Final Report Summary - BIO-CT (European biotechnologies common tools) Executive summary: BIO-CT was a project that brought together five bioregions across Europe to identify common challenges for the economic delivery of biotechnology and develop key tools that could be delivered in partnership across Europe. The key regions had a diverse history and pathway of development, and included: - Paris (represented by GENOPOLE, project coordinator) - significant economic cluster with significant concentration of academic, biotech and pharma actors. - Berlin (represented by BIOTOP) - maturing cluster almost at economic maturity and a one of the main clusters in Germany, with strong biotechnology development and maturation. - Barcelona (represented by BIOCAT) - Earlier stage cluster than Berlin or France but strong development based on long term political and financial support. - Piemonte region (represented by BIOINDUSTRY PARK Silvano Fumero SpA / bioPMed cluster) - Early stage cluster based on solid research foundations and strong cluster strategy implementation. - Debrecen (represented by GND) - Embryonic commercial bio community, based on a strong Hungarian university and long term regional planning and support. These clusters / bioregions were supported in the project by i) the Council of European BioRegion, a network of over 60 bio communities in Europe with the mission to defragment biotechnology, and ii) InnoTSD, a expert consultancy which undertook cross cluster analytical work. The project started with a Strengths, weaknesses, opportunities, and threats (SWOT) analysis of bio community strengths and weaknesses. This was then used to identify common needs between all bio communities and the potential tools that could be utilised by the bio communities in partnership. Three key tools were identified for the joint action plan: Project scouting and maturation: One of the Europe's major commercialisation challenges is the development of the right technologies at sufficient maturity to be able to survive as a commercial platform. TSB Innovationsagentur Berlin (in the Berlin-Brandenburg region) and Genopole (in the Paris region) developed their respective well proven scouting and maturation tools that can be delivered on a range of budgets and which would add significant value through being delivered across clusters. Reversing brain drain and cross-regional mobility: the primary rate-limiting factor for cluster development is experience biotechnology development skills such as CEOs, CFOs, clinical and regulatory specialists. A defining feature of mature clusters is the availability and recycling of these skills. Biocat (in the Catalonia region) developed a successful scheme that it already delivers to enable biotechnology Small and medium-sized enterprise (SME)s, where they can access short-term business skills from anywhere in Europe for critical periods of company development. Sharing facilities: Europe has a wealth of specialist research platforms but many are not open for small companies to access, making poor use of high cost public investment. Bioindustry Park Silvano Fumero SpA / bioPMed cluster (in the Turin region) developed a platform for increasing access to facilities and skills where markets do not deliver, opening up facilities for Europe-wide access and ensuring maximum value to SMEs. These tools were combined into a joint action plan for launch post-project and supported by an online cluster-mentoring platform. Project context and objectives: Project context The BIO-CT project was developed from a core group of biotechnology clusters in Europe that wished to develop common tools for the support of biotechnology economic delivery in clusters across Europe. The objectives of this project focussed on key platforms that underpin cluster development and continued growth, with the following topics selected as not only important for cluster development, but also reproducible across clusters in Europe. European regions and countries have to join forces if they want to have a chance to be competitive in the new global scenario expected for the 21th century: a strong (political, economic and technological) prevalence of China; growing emerging economies and markets (Brazil, India, Russia) anxious to have a stronger presence worldwide; a deep crisis of the ideologies behind the political and economic powers that characterised the 20th century in the United States, Latin America, the Middle East, northern Africa and the Far East. Unless European regions and countries join forces and vision and become truly aligned, Europe will have a hard time to thrive and even to survive as a competitive biotechnology region. In the frame of such a scenario, and within the scope of biotechnology, the BIO-CT project was aimed at bringing together a number of leading European bioregions to imagine, discuss and propose a pathway(s) to fostering the competitiveness and efficacy by which European early stage biotech companies (or projects) may successfully go through the so-called death valley from research to business, i.e. through the early stages of uncertain development up to the industrial validation of their technologies and businesses. The seed ideas behind BIO-CT relied on a core concept: the sharing of assets among European bioregions as the key way to support a growing European competitiveness and a rational, integrated and economically sustainable growth. Shareable assets or shareable tools are understood as all kinds of material or immaterial instruments, like expertise, procedures, good practices, skills, equipment, buildings, platforms. Such instruments can be grouped into three categories: (i) human resources, (ii) facilities and equipment and (iii) processes, structures and collective know-how. The concepts supporting BIO-CT are relatively straightforward, namely the engagement of the triple helix to build sustainable cluster and regional support and interaction. The challenges behind the triple helix engagement became evident during the project - particularly the need to engage regions through the policy levels. Political and financial structures have changed radically since project launch and the most effective methods of implementation and delivery often lie lower down the operation ladder. Partners also faced the challenge of finding common ground for needs and shareable tools that can be shared realistically and productively. BIO-CT brought together, for the first time, and with a focused task, people and teams who collectively manage a budget that is 100+ times larger than the cost of the project. It has developed trust and a multi-biocluster forum that the consortium partners are now committed to keep alive and at the heart of their respective activities. It developed a strong awareness about that sharing (of any type) has been, and still is, rather absent in the minds and activities of most European bioclusters, including the consortium partners themselves. Project objectives The overall project objective, is to create a joint action plan that enables any region in Europe to pick up and deliver, within a wider network of clusters, support services that are validated as effective for economic delivery of biotechnology. Objectives within this overall project objective include: to undertake a full SWOT analysis of regions involved; - to create a model for inter-regional support to support brain drain and mobility; - to create a model for inter-regional support of project scouting and maturation; - to create a model for inter-regional networking and access to facilities; - to create a Joint Action Plan to integrate each model for implementation; - to support the project with extensive dissemination and project partnerships ; - to develop a cluster mentoring programme. Project results: