The Siena Life Sciences Steering Committee is founded in autumn with the aim of defining the strategic lines and the executive project for the creation of a biotech district in the Siena area.  The MPS Bank and Foundation, the Region of Tuscany, the Province of Siena, the Municipality of Siena, the University of Siena, Chiron Vaccines SpA, Siena Biotech SpA, the Siena Industrial Association, the Siena University Hospital, and the Chamber of Commerce, Industry, Trade and Agriculture of Siena all participate.  The feasibility study, commissioned to the company Alta, is delivered in April 2004.

The Toscana Life Sciences Foundation, a private non-profit organization, is founded on December 2, 2004.  The three Tuscan universities (Florence, Pisa, and Siena) and the Sant’Anna and Pisa Normale Schools for Advanced Studies are among the founding partners, in addition to the Region of Tuscany, the MPS Bank and Foundation and all of the Sienese institutions.  The challenge of transforming the research activities of one of Tuscany’s sectors of excellence, the Life Sciences, into business opportunities begins.

In September 2005 Germano Carganico is nominated General Director of the TLS Foundation.  The first “Call for Applications” is released in December of the same year; it is opened internationally and aims at start-up and spin-off companies active in the pharmaceutical, biotechnological, and diagnostic fields and in innovative biomedical technologies interested in locating a new business activity at the TLS Science Park.

The renovation works of Building 36, located within the “Torre Fiorentina” Campus, begin in order to create spaces appropriate for business incubation.  The operation is completed in eight months; the TLS bio-incubator is inaugurated on November 25 with two floors of laboratories, offices and completely equipped technological platforms.  The initial investment, including the acquisition of scientific equipment, is 12 million Euros. 
2006 also witnesses the activation of financing instruments to support the TLS Foundation’s activities.  The seed capital company Biofund Spa (Monte dei Paschi di Siena Foundation and Bank, Siena Financial Development and Fidi Toscana) is formed in September.  In February 2007 it is transformed into an operating company of the MPS Foundation for the pursuit of institutional objectives in scientific and technological research.

The first two biomedical research companies are incubated at TLS: Molteni Therapeutics (January), a spin-off based on the research activities of Molteni Pharmaceuticals, a historical entity from the Florence area, and Toscana Biomarkers (March), a university spin-off of the Universities of Pisa and Florence, with a strong patent position.

Over the course of the year thee non-profit research groups active in the field of orphan drugs and particularly committed to rare diseases settle at TLS: the CNR Institute of Clinical Physiology (IFC-CNR), Siena SOU; the Umberto Di Mario Foundation (FDM) and the Tuscan Tumor Institute (ITT). The Orphan-1 project, with a co-financing of research already underway at Tuscan public laboratories and the Orphan-2 project, aimed at the management and support of development activities in the field of enzyme replacement therapy for rare diseases begin, for which the Region of Tuscany assigns a significant financing to TLS. In April the service company Regulatory Pharma Net (RPN) enters TLS, and in July the third biomedical research company, Externautics, which is founded as a strategic spin-off of Primm S.r.l. to identify new biomarkers in the oncology field, settles in.

In October the coordination of the Italian BioParks group, which is sponsored by Assobiotec and APSTI (Italian Association of Science and Technology Parks) is entrusted to TLS; the group includes the Italian science parks with a special emphasis in the Life Sciences field.  The relationships between the Region of Tuscany and the TLS Foundation continue profitably and in November 2008 the Office for the Exploitation of Biomedical and Pharmaceutical Research (UVaR), is established and its management is entrusted to TLS.

Three major facts characterize 2009: the collaboration with Genzyme within the project Orphan-2, the establishment of two new companies at the bio-incubator (SetLance in May and ProteoGenBio in September), and Assobiotec’s entrustment to TLS of the management of the annual edition of BioInItaly, the most important “Business matchmaking” event of the Italian biotech sector.  The availability of additional spaces derives from the restructuring of the second floor of Building 36, which also includes an area for the production of biological products in compliance with the Good Manufacturing Practices (GMP) European regulations.

With the entrance in the corporate structure of SetLance, the service company for the development of companies in the pharmaceutical field, Eudax opens a service at the incubator. The Italian Biosafety Platform, an independent and non-profit association created to share experiences and provide information and training on the management of biosecurity and bio-risk finds space at TLS in September.  Scientific dissemination activities also begin in 2009: “TLS Open Doors” and “Scientists for a day”, aimed at secondary school students in the region.

