Evidence map›Paper›PMID 32113184›Full record

ArticleALTEX2020

Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development

Uwe Marx, Takafumi Akabane, Tommy B Andersson, Elizabeth Baker, Mario Beilmann, Sonja Beken, Susanne Brendler-Schwaab, Murat Cirit, Rhiannon David, Eva-Maria Dehne and 36 more

Open access · goldAbstract read
In one paragraph

Article in ALTEX, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 158 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
158citing papers in PubMed, 4 pooled it
13.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

158 citing papers in PubMed, 4 syntheses or guidelines pooled it, 195 citations in OpenAlex.

  1. Integration of microphysiological systems with computational and digital twin modeling for pharmaceutical development: a systematic review.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026
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  5. A targeted lipidomics workflow for high-throughput phenotyping and mechanism-based in vitro hepatotoxicity studies.Toxicology in vitro : an international journal published in association with BIBRA · 2026
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  6. Driving emerging technology to clinical impact.Journal of the American Dental Association (1939) · 2026
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98 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors at 1 institution in 1 country.

Uwe MarxTissUse GmbH, Berlin, Germany.
Takafumi AkabaneStem Cell Evaluation Technology Research Association, Tokyo, Japan.
Tommy B AnderssonDMPK, Research and Early Development Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Elizabeth BakerPhysicians Committee for Responsible Medicine, Washington DC, USA.
Mario BeilmannBoehringer Ingelheim Pharma GmbH & Co. KG, Non-clinical Drug Safety, Biberach, Germany.
Sonja BekenFederal Agency for Medicines and Health Products, Brussels, Belgium.
Susanne Brendler-SchwaabBfArM, Bonn, Germany.
Murat CiritJavelin Biotech, Inc, Woburn, MA, USA.
Rhiannon DavidClinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK
Eva-Maria DehneTissUse GmbH, Berlin, Germany.
Isabell DurieuxTissUse GmbH, Berlin, Germany.
Lorna EwartClinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK
Suzanne C FitzpatrickUS Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA.
Olivier FreyInSphero, Schlieren, Switzerland.
Florian FuchsNovartis Institutes for BioMedical Research Chemical Biology & Therapeutics, Basel, Switzerland.
Linda G GriffithMassachusetts Institute of Technology, Cambridge, MA, USA.
Geraldine A HamiltonEmulate Inc., Boston, USA.
Thomas HartungCenter for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Julia HoengPhilip Morris International R&D, Neuchâtel, Switzerland.
Helena HogbergCenter for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
David J HughesCN Bio Innovations Ltd., Welwyn Garden City, UK.
Donald E IngberWyss Institute for Biology Inspired Engineering, Harvard University, Boston, USA.
Anita IskandarPhilip Morris International R&D, Neuchâtel, Switzerland.
Toshiyuki KanamoriNational Institute of Advanced Industrial Science and Technology (AIST), Tokyo, Japan.
Hajime KojimaJapanese Center for Validation of Animal Methods, Tokyo, Japan.
Jochen KuehnlBeiersdorf, Hamburg, Germany.
Marcel LeistCenter for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany.
Bo LiNational Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing, P.R. China.
Peter LoskillFraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Stuttgart, Germany.
Donna L MendrickNational Center for Toxicological Research, FDA, Silver Spring, MD, USA.
Thomas NeumannNortis Inc., Seattle WA, USA.
Giorgia PalloccaCenter for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany.
Ivan RusynTexas A&M University, College Station, TX, USA.
Lena SmirnovaCenter for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Thomas Steger-HartmannBayer, Investigational Toxicology, Berlin, Germany.
Danilo A TagleNational Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.
Alexander TonevitskyM.M. Shemyakin & Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, Russia.
Sergej TsybRussian Ministry of Production and Trade, Moscow, Russia.
Martin TrapecarMassachusetts Institute of Technology, Cambridge, MA, USA.
Bob Van de WaterUniversiteit Leiden, Leiden, The Netherlands.
Janny Van den Eijnden-van RaaijInstitute for Human Organ and Disease Model Technologies, Eindhoven, The Netherlands.
Paul VultoMIMETAS BV, Leiden, The Netherlands.
Kengo WatanabeDaiichi Sankyo Co., Ltd., Tokyo, Japan.
Armin WolfInSphero, Schlieren, Switzerland.
Xiaobing ZhouNational Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing, P.R. China.
Adrian RothF. Hoffmann-La Roche Ltd, Roche Innovation Center Basel, Switzerland.
Technische Universität Berlin · DE

