Roche Position on Human Stem Cells

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1 Roche Position on Human Stem Cells Background Stem cells and treating diseases. Stem cells and their applications offer an enormous potential for the treatment and even the cure of diseases, along with enhancing and extending the quality of life. Roche is highly interested in scientific developments in stem cell research and its related applications both as a discovery tool and as a potential therapeutic modality. Roche is also fully aware of the important societal and ethical questions raised with regard to stem cell research and its potential applications. As in all our activities, we follow applicable law and we are open to dialogue with all stakeholders surrounding this area of research. About stem cells. Stem cells are particular cells that have the unique capability to renew themselves and to give rise to all specialized cell types such as heart cells or blood cells. Stem cells can be classified as follows: Adult stem cells are derived from tissues like bone marrow or cord blood. They are already successfully used for the treatment of patients with e.g. leukemia. The treatment of further diseases with adult stem cells is currently under evaluation. However, those cells only develop into a limited number of cell types. Hence the need remains for concomitant research with embryonic stem cells for specific applications. Embryonic stem cells are isolated from embryos. These cells are pluripotent, which means that they can develop into any fetal or adult cell type (blood, heart, brain cells, etc.), but they cannot develop into a complete organism. Induced pluripotent stem cells (ips) are derived from adult cells, such as skin cells, and are being re-programmed to a pluripotent stage: once re-programmed, they exhibit similar properties as embryonic stem cells. If ips cell technology develops as expected, it may eventually replace the need to derive stem cells from embryos. Stakeholders Concerns and Expectations 1

2 Expectations and hopes within this area of research are high: stem cells and their applications may eventually enable researchers to find successful treatments for severe diseases for which we can offer few, if any, effective therapies today. Diseases or indications often mentioned in this context include Alzheimer s, multiple sclerosis, paraplegia, diabetes, Parkinson s and heart failure. Ethical considerations on the use of stem cells vary widely and depend, to some extent, on an individual s cultural and religious background. The discussion centres on the following topics: The use of blastocysts (a blastocyst is a human embryo in a very early, preimplantation stage of development from which embryonic stem cells can be isolated). Whether human embryonic stem cells should be used for research and/or as potential treatments for various diseases. Whether and how society should accommodate these diverse views in regulating the use of stem cells, with due consideration of the effect of such regulation on freedom of research and benefit for patients. Roche s Position Stem cell research is necessary. Worldwide progress in stem cell research over the past years has shown that scientific developments in pluripotent stem cell biology (i.e. the reprogramming of adult stem cells or somatic cells into pluripotent ones) provides a promising opportunity for the future and Roche is also engaged in using these technologies. However, the scientific understanding of these technologies is still at an early stage. Therefore, parallel research using both adult and embryonic stem cells is necessary to increase the understanding of diseases and develop treatments. Roche conducts stem cell research, in-house as well as in cooperation with external partners, to become technically enabled in this research area, and with the ultimate aim to develop treatment strategies for incurable or inadequately treated severe diseases. Roche is aware of the ethical concerns related to stem cell research. However, we believe that the vast potential and hope that stem cells might bring to patients to treat, prevent or diagnose a disease justifies this research, provided it is done responsibly, in compliance with laws and regulations, in dialogue with stakeholders, and with the ultimate aim of 2

3 developing new and more effective therapies for diseases that can currently not, or only partly, be treated. Principles for using Human Stem Cells in research. Roche is committed to a responsible and transparent approach to stem cell research. For this reason, clear principles for the Use of Human Stem Cells in research have been developed. The following principles apply to all research projects involving human stem cells, which Roche undertakes. They include: projects using stem cell research as a discovery tool projects looking into potential therapeutic modalities. All Roche employees involved in human stem cell research are subject to these principles, which are designed to be applicable worldwide, subject to national laws and regulations. General Principles for Human Stem Cells for Research Principles 1-7 apply to research on all human stem cells. 1) The ultimate aim of Roche s research using stem cells is to increase the understanding of serious diseases and to develop effective diagnostic tools and treatments. 2) Each research project must have clear scientific objectives and design, in particular in accordance with good clinical practice. 3) Prior written, voluntary informed consent of the donor 1 of the genetic material 2 must be obtained before human stem cell research is carried out. 4) Roche will not offer any inducements, financial or otherwise, to donors. 5) Roche will comply with all applicable national laws and regulations on stem cell research, which may differ from country to country. 6) Roche is committed to an open dialogue with stakeholders in this area of research. 1 The term donor is generally understood as an individual who donates biological material, and, in the case of human embryo donation (in jurisdictions where applicable), the individual or couple for whose reproductive use embryos were created. 2 Examples of genetic material: tissue, gametes (=eggs or sperm), embryos. 3