Description of main Science and technology (S&T) results SWOT analysis The SWOT analysis was undertaken with the following actions: - methodology to collect information; - analysis of the data; - results and synthesis; - conclusion. Main interviews within the SWOT were: - Torino / Piedmont: 10 interviews - Paris / Ile-de-France: 13 interviews - Berlin / Brandenburg : 10 interviews - Barcelona / Catalonia: 11 interviews - Debrecen / Hajdu - Bihar: 8 interviews SWOT content The following factors were assessed in each cluster: - The innovation value chain in the biomedical field and on the evolution of Biomedical clusters to give a common understanding on the concepts and vocabulary used in the analysis. - Description of the cluster, key figures for companies, key figures for research, key figures for human resources and training, description of scientific and technological field. - Global analysis (each marked 1-5) of the different activities of the cluster, as following: i. Research and networking: activities like attracting talents, promoting the region through conferences, fostering thematic networks, connecting research organisations. ii. Policy action: activities like contributing to an improved public perception of biotechnology, its benefits and its applications, publishing informative material, organising conferences, setting-up programs dedicated to biomedical matters. iii. Cluster expansion: activities like structure of the cluster and increasing the number of members. iv. Innovation and technology: activities like enhancing the exploitation and the marketing of research in life sciences, developing partnerships between enterprises and research laboratories, increasing the value of research results, leading innovation to the market. v. Education and training: activities like increasing attractiveness of jobs in the field of biotech and biomed, improving the skills at regional level, increasing the number of students and qualified people, setting up specialised training courses. vi. Commercialisation and cooperation: activities like fostering the consolidation of the regional biotechnology and biomedical business sector, accessing to capital (seed money, venture capital), increasing internationalisation and cooperation with foreign clusters / markets. SWOT analysis conclusions Each cluster of the BIO-CT consortium represents a significant part of the bio-health potential in its respective country and, for 3 of them (Barcelona, Paris and Berlin), they can be ranked in the top 5 European bioclusters. Therefore those can provide the BIO-CT project with much experience and many assets. Moreover, Turin which is not far from the three ones mentioned here above and Debrecen, that is under development and smaller than the others, can provide some specialities that are less developed in the others or are complementary to the existing potential. For instance, Debrecen can provide a significant potential in clinical trials and testing and certification while Turin can bring imaging competencies and the link between the mechanical field and its technologies and the medical devices. The cooperation amongst the members of BIO-CT will be facilitate by the fact that the strategic positioning of each cluster that has been put in evidence by the SWOT analysis is in many parts complementary to other positioning. As for example, Paris region needs a stronger biotechnology sector and therefore to increase the number of companies but also their size. The project maturation phase is well developed with plenty of actors (TTO in the research institutes and universities, incubators, seed capital, strong expertise in analysing the projects). However some problems remain in the coordination of the actors, in finding the appropriate human resources, in solving IP issues and in increasing links with the market, in fine chemistry or in animal testing. These two competencies can be found respectively in Barcelona or in Debrecen. Therefore, in this case, BIO-CT actors might gather their respective efforts to develop in common a strategy to get the Paris region expertise in project maturation but also to speed up the development of their own Biotech companies. It will be an asset for their big players but also give attractiveness for skilled persons out of Europe that are thinking about coming back. As for another example, Barcelona can offer good expertise in chemistry and structural biology which is a weakness in Germany and France for instance while Turin can provide expertise in imaging. Therefore, the SWOT analysis has shown that each cluster is working on its strategic positioning and that everyone is looking for something different from the others. BIO-CT project, by the choice of the tools on which it will focus the next steps of its work and by the way it will implement the cooperation, can help each cluster to reach its strategic positioning. For instance, clinical trials are a strong issue and, if a shared facility to analyse the results, to set-up a common language, has to be developed, it can be located in a cluster in which this specialty is the most developed. 86 tools have been identified as of significant importance, a majority of them can be duplicated from one region to another one, validating the concept of BIO-CT: mutual exchange among the regions. The goal of the next steps of the BIO-CT project were to define how those tools can be adapted to the background of each region and how the transfer of knowledge can be done, keeping in mind the necessary financing of such transfer, the intellectual property that can be attached to and the preservation of the specific interests of each region competing for competences, economic development and enterprises. In addition to those tools that can be replicated, a large number of other tools, 30 in total, exists in each cluster and therefore does not need to be shared or replicated, but to be coordinated in order to gain effectiveness through reaching a critical mass, getting more means, accessing scale effects. The next steps of BIO-CT will be devoted to define the processes, regulations, governance to set up in order to implement and manage in a sustainable way this coordination. Main components from SWOT for development: Human resources to feed the new companies that will be set-up, the teams in charge of developing new processes and products, research laboratories that have to expand their activities. Human resources can be developed through existing training courses, but also through attracting talents located in other regions, especially outside Europe as a significant brain drain has occurred in the last twenty years. Each cluster has developed its own strategy and its own tools to fix that issue. Project maturation that consists in facilitating the transformation of a research result into an economic product or process: It requires many actions like consultancy to design the maturation process, to protect Intellectual property, to develop prototypes at large scales, to attract seed capital and later on venture capital. To facilitate the analysis, this topic has been divided in two sections: consultancy and financing. Each cluster has developed its own tools to solve that issue and some synergies may be set-up among them. Shared facilities as the transformation of research results into economic product or process requires many activities, testing, prototyping, clinical trials and therefore use of equipment. Some of them are expensive, rare, difficult to maintain and to use and cannot be duplicated in each European region. Procedures, regulations have to be set-up to enable every user in Europe to identify those equipment and to use them. Technology scouting and maturation Introduction The analysis in WP4 contributed to compare project