Bioinnovation Institute Playbook by Jesper Laursen

The BioInnovation Institute An international research, innovation and entrepreneurship initiative in Denmark

This project description presents a comprehensive concept of how to stimulate early innovation in Denmark by establishing the BioInnovation Institute: BII. The project is pending approval bythe Board of the Novo Nordisk Foundation in December 2017.

THE BIOINNOVATION INSTITUTE AT A GLANCE

BACKGROUND

THE BII VISION

BII PHASES AND PROGRAMMES

3.1 Discovery

3.2 Transition

3.3 Incubation

3.4 Growth

3.5 Case Studies

PEOPLE, ORGANISATION AND GOVERNANCE

4.1 Culture

4.2 Capabilities and Recruitment

4.3 Organisation and Governance

INFRASTRUCTURE

5.1

Laboratories and Technological Platforms

5.2 Offices and General Spaces

STAKEHOLDER MANAGEMENT

6.1 Main Stakeholders

6.2 Main Priorities

6.3 Examples of Engagement Activities

KEY PERFORMANCE INDICATORS

7.1 Critical Success Factors and Key Performance Indicators

FINANCE MODELS

8.1 Grants and Convertible Loans

8.2 Allocation of Funding

8.3 Quality Assessment and Progression Management

8.4 Funding the BII Core and Finance Operations

PRINCIPLES FOR OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS

Acknowledgement In 2015, the NNF Board of Directors initiated a number of activities investigating how to position Denmark as a leading international innovation ecosystem within the life sciences. This led to the preparation of a vision paper for the BioInnovation Institute, inspired by the strongest bioscience research hubs and incubators in the USA, Asia and Europe. Common factors for success were identified and adapted to the Danish life-science innovation ecosystem in framing BII. The vision paper was approved by the NNF Board of Directors in December 2016, conferring the mandate to develop the plans presented in this project description. As part of the development of the vision for BII, several of the hubs and institutions used as reference points, particularly in the Boston and San Francisco Bay areas of the USA, together with institutions in Israel, Norway, Singapore and Sweden were visited, each providing generous time, information and inspiration for the plans. In Denmark, numerous stakeholders from academia, industry, organisations and start-up investors in the life-sciences community have been engaged in demarcating the needs in and potential impact of furthering research idea generation, innovation and entrepreneurship in the national ecosystem. The enthusiasm and support met underway have been strongly encouraging, and everyone contributing to the plans presented here is deeply acknowledged.

The BioInnovation Institute at a Glance

New solutions through innovation in life science BII will promote collaborative, interdisciplinary, research-based innovation in the life sciences and help build viable start-up companies with the necessary skills to ensure such innovations become widely available solutions for the benefit of human welfare and society. Along with advancing health and well-being, BII will position Denmark as a leading international research and innovation centre within the life sciences.

WHAT? The BioInnovation Institute (BII) will drive the development of widely available novel solutions by: 1) Increasing the number of novel research projects with application-oriented focus, by encouraging interdisciplinary idea generation and exploration within a market-focused environment 2) Increasing the translation of viable research-based innovations into available solutions by supporting start-up company formation and early growth The research supported through grants from BII will be of an interdisciplinary nature, with a focus on applied research that translates results into solutions for the benefit of human welfare and society. Promising research by groups not affiliated with BII will also be supported through the allocation of Proof of Concept Grants to validate the technical and market potential of their research results. In order to make these solutions available to society, viable start-up companies need to be created. While not a direct objective of the Institute, it is likely that the innovative solutions and the start-up companies coming out of BII will be those with large potential markets in life-science fields applicable to human health and wellbeing.

WHERE? BII will be located in the Greater Copenhagen area and remain committed to this location with potential for further expansion. WHY? Denmark has a strong life-sciences sector with considerable public and private investment in research and development. However, this research is often limited to single disciplines, despite the value of an interdisciplinary approach being demonstrated by innovation hubs abroad. Denmark has also shown limited success in translating life-science research into realised solutions as there is very limited support currently dedicated to the early stages of start-up development, which may discourage academic researchers from pursuing commercial opportunities. Therefore, there is a need to increase the number of available solutions reaching society by not only promoting interdisciplinary idea generation, but also by encouraging a business-focused mindset while supporting nascent start-ups. WHO? BII needs to be populated by passionate, skilled, entrepreneurial individuals who are open-minded and collaborative, something that will be fostered by the culture and activities at BII. There will be an entrepreneurial focus throughout the Institute, with teams supported by a network of entrepreneurs and industry experts providing commercial insight and practical knowledge. This will be across all stages, from input into research through to hands-on training and support to turn viable ideas into start-up companies. Projects developed outside BII in academia, industry or hospitals will also be able to apply to enter the Institute, contributing to a critical mass of entrepreneurs, investigators and start-ups (also supplemented by a network beyond the Institute), further enhancing idea generation and ensuring a steady pipeline for BII. While the majority of individuals associated with BII will be investigators and start-up teams, a number of full-time employees will be recruited to support the project teams in roles critical to ensuring swift progression of viable ideas to commercially available solutions. HOW? BII will be structured into four phases: Discovery, Transition, Incubation and Growth, within which there are a number of specific programmes. Discovery brings together investigators and innovators from a multitude of disciplines to cross-pollinate ideas and develop new research projects with the potential to translate into beneficial applications. The facilities offered by BII will include a number of advanced technological platforms that cannot be found in investigatorsâ&#x20AC;&#x2122; home institutions. These will be highly specialised, driven by the needs of the investigators and their projects, and will sit alongside more general and specialised laboratory space. A pay-per-use system will ensure teams are commercially focused and also ensure the most efficient use of the facilities. Transition supports establishing proof of concept for promising projects from both Discovery and outside BII, while offering a hands-on educational programme on business formation and early planning with a view to entering Incubation. Discovery and Transition are supported by grants from BII. Incubation, backed by convertible loans, supports newly formed companies as they refine their solutions and develop a robust business plan and team capable of attracting external finance. After Incubation teams will be in a position to exit BII and work independently. Growth offers the opportunity for the start-ups to continue to benefit from the mentoring, facilities and networking opportunities afforded by the Institute while also ensuring start-up teams can continue to focus on progressing their projects rather than spending time and investment capital on relocating.

1 Background

The recommendations on the purpose, setup and content of the BioInnovation Institute (BII) have been developed based on extensive engagement with key stakeholders in Denmark and across the globe. Over 100 interviews have been conducted with key stakeholders from academia and industry, as well as investors. Feedback we have received on the proposed initiative has included comments on the global political landscape, particularly in the US and the UK, but also on the changing nature of the next generation of Danish researchers, stressing that there is a current window of opportunity for such an initiative. Recent tax structure changes in Denmark further support the timing of the initiative.1 Several innovation hubs across the globe were also visited to experience the environments first-hand. Supporting these engagements, a comprehensive best-practice research study was conducted on 92 existing start-up incubators while an in-depth quantitative cost analysis was conducted to form the basis of the plans for BII Incubation. Lastly, extensive desktop research was carried out to gather market needs, intelligence and insights in Denmark, providing the basis for the scope of BII within the life sciences. The Barriers Between Research and Solutions While crossing disciplines is known to drive innovation, it can be difficult within the traditional university setting. Moreover, interdisciplinary grant proposals often fare worse with review panels compared with projects with a narrower scope.2 It can also be more difficult for the researchers themselves to carry out interdisciplinary work as, for example, biologists and engineers will have very different vocabularies. It takes time and commitment to develop the understanding needed for successful interdisciplinary collaboration,3 along with the right settings to promote it.