4 7) Roche will proactively encourage all its external contractors, who perform stem cell research for Roche, to abide by the same principles and conduct their research with the same high standards as Roche. In addition to principles 1-7, principles 8-10 apply to research on human embryonic stem cells. 8) Roche intends to move increasingly toward using technologies such as induced Pluripotent Stem Cells (ipscs) that could one day replace the need to derive stem cells from embryos. Until such technologies are fully developed, parallel research using both embryonic stem cells and ipscs will remain necessary. 9) In the case of stem cell lines derived from embryos, Roche uses only embryos that have been created through in vitro fertilisation for reproductive purposes, that are no longer needed for those purposes, and that have been donated for research (with voluntary and informed consent). 10) Roche will not engage in human reproductive cloning. Current engagement, initiatives and guidelines Examples of Roche s current engagement, initiatives and guidelines can be found in Appendix 1. Outlook The Roche Science and Ethics Advisory Group (SEAG) offers advice and counsel on a broad range of ethical matters. It is a panel made up of independent external experts in bioethics and philosophy, and provides consultative feedback on ethical approaches to biomedical and clinical research, in particular on topics that are perceived as particularly sensitive or controversial by the public at large in order to take into account as many perspectives as possible. SEAG has also provided feedback to this Position Paper. This updated position paper was proposed by the Corporate Sustainability Committee and adopted by the Corporate Executive Committee on 13 May, 2013 and entered into force the same day. It replaces the version from May 12, 2009 and was reviewed in May

5 Appendix 1 Current engagement, initiatives and guidelines Roche Principles for Use of Human Stem Cells In 2011, Roche adopted principles governing the use of human stem cells for research, which have been developed in consultation with the Roche SEAG. They apply to all research projects involving human stem cells that Roche or its contractors undertake. Roche s in-house activities Roche s in-house stem cell research includes the use of human stem cells both as a discovery tool and as a potential therapeutic modality. Roche is developing expertise to become technically enabled in this research area and to conduct research on human stem cells and their use in drug discovery. The aim is to develop treatment strategies for incurable or inadequately treated severe diseases, for example, Central Nervous System disorders. Roche has also started research and pre-clinical feasibility projects on the use of adult stem cells also in devastating diseases. Roche s external collaborations Roche provides our external partners with compounds from our drug library for toxicological and safety tests and screening in various human stem cell lines in an effort to improve drug development whilst reducing animal testing and potential Serious Adverse Events in human trials. Massachusetts General Hospital (Boston, USA) and Harvard University (Cambridge, USA). In 2010, Roche commenced a three-to-five year joint research collaboration with Massachusetts General Hospital (Boston, USA) and Harvard University (Cambridge, USA). In this collaboration stem cell technologies are used to advance drug discovery in areas of high unmet medical need with an initial focus on metabolic disorders and cardiovascular disease. The aim is to develop cellular models of diseases based on human stem cell lines and to investigate the potential efficacy, safety and toxicology profile of new drug candidates 5

6 from Roche s compound library. Cell lines will be derived from the tissues of healthy volunteers and from patients with various diseases. In January 2012, Roche entered a research and development agreement together with the Harvard Stem Cell Institute, Harvard Medical School, and Children s Hospital Boston, to create in-vitro drug screening assays for the modelling of autism spectrum disorder (ASD) with the ultimate aim is to screen and identify new drugs for the treatment of the condition. In this unique partnership, skin biopsies from suitable individuals, after genetic screening of patients with specific genetic conditions causing ASDs, will be provided for fibroblast isolation and reprogramming into induced pluripotent stem cells (ipscs). These stem cells will be differentiated into lines of functional neurons that will be used to identify potential therapeutic targets and for a variety of drug screening assays. UK Stem Cell Consortium (SC4SM -Stem Cells 4 Safer Medicines). The objective of this consortium is to create a repository of stem cells suitable for toxicology testing in high-throughput platforms. The initiative is mainly supported by the UK government with Roche and two other pharmaceutical companies contributing. Activities are coordinated by a Board of Directors and a Scientific Advisory Board. Roche is represented on the steering bodies of this initiative and funded this initiative for the pilot phase. UCLA. In June 2011, Roche entered into a collaboration agreement with UCLA to access its technologies to support the research conducted by the Eli and Edythe Borad Center of Regenerative Medicine and Stem Cell Research and UCLA's Jonsson Comprehensive Cancer Center. Roche will provide UCLA with advanced reagents, technologies and bioinformatics support to further understand complex diseases and discover new predictive biomarkers that will be used as targets for future therapeutics. University Medical Center Utrecht in Netherlands/Bioscience Department of AstraZeneca R&D. In February 2012, Roche's xcelligence Cardio Instrument was used to detect beating rhythm and proarrhythmic effect of drug compounds in cardiomyocytes, obtained by differentiating human induced pluripotent stem cells (hipsc) or mouse embryonic stem cells (mesc). The study was conducted by scientists from the University Medical Center Utrecht in Netherlands and the Bioscience Department of AstraZeneca R&D in Sweden. According to the company's website, Roche's xcelligence Cardio systems can be used in combination with stem cell-derived cardiomyocytes as an assay system to support screening of compound toxicity and risk 6

7 assessment. The system can be used to directly measure drug effect on beating of cardiomyocytes derived from mescs, hipsc, and human embryonic stem cells. Comprehensive Pulmonary Center, Helmholtz Association, Munich, Germany. Since October 2010, Roche supports a research group of the Comprehensive Pneumology Center (CPC) and the institute of Lung Biology and Disease (ilbd) with its department of pharmaceutical research. The group will do research on new cell therapy methods with adult mesenchymal stromal-type cells for chronic lung diseases such as idiopathic lung fibrosis (IPF), diseases with a high unmet medical need. Lung fibrosis leads amongst other symptoms to considerable breathing troubles contributing to a severe loss of quality of life and has a poor prognosis of only a few years life expectancy after diagnosis. 7

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