Advanced Therapy Medicinal Products, sometimes known as advanced therapies, are also often referred to as ‘living drugs’, and include cell therapy products, gene therapy products and tissue engineered products, as well as the combination of these products with biomaterials. Advanced therapies hold considerable curative potential. The overarching goal of RESTORE is to treat patients using these therapies, aiming to restore normal function while also maintaining the highest ethical and quality standards. Should the consortium remain successful in the final phase of the competition, it will be established as ‘large-scale research initiative’ and funded via the EU Framework Program. This would enable the initiative to invest up to €1 billion in new research projects over the long term.
RESTORE is backed by an international and interdisciplinary community comprising research institutions, hospitals, patient associations and industrial partners, and coordinated by Prof. Dr. Hans-Dieter Volk and his team. As the Director of Charité’s Institute for Medical Immunology and the BIH Center for Regenerative Therapies, Prof. Volk works at both the Berlin Center of Advanced Therapies (BeCAT) and the BIH.
“Advanced therapies are a potential game changer in health care, aiming to shift our focus from chronic treatment of disease to regeneration of health,” explains Prof. Volk. He adds: “We see a growing number of success stories where patients have been cured of end stage disease. At the same time, there are still numerous obstacles to implementing these promising therapies in routine clinical care. RESTORE provides us with a unique opportunity to overcome these obstacles, in terms of the technology involved and in terms of manufacturing, clinical management and reimbursement. We are determined to translate promising research findings into safe therapies, and we will be working across disciplines and national borders in order to achieve this goal”.
The RESTORE core team comprises world leaders in basic research, clinical research and biotechnology. In addition to Charité, these include INSERM – Institut National de la Santé et de la Recherche (France), the University of Zurich (Switzerland), Miltenyi Biotec GmbH (Germany), TissUse GmbH (Germany), Cell and Gene Therapy Catapult (United Kingdom), Pluristem Ltd (Israel), Innovation Acta S.r.l. (Italy), Fondazione Telethon Milan (Italy), and the University of Minho (Portugal). More than 250 experts, representing science and industry, non-profit organizations and patient associations from across Europe and beyond, have pledged their support for the RESTORE Health research initiative, their response underlining the remarkable scientific, economic and societal potential of advanced therapies.
“The decision to support RESTORE demonstrates three things: that there is an acknowledgment of the need for better treatment options for patients across Europe; recognition of the quality of European research in this field; and support for our collaborative efforts to become world leaders in this important field,” says Prof. Volk. He adds: “We thank our partners and supporters. We consider ourselves fortunate to have them on our side. We are now starting preparations to create a large-scale research initiative: We will do our utmost to ensure we engage all stakeholders, identify the challenges ahead, and further develop our plans to make advanced therapies a clinical reality, so that every patient in Europe who could potentially benefit from these innovative treatments will have access to them.”
The BIH Center for Regenerative Therapies
The BIH Center for Regenerative Therapies is an interdisciplinary translational research center which is jointly operated by the BIH and Charité. Its main aim is to enhance the body’s ability to use cells, factors and biomaterials as part of natural regeneration processes and to promote alternative strategies that can be used to develop innovative therapies and products. The Center's primary focus is on diseases of the immune, musculoskeletal and cardiovascular systems, as well as areas of research that straddle different medical disciplines, such as tissue homeostasis and cachexia. Between 2006 and 2018, the center was cofinanced by the Federal Ministry of Education and Research. Following a change in cofinance arrangements in 2019, the center is now being cofinanced by the Berlin Institute of Health (BIH) and known as the BIH Center for Regenerative Therapies.
Berlin Center for Advanced Therapies (BeCAT)
Established thanks to a €30 million grant from the German Council of Science and Humanities (Wissenschaftsrat), the BeCAT aims to provide the necessary infrastructure, platforms, mentality and expertise in order to facilitate the development and clinical translation of advanced therapies in the areas of regenerative medicine and haemato-oncology.