Funding

Single cell, multi-parametric high throughput platform to classify endocrine disruptor potential of mixturesP42ES027704 · NIEHS · TEXAS A&M UNIVERSITY · PI Thomas Joseph McDonald · 2017 to 2026
$21.2M
Texas A&M Center for Environmental Health Research (TiCER)P30ES029067 · NIEHS · TEXAS A&M UNIVERSITY · PI Weston W Porter · 2019 to 2026
$13.0M
GuMI: New In Vitro Platforms to Parse the Human Gut Epithelial-Microbiome-Immune AxisR01EB021908 · NIBIB · NORTHEASTERN UNIVERSITY · PI CARRIER, REBECCA L, GRIFFITH, LINDA G · 2016 to 2020
$5.2M
TEX-VAL: Texas A&M Tissue Chip Validation CenterU24TR001950 · NCATS · TEXAS A&M UNIVERSITY · PI RUSYN, IVAN · 2016 to 2017
$4.2M
TEX-VAL: Texas A&M Tissue Chip Validation ConsortiumU24TR002633 · NCATS · TEXAS A&M UNIVERSITY · PI RUSYN, IVAN, STEPHAN, CLIFFORD C · 2018 to 2019
$3.0M
NCATS NIH HHS U24 TR001950NCATS NIH HHS U24 TR002633NIBIB NIH HHS R01 EB021908NIEHS NIH HHS P30 ES029067NIEHS NIH HHS P42 ES027704
6 · The paper itself

Abstract

The first microfluidic microphysiological systems (MPS) entered the academic scene more than 15 years ago and were considered an enabling technology to human (patho)biology in vitro and, therefore, provide alternative approaches to laboratory animals in pharmaceutical drug development and academic research. Nowadays, the field generates more than a thousand scientific publications per year. Despite the MPS hype in academia and by platform providers, which says this technology is about to reshape the entire in vitro culture landscape in basic and applied research, MPS approaches have neither been widely adopted by the pharmaceutical industry yet nor reached regulated drug authorization processes at all. Here, 46 leading experts from all stakeholders - academia, MPS supplier industry, pharmaceutical and consumer products industries, and leading regulatory agencies - worldwide have analyzed existing challenges and hurdles along the MPS-based assay life cycle in a second workshop of this kind in June 2019. They identified that the level of qualification of MPS-based assays for a given context of use and a communication gap between stakeholders are the major challenges for industrial adoption by end-users. Finally, a regulatory acceptance dilemma exists against that background. This t4 report elaborates on these findings in detail and summarizes solutions how to overcome the roadblocks. It provides recommendations and a roadmap towards regulatory accepted MPS-based models and assays for patients' benefit and further laboratory animal reduction in drug development. Finally, experts highlighted the potential of MPS-based human disease models to feedback into laboratory animal replacement in basic life science research.

Indexed as

Animal Testing AlternativesAnimal WelfareDrug DevelopmentLab-On-A-Chip DevicesAnimalsDrug Evaluation, PreclinicalDrug IndustryHumansModels, Biologicalassay qualificationdrug testingindustrial adoptioniPSC-derived organoidsmicrophysiological systemsmulti-organ-chiporganoidsorgan-on-chipregulatory acceptance

Identifiers

PMID32113184
PMCPMC7863570
OpenAlexW3008131683

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.