Stem cells for biological assays of novel drugs and predictive toxicology (StemBANCC)


At a Glance
  • Status: Active Consortium
  • Year Launched: 2012
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • No disease focus
  • Location: Europe

Abstract

The Stem cells for biological assays of novel drugs and predictive toxicology (StemBANCC) consortium aims to generate and characterize 1,500 high-quality human induced pluripotent stem (iPS) cell lines that can be used by researchers to study a range of diseases, including diabetes and dementia, and test for drug efficacy and safety. The cell lines will help to improve and speed up the drug development process and ensure that patients benefit from more effective and safer drugs.

Mission

The StemBANCC consortium is an effort of the European Innovative Medicines Initiative. The goal is to generate 1,500 iPS cell lines from 500 people, characterize them in terms of their genetic, protein, and metabolic profiles, and make them available to researchers.

Managed by the University of Oxford, the consortium will collect skin or blood samples from 500 individuals and derive stem cells to make available for research and drug development through their biobank. Patients with well-defined pathologies (of fairly frequent occurrence, such as diabetes, heart ailments, neurodegenerative illnesses, and psychiatric disorders) will be recruited to help populate the stem cell bank.

Consortium History

2012 – Project start date

Structure & Governance

Scientific and Ethical Advisory Board

The Scientific and Ethical Advisory Board consists of five international leading experts in the field. The board is a consultative body to ensure and improve the scientific performance and the quality of results.  It will also monitor and consult the consortium on any ethical issues.

Prof. Beatriz Silva Lima
Lisbon University, Faculty of Pharmacy, Portugal

Prof. Kevin Eggan
Harvard University, Department of Stem Cell and Regenerative Biology, United States

Prof. Leif Groop
Lund University, Diabetes Centre, Sweden

Dr. Glyn Stacey
National Institute for Biological Standards and Control, Division of Cell Biology, United Kingdom

Prof. Nils Hoppe
Leibniz University Hannover, Centre for Ethics and Law in the Life Sciences, Germany

Coordinator of StemBANCC:
Martin Graf (F. Hoffmann–La Roche Ltd) is the coordinator of StemBANCC. The coordinator is responsible for the overall scientific progress of the project and the quality of the results. In his role as coordinator, Graf is the chair of the Steering Committee and the General Assembly.
 
Managing entity of StemBANCC:
Dr. Zameel Cader (University of Oxford) is the StemBANCC managing entity of the IMI JU funding. As the leader of the academic and SME participants in the consortium, he is responsible for the scientific management and the supervision of the overall progress in collaboration with the coordinator.

Project management office:
The StemBANCC Project management office consists of Martin Graf at F. Hoffmann-La Roche Ltd in Basel, Zameel Cader at the University of Oxford, and Barbara Heißerer at concentris in Fürstenfeldbruck. The project office is responsible for the scientific management of the project and the day-to-day coordination of all StemBANCC activities. Heißerer as project manager at concentris takes care of the financial and overall project management.

StemBANCC is a five-year programme divided into 12 work packages (WP). The work packages are broadly divided into provision of biomaterials and biodata (WP2 - 6), cellular phenotypic discovery (WP7-10), and assay development and validation (WP11). WP1 concerns project management including planning to ensure long term viability, and WP12 concerns communication for effective integration with other European Union- (EU) funded initiatives.
 
A key objective of StemBANCC is to furnish the EU research community (academic and industry) with a biorepositry of well-characterized iPSC from different disease groups. The pipeline to establishing this biobank begins with WP2, which is tasked with robustly identifying, recruiting, clinically phenotyping, and collecting tissue samples from subjects with defined disease and adverse drug responses as well as healthy controls. Biomaterials from WP2 are then passed to WP3 for reprogramming subjects’ primary cells to pluripotency and from 500 subjects, at least 1,500 quality-assured iPSC lines are generated. WP3 has the important work of ensuring the best methods are adopted for reprogramming and meet a minimum defined quality control criteria to then enable downstream studies unhampered by reprogramming artefacts.
 
WP4 has three critical tasks – firstly, to coordinate the varied differentiation being undertaken by WP7-10 and develop common standards for use by all participants; secondly, to develop technology to support iPSC and progenitor expansion such that all participants will be adequately supplied with sufficient starting material; and, thirdly, to develop some key tools for enhancing the differentiation process as well as cellular phenotyping. In regards to the latter, the provision of isogenic control iPSC lines through genome editing will be highly valued.
 