maturation instruments of the individual regions in terms of their quality and implementability in other clusters. In the first line, the results can serve as a background to support the selection or the development of appropriate maturation instruments in the BIO-CT regions. These tools also have to promote the development of the bioregions and offer a long-term perspective for them. The results have shown that regional instruments could be successfully implemented in other bioregions. It should be noted here that an adjustment to the single strategy of the cluster has to be done and that tools have to build on the specific needs and on existing, working institutions and programmes. It should also be sought to establish common tools at the European level. This could be a common structure for project evaluation as criteria of quality of early-stage projects and the establishment of a central pool of start-up managers who practice a systematic exchange of experience within a European network. And finally, standardised best practice examples should be offered for central areas of the project maturation process, which can be incorporated into regions with less experience in the future. A great deal can be reached here through targeted measures. In the course of the analysis the following key features have been identified as essential for implementing a common maturation model in Europe: - experts from industry are the key instrument for early stage projects; - intensive project management is essential; - intensive cooperation with PEAs required/ development of new common strategies for patenting. Two already existing instruments already feature these criteria: Berlin-Brandenburg's top 50 instruments (version I, see below) and the Genopole Entreprises tool of Paris region (version II, see below). These tools have been agreed to provide a basis for the formulation of a common European maturation concept. However, while serving the same need (taking early stage projects further significantly) these models vary in terms of structure, financing and organisations behind. Therefore, it has been agreed that a European model will have to unite the strengths of both tools and will have to offer two ways to maturate projects - following more the one or the other approach and depending on a region's real needs but also its capacities in terms of available funding, support infrastructure. The joint action plan for project maturation aims at giving guidelines for how to implement a common European maturation model based on the experiences and special requirements of individual clusters. A maturation model for Europe in two versions Version I (Berlin-Brandenburg's top 50) The essence of this tool lies in systematically structuring the project maturation mechanisms already existing in different bioregions. Sharing this tool means harmonising the project maturation efforts of the regions following this common model given above. The following goals should be achieved with the joint project: - bring basic research projects, which are not in use and do not have any chance of exploitation, into industrial value creation; - systematically close the gap between publicly funded academic basic research and industrial development; - establish a sustainable model for the development of the proof of concept (PoC) and for technology transfer in the life sciences and beyond. The project will be composed by five main modules (details to be found in the joint action plan module for project maturation): - raising awareness amongst academics; - identification of promising projects and findings in the scientific organisations; - assessment of projects involving external experts; - ensuring the PoC by involvement of appropriate partners or by taking advantage of existing and new instruments; - systematic technology transfer into SMEs, through creation of start-ups and licensing to industry or cooperation projects. Steps to follow / value chain: - motivation of scientists through very early networking with industry and offering a support program on its way to commercialisation; - development and establishment of an effective communication network between science, transfer institutions and the economy. This results in a better coordination of supply and demand; - development of a development plan for suitable projects taking advantage of existing instruments. This allows optimal use of available funding instruments; - elaboration of project development plans with the participation of industry experts; - monitoring and controlling of project development plans by the central project management; - marketing is accelerated by the involvement of various multiplicators. Success control: A quantity and indicator-based success control will be implemented for ongoing evaluation of the project. The controlling divides the overall process into three phases: identification, PoC and exploitation phase. A ratio system should measure performance and provide information on the efficiency and necessary measures for optimisation and control. In addition to the quantitative measurement and evaluation qualitative indicators will be used, which include a not directly measurable and mainly long-term evaluation. Integration into the regions' infrastructure: The project will be fully integrated into the transfer strategies of the university/ the research institutions and the institute. The connection to the universities' transfer strategies is ensured from the beginning. As part of a successful agreement, jobs will be integrated, too, for example by the possibility of conversion of employee contracts into long-term status or other long-termer commitment. Sharing of this tool: Not necessarily all components, actors and infrastructures of the 'ideal' model described above may be at hand and work the same way in all bioregions. However, the model is sufficiently flexible to be adapted to regional differences. On the other hand, the lack of one of the stakeholders described in the ideal model is not an obstacle to the functioning of the overall mechanism. For example, in emerging bioregions 'traditional' cluster management activities may not be carried out by a dedicated coordination agency but by a university department or a technology transfer office. Therefore, as a starting point for implementation of this common maturation tool one will have to look closely at the single components of it. Starting point always is the status quo in one region: Which components are already existing, which would need a slight adjustment to fit into the structure and which would have to be newly created? These are the factors that will have to be analysed in terms of existence, functionality and ability to be integrated into a larger maturation concept: -identification of projects/ project scouting; - expert evaluation/ assessment of projects; - maturation support I: application support for funding; - maturation support II: searching for industrial partners; - maturation support III: other means of support. Version II (Genopole Enterprises) The aim of maturation model proposed from BIO-CT is to make available to the project leader (whether it is a scientist willing to consider the creation of a company or a company founder already) a dedicated team who will work together with it, all along the maturation process, as needed. The supporting team is built as to being capable to walk together with the project leader from the initial idea up to the stage of the company where the project leader can move on alone. The supporting team may be composed of a variable number of members, according to the number of projects to be followed. Each member of the team is responsible and dedicated to follow together with 5-10 projects or companies. The supporting team is made of young