Swiss institute for translational and entrepreneurial medicine (sitem-insel)

Abstract

sitem-insel – the Swiss Institute for Translational and Entrepreneurial Medicine in Bern – was created to establish, operate and develop a National Center of Excellence for Translational Medicine. sitem-insel is organized as a non-profit oriented public private partnership. Translational medicine is a new, process-oriented discipline that aims to translate new findings and products emerging from private-sector development and basic research into clinical application. The discipline seeks to professionalize the essential interaction between scientists conducting basic research in the private sector and universities, clinicians, regulatory bodies and investors. The mission of sitem-insel is to create and foster an enhanced environment for translational medicine in Switzerland. The sitem-insel strategy rests on three pillars: 1) The sitem-insel School offers university-level continuing professional development courses taught by university and private-sector lecturers. 2) The sitem-insel Enabling Facilities provide infrastructure to foster cooperation between industrial partners, basic scientists and clinicians on the campus of the University Hospital of Bern (Inselspital) with the ultimate goal to bring novel diagnostic and therapeutic products towards clinical application. 3) The sitem-insel Promoting Services aim to optimize the administrative-regulatory effort along the route from laboratory bench to commercial products.

Background

The term translational research has been used for half a decade. However, it has really come into focus in medicine in the last 10 years and is now relevant for industry, academic medicine and international health policy. ^1,2 The definition of translation is still a matter of debate since it was mostly known to comprise the development of new diagnostic or therapeutic products from ‘bench to bedside’. Such a definition has to be questioned for two reasons. First, bench work is often heralded to be of clinical utility, also future bedside application is highly unlikely or long delayed to the point of time of application, and second, considering only the bench and the patient as too narrow a concept for successful translation, since an array of players are involved in the translational process. ^3,4 Therefore, the concept of translational science as a field of investigation focusing on understanding the scientific and organizational principles underlying each step of the translational process has emerged at the National Center for Advancing Translational Sciences (NCATS; https://ncats.nih.gov/files/translation-factsheet.pdf). According to these recent analyses, translational medicine is now considered as a process-oriented discipline that aims to translate new findings and products resulting from industrial development and basic research into clinical applications. To do so, it seeks to professionalize the interaction between basic science researchers from industries and universities, clinicians, regulatory bodies and investors.

Recent development of translational medicine

Surprisingly the number of innovative novel products reaching clinical application appears insufficient in the last 20 years, a fact underlined by the NCATS’s directors message in 2013: ‘…given the historically unique abundance of new discoveries from basic research and industrial development, the lack of transformation of these discoveries into practical products is seen as a paradox today’. This appears not only to be the case in the United States but also in Switzerland, where the number of clinical studies declined steadily from 2004 to 2014 (Figure 1). This decline was not diminished by creating the clinical trial centres (CTCs) or the Swiss Clinical Trial Organisation (SCTO) by the Swiss National Science Foundation Research (Figure 1). Therefore, the mechanisms for the delayed and impaired translational process have been analysed.

Figure 1.

Clinical trials in Switzerland.

The sluggish interaction between industrial, laboratory and clinical investigators appears to be a hindrance for fruitful translational developments. In the past, many scientists around the world view the business world as distasteful or even as a cop-out – a side show to the original desire to help humanity through research. ⁵ Furthermore, academic and hospital institutions have conflicting needs to foster academic achievement and to provide healthcare solutions. ¹ Last but not least, investors are too much focused on short-term returns.

The regulatory obstacles steadily increased over time in the field of translational medicine, which cannot be overcome by individual clinical investigators and basic scientists without professional help at the present time. Not surprisingly, it has also been suggested that regulatory and governance processes have to be streamlined. ¹ For all these reasons, representatives from industry together with the governmental Bern Economic Development Agency, the University, the Fachhochschule and University Hospital (Inselspital) of Berne decided to create a national competence centre, Swiss institute for translational and entrepreneurial medicine (sitem-insel), with the ultimate goal to improve the general environment for translational medicine in Switzerland. The centre is financially supported by the Swiss Government.