“Things have changed — now people focus on big problems, and if you go for a big problem you need to be interdisciplinary.”2 Theodore Brown, first Director of the Beckman Institute for Advanced Science and Technology, University of Illinois, Urbana, USA

1 Danish Business Authority, press release 13 November 2017. Available at: https://em.dk/nyheder/2017/11-12-erhvervs-og-ivaerksaetteraftale 2 Ledford, H. How to solve the world’s biggest problems. Nature 2015;525:308–311 3 Deconinck, A. The Koch Institute, personal communication 9

Despite a strong focus on life-science research, Denmark has shown limited success in translating basic research discoveries into realised solutions able to benefit society.4 A gap exists in the ecosystem between research bodies and the start-up companies needed to bring new solutions to society. There is very limited support and resource currently dedicated to translating research findings with the potential to provide novel solutions into start-up companies, which has both practical and cultural consequences. Not only is there a lack of support and expert networks to bring business people and academics together, but investing time and resources in a start-up company to turn one’s research into a practical solution may be perceived as a high-risk opportunity, discouraging academic researchers from even attempting to do so. While the culture gap between academic researchers and those in industry appears to have narrowed in the past decade, it is still present in Denmark. Bridging this gap and bringing together academics and business people in collaboration would significantly contribute to enhancing an entrepreneurial mindset, increasing the number of ideas becoming solutions to help society. Supporting this requires financial and physical capital but it also needs to ensure the most appropriate individuals are involved and that they have access to the best knowledge, experience and social networks to establish a new culture of commercial awareness.5 This ensures their ideas progress quickly and efficiently towards becoming available solutions.

RESEARCH

INNOVATIVE SOLUTIONS

DEFICIENCIES

CULTURE

FUNDING

NETWORK

Q PROGRAMMES AND EDUCATION

OUTREACH

EXPERTS AND SUPPORT

PHYSICAL INFRASTRUCTURE

Figure 1. The ‘commercialisation gap’, preventing research from becoming fully realised innovative solutions.

The Opportunity for BII Denmark provides a solid platform on which to build BII as it is home to a strong life-science sector where industry and the government have invested substantially in research and development. Indeed, Denmark remains one of the largest funders of public research and development in the world, measured as a percentage of GDP.6 These investments have been significantly supported by the Novo Nordisk Foundation (NNF), not least with the establishment of four major research centres, renowned infrastructures such as the Danish National Biobank and clinical registries, along with many new research funding programmes. These investments have produced noteworthy results within life-science research, with Denmark now positioned in the top tier when measured by traditional bibliometric indicators.

4 IRIS 2017, Analyse af perspektiver og vækstbarrierer for udvikling af dansk biotek 5 Hargadon, A. 2010, Into the Valley of Death. Available from: www.greentechmedia.com/articles/read/into-the-valley-of-death (Accessed October 2017) 6 OECD 2017, Main Science and Technology Indicators 10

The NNF research centres and programmes have demonstrated that Denmark can attract international talent and conduct high-impact research, matching some of the best universities abroad.7,8 This research is complemented by major Danish university hospitals, which have an increasing focus on research and innovation, and Denmark holds unique registries on health, medication and related patient information that can contribute to the development of new treatment strategies and medication. Denmark is in a strong position to bridge the gap between this strong research and industry, turning that research into fully realised novel solutions. The building blocks are in place and the principles have been demonstrated; Denmark has the potential to become a leading international hub for lifescience innovation and addressing the need to facilitate translation and early innovation is among the recommendations of the recent report from Vækstteam for Life Science.9 Inspired by similar successful institutes in Europe and the US, BII will be founded on a generous grant by the NNF to society as a charitable donation, and it is this vision that the Institute seeks to serve. As outlined by McKinsey & Company,10 four major factors are important for bringing new solutions to the market: presence, connectivity, capability and support. By providing 1) the physical infrastructure, 2) access to an extensive network connecting academia, start-ups, industry and investors, 3) an increased local talent mass through attraction of capabilities, and 4) financial and expert support, BII will strongly complement the existing ecosystem and bridge the commercialisation gap.

Multi-disciplinary collaboration within a competitive, business-focused environment drives successful innovation. Larry Smarr is one of the most important synthesisers and conductors of innovation, discovery and commercialisation of new technologies across areas from the web browser to personalised medicine. In 2000, he worked with the University of California at San Diego (UCSD) and UC Irvine to establish the California Institute for Telecommunications and Information Technology (Calit2). Everyone would compete for lab space, which was intentionally kept fluid and ad hoc. Real estate occupied by nanotechnology could quickly be turned over to communications, or to something unexpected. In its 17 years, Calit2 has evolved into what Pradeep Khosla, UCSD’s chancellor, calls a “safe space where people won’t prejudge the outcome.” Which has made it a hotbed for innovation and collaboration. “There are a lot of lessons here for any corporation, any government agency, any large-scale organisation, the question is how can you get the best return, after the investment you make in capital and people, in that organisation. There has to be a superstructure that will lift up and temporarily hold together a multidisciplinary team that attacks a problem. The key to progress is to synthesise world views, scientific philosophies and competencies to make sense of the immense data that can be collected and analysed. You can’t predict the future, but if you’re going to create it, you have to be collaborative.” – Larry Smarr, 2017. https://www.strategy-business.com

7 NNF Årsrapport 2016 8 NNF Impact Assessment Report 2016 9 Life science i verdensklasse 2017 10 McKinsey & Company. Evolution or revolution? McKinsey perspectives on drug and device R&D 2012 11

2 The BII Vision

BII will bring together scientific research and entrepreneurship. A purposefully broad sector focus will encourage collaboration between a variety of disciplines with the potential to have a positive impact within the life sciences, generating novel ideas and research projects, and ultimately solutions. A business-focused mindset will be encouraged throughout BII, and the in-house specialist expertise will help support the turning of viable ideas into new start-up companies capable of attracting external investment, thereby helping generated solutions to make it to market. By encouraging novel ideas and supporting the journey from basic research to start-up, BII will help generate new solutions to promote health and well-being. Initially, the Institute will focus on biomedicine, medical technology and biotechnology as these fields are strongly represented in the Danish research and industrial communities. However, the scope of BII will be flexible and agile, adapting to changing trends and opportunities as the Institute expands, ensuring its longevity and continuity. The value and high level of innovation from interdisciplinary research is demonstrated by the success of similar institutions abroad. In BII, combining disciplines will be a defining feature and collaboration will be an important feature across the Institute.