professionals, in the range of 30-35 years old, with previous professional experience in science and business. A senior group leader with science and business experience manages the team, as well. Collectively, the supporting team brings together a panel of crossed skills including science and technologies, intellectual property, business planning, finance, legal, negotiation, management and organisation. The starting point of the process is when a project leader spontaneously approaches the supporting team with a candidate project. After evaluation, the supporting team decides, collectively, whether the candidate project will be further supported or not. The evaluation takes into account key aspects such as the science / technology underlying the project, the supporting intellectual property and the basic business idea behind the project. Essentially, this maturation model is characterised by the fact that there is no proactive scouting of candidate projects. The starting point of the process is the decision, by a project leader, to move on a project and potentially develop a company out of it. The maturation model is fed by the spontaneously existing flow of candidate projects. Projects preselected by the supporting team are then submitted to evaluation by an expert committee. The expert committee makes part of the maturation model. The project leader works together with the supporting team to prepare and complete the project dossier that is submitted to the expert committee. The outcome of the evaluation by the expert committee is a Go / No-go decision on supporting the project. The No-go decision may include recommendations for improving or completing the dossier and resubmitting it at a later date. In case of a Go decision by the expert committee, the project is assigned to the supporting team for further maturation / incubation. At that point, a specific member of the supporting team is assigned to the project and will be responsible for the mentoring, follow up and maturation / incubation of the project inside the structure. In practice, the input of the supporting team turns to be quite essential for the early steps in the development of the projects and companies. In addition to offering an external, objective, professional view on the project and on its fundamentals (science, technology, business idea, management, opportunity), the supporting team contributes with significant amount of time (man-hours). Such time is dedicated to supporting both, the project itself (collecting and evaluating information (IP, market and other types), assistance with project/company presentations to public and private investors, assistance in the preparation of plans (business plan, product development plans), as well as the project leader or entrepreneur (mentoring, coaching, teaming up to kind of motivational / psychological support). The supporting team works together with the project leader / entrepreneur and follows the project / company as long as it is needed and requested to do so; there is no time limit a priori. In some cases, the entrepreneur and the company become autonomous relatively quickly and continue their development independently and out of the frame of the supporting team. In other cases, they need a continued, long lasting support before they are ready to taking off. The same applies to the intensity of the need, which in some cases may be a rather circumstantial need of some support; while in other cases require a deep involvement of the member of the team involved. As described, the model requires a basic structure made of two elements: an expert committee and a supporting team. The expert committee controls the entry of candidate projects to the process, based on their pertinence and eligibility on a number of aspects (science-technology, business, management, opportunity). The specific criteria used by the expert committee for the selection of projects can be eventually modified and adjusted to fit with specific temporal or geographical circumstances or environments. They can be made more stringent whenever the project flow increases, or the resources available by the supporting team become a limiting factor, or to adjust to the fluctuating liquidity of the financial markets (venture capital or other) expected to support the incubated projects / companies. The supporting team, on the other side, is in charge of moving the selected projects / companies forward through the maturation / incubation process up to a point where they become independent and can continue their development as autonomous entities. The role of the supporting team is to creating a contained environment where the project leader / entrepreneur and the project can growth, mature and develop themselves in a protected, incubated, mentored frame, while at the same time they are challenged and pushed to perform and to move forward, by the dynamic and professional members of the team. How to share this tool? One feature of the model is that the application of the model can be delocalised. This is of key importance when considering the sharing of tools between regions or countries. The process can, in principle, be applied by steps or modules, and more or less irrespective of the geographic location of the parties, and this at different levels as is explained below: 1. The expert committee can be composed of members from different regions or countries. The expert committee itself can be either physical body, with members acting from the same location, cluster or region and holding physical meetings, or, alternatively, it can be a virtual body, with well-defined and common rules but composed by professionals acting from different places. 2. The expert committee, whether a physical or a virtual body, can receive and assess projects / companies originated from clusters, regions or countries different from the one where the committee is supposed to operate. 3. The supporting team can handle projects or companies, and work with project leaders or entrepreneurs from clusters, regions or countries other than the one where the supporting team is physically present. 4. The supporting team can eventually be, or become, either virtual or decentralised. Effectively, the supporting team can be composed by active members who will be operating from different clusters, regions or countries, while following common rules and a common process. For the above, the model appears to be an ideal shareable tool. In addition, it is relatively easily convertible into a shared configuration. The simultaneous practice of the model by different European regions would be an effective way to foster convergence within Europe. The practice of the model would favour the exchange of human resources, expertise, know-how and practices among clusters of different degree of maturity, thus helping younger organisations and less mature regions to benefit from those more mature. expert committees composed by the best possible skilled professionals from different regions, would be accessible by all regions involved and, thus, their candidate projects would benefit from the best possible advice. More developed and structured Supporting Teams will be able to host and train members of supporting teams from less mature regions. Members of supporting teams from less mature regions will thus benefit directly from the environment and experience of more mature regions. In our view, the simultaneous practice of the model by different regions can be implemented with relative easy, with no major financial or operational burden for the clusters involved. To foster the exchange of staff members amongst supporting teams, we propose here the implementation of an ad doc exchange programme between the clusters involved. By the exchange programme, a cluster will