10.1038/nbt.2786 · 2014 · External reference

Phase II and phase III failures: 2013-2015

10.1038/nrd.2016.184 · 2016 · External reference

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

10.1056/nejmoa063842 · 2006 · External reference

Implications of the BIA-102474-101 study for review of first-into-human clinical trials

10.1111/bcp.12920 · 2016 · External reference

Standardizing designed and emergent quantitative features in microphysiological systems

10.1038/s41551-024-01236-0 · 2024 · External reference

Modeling development and disease with organoids

10.1016/j.cell.2016.05.082 · 2016 · External reference

Induced pluripotent stem cells and their use in human models of disease and development

10.1152/physrev.00039.2017 · 2019 · External reference

Organoid factory: the recent role of the human induced pluripotent stem cells (hiPSCs) in precision medicine

2022 · External reference

The FDA Modernization Act 2.0: drug testing in animals is rendered optional

10.1016/j.amjmed.2023.03.033 · 2023 · External reference

Next-Gen therapeutics: pioneering drug discovery with iPSCs, genomics, AI, and clinical trials in a dish

10.1146/annurev-pharmtox-022724-095035 · 2025 · External reference

Challenges and opportunities for digital twins in precision medicine from a complex systems perspective

10.1038/s41746-024-01402-3 · 2025 · External reference

FDA Modernization Act 2.0 paves the way to computational biology and clinical trials in a dish

10.1161/circulationaha.123.065585 · 2023 · External reference

Unresolved reference

2022 · External reference

Self-organized formation of polarized cortical tissues from ESCs and its active manipulation by extrinsic signals

10.1016/j.stem.2008.09.002 · 2008 · External reference

Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche

10.1038/nature07935 · 2009 · External reference

Directed differentiation of human pluripotent stem cells into intestinal tissue in vitro

10.1038/nature09691 · 2011 · External reference

Method of the year 2017: organoids

10.1038/nmeth.4575 · 2018 · External reference

Clinical applications of human organoids

10.1038/s41591-024-03489-3 · 2025 · External reference

Human organs-on-chips for disease modelling, drug development and personalized medicine

10.1038/s41576-022-00466-9 · 2022 · External reference

Prospective derivation of a living organoid biobank of colorectal cancer patients

10.1016/j.cell.2015.03.053 · 2015 · External reference

Intestinal organoids in coculture: redefining the boundaries of gut mucosa ex vivo modeling

10.1152/ajpgi.00043.2021 · 2021 · External reference

The use of murine-derived fundic organoids in studies of gastric physiology

10.1113/jphysiol.2014.283028 · 2015 · External reference

Three-dimensional gastrointestinal organoid culture in combination with nerves or fibroblasts: a method to characterize the gastrointestinal stem cell niche

10.1155/2016/3710836 · 2016 · External reference

Induction of pluripotent stem cells from adult human fibroblasts by defined factors

10.1016/j.cell.2007.11.019 · 2007 · External reference

Chemical reprogramming of human somatic cells to pluripotent stem cells

10.1038/s41586-022-04593-5 · 2022 · External reference

Recent advances in deriving human endodermal tissues from pluripotent stem cells

10.1016/j.ceb.2019.07.009 · 2019 · External reference

Extracellular matrix cues regulate the differentiation of pluripotent stem cell-derived endothelial cells

10.3389/fcvm.2023.1169331 · 2023 · External reference

Small molecule-mediated directed differentiation of human embryonic stem cells toward ventricular cardiomyocytes

10.5966/sctm.2013-0110 · 2014 · External reference

Interplay between pioneer transcription factors and epigenetic modifiers in cell reprogramming

10.1016/j.reth.2024.12.014 · 2025 · External reference

Neural differentiation of human induced pluripotent stem cells follows developmental principles but with variable potency

10.1073/pnas.0910012107 · 2010 · External reference

Cerebral organoids model human brain development and microcephaly

10.1038/nature12517 · 2013 · External reference

A nomenclature consensus for nervous system organoids and assembloids

10.1038/s41586-022-05219-6 · 2022 · External reference

A highly efficient human pluripotent stem cell microglia model displays a neuronal-co-culture-specific expression profile and inflammatory response