The culture, expertise and support within BII will engender confidence in the possibility to translate research into solutions benefiting society, something even the most entrepreneurial of academics may be cautious about. This is further encouraged via the BII funding system, which takes the form of grants for initial research and transitions to convertible loans as ideas become solutions and businesses are formed around them. The environment will be highly competitive throughout the Institute to ensure that people are pushed to the best of their abilities and projects progressed towards becoming solutions, while commercial awareness will be encouraged via a pay-per-use system for access to BIIâ&#x20AC;&#x2122;s technical facilities and platforms. BII will not just encourage answers and solutions: new questions will be a key goal. A defining benefit of bringing together leading academics from an array of fields, together with entrepreneurs and business experts, is that current questions can be completely rephrased in the light of a new discipline, leading to revolutionary solutions rather than evolution of existing ones. It is also important to bring together the entrepreneurial experts and investigators early on in the process to ensure projects are given a commercial focus from inception. BII will offer generalised and speciality labs from inception, with the initial focus being in biomedicine, medical technology and biotechnology. Over time, a number of state-of-the art technological platforms and services, run by experts, will be developed to support these areas and further expand the scope of BII. The nature of these platforms will be driven from the bottom up: they will be selected and developed according to the needs of the BII investigators, providing platforms and/or services that cannot be found in investigatorsâ&#x20AC;&#x2122; home institutions. Access to these platforms, in addition to the networking and collaboration opportunities (including hands-on business experts), constitutes an exceptional proposition for entrepreneurial investigators. BII will also be of high value to academia, entrepreneurs and industry in general, offering a major stepping-stone towards commercialisation of early life-science research, which is currently missing in Denmark. The most important asset of BII will be the people, as innovation is driven by people with passion, expertise and ideas. BII will promote a culture of innovation in those who have good ideas, research skills and an entrepreneurial attitude, and the values throughout the Institute will serve to reinforce the collaborative environment with an enthusiasm for driving solutions to market. The culture will be reinforced within the Institute by the physical surroundings and infrastructure, within which a mixture of regular formal and informal meetings and social events will take place. Thus, through organised events and day-to-day interactions, the culture is reinforced, both through role model behaviour and peer-to-peer interaction; this culture will be spread beyond the Institute through outreach events, reaching international innovation hubs and fostering a network that will be key to building successful start-up companies. It is anticipated that when fully implemented, BII will have around 300 individuals associated with it. The majority will be the investigators and start-up company teams, with investigators remaining employed by their home institutions, but a small proportion will be direct employees of BII (see Section 4.3). Having a critical mass of the most appropriate people in house and associated with BII will attract further talent and continue to build the reputation of the Institute, expanding its influence beyond Denmark. It is envisaged that BII will gradually branch out, bringing together investigators and entrepreneurs from southern Sweden, northern Germany and beyond. At inception, BII will be housed within the Copenhagen Bio Science Park (COBIS) as this provides access to an excellent infrastructure in a well-suited location in Greater Copenhagen. While BII will remain committed to the Greater Copenhagen area, its success may drive expansion beyond this region.

â&#x20AC;&#x153;Diversity, and cognitive diversity more specifically, is the antidote to business-as-usual groupthink. Academic studies have repeatedly shown that cognitive diversity, as defined by differences in knowledge, thinking styles, skills, values and beliefs, is the key factor driving innovation. Teams with cognitive diversity are able to free themselves from functional bias and envision problems and solutions in disruptive new ways.â&#x20AC;? Shomit Ghose, International Advisory Board for Open Entrepreneurship 2017

3 BII Phases and Programmes

To achieve its aim of generating ideas, developing solutions and getting these to market via successful businesses, BII will be structured into four phases: Discovery, Transition, Incubation and Growth. Within these phases, there are a number of programmes through which a broad range of commercially focused ideas are generated, the most promising solutions investigated for viability, and businesses formed and refined to be able to successfully bring solutions to market. While the commercial aspects of ideas will be in focus from the early stages through input from the BII experts, there will be an increase in business focus as projects and people progress through the four phases. Furthermore, for those wishing to make use of the BII laboratory facilities, this will be through an affordable pay-peruse system throughout all phases, ensuring that teams develop and maintain a commercial focus to research and development. While individual ideas generated in Discovery may move through proof of concept in Transition and become venture-capital-attracting start-ups in Incubation (which may remain at BII within Growth), this will not be a closed, end-to-end system; projects, people and start-ups may enter and leave BII at various points through the phases, and individuals may be involved across more than one phase simultaneously. Indeed, as the initiative progresses there will be an increasing pool of investigators experienced at turning ideas into innovative solutions and successful businesses, something to be leveraged in encouraging those new to the Institute. Similarly, as this will not be a closed system it will be possible for external investigators and businesses to access the resources and support across all phases, including the state-of-the-art technological platforms to be developed (see Section 5.1).

GROWTH

External funding

Business growth

POST-INCUBATION

Convertible loan TRACTION FACTORY

INCUBATION Business formation and solution refinement

Convertible loan CREATION HOUSE

Accelerator Grant BUSINESS ACCELERATION ACADEMY

TRANSITION Proof of concept and business planning

Proof of Concept Grant PROOF OF CONCEPT

Discovery Grant

DISCOVERY

INVESTIGATOR PROGRAMME

Idea generation and research

Figure 2. Overview of the four phases of BII and the overall aims of each phase. The focus throughout BII is on speedy progression towards the market.

TRACTION FACTORY

DISCOVERY

3.1

INCUBATION

The goal of Discovery is to generate a portfolio of ideas for novel solutions in the life sciences with the potential to impact human health and well-being, thereby providing a pipeline of interdisciplinary CREATION HOUSE projects for entry into Transition and Incubation. The initial scope for BII will be within biomedicine, medical technology and biotechnology, but the scope is expected to broaden over time. Discovery’s structure and activities serve to catalyse collaborative innovation by providing a challenging forum for enthusiastic researchers to meet and generate and develop new ideas. They will have BUSINESS ACCELERATION ACADEMY access to the support and resources of BII and the wider network to robustly explore their ideas from TRANSITION a scientific and technical viewpoint, while ensuring their ideas and projects are focused on delivering solutions with the greatest impact on society. PROOF OF CONCEPT

DISCOVERY DISCOVERY

INVESTIGATOR PROGRAMME

INTERDISCIPLINARY IDEA GENERATION AND EXPLORATION •

Discovery Circle of investigators facilitated by two Lead Investigators

•

Regular Discovery Circle Meetings for idea generation and Business of Innovation Meetings for entrepreneurial input

•

Outreach activities at home institutions and beyond, to expand the reach of the BII network

•

Discovery Grant contributes to ongoing research along with the development of novel interdisciplinary projects

DISCOVERY CIRCLE

INVESTIGATOR PROGRAMME

Technical lead Innovative idea

Discovery Grant

BII Transition or continuation of research elsewhere

ENTRY CRITERIA

FUNDING

EXIT PATHWAY

Figure 3. Overview of the Discovery phase and its associated Investigator Programme.