WP5 provides the molecular profiling support that will be required by all the other research WPs and will profile biomaterial at genomic, transcriptomic, proteomic, and metabolomic levels. These data will be used to confirm cell identity following differentiation as well as enabling hypothesis generation for disease-relevant cellular phenotypes. The wealth of omics data along with the rich clinical dataset need to be securely housed, integrated, and interpreted, and this considerable undertaking is led by WP6. This WP will closely and reciprocally interact with clinical and non-clinical disease experts in the consortium to ensure that data interpretation is correctly contextualized and work undertaken for cellular phenotyping is well supported.
 
WP7, WP8, WP9, and WP10 cover the cellular phenotyping of iPSC lines from the subjects recruited to develop robust models of peripheral nervous system disease, central nervous system disease, diabetes, and toxicology. These WPs have two major components: first, to develop the differentiation protocol and, working closely with WP4, to ensure standardization; and, second, to undertake a wide array of assays including targeted molecular investigation, pharmacological responses, and functional studies. Adapting findings from WP7-10 into assay platforms suitable for drug screening is the task of WP11. This WP perhaps best encapsulates the strength and advantages of academic-industry partnerships since both groups must work closely together to ensure that the resulting drug screening assays are both relevant and have practical value.

Financing

This project is funded by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA), resources of which are composed of financial contribution from the EU Seventh Framework Programme and EFPIA companies’ in-kind contribution. Large pharmaceutical companies participating in IMI projects do not receive IMI funding.

The IMI Intellectual Property (IP) Policy governs the IP regime of all projects funded by the IMI JU.  To assist with specific IP queries, IMI has set up a dedicated IP Helpdesk that can be contacted by e-mailing IMI-IP-Helpdesk@imi.europa.eu. The IMI IP policy can be accessed at the following address: http://www.imi.europa.eu/sites/default/files/uploads/documents/imi-ipr-policy01august2007_en.pdf

Data Sharing

According to IMI’s intellectual property policy, the participants undertake to disseminate the data
as soon as reasonably practicable but not later than one year after the termination or expiry of the project. The Project Agreement shall include a description of the material that must be disseminated in accordance with the IP Policy and referenced in the Grant Agreement. If the participants do not disseminate within such time periods without good reason, the Executive Office has the right to disseminate such results in a manner consistent with the Grant Agreement.

Ultimately, STEMBANCC will be a source of well-characterized, patient-derived iPS cells that will help researchers study diseases, develop new treatments, and test the efficacy and safety of new drugs.

Homepage

http://stembancc.org/

Other website

http://www.imi.europa.eu/content/stembancc

Sponsors & Partners

Martin Graf
F. Hoffmann-La Roche Ltd
Tel: +41-616889246
E-mail: martin.graf@roche.com

Zameel Cader
University of Oxford
Tel: +44 1865 285875
E-mail: zameel.cader@ndcn.ox.ac.uk

 Sponsors and Partners

F. Hoffmann-La Roche Ltd, Basel, Switzerland

Abbott GmbH & Co KG, Wiesbaden-Delkenheim, Germany

Boehringer Ingelheim International GmbH, Ingelheim, Germany

Eli Lilly, Hampshire, United Kingdom

Janssen Pharmaceutica NV, Beerse, Belgium

Merck KGaA, Darmstadt, Germany

Novo Nordisk A/S, Bagsværd, Denmark

Orion Corporation, Espoo, Finland

Pfizer Limited, Sandwich, UK

Sanofi-Aventis Research and Development, Chilly-Mazarin, France

University of Oxford, Oxford, UK

Charité - Universitätsmedizin Berlin, Berlin, Germany

Hebrew University of Jerusalem, Jerusalem, Israel

Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH), Neuherberg, Germany

Institut National de la Santé et de la Recherche Médicale, Paris, France

King’s College London, London, UK

Linkopings Universitet, Linköping, Sweden

Medical Research Council UK, Swindon, UK

Medizinische Hochschule Hannover, Hannover, Germany

Medizinische Universität Innsbruck, Innsbruck, Austria

Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen, Reutlingen, Germany

Region Hovedstaden - Capital Region of Denmark, Hillerød, Denmark

Tel Aviv University, Tel Aviv, Israel

Universitätsklinikum Schleswig-Holstein, Lübeck, Germany

Université de Genève, Geneva, Switzerland

Université de Lausanne, Lausanne, Switzerland

Université de Technologie de Compiègne, Compiègne, France

University College London, London, UK

University of Birmingham, Birmingham, UK

University of Cambridge, Cambridge, UK

University of Edinburgh, Edinburgh, UK

University of Lübeck, Lübeck, Germany

University of Newcastle upon Tyne, Newcastle upon Tyne, UK

Concentris Research Management GmbH, Fürstenfeldbruck, Germany

Islensk Erfdagreining EHF, Reykjavik, Iceland

Univercell-Biosolutions, Toulouse, France


Last Updated: 04/08/2016

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