10.1016/j.stemcr.2017.05.017 · 2017 · External reference

Generation of vascularized brain organoids to study neurovascular interactions

10.7554/elife.76707 · 2022 · External reference

Development and implementation of large-scale quality control for the European bank for induced pluripotent stem cells

2020 · External reference

Choices for induction of pluripotency: recent developments in human induced pluripotent stem cell reprogramming strategies

10.1007/s12015-015-9622-8 · 2016 · External reference

Recent advances in engineering hydrogels for niche biomimicking and hematopoietic stem cell culturing

10.3389/fbioe.2022.1049965 · 2022 · External reference

Advances in TEER measurements of biological barriers in microphysiological systems

10.1016/j.bios.2023.115355 · 2023 · External reference

Biology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare

2025 · External reference

Advances in human induced pluripotent stem cell (hiPSC)-based disease modelling in cardiogenetics

2025 · External reference

An immune-competent human gut microphysiological system enables inflammation-modulation by Faecalibacterium prausnitzii

10.1038/s41522-024-00501-z · 2024 · External reference

The need for an organoid manufacturing, preservation, and distribution center

10.1093/stcltm/szaf031 · 2025 · External reference

Considerations from an international regulatory and pharmaceutical industry (IQ MPS affiliate) workshop on the standardization of complex in vitro models in drug development

2024 · External reference

Validation of microphysiological systems for interpreting patient heterogeneity requires robust reproducibility analytics and experimental metadata

2025 · External reference

Simulating drug concentrations in PDMS microfluidic organ chips

10.1039/d1lc00348h · 2021 · External reference

Foundational research gaps and future directions for digital twins

2024 · External reference

Digital twins for health: a scoping review

10.1038/s41746-024-01073-0 · 2024 · External reference

In silico modeling and simulation to guide bioequivalence testing for oral drugs in a virtual population

10.1007/s40262-021-01045-7 · 2021 · External reference

Applied concepts in PBPK modeling: how to build a PBPK/PD model

10.1002/psp4.12134 · 2016 · External reference

A roadmap for the development of human body digital twins

10.1038/s44287-024-00025-w · 2024 · External reference

Data-driven personalization of a physiologically based pharmacokinetic model for caffeine: a systematic assessment

10.1002/psp4.12646 · 2021 · External reference

Investigating oxygen transport efficiencies in precision-cut liver slice-based organ-on-a-chip devices

10.1007/s10404-021-02434-x · 2021 · External reference

Simulation of nanoparticle transport and adsorption in a microfluidic lung-on-a-chip device

10.1063/5.0011353 · 2020 · External reference

Oxygen levels in thermoplastic microfluidic devices during cell culture

10.1039/c3lc51160j · 2014 · External reference

DigiLoCS: a leap forward in predictive organ-on-chip simulations

10.1371/journal.pone.0314083 · 2025 · External reference

Beyond the basics: a deep dive into parameter estimation for advanced PBPK and QSP models

10.1016/j.dmpk.2024.101011 · 2024 · External reference

Sensitivity analysis methods in the biomedical sciences

10.1016/j.mbs.2020.108306 · 2020 · External reference

A review of cell-based computational modeling in cancer biology

10.1200/cci.18.00069 · 2019 · External reference

Drug transport modeling in solid tumors: a computational exploration of spatial heterogeneity of biophysical properties

10.1016/j.compbiomed.2023.107190 · 2023 · External reference

State-of-the-Art on model-informed drug development approaches for pediatric rare diseases

10.1002/psp4.70083 · 2025 · External reference

Machine learning for toxicity prediction using chemical structures: pillars for success in the real world

10.1021/acs.chemrestox.5c00033 · 2025 · External reference

Implicit versus explicit Bayesian priors for epistemic uncertainty estimation in clinical decision support

10.1371/journal.pdig.0000801 · 2025 · External reference

Practical guide to SHAP analysis: explaining supervised machine learning model predictions in drug development