The selection process for Discovery will prioritise people, potential and projects. While those selected to become part of Discovery will have demonstrated robust scientific excellence, they may not necessarily be those with the most impressive academic track record in their particular field. Rather, an entrepreneurial, open and ambitious personality, commitment, drive and potential will be most important. Commercial experience or eagerness will likewise be important. BII will also be open to proposals from researchers from industry.

Discovery Circle At the heart of Discovery is the Discovery Circle, a network of enthusiastic and tenacious investigators across disciplines with the potential to have an impact within life science, brought together to promote a culture of idea sharing, research and innovation. The Discovery Circle will comprise approximately 40 investigators, ideally from a wide range of disciplines and institutions, with a mix of seniority from the post-doctoral level to senior researchers. It is anticipated that, over time, elements of the Discovery Circle will naturally coalesce according to speciality. While interdisciplinary idea generation is encouraged, it is a natural expectation that speciality-driven subgroups will develop within the Discovery Circle. The group will be facilitated by two Lead Investigators (see Section 4.3), serving as role models and advisors as well as leading the group in more practical elements such as chairing meetings. The Discovery Circle Investigators will remain based at their home institutions but will participate in Discovery Circle Meetings and will be encouraged to make best use of both the Discovery Circle network and the wider BII network of experts, further enhancing a culture of cooperation and innovation in the Danish research community and beyond.

Profile of a Discovery Circle Investigator The aim of BII Discovery is to generate a portfolio of innovative ideas with the potential to become commercially successful solutions in the life sciences. To best achieve this, the Discovery Circle needs to be populated with researchers who are most likely to thrive in the collaborative, entrepreneurial environment it provides, enabling the whole to become greater than the sum of its parts. The key attributes for a member of the Discovery Circle are: • Eagerness for innovation • Scientific excellence and contribution to science • Collaborative skills, including willingness to work across disciplines • Open-mindedness and creativity • Entrepreneurial spirit

Face-to-face interaction is vital for collaboration and idea sharing. In addition to ongoing peer-to-peer interaction and social activities, Discovery Circle Meetings will be held regularly, either as more frequent one-day or less frequent two-day meetings according to logistical challenges determined by the geographical spread of the investigators. It will be a condition of the Discovery Grant that investigators attend a majority of these meetings. Discovery Circle Meetings will be structured to provide both a forum for idea generation across disciplines as well as updates from the investigators themselves on their ongoing research for Discovery Circle input. These meetings will be supplemented by Business of Innovation Meetings in which the Discovery Circle is joined by members of the Entrepreneur Mentor Circle (see Section 3.2) and other selected experts and entrepreneurs who have successfully taken ideas through to commercialisation. The purpose of this is to provide a commercial anchor to proceedings, ensuring the idea generation and exploration of the Discovery Circle remain committed to addressing commercially viable solutions with the potential to impact society. Given the attributes of the investigators to be selected for the Discovery Circle, it is anticipated that they will be very keen to become ambassadors for BII and work to expand the network beyond BII and into academia. In addition to the BII-centred meetings, the Discovery Circle Investigators will contribute to outreach activities at their home institutions, spreading the culture of innovation beyond BII while raising awareness of the Institute, its goals, activities and resources.

INVESTIGATOR PROGRAMME The Investigator Programme is the platform for the research of the Discovery Circle Investigators. Participants will be funded by the Discovery Grant, which covers expenses for their own research, paid in yearly tranches to fund operating expenses, small equipment, salary/technical assistance and, if the awardee is a clinician, salary for a substitute clinician to support the clinical responsibilities of the awardee. Some investigators may then take mature projects into Transition or qualify for an additional amount by developing collaborative research ideas together with other members of the Discovery Circle or, where appropriate, researchers from outside of the Discovery Circle. It is expected that investigators come together across disciplines to develop proposals as co-applicants (one of whom must be a Discovery Circle member). Additional funding may also be made available for external collaborators to ensure all potential initiatives can be explored. There will be a broad remit for proposals but they must be innovative and have potential within the life sciences, and encompass at least two disciplines. A simple application process will be developed for the selection of Discovery Circle Investigators, differing from a classic research grant in that it will be designed to assess potential for collaborative innovation. Based on open calls and assessed by an evaluation committee of international scientific experts and entrepreneurs (see Section 4.3), applications for the Discovery Grant/Circle will be assessed in terms of personal attributes (motivation, creativity, initiative, collaboration), experience and eagerness to work on interdisciplinary research, and evidence of ideas and vision for how other disciplines and perspectives could advance their ongoing research as well as impact novel ideas that have the potential to become applied solutions in the life sciences. There will be an expectation for investigators to demonstrate new ideas with commercially viable potential and push these through the pipeline into Transition and Incubation. To maintain a competitive environment, project monitoring will mostly be achieved through frequent discussions, interaction and the general presence of the BII leadership. Once they have progressed sufficiently, projects will be evaluated for entry into Transition. At the end of the five-year Investigator Programme, investigators may continue to qualify for another Discovery Grant or they may leave BII and continue their research elsewhere. Idea Generation Within the Investigator Programme As the Discovery Circle is formed, the investigators will be carrying out their own general research, supported by the initial Discovery Grant funds, but the crucial goal of the Discovery Circle is the development of novel research ideas to feed the pipeline for Transition and Incubation. The Discovery Circle Meetings, facilitated by the Lead Investigators, will catalyse the development of such ideas by bringing together the selected investigators into an inspiring forum encouraging ambitious creative thinking and collaborative discussions. At the Business of Innovation Meetings, the Discovery Circle will be joined by members of the Entrepreneur Mentor Circle and other members of BII, to provoke new thinking. They will also provide insight into scalable solutions to significant problems, while ensuring projects are viewed through the lens of market demand.

As individual research projects progress and new ideas are explored (with positive or negative outcomes), there will be interdisciplinary feedback and refinement, which may in turn spawn further new ideas. The process will be further seeded through input from BII investigators and entrepreneurs but also through the involvement of investigators from outside BII. The overall result is a synergy between the various groups – both within BII and with external investigators – with robust feedback channels established to maximise idea generation and refinement. While openness and sharing of ideas are cornerstones of BII, it is fully acknowledged that many scientists and entrepreneurs are concerned about confidentiality. A confidential disclosure agreement (CDA) covering all matters discussed in Discovery will be signed by the participants. Failure to comply with these basic rules will lead to immediate termination of all engagements with BII.