exchange one-to-one, one member of its respective supporting team by a member of the supporting team of the other party. The exchange would be subject to a certain number of conditions to facilitate its feasibility: (i) it will be limited to a well-defined period of time, ideally in the range of 1 to 2-year time; (ii) during such period of time, the exchanged-members will be 'expatriated', i.e. they will continue being employees of their respective clusters of origin, while temporarily delocalised to a different country. This will give to the exchanged-members the security and visibility necessaries for them to decide moving (with their families) to a different country. As the exchange programme will be based on the exchange of pre-existing job positions, the expected financial burden for the cluster willing to participate to the program is minimal; as the out-coming expatriated member of its staff will be simultaneously replaced by an in-coming expatriated member of the staff of the partnering cluster. The practice of the exchange programme will be of great utility to favour communication and understanding among clusters; it will favour the convergence and spread of good practices and it will contribute to the coming closer of different cultures amongst other benefits. Clusters with higher level of resources, development or sophistication will be able to practice a higher number of simultaneous exchanges; while less resourced clusters will have a more limited number of people to exchange. Clusters with no such a thing like a pre-existing supporting team will be able to participate to the exchange programme by engaging one or more newly recruited, or recycled, employees into the programme. After the exchange period, expatriated members would come back to their countries of origin, and will be able to implement their learning and novel skills in their original clusters. In the eventuality some expatriated members did not return to their clusters of origin, their novel expertise would have in all cases contributed to the convergence of skills throughout Europe. Eventually, the exchange programme may include a 'come-back clause' in order to minimise the leakiness of the system and the staying of the expatriated members in the hosting country. The sharing model for project maturation and company incubation described above, together with the exchange program, are the perfect frame for the implementation of what we can call 'project co-incubation'. We understand by 'co-incubation' the simultaneous existence and development of the same project (or company) in two different countries. Co-incubation may be an attractive option for early stage companies (or projects) that can benefit from their double existence in two separate environments, whether it is to access skilled staff, investors, grants, or other. The existence of fluid, dynamic and mixed supporting teams which would integrate members from different regions or countries would definitively increase the number of cases of co-incubation. In spite of the simplicity of the concept behind the idea, the sharing of human resources, expert committees or maturation/incubation processes represents, in practice, a huge and demanding challenge. Clusters and regions are confronted to strong barriers that, first of all, need to be overcome; none of them is a real obstacle provided the willingness to collaborate and share is present. Such barriers are, for instance, culture diversity (different ways of doing things), language (sharing project/company information among clusters, staff members and expert committees from different countries presupposes that all oral and written exchanges are in a common language), the sense of self-sufficiency (specially present in more mature clusters and regions), as well as restrictions, in many regions, to invest or spend money in other regions and, specially, in other countries. A fundamental question behind the sharing of a maturation model is the source of financing. As a principle, the activity got to be financed by that or those parties that may find a benefit in such activity. In the sharing of a maturation model across Europe, there are at least three parties that can be identified: the cluster or region that 'provides', the cluster or region that 'receives' and Europe as an entity in itself. As a general case, it may be defended that the contribution of the 'receiving' cluster/region to the financing of the sharing activity should be more important than the contribution of the 'providing' cluster / region. The relative contribution of each of those two parties will be variable on a scale where on one extreme there is the notion of a pure service; where there is a net provider and a net receiver, and in which case the financing is expected to be made by the receiver. On the other extreme of the scale, the sharing may be equal-to-equal, in which both clusters or regions provide and receive at the same time, and somehow, each of them finds a benefit in such an exchange. In this case, both parties could be expected to equally co-finance the sharing activity. In all cases, however, the supra-entity called Europe is present and participates as a third party involved. Without Europe in between, the sharing would become a mere self-fishing activity between the clusters or regions. It is in the prime interest of Europe to promote and foster such things like convergence, co-development, transfer, joint and integrative strategies; all being concepts that would not necessarily be a part of the equation if the activity involved regional interests only. As Europe, itself, is a unquestionable, and likely the first, beneficiary of the sharing activity, it can legitimately be expected that Europe should heavily contribute to the co-financing of any sharing activities; and that Europe would likely have to take over the biggest financing contribution out of the three parties. Without the interests of Europe, the sharing between regions would most likely not spontaneously occur. 3.2 Harnessing talent The main objective of this section is to identify a compendium of recommended good practices in fostering reverse brain drain across Europe, and improving inter-sectorial and cross-regional mobility. After the analysis of different instruments to achieve the goals of this WP, the conclusion was the proposal of the creation of a 'Pool of biomanagers' as an effective tool to foster a reverse brain drain. General description: pool of biomanagers is a platform containing a database of high experienced specialists that will allow the entities from biopharmaceutical sector, identified as target client in this document (see below), to access to these high skilled professionals in order to enhance their competitiveness and, on the other hand, to enable these professionals to open up the possibilities of career. Expert profiles: It has been identified six expert profiles considered key positions for the optimal plan and execution of projects in such fields as drug development, diagnostic and biomedical technologies, in their early stages: - Chief EXECUTIVE OFFICER (CEO); - business development; - Chief operating officer (COO); - regulatory affairs; - preclinical development; - Chemistry, manufacturing, and controls (CMC). In the D3.2 the detailed description of these profiles can be found, including skill and duties of each job position. Importantly, all profiles must meet common requirements: - senior experts with minimum five years of international experience (recommendable ten years) in biotech, big pharmaceuticals, technology or diagnostic companies, directly involved in the development, licensing or marketing authorisation of drugs or medical devices; - strong technical and professional skills; - flexibility to switch into entities in