10.1111/cts.70056 · 2024 · External reference

Towards generative digital twins in biomedical research

10.1016/j.csbj.2024.09.030 · 2024 · External reference

Industrial agentic AI and generative modeling in complex systems

10.1016/j.coche.2025.101150 · 2025 · External reference

PhysiCell studio: a graphical tool to make agent-based modeling more accessible

10.46471/gigabyte.128 · 2024 · External reference

Building multiscale models with PhysiBoSS, an agent-based modeling tool

10.1093/bib/bbae509 · 2024 · External reference

Patient-derived organoids can predict response to chemotherapy in metastatic colorectal cancer patients

10.1126/scitranslmed.aay2574 · 2019 · External reference

Patient-derived organoids model treatment response of metastatic gastrointestinal cancers

10.1126/science.aao2774 · 2018 · External reference

Performance assessment and economic analysis of a human liver-chip for predictive toxicology

10.1038/s43856-022-00209-1 · 2022 · External reference

Systematic review: predictive value of organoids in colorectal cancer

10.1038/s41598-023-45297-8 · 2023 · External reference

Patient-derived organoids predict treatment response in metastatic colorectal cancer

10.1158/1078-0432.ccr-25-1564 · 2025 · External reference

Patient-derived tumor organoids can predict the progression-free survival of patients with stage IV colorectal cancer after surgery

10.1097/dcr.0000000000002511 · 2023 · External reference

Precision medicine applied to metastatic colorectal cancer using tumor-derived organoids and in-vitro sensitivity testing: a phase 2, single-center, open-label, and non-comparative study

10.1186/s13046-023-02683-4 · 2023 · External reference

Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020

10.1016/j.annonc.2021.04.003 · 2021 · External reference

Rectal organoids enable personalized treatment of cystic fibrosis

10.1016/j.celrep.2019.01.068 · 2019 · External reference

Centralized intestinal organoid generation is a feasible and safe approach for personalized medicine as demonstrated in the HIT-CF Europe organoid study

10.1016/j.jcf.2024.04.016 · 2024 · External reference

Ataluren in cystic fibrosis: development, clinical studies and where are we now?

10.1080/14656566.2017.1359255 · 2017 · External reference

Insights into post-marketing clinical validation of companion diagnostics with reference to the FDA, EMA, PMDA, and MFDS

10.1016/j.omtm.2024.101346 · 2024 · External reference

Patient-derived organoids as a predictive biomarker for treatment response in cancer patients

10.1038/s41698-021-00168-1 · 2021 · External reference

Research and development costs of new drugs-reply

10.1001/jama.2020.8651 · 2020 · External reference

The costs of developing treatments for Alzheimer’s disease: a retrospective exploration

10.1002/alz.12450 · 2022 · External reference

Alzheimer’s disease drug-development pipeline: few candidates, frequent failures

10.1186/alzrt269 · 2014 · External reference

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen

10.1016/j.ejps.2019.105170 · 2020 · External reference

Translation of research evidence from animals to humans

10.1001/jama.296.14.1731 · 2006 · External reference

Introducing individual sentience profiles in nonhuman primate neuroscience research

10.1016/j.crneur.2023.100104 · 2023 · External reference

Implementing patient derived organoids in functional precision medicine for patients with advanced colorectal cancer

10.1186/s13046-023-02853-4 · 2023 · External reference

Patient-derived micro-organospheres enable clinical precision oncology

10.1016/j.stem.2022.04.006 · 2022 · External reference

Patient-derived tumor organoids for guidance of personalized drug therapies in recurrent glioblastoma

10.3390/ijms23126572 · 2022 · External reference

Prospective experimental treatment of colorectal cancer patients based on organoid drug responses

10.1016/j.esmoop.2021.100103 · 2021 · External reference

Organoids as a biomarker for personalized treatment in metastatic colorectal cancer: drug screen optimization and correlation with patient response

10.1186/s13046-024-02980-6 · 2024 · External reference

Precision medicine in cystic fibrosis: predictive role of forskolin-induced swelling assay

10.1183/13993003.00156-2024 · 2024 · External reference

Correlation between patient-derived intestinal organoids and clinical responses to CFTR modulators in people with cystic fibrosis homozygous for F508del

10.1016/j.jcf.2025.08.011 · 2025 · External reference