Call for Applications for BII Discovery Investigatorships The BioInnovation Institute (BII) promotes collaborative, interdisciplinary, research-based innovation in the life sciences and helps build start-up companies with the necessary skills to ensure these innovations become widely available solutions for the benefit of human welfare and society. A key component of BII is the Discovery Investigator Programme, which aims to bring together a diverse group of investigators to cross-pollinate ideas and expertise to develop new research avenues. The Discovery Grant provides financial support for investigators’ ongoing research interests at a level of up to DKK 1 million per year over 5 years. An additional element to the Discovery Grant is awarded, up to a further DKK 5 million, to pursue novel research ideas developed during Discovery. Moreover, investigators will have access to BII core facilities and cutting-edge technology platforms. Investigators will play an important role in building the BII collaborative scientific and entrepreneurial culture, and will be expected to attend regular scientific meetings. BII welcomes applications from diverse disciplines such as engineering, computer science, informatics, the physical sciences as well as the biomedical sciences. BII encourages enthusiastic applicants who are at an early stage of their career. The application form calls for the following items: 1) The applicant’s curriculum vitae including a complete bibliography 2) An account of the applicant’s major research accomplishments and descriptions of the applicant’s most important papers 3) A personal statement detailing the applicant’s ambition and ideas for interdisciplinary collaboration Adapted from the Chan Zuckerberg Biohub call for applications

POST-INCUBATION

3.2 TRACTION FACTORY

TRANSITION

The goal of Transition is to take the most promising ideas explored during Discovery, or invited in from INCUBATION outside BII via open call or active scouting, and demonstrate feasibility together with developing a plan for commercialisation, guided by expert mentors. This plan will serve as the application for entering Incubation. CREATION HOUSE

BUSINESS ACCELERATION ACADEMY

TRANSITION TRANSITION PROOF OF CONCEPT AND EARLY BUSINESS PLANNING •

Establishing proof of concept for ideas developed by the Discovery Circle and external researchers

•

Business formation educational programme

•

Identify a significant market opportunity and understand what a new business model needs to look like in this market

•

Support in establishing appropriate network contacts

DISCOVERY

EXTERNAL RESEARCH

DISCOVERY

BUSINESS ACCELERATION ACADEMY

PROOF OF CONCEPT

INVESTIGATOR PROGRAMME

Feasibility

Accelerator Grant

Creation House or exit BII

A promising research-based idea

Proof of Concept Grant

Business Acceleration Academy, Creation House or exit BII

ENTRY CRITERIA

FUNDING

EXIT PATHWAY

Figure 4. Overview of the Transition phase and its programmes.

PROOF OF CONCEPT The Proof of Concept Grants are intended as a tool to identify and develop projects with the potential to move into the Business Acceleration Academy and Incubation; that is, likely viable business opportunities. In addition to Discovery Circle Investigators, Proof of Concept Grants will be available to external investigators by open call as a key purpose of these grants is to foster innovation for academics not affiliated with Discovery, thereby building a strong pipeline of potential projects to proceed into Incubation. This is furthered through active scouting for research projects to be invited in to BII, from academia, research hospitals and industry. In all cases, there will be an expectation to actively share the research with, and draw upon the expertise of, the BII experts. To be eligible to receive a Proof of Concept Grant, research projects will need to show clear potential. Those that successfully demonstrate proof of concept may be evaluated for proceeding into the Business Acceleration Academy or directly to Incubationâ&#x20AC;&#x2122;s Creation House.

BUSINESS ACCELERATION ACADEMY Following demonstration of feasibility and evaluation, the Business Acceleration Academy supports the development of an initial business plan to confirm the commercial opportunity. An Accelerator Grant is available to support items such as salary, consultancy and travel expenses. As with Proof of Concept, this programme is aimed both internally and externally through outreach to universities and hospitals, and offers teams an intensive, three-month programme of educational modules and mentorship. The programme is expected to run twice a year. To enter this programme, technical feasibility will have been demonstrated and the goals of the programme are to explore commercial opportunities, the overall approach to business and scalability, and to explore the key assumptions to be able to commercialise. The programme will revolve around mentoring sessions, fieldwork, presentations and feedback processes, together with educational modules. Examples of the latter are provided in Figure 5. Industry-specific scientific and commercial mentors will help the project teams to establish contact with potential stakeholders, such as relevant industry, customers and potential investors. The key outcomes of the Business Acceleration Academy are the early business plan, extensive stakeholder feedback and early-stage traction, a pitch and a team with relevant competencies to deliver on the business plan. At the end of the programme, there will be a Demo Day where start-ups will present their progress. The presentation will be open, to increase visibility and competition and enable matchmaking with early investors and potential partners. The best teams may then be offered the opportunity to establish a start-up proceeding into Incubation or they may leave BII.

BUSINESS ACCELERATION ACADEMY MODULE EXAMPLES

WELCOME

Welcome, intro, programme, outcome of programme, mentor and advisory board establishment

Concept and idea development

Product: roadmap, requirements

User test: customer understanding

Market access, competitor landscape and value chain understanding

Business model

IP law and legal issues

Action plan and team development: KPIs, milestones, experiment design, phases

Go-to-market models and marketing

Strategic partnerships

Financing, accounting and budget

Storytelling and pitch training + Demo Day and early business plan

Figure 5. Overview of educational modules included within the Business Acceleration Academy programme.

Entrepreneur Mentor Circle To help guide teams through Transition and Incubation a network of entrepreneurs will be established: the Entrepreneur Mentor Circle. Anticipated to initially comprise approximately 20 serial entrepreneurs, business angels, venture capital managers, corporate directors and similar, the group is expected to grow over time. These mentors will come from start-ups, academia and industry in Denmark as well as from innovation hotspots across the globe. The Entrepreneur Mentor Circle will be facilitated by two Lead Entrepreneurs. The members of the Entrepreneur Mentor Circle will provide hands-on mentorship to the Transition and Incubation start-ups. As projects develop, complementary expertise and experience will become evident and members of the Entrepreneur Mentor Circle will be assigned to certain start-up teams. These mentors will help identify business strategies unique to each innovation, and support the development of relationships with industry and appropriate strategic partners. They will also interact with the Discovery Circle Investigators at project pitch events, offering their commercial insight. Their influence will extend beyond BII as they too become ambassadors for the Institute, spreading the innovative culture while scouting for projects. In return, the Entrepreneur Mentor Circle members gain early insight into investment-grade projects, with the potential to become CEOs or board members of Incubation start-ups, the possibility of licensing opportunities; as well as being part of a prestigious network. They also receive appropriate remuneration for their time.

3.3

INCUBATION

BII Incubation supports companies in their early life as they begin to execute their business plans and refine their solutions. The early development stage of a business is crucial for success; Incubation offers a business-building platform and tailored guidance through this stage. It is anticipated that when fully implemented, there will be around 30 companies in various stages of maturity through Incubation GROWTH at any one time. The end of Incubation is marked by start-up teams achieving closure on series A financing for initial operation from a venture capitalist firm or a corporate investor. POST-INCUBATION

TRACTION FACTORY

INCUBATION INCUBATION BUSINESS FORMATION AND SOLUTION REFINEMENT

CREATION HOUSE

•

Identify a repeatable and scalable business model

•

Continue to refine product and seek external funding

•

Flexible phase with programmes and resources available according to individual needs

•

Funded by convertible loans from BII

BUSINESS ACCELERATION ACADEMY

TRANSITION

EXTERNAL PROJECTS

TRACTION FACTORY

Completed Creation House but further development required

DISCOVERY TRANSITION

CREATION HOUSE

Convertible loan

PROOF OF CONCEPT Growth, Exit BII

INVESTIGATOR PROGRAMME Business plan, complementary team, control of IP

Convertible loan

Traction Factory, Growth, Exit BII

ENTRY CRITERIA

FUNDING

EXIT PATHWAY

Figure 6. Overview of the Incubation phase and its programmes.