different countries (mobility commitment will be compulsory); - entrepreneurial spirit: leadership, team management skills. Target clients: The tool is aimed at helping the entities that work on early stage development in biopharmaceutical sector. These are usually Young innovative companies (YIC), incubators, and Technical transfer offices (TTO). The pool will be restricted only for these types of the entities. Therefore, big pharmaceutical and head hunters companies will not be allowed to register as a tool user. Location: CEBR, as the European Council of Bioregions, will host the Pool of Biomanagers database on its website. CEBR is the most appropriate institution for this task because of its multiplier feature. Due to its close relation with different clusters and bioregions can act as a perfect communication channel and then facilitate the flow of information and accessibility to the pool. This will result in the dissemination of the tool much far away that among the Project partners. Operability: Log in and selecting experts To avoid a non-appropriate use of the 'Pool of biomanagers' by such companies as big pharmaceuticals or human resource companies, a previous registration of the client (YIC, incubators and TTOs) is required in order to verify its data. The client, once logged, accesses to a search form where defines the kind of experts looked for. When defined them, the client accesses to the list of experts that match the selecting criteria, classified by categories if more than one have been selected. The list will be anonymous and only the information from CV defined as public will be displayed: work experience, educational background and comments of the professional. Contacting experts: The user does not contact the experts directly. The system sends automatically an e-mail to the expert selected by the client with the information about which company is interested in acceding to his full CV. This mail will contain live links to answer yes or no depending on the expert decision. If positive, the client will receive the following information: Contact information such as telephone or e-mail, and full CV of the employee. If the answer is 'not' the additional explanation will be required on why the expert denies this access. Simultaneously, the system will send an alert to the tool administrator that the contact with the expert has been established and will inform him if the response was positive or not. Job interviews: Database manager's work will be limited to contacting job offers with professionals without any further responsibility on the selection process. However, in order to evaluate the success of the platform, the information on the results of the selection process will be collected. Two months after sending the full CV of the selected expert the client will get an e-mail with live link to the evaluation questionnaire and will be invited to answer it. Others: Dissemination actions are planned to ensure the project success and to incorporate new users from outside of the initial clusters. During the implementation of the tool all legal aspect of the terms and conditions of use will be defined. Dissemination actions are planned to ensure the project success and to incorporate new users from outside of the initial clusters. Conclusions: It is noteworthy that the objective of this platform is not the professional recruitment. The Pool aims only at facilitating a contact between the clients and the experts, so any legal responsibility of the selection process will be of its users. It is expected that the availability of the pool of biomanagers across European regions will provide the following benefits for all involved parties; biomanagers, regions and target clients: - availability of a European centralised pool of biomanagers which includes key expert profiles for an optimal development of drug projects in early stages; - availability of standardised professional profiles across European regions; - integrated system of European pool of biomanagers linked to job vacancies. The proposed design and functionalities of the pool should be attractive for the potential target users. In fact, the initial feedback received demonstrates that there is a great interest of European and United State clusters in implementation of such kind of tool. 3.4 Shared facilities Technology platforms can be broadly defined as research and / or production facilities for exploration and exploitation of new knowledge. These facilities are complex sets of instruments and knowledge, whose importance, cost and power structures the scientific community often need decisionmaking at regional (while not at national) level and multiannual funding. Technology platforms have traditionally been associated with the large scale research facilities and are engaged in 'community based' scientific information systems production, based on extensive transnational collaborations within a large number of scientists. For the production of knowledge, they heavily rely on single, large-scale and high complex tools that require very high initial investment and show high maintenance costs. In addition, these facilities are located in specific places, in environments where scientific and technical knowledge are specialised in order to properly manage and exploit the tools and their potential. With the introduction of new ways to explore living organisms, heavy instrumentation not only altered the technological methodologies to develop new products (therapeutic, diagnostic equipment) but also the way technological innovation is organised and takes place, since laboratories became more dependent on public financing both for investment and for the day-by-day management and operations. The necessity to share and to smartly combine This 'modern' model of functioning of large scale facilities, does not completely explain the real situation of life sciences technology platforms, where the 'big' presence of a large scale facility or instrument is not enough for producing high level scientific knowledge: the expertise and instrumentations required are diversified and complementary. One facility alone simply 'doesn't do the job' and also their average size is not so large in its strict sense. What is useful is the (smart) combination of different powerful tools and instruments that are used for the collection of data and their processing. This is typical of the first, initial, discovery phase, very often performed in academia and sometimes 'spill over' in the industrial sector, where the first industrial projects and the start-ups dominate the scene. On the other hand and at a different development stage, we find the privately owned technology platforms, which are specialised in a segment of the production cycle, such as Contract research organisation (CRO)s, offering production services for the pharmaceutical industry. When a technology is mature enough to be exploited without further investigation, it is often outsourced to private companies. Some technology platforms are highly stabilised, fully operational tools which run on a routine basis (e.g. sequencing platforms) while, on the other hand, some other areas are still to develop technologies that require greater investment in costly research and implementation before it is possible to expect routine work (e.g. proteomics platforms). These elements clearly emerged also during the meetings that have been organised in the first phase of Bio CT project and in the SWOT analysis. Those considerations have represented a starting point for further developments on the topic. What happens in real life is that, for each technology platform, the user is not the same. When a research facility can run on a routine basis, a set of services can be offered to customers and the production of