Drug Discov Today. 2016 Oct 28. pii: S1359-6446(16)30390-7. doi: 10.1016/j.drudis.2016.10.011. [Epub ahead of print]

Towards a 21st-century roadmap for biomedical research and drug discovery: consensus report and recommendations.

Langley GR1, Adcock IM2, Busquet F3, Crofton KM4, Csernok E5, Giese C6, Heinonen T7, Herrmann K8, Hofmann-Apitius M9, Landesmann B10, Marshall LJ11, McIvor E12, Muotri AR13, Noor F14, Schutte K15, Seidle T16, van de Stolpe A17, Van Esch H18, Willett C19, Woszczek G20.

Author information

• 1Research & Toxicology Department, Humane Society International, London, UK. Electronic address: sciencesources@btinternet.com.
• 2Respiratory Cell & Molecular Biology, National Heart & Lung Institute, Imperial College, London, UK.
• 3Center for Alternatives to Animal Testing (CAAT) Europe, Brussels, Belgium.
• 4National Center for Computational Toxicology, US Environmental Protection Agency, Research Triangle Park, NC, USA.
• 5Department of Internal Medicine-Rheumatology, Esslingen District Clinics GmbH, Kirchheim Clinic, Academic Teaching Hospital, University of Tübingen, Kirchheim unter Teck, Germany.
• 6ProBioGen AG, Berlin, Germany.
• 7Finnish Centre for Alternative Methods, School of Medicine, University of Tampere, Tampere, Finland.
• 8Dahlem Research School, Free University Berlin, Berlin, Germany.
• 9Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Institutszentrum Birlinghoven, Sankt Augustin, Germany.
• 10European Commission, DG Joint Research Centre, Directorate F-Health, Consumers and Reference Materials, F3 Chemical Safety and Alternative Methods Unit, Ispra (VA), Italy.
• 11School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, UK.
• 12Humane Society International, London, UK.
• 13Department of Pediatrics & Cellular & Molecular Medicine, UCSD School of Medicine, Rady Children's Hospital, Sanford Consortium, La Jolla, CA, USA.
• 14Biochemical Engineering Institute, Saarland University, Saarbrücken, Germany.
• 15European Commission, DG ENVIRONMENT, Directorate A-Green Economy, Unit A.3-Chemicals, Brussels, Belgium.
• 16Research & Toxicology Department, Humane Society International, Toronto, Canada.
• 17Philips Research (Philips Group Innovation), Eindhoven, The Netherlands.
• 18Center for Human Genetics, University Hospitals Leuven, Leuven, Belgium.
• 19Animal Research Issues, The Humane Society of the United States, Boston, MA, USA.
• 20MRC/Asthma UK Centre in Allergic Mechanisms of Asthma, Division of Asthma, Allergy & Lung Biology, King's College London, Guy's Hospital, London, UK.

Abstract

Decades of costly failures in translating drug candidates from preclinical disease models to human therapeutic use warrant reconsideration of the priority placed on animal models in biomedical research. Following an international workshop attended by experts from academia, government institutions, research funding bodies, and the corporate and nongovernmental organisation (NGO) sectors, in this consensus report, we analyse, as case studies, five disease areas with major unmet needs for new treatments. In view of the scientifically driven transition towards a human pathway-based paradigm in toxicology, a similar paradigm shift appears to be justified in biomedical research. There is a pressing need for an approach that strategically implements advanced, human biology-based models and tools to understand disease pathways at multiple biological scales. We present recommendations to help achieve this.