What does sitem-insel do?

The mission of sitem-insel is to improve the general environment for translational medicine in Switzerland. The strategy chosen to facilitate the translation process comprises three pillars located in one building to encourage cooperation (Figure 2; www.sitem-insel.ch):

Figure 2.

Building of Swiss institute for translational and entrepreneurial medicine (sitem-insel) under construction.

sitem-insel School

University-level courses given by lecturers from industry and academia designed as continuing professional development for specialists. The program aims at educating academic specialists in the field of translational medicine and entrepreneurship. Participants are expected to acquire the necessary skills to initiate and implement the process of transition of biomedical products from the stage of development in industrial or basic science institutions into clinical applications, with the ultimate goal of their commercialization. The focus will be on both diagnostic and therapeutic (Medtech, pharmaceutical) products.

For further information, please visit www.sitem-insel.ch

sitem-insel Promoting Services

The ultimate goal is the creation of services for optimizing the administrative and regulatory affairs from bench to commercialization. The focus of this institution is to analyse specifically the regulatory field in Switzerland in relation with the major export target countries (European Union, United States and Far East) of Swiss medtech and pharmaceutical companies. Based on these analyses, strategies should be developed to encourage local regulations for facilitating the translational process. Teaching in the faculty of business, economics and social sciences and further education will be part of the range of services provided by the promoting services.

sitem-insel Enabling Facilities

The purpose of these facilities is to encourage clinical investigations designed to bring novel diagnostic and therapeutic products towards clinical application. For that purpose, a new building is currently under construction on the campus of the University Hospital of Bern (Inselspital). Specialists for translation from industry, academia and the University Hospital shall use the ∼20,000 m² surface. The University Hospital of Berne comprises all tertiary medical disciplines. Since one cannot predict in which area disruptive innovations might occur, the architectural structure of the building is such that it can be easily adjusted to non-anticipated requirements. At present, the infrastructure comprises the following units:

open space for not yet defined technologies and start-ups,

clinical trials unit,

neurological investigation centre,

good manufacturing practices (GMP) labs for cellular therapy,

experimental radiology investigation centre including 7 T magnetic resonance imaging,

clinical anatomy,

dental translational research centre,

simulation centre and

institute for surgical technology, biomechanics and artificial organs.

Organization of sitem-insel

Sitem-insel is organized as a non-profit-oriented public–private partnership. Government funding has been sought for the start-up phase (8 years). After that time, sitem-insel should become financially self-sufficient.

Board of directors

• Uwe E. Jocham, general manager CSL Behring AG, President of sitem-insel AG, Bern

• Gabor Szekely, PhD, Prof. em. ETH ZH, president elect sitem-insel, Zurich

• Michèle Etienne, PhD, Mitinhaberin Innopool AG, Co-Geschäftsführerin GetDiversity, Schüpfen

• Bruno Oesch, PhD, Executive Chairman Neurotune Ltd., CEO Malcisbo Ltd, founder Prionics, Zürich

• Claudio L. Bassetti, Prof. Dr Med. and Chairman, Department of Neurology, Berne University Hospital (Inselspital), Bern

• Gerhard Bauer, Head Research, Development & Operations, Institut Straumann AG, Basel

• Martin Täuber, Prof. Dr Med., Rector of the University of Berne

Managing director

• Felix Frey, Prof. Dr Med., em.

Legends to Figures I and II

• Fig. I: Number of clinical studies in patients approved by Swissmedic as a function of time. The number of studies of all phases steadily declined from 2004 to 2014 independent of the introduction of the CTCs in 2007 or the foundation of the SCTO in 2010.

• Fig. II: The sitem-insel will be harboured in a novel building in the heart of the campus of the University and University Hospital of Berne.