Incubation provides facilities and expert assistance to the teams, helping them to engage external investors and launch as start-up companies, thereby bringing their innovative products to market in the smoothest possible way. Therefore, teams graduating from Incubation will have achieved the following: • • • • •

Produced a prototype/lead candidate (following proof of concept) Begun executing a robust business plan Developed a team with the complementary skills needed to fully execute the business plan Obtained the necessary rights from the institutions owning the intellectual property (IP) Obtained or be ready to obtain venture capital/business angel financing or been acquired/received investment from a corporate organisation

The Incubation programmes represent a framework that is tailored to individual projects, teams and life-science sector according to need. Applying a stage-gated approach is a way for BII to mitigate risk and optimise resource utilisation: certain requirements will be defined for project teams to advance to their next stage of convertible loan funding, encouraging competition and progression and increasing the likelihood of success. The funding corresponds to the costs incurred by projects during the different development phases, which vary according to industry type, including basic salaries, product development costs and external consulting services. It is anticipated that successful projects may stay in Incubation for up to 3 years, within which teams will be expected to deliver on key milestones and continue to show progression.

CREATION HOUSE

The goal of the Creation House is to develop a prototype/lead candidate, supported by a robust business plan, behind which stands a skilled team able to confidently secure external funding. At this point, if teams have secured an external investor they may exit BII or remain within the Institute under Growth. If they require additional support before they are able to secure external investment they may also enter the Traction Factory. Within Creation House, teams will refine and execute the business plans developed during the Business Acceleration Academy programme (or independently for external teams entering BII in this phase), with a scientific focus on the development of prototypes or demonstrating the â&#x20AC;&#x2DC;druggabilityâ&#x20AC;&#x2122; of a new target. A lot of this work may be outsourced beyond BII as this is often the most efficient approach. Startup teams may additionally outsource basic key tasks such as legal, reporting, IT and accounting to BII support staff, allowing the teams to focus on research and business development. Any mature project entering the Creation House directly will be assessed on the strength of the business plan as well as excellence of research, meeting a significant and currently unmet need, and have a potential market. Of equal importance will be the project team. Teams entering BII should be strongly committed, willing to embrace risk and have the drive to learn, execute and deliver the plan. In addition to the continuing peer-to-peer informal and social activities, as part of the Creation House, teams will also attend Presentation Days, when all teams meet to update on project progress. These days will also be attended by the Entrepreneur Mentor Circle as well as external experts. Teams at similar stages and with comparable projects will be grouped to allow experience exchange and knowledge sharing on a scientific as well as an entrepreneurial level. Mentoring will also focus on assisting teams in establishing strategic, commercial partnerships.

TRACTION FACTORY The Traction Factory is a programme within Incubation for teams requiring further refinement or expansion of a project to gain traction and secure external funding. This may be a requirement for certain life-science sectors that require a greater degree of customer-centric product testing, while in other sectors there may be additional factors that could not have been foreseen that need to be addressed before teams can attract the external finance they need to become financially independent. Unlike many of the programmes within BII, the Traction Factory cannot be entered directly from outside the Institute; this programme is for Creation House alumni only. Funding for both the Creation House and the Traction Factory will be provided in the form of convertible loans, as described further in Section 8.1.

3.4

GROWTH

Teams completing the Incubation phase have the option to exit BII and work independently. However, there are clear benefits to remaining affiliated with and working within the Institute during the infant stages of the business.

GROWTH GROWTH BUSINESS GROWTH AND NETWORKING

POST-INCUBATION

•

Option for BII-graduating start-ups to continue to base themselves within the Institute

•

Continued benefit of facilities and network

•

Allows teams to focus on growing their businesses

•

Lab pay-per-use and office space rent at market rates

TRACTION FACTORY

INCUBATION

CREATION HOUSE INCUBATION

POSTINCUBATION

Fully funded, customer-validated product

ENTRY CRITERIA

External

Exit BII

FUNDINGBUSINESS EXIT PATHWAY ACCELERATION ACADEMY

TRANSITION Figure 7. Overview of the Growth phase.

OF CONCEPT The teams continue to benefit from the network and infrastructure of the PROOF Institute, giving them time to grow, take over support functions themselves and complete the move to a fully externally funded and operating company. Rather than pause their activities and use initial investment to relocate, teams are able to maintain focus on their work while remaining at BII. However, to ensure they are able to survive outside of BII when they eventually move on, they will pay market rate rent for offices within BII INVESTIGATOR PROGRAMME DISCOVERY and for access to BII’s facilities.

Start-up teams also continue to benefit from the various informal meetings and social events held at BII, expanding their network and potentially seeding further ideas. BII will also be able to continue to provide guidance for networking beyond the Institute, as well as continued ad hoc support and guidance with regards to fundraising. It is beneficial for BII to keep these companies affiliated with the Institute as these teams are now very experienced and can share their expertise and encouragement with project teams at earlier stages. Thus, they become role models and mentors themselves. They may also be invited to become part of the Entrepreneur Mentor Circle. For start-ups that take advantage of the opportunity to stay beyond Incubation into Growth, each will have a distinct optimal growth plan and BII will adapt to that. However, the rental agreements with BII will be of fixed duration, allowing review of progress and providing a natural limit to post-Incubation stay.

3.5

CASE STUDIES DISCOVERY

Biology meets engineering: Institute-driven multidisciplinary collaboration leading to new solutions. Together with a multidisciplinary team of collaborators, Donald Ingber and colleagues at the Wyss Institute have made a game-changing advance in microengineering and produced what they describe as ‘organs-on-chips’. These chips are composed of a flexible polymer with hollow microfluidic channels, lined with living human cells, and present an ideal microenvironment to mimic human-specific pathophysiologies. The construct has innumerable applications, including discovery of new therapeutics, investigation of the living microbiome in direct contact with living human intestinal cells, exploration of viral strategies upon infection or the examination of harmful effects from environmental factors like cigarette smoke. A Wyss Institute-launched start-up company, Emulate, Inc., has licenced the technology and is now further developing and commercialising the organs-on-chip technology and automated instruments to improve industrial development and personalised medicine. https://wyss.harvard.edu

TRANSITION

Business development acceleration programmes: Pushing research toward beneficial solutions. IndieBio is a USA-based, 4-month acceleration programme for people with life-science-based business ideas. The focus is on developing business cases and the process of improving business cases and products in response to customer interaction. An IndieBio alumnus, Holly Ganz, used to work at the University of California, Davis, where she developed a computational pipeline for analysing microbiome data and identifying microbial biomarkers of disease. She entered the programme with an idea of offering an improved specialist diagnostic tool for pets. During the acceleration programme at IndieBio, she changed her product assumptions and pivoted from her original business plan: “During the IndieBio programme, we were faced with a huge consumer interest in solving pets’ digestive problems. To meet this need, I developed an oral–faecal microbiota transplant pill. Currently we offer this product with a companion diagnostic. The pill is stable at room temperature and highly effective at meeting customer requirements.” http://indiebio.co/