In 2010 the TLS Foundation concludes the first phase of its mission with the final set-up of the incubation structures and the consolidation of a close collaboration with and technical/scientific support of the Region of Tuscany.  In particular, over the course of the year, the Class 2 PCL-3 laboratory authorized by the Ministry of Health also for the use of genetically modified microorganisms (GMM) is activated within the bio-incubator.  Four companies are hosted in the TLS modules beginning in 2010 - two biomedical research companies and two service companies: Diesse Ricerche; VisMederi; Technology 4 All (T4A) and Siena BioGrafix, a spin-off company of the University of Siena already present at the Torre Fiorentina site since 2004. The company Areta International, at the incubator since 2008 with only communications and promotional activity, sets itself up with a pilot protein production laboratory.  Thanks to the involvement of TLS, the Region of Tuscany participates in the most important world partnering event in the industrial biotechnologies sector: the Bio International Convention in Chicago.

The year begins with a change in the leadership of the Foundation: from January 1, five years after the birth of TLS, Andrea Paolini takes the place of Germano Carganico in the role of General Director.  2011 is the year in which the TLS’s role in the regionalization of the Life Sciences sector is consolidated.  The Toscana Life Sciences Foundation is appointed as the leader of the managing body of the new Tuscany Life Science Cluster, one of the twelve identified by the Tuscany region to carry out roles of facilitators and actuators in the innovation and technology transfer actions in the most significant sectors of the Tuscan economy.  Strategic partners such as the Pont-Tech Consortium, the three Universities of Siena, Pisa, and Florence and the Sant’Anna and Pisa Normale Schools for Advanced Studies flank TLS.  The region also gives TLS a strategic role in the creation of the corresponding Regional Technological District of the Life Sciences, which is configured as the orientation entity for the Cluster’s activities in support of the national and regional policies for research and technology transfer in the Life Sciences field.

In terms of incubation activities, 2012 saw the entry of two biomedical research companies, Dicofarm and Exosomics Siena, and a service company, Bioconsulting-LN. With regard to the incubated companies and research groups, 2012 confirmed the growth trend of the previous years, with excellent results in terms of research and development activities, the attraction of investments, and the generation of products to be placed on the market. In terms of orphan diseases, it was the year in which the Orphan-2 project – a project that allowed the involvement, in addition to the regional partnership, of several national research groups and confirmed the achievement of very interesting scientific results with a high development potential – was completed. 2012 was a year full of activities for TLS, including the beginning of the operational phase of the Tuscany Life Sciences Cluster and, consequently, the national cluster.

The incubation activity continued with new companies and research groups joining TLS. In 2013, two additional R&D companies found their home at the incubator: Sivis Srl, which is involved in the design, manufacture and marketing of electronic and optoelectronic equipment and systems, and the SME Epigen Therapeutics, which is focused on the experimental research and development of diagnostic and therapeutic devices for the immuno-oncologic sector. Two service companies joined the incubator in 2013: Accurange, which specializes in assistance with and maintenance of the technological equipment necessary for biological research, and Over, a micro-enterprise active in the development of medical and pharmaceutical devices.
The technological platforms available to incubated companies and external subjects also grew with the acquisition of in vivo microimaging instrumentation.

The research group NIBIT, the Italian Network for Tumor Biotherapy, which is involved in scientific and research activities in the biomedical-oncologic field, also joined TLS. With regard to research activities, in 2013 the Foundation began participation in the NERRI project (Neuro-Enhancement: Responsible Research and Innovation , which involves 11 European countries, the Italian partners being TLS and SISSA in Trieste. Also in 2013 TLS became the coordinator of the Tuscany Life Sciences Cluster and a representative in the National Life Sciences Cluster ALISEI.

In 2014 the TLS Foundation continued the process of valorizing the available incubation structures and grew in its role as a provider of services with a high added value. Noxamet and Toscana Formazione entered the incubator during the year, while Bakker Medical and Bird became affiliated companies. With regard to incubated companies and research groups, 2014 showed a positive trend with regard to both technical/scientific activities and the business development component. The staff increased, as well as the resources attracted. On the orphan disease front, the commitment of TLS went on mainly due to the continuation of the project financed by Telethon, deriving from the research activities performed as part of the Orphan-1 and Orphan-2 projects. The relationship of close collaboration and technical/scientific support with the Tuscany Region continued, especially as part of the Life Sciences Technological Cluster, which TLS coordinates, and with the newly formed national cluster. In 2014 the project “Toscana Pharma & Device Valley” also began, in which TLS has played a role of coordination and management of the activities. Particularly relevant were the networking activities and the creation of international partnerships that culminated, among other things, with TLS, as coordinator of the cluster, being recognized with the Bronze Label as a European cluster of excellence.