services can be made with a standardised quality and low uncertainty of delivery time. By contrast, when platforms are constructed and used for research purposes at the same time, two types of uncertainties arise: uncertainty of science, technology and platform development and the scientific uncertainty under investigation. All those problems are affecting the real possibility to offer 'access' to SMEs for something that is more similar to a scientific service that to a Research and development (R&D) project. Scientists studying through life sciences platforms and those who work in the development of the platform itself are co-producers of scientific results, even if they are not clients of the platforms, but rather the users. Therefore, the degree of maturity of scientists and the technological advances of the instruments may influence the choice of the internal organisation. In different cases, performance criteria might not be the same and the platform manager may assign different levels of priority between different types of customers / users. When platforms are run on a commercial basis, the propensity to pay is a key criterion to select customers, while when the platforms are still in development, scientific and technological criteria prevailing for prioritising. So, to summarise, the results of initial analysis, culminated in a focused BIO-CT workshop held in Torino (Italy) on February 2010, is that research in life sciences increasingly depends on different expensive equipment and on the highly trained team of specialists present in different facilities required for their operation. This implies the need for a new strategy for the entire infrastructure of transnational research: an approach that will develop a new model to offer to the international community, particularly SMEs, the possibility to access shared facilities and the technology platforms that are necessary for the progress of companies R&D activities. The trend towards shared research infrastructure is recommended not only by economic pressures and general reason of efficiency, but also by a new focus on research activities in smaller groups with greater interdisciplinary cooperation. There are strong reasons to believe that the core shared facilities and technology platforms that will be used for both business and scientific purposes will be a standard feature in universities and research institutes in the next future. There are indications that the main facilities can represent an important tool of regional policy, as companies locate their premises wherever the best research infrastructure for their projects are. Since specific studies on the sharing of research infrastructures for life sciences do not exist, for this document we rely on information gathered from various sources, with the cooperation and advice of the project partners and the results of many interactions with dedicated professionals. It is clear that in life sciences a single facility itself, even with the best research teams, has a limited capacity in solving complex problems on its own. Literature - and specific meetings with professionals - confirmed that both academic teams and the industry can benefit of a series of distributed facilities, allowing them to be more efficient in their research and their cooperation, especially when they make use of contractual research agreements. In a shrinking credit environment this is even truer and, within the industrial world, it applies both to SMEs (in particular) and to large companies: neither of them can afford to buy all the necessary up-to-date equipment and develop all the skills to run them properly within their teams. At the same time collaboration with academia can provide relevant knowledge, including access to equipment: where the investment is too high compared to the market or when employer has identified as a potential market niche, temporary facility sharing can last in the long term. The organisation of shared mechanisms for research and early production definitely requires flexibility in its design: the flexibility to move easily from public to private and vice versa, flexibility adapt the rules of use, depending on the stage of technology development and maturity industry. This situation is in favour of hybrid solutions, where public and private initiatives seem to better answer the inputs from the industry. It is natural that such general approach has to be matched with specific local territorial conditions (i.e. availability of facilities), with the typology of the considered facility and with the degree of maturity of the specific bio-cluster where such strategy will be implemented. According to the degree of maturity of the technology, cluster and industry strength (presence of large companies, existence of a dense network of SMEs and start-ups), the delivery of scientific services by a facility can be punctual, temporary or may acquire a degree of permanence. The development of a 'new' model of sharing In coherence with the analysis and to develop and propose a new way to solve the facility problem, the BIO-CT partners decided to identify in parallel through a review of critical facilities needed, at regional level, then at a set of complementary and synergistic facilities present in different clusters that, together are covering the value from preclinical to clinical phase 1. BIO-CT main focus is on sharing platforms/facilities that are accessible and which offer a serviceâ?like type of relation and not are research collaboration. The SWOT analysis, that has been carried out at the beginning of BIO-CT, served as a background to support the selection of tools, and shown that each cluster is working on its strategic positioning and that everyone is looking for something different from the others. The SWOT analysis too has showed what is strong and what is weak in each cluster, but also the existing tools that they have developed and the tools / needs that remain to be set up or covered. The basic idea was to build on a solid basis and, by a collective and shared action plan, a common model to reinforce each cluster and its complementarities with the other, without avoiding the necessary competition that has to remain among them. In such perspective the cooperation amongst the members of BIO-CT has been facilitated by the fact that the strategic positioning of each cluster (as it emerged from the SWOT analysis) is in many parts complementary to other positioning. In order to identify the facilities to be considered for the development of the shared model some key variables have been considered: - the consistency of the facility with maturation process; - the Excellence of the facility (qualified, labelled); - the accessibility of the facility (i.e. the structure / platform is not dedicated to a specific (restricted) group of users); - the lacking of the facility in one of the other cluster; - the fact that the facility meet needs of projects / companies in the death valley; - the facility positioning along the value chain of the biotech industry (specifically from discovery to early clinical development). A last element was the consideration of the 'service' dimension i.e. the capability of the facility to be able to manage a 'service' relation with a company. The exercise has been concluded with the identification of 12 different facilities in the 4 cluster involved that respected all the criteria identified. Starting from such 12 facilities a sub group of 5 has been identified as basic core of the analysis. It was natural in meantime to try to forget the 'scientific interest' of the selected facilities and to concentrate our efforts in understanding which are the organisational, marketing economic and regulatory problems behind a shared model of access taking in account the