INCUBATION

BII aims to nurture home-grown talent, allowing researchers to realise their full potential, and to establish Denmark as a leading commercially aware innovation centre to prevent such talent looking elsewhere for support. Magnetic Insight promotes magnetic particle imaging, a non-toxic and non-radiative diagnostic tool for procedures such as cell therapy monitoring or neurovascular imaging. It employs a robust artificial intelligence platform for truly quantitative data and deep-learning diagnostics. The founder and CEO of the company, Anna Christensen, completed her PhD at the University of Copenhagen and despite working with cutting-edge science, did not find support for the commercialisation of her technologies. Upon moving to the US, Anna started pursuing her dream of bringing new solutions to market and received funding from SBIR, an American commercialisation support programme, in October 2014. She then participated in Start-X, CLSI FAST and moved into the Triple Ring Technologies incubator. In June 2016, she signed a strategic partnership with nanoparticle developers and a month later got over-subscribed seed series funding. In August 2016, the company initiated a development partnership for product optimisation, shipped its first unit in September 2016 and started generating revenue in January 2017. Annaâ&#x20AC;&#x2122;s team now comprises 16 people and continues to grow. â&#x20AC;&#x153;To me, the ability to sign industrial partnerships, raise funding, attract customers and generate revenue has come from strong mentorship, interaction with experienced peer CEOs, start-up training, investor-friendly funding schemes, not to mention branding from the programmes I have been through,â&#x20AC;? Anna says. https://www.magneticinsight.com; personal communication

GROWTH

Bringing businesses together to make the whole greater than the sum of its parts. Arzeda uses computational protein design and synthetic biology to develop a portfolio of proteins and speciality chemicals for polymers, advanced materials and health and nutrition products. Arzeda’s proprietary platform and validation process rapidly creates ‘cell factories’ that can be used on an industrial scale to create opportunities and solve problems that would otherwise be impossible to address. Arzeda has a long track record of collaboration with industry and in late 2017 it signed a partnership with TeselaGen Biotechnology Inc., a software company providing automated DNA design solutions with its Synthetic Evolution™ software platform. This collaboration will yield an advanced information technology system for the forward engineering of microbial systems. “These tools will accelerate our design–build–test cycle, which will enable us to get products to market faster,” says Arzeda’s CEO. Michael Fero, PhD, CEO, TeselaGen, says, “TeselaGen is building a platform that automates and optimises protocol generation and information flow for biomanufacturing. Our hypothesis is that biotechnology is essentially an information technology. Improving the flow, handling and interpretation of information is a tremendous accelerant for biotech product development.” http://qb3.org

4 People, Organisation and Governance

CULTURE

4.1

In order to be successful in fostering collaboration and support among researchers, entrepreneurs and experts, BII needs to be populated with individuals sharing certain core values as outlined below. While commercial focus and ruthless objectivity is a fundamental aspect to BII, the Institute aims to provide an inspirational hub for investigators and start-ups rather than a â&#x20AC;&#x2DC;corporateâ&#x20AC;&#x2122; environment. This culture should be tangible to everyone working at or visiting BII to foster trust and inspiration within and beyond the Institute.

BII Cultural Values Open-mindedness and trust An open mind is required to foster disruptive ideas in an interdisciplinary setting and enable the best ideas to be brought forward. The ability to actively listen and learn from each other in a trusting environment, while respecting the ownership of other individualsâ&#x20AC;&#x2122; ideas, is essential. Those welcoming constructive feedback are more likely to have potential obstacles removed efficiently; individuals should see failure as an opportunity to learn. Collaborative The sharing of knowledge, ideas and perspectives is a core aspect of being part of BII. Passionate Everyone at the Institute should be passionately engaged in what they do and be willing to take risks to explore and advance their ideas. As well as possessing a strong drive to expand their current work they should be excited by the BII mission of driving life-science innovation in a competitive environment.

While there will be permanent BII employees as described below, most members of the Institute will not be employed by BII. Many will be contracted to their host research institutions and others will be linked to their companies. Nevertheless, the focus on shared values and consistency in people management should serve to create a strong and unified BII. Furthermore, while there will be a significant turnover in those affiliated with BII (as investigators come to the ends of their grants and project teams exit, new investigators and new teams will enter), a robust culture-building process will be developed to instil the core values and working practices of the Institute, reinforced by the array of informal meetings, social events and peer-to-peer interactions that will be organised and/or promoted by BII.

CAPABILITIES AND RECRUITMENT

4.2

Certain key functions will be brought in house in the form of the permanent BII staff. Positions related to vital capabilities will be prioritised and filled with the strongest talent either from within the organisation, from Denmark or from abroad. These critical positions will be targeted with a recruitment strategy to ensure strong affiliation with BII. Other roles may be initially outsourced or filled by contractors to provide flexibility. The recruitment plan needs to be backed by competitive remuneration and considerations around flexible working arrangements, particularly where the positions are critical and talent is scarce. However, the strong value proposition of BII, including its culture and career prospects, will support recruitment and retention. With respect to building competencies within BII, on-the-job training and mentoring will be available to all, particularly with regards to building entrepreneurial skills, together with more structured internal and external training programmes.

ORGANISATION AND GOVERNANCE

4.3

The BII organisation will be multifaceted as the Institute will be home to self-organised and partly self-governing project teams and start-ups. BII will support this feeling of independence and ownership as it encourages entrepreneurism and there will be clear governance, clarity in terms of funding and intellectual property, efficient decision-making and transparency with regards to expected performance. However, the interdependence of the teams will also be cultured to ensure knowledge sharing, learning and exchange of experience among researchers and entrepreneurs across BII. Governance BII governance will be designed to enable effective, continued innovation and maturation of start-ups through efficient decision-making and close collaboration across BII. It will provide a structure through which the objectives of the Institute are set, and the means of attaining those objectives and monitoring performance are determined.

Board of Directors

Lead Investigator

Head of Science and Technology

Director

Advisory Board

Head of Operations

Head of Business and Entrepreneurship

Lead Entrepreneur

Figure 8. BII governance outlining the Leadership Team (solid outlines), including both full-time employees (solid rectangles) and associated roles (solid circles) in addition to the Board of Directors and Advisory Board.