explicit need for a self-sustainable model. We tried in such perspective to consider also what could be the specific advantages for each single facility to be involved in such approach. After a common work, the main answers can be summarised as follows: - A bigger 'market' for services: usually facilities are conceived to offer service to a local market or even to a very limited 'captive' market. The only exceptions are those facilities that, from the very beginning of their life, are conceived to be 'international'. In any case, also for those facilities, a better 'marketing proposal' could be a plus. - Better synergies with other complementary facilities, so they could be able to follow the development of a product through many different steps and to work with complementary actors. - Standardisation of internal documents and a boost to quality level assurance: facilities with more difficulties in contact with the market could learn from more advanced facilities. - Better understanding of market needs: the BIO-CT activities and tools will help them to move from fundamental research facilities to more market oriented services platforms. - Better technological integration between facilities: solutions are more and more the result of different technologies/services linked to each other. And of course integrated alongside the product value chain. - Possibility to leverage their internal asset through a pan-European offer. This will also provide more visibility out of the local territory (and, why not, also on the local stage). - If they are integrated in an international system of services, more visibility means more clients, more clients mean more money, more money means more resources to invest in R&D and new technologies. Starting from such possible advantages we analysed the different variables that a shared model has to consider in term of efficiency and efficacy and with a focus mainly on 3 different dimension: - contracting; - management; - control; - in order to develop both an organisational and a service delivery 'ideal' model to be implemented in a possible pilot action at trans-cluster level. All those activities have been realised collecting information from the facilities themselves but also from companies and stakeholders (i.e. regional authorities through their local R-SACs). The basic idea was to develop a 'win-win' model where all actors would have advantages from a full implementation of the solution. The 'ideal' model of collaboration has been developed and shared with all the cluster involved and with the selected facilities in order to allow the positioning of each territory within the model. The positioning has been done considering the stage of development of each cluster (position relative to the development timeline of a biotech cluster) and the typology of facilities already existing and that have to be built. Concretely, this has meant for a cluster to compare the facilities it has with those that the model has identified as critical for the transition of the entire system into a preclinical phase 1. After the identification of facilities that can be considered as 'lacking' or 'not enough developed' in each partner cluster during the stage of the product life cycle, it has been necessary to evaluate the real systemic impact. That has meant that, depending on the strategic vision of development of the cluster, it has been finally decided what typology of facilities had to be inserted in the pilot actions and, in a more strategic way, what could be the priorities for the strategic and logical development of the whole biotech cluster system. A 'make or buy' option has been analysed in this phase, together with financing and self-sustainability issues. The systemic approach leads to an overall definition of a common relational business model and a focus on services more than on facilities 'in se'. This approach allows to tackle from a more interesting perspective the self-sustainability issue that, in this way, is interpreted from a real 'market' point of view. This is due to the fact that the starting assumption is that if there is a 'market failure' that justifies huge public investments in building new facilities that have to be shared, the self-sustainability model will have to be 'market based'. So the role of the public sector will remain focused on maintaining an external 'positive' environment instead of the support, after the start-up phase of facilities 'in se'. This business model that has been developed as a consequence of such considerations, has been analysed on the basis of the regional policies and on the inputs provided by the different partners. Indeed, several good/best practices for the self-sustainability of biotech facilities have been shared by the partners, in order to handle different 'Business model propositions' which can be potentially applicable to every partner cluster but also, in general, to every biotech cluster. The different business model propositions have been analysed following a trans-cluster perspective, i.e. as if they are part of a trans-cluster initiative that follows the practical option to adopt a 'sharing facilities' model among the clusters involved. This is based on the idea that using synergies and managing key facilities in different territories in a complementary way, it will be possible to avoid duplications and generate economies of scale. This of course generates positive impacts on the regions, the cluster members and the facilities. Such approach also allows to simplify the financial issues related to the sharing facilities proposal: if the sharing facilities / services model is self-sustainable, it has to coordinate its activities with public policies and schemes but, at the same time, it has to follow a market approach. The resulting model is conceived as practical tool to offer a shared access to SMEs to facilities that are able (and ready) to open their platforms and services to multiple users, regardless their geographical localisation, within or outside the local cluster. The model based on a business approach, the procedures for use, the commercialisation strategies and the identification of some key starting facilities represents the basis for the proposed join action plan that contains the description of the collaborative model and of the basic strategic tools (i.e. marketing plan, standard contract, cooperative agreements, business plans, different scenarios). The identification and selection of some starting facilities permits in an immediate perspective the start-up of a pilot initiative and the definition of involvement through a transfer of experience to other clusters and to other industrial sectors. The scalability of the solution and its transferability to other technological sectors has been considered, together with policy implications and recommendations. Recommendations on implementing shared facilities In such last perspectives a basic set of recommendations have been developed: 1. Use of vouchering schemes for SME to access sharing facilities schemes (some good examples are already ongoing). 2. Inclusion of the possibility of trans-cluster sharing services schemes in public financing schemes. 3. Support the creation of state of the art facilities in complementarity with other clusters. 4. Require self-sustainability plans to facilities financed by public financing schemes. The joint action plan is not only a passive activity based on a sharing policy respecting what is already existing: the joint action plan starts from what is already existing and through an innovative way, permits a shared access to already existing facilities, for the benefit of all the players. List of websites: http://www.BIOCT.net Related documents Final Report - BIO-CT (European biotechnologies common tools)