Board of Directors The Board will consist of 6â&#x20AC;&#x201C;8 members, representing the entire BII value chain from idea generation to product, and will provide a thorough understanding of the environment in which BII operates. The Board of Directions shall collectively cover the value chain from early research through innovation and venture investment to a potential stock exchange listing of the company, with experience in, for example, entrepreneurship, industrial management, research, innovation, technology, investment, and people management and development. The Board sets the vision, strategy and direction of BII as well as having overall responsibility for budgets. They will also be responsible for hiring the Director and the rest of the BII Leadership Team. Externally, the members of the Board are expected to advocate for the Institute and its mission. Not least, this includes engagement with NNF, the founder of BII. Leadership Team The BII Leadership Team will consist of 8 members, and will play a central role in anchoring the values of the Institute and ensuring that those joining BII expand its values and ideals. Their responsibilities include reviewing BIIâ&#x20AC;&#x2122;s overall performance and optimising operations as needed in line with the strategy, adherence to integrity and risk assessment. Through their daily work, they will play an active role in setting the tone on aspects such as ethics and values.

DIRECTOR

Overall responsibility for implementing the strategy set by the Board, for developing the annual business plan, for meeting the BII key performance indicators, and for the day-to-day running of the Institute. A key task for the Director will also be to attract mentors and relevant staff, and to develop and strengthen the BII network.

HEAD OF OPERATIONS

Responsible for administrative tasks including HR, finance, PR, internal events and outreach. He/she will also lead the secretariat, taking care of calls and applications, and be responsible for all key support staff.

HEAD OF SCIENCE AND TECHNOLOGY

Together with the Director and the Discovery Evaluation Committee, responsible for identifying the technological platforms to be developed at BII. He/she will be responsible for running these platforms and the general and special labs as well as for the technical and scientific expert staff. He/she will also run Discovery Circle operations with regard to planning, logistics and facilitation. The Head of Science and Technology will act as the secretary for the Discovery Evaluation Committee.

HEAD OF BUSINESS AND ENTREPRENEURSHIP

Responsible for commercial support functions, intellectual property, and tax and legal as well as the commercial expert staff. He/she will also run Entrepreneur Mentor Circle operations with regard to planning, logistics and facilitation. The Head of Business and Entrepreneurship will act as the secretary for the Incubation Evaluation Committee.

LEAD INVESTIGATORS

The two Lead Investigators should be at a professor level and be employed at a Danish university. Their presence at BII will be part time and they will lead the scientific direction for BII and serve as inspirational role models. They will be responsible for the Discovery Circle, for attracting talented scientists to the Discovery Circle and for supporting collaboration among Discovery Circle Investigators, including chairing meetings. They will also chair the Discovery Evaluation Committee.

LEAD ENTREPRENEURS

The two Lead Entrepreneurs will be employed by industry or a biotech company and be at BII part time. They will be responsible for attracting expert mentors from industry and start-up companies and for leading the Entrepreneur Mentor Circle. They will assist in identifying exit strategies for individual start-up teams and help incubees develop relationships with industry and strategic partners. They will also chair the Incubation Evaluation Committee.

Figure 9. Outline of responsibilities for the Leadership Team members.

Advisory Board An Advisory Board consisting of 4â&#x20AC;&#x201C;6 members will be assembled. Their primary responsibility will be to challenge and advise the Institute on vision, strategy and the long-term approach. Advisory Board members will be highly experienced individuals from the international environment of life-science innovation. They will provide their input via the BII Director. Evaluation Committees Two evaluation committees will be established; a Discovery Evaluation Committee and an Incubation Evaluation Committee (also evaluating Transition phase awards). Each committee will consist of 4â&#x20AC;&#x201C;6 members, with supplementary support from relevant experts and between committees as needed, especially where specific life-science sector experience is required. The members of the evaluation committees are selected by the Board and include the Lead Investigators and the Lead Entrepreneurs. The primary task of the evaluation committees will be to evaluate and prioritise applications for Discovery and Transition/Incubation and prepare a recommendation. They will also oversee project development in terms of milestones and project-gating. An important responsibility will be to identify projects that may need to be deprioritised or stopped. The Head of Science and Technology will act as the secretary for the Discovery Evaluation Committee and the Head of Business and Entrepreneurship will act as secretary for the Incubation Evaluation Committee.

Discovery Evaluation Committee

Lead Investigator

Incubation Evaluation Committee

Director

Head of Science and Technology

DISCOVERY

Head of Operations

Head of Business and Entrepreneurship

Lead Entrepreneur

INCUBATION & GROWTH

Figure 10. Division of the Leadership Team into evaluation committees, to be supplemented by additional permanent committee members.

Project and Start-up Teams The composition of project and start-up teams will vary according to the nature of the project and the point it has reached on the journey from idea to product. Discovery Circle Investigators will have ongoing research at their home institutions, where they will remain based, but will meet regularly as part of the Discovery Circle. They may also conduct some of their research with the Institute using the general laboratories and platforms. Teams entering Incubation (either from Discovery or externally) will consist, as a minimum, of a technical lead and a commercial lead. The Entrepreneur Mentor Circle (see Section 3.2) will primarily support the start-up teams within Transition and Incubation but will also provide regular insight to the Discovery Circle Meetings, in particular the Business of Innovation Meetings. At any point in time, across the phases and units in BII, the team composition should reflect the mixture of competencies required to ensure best possible progression.

BII Staff BII will hire staff to support the projects and technological platforms of the Institute as well as running the various programmes and performance evaluations. The overarching responsibility of the BII staff is to help increase the value of the teamsâ&#x20AC;&#x2122; projects and facilitate the journeys from research to commercialisation. BII will be staffed by employees on a mixture of full-time and part-time contracts and, as a shared resource, they will provide important connections across the Institute, reinforcing the culture and environment.

SUPPORT STAFF

SCIENTIFIC EXPERTS HR specialists IT specialists Legal specialists Fundraiser specialists Accounting and financial analysts

Medicinal chemists Biochemists Biologics specialists Bioinformaticians PKâ&#x20AC;&#x201C;PD specialists Software engineers

LEADERSHIP TEAM

TECHNICAL EXPERTS

COMMERCIAL EXPERTS

Business development specialists Market intelligence specialists IP attorneys Project managers Marketing and relation specialists

Biomedical engineers Electrical engineers Mechanical engineers Laboratory technicians

Figure 11. Illustration of the potential staff competencies that may support BII as either permanent staff or outsourced services.

SCIENTIFIC AND TECHNICAL EXPERTS Scientific and technical experts primarily support project teams within Incubation in the core functions needed to develop and validate prototypes/lead candidates. In addition to full-time employed experts, who can assist with general research and problem solving for both Incubation and Discovery teams, a pool of expert consultants with specific skillsets may be brought in to provide assistance on specific projects. COMMERCIAL EXPERTS Commercial experts provide input into projects from Discovery through Incubation, particularly contributing to the development of strong business plans and strategic partnerships with industry. Most are expected to come from the Entrepreneur Mentor Circle, but other external consultants may be engaged where specific sector experience is necessary. In addition, there will be a number of full-time, in-house experts to provide general advice and assistance, in particular regarding IP issues as well as general project management processes. SUPPORT STAFF The support staff employees comprise the administrative staff as well as legal, communications, marketing, IT and human resources. These members of staff oversee the daily tasks at BII, support the various teams and provide programme support. BII Network While BII aims to become an outstanding centre in its own right, to achieve its full potential its reach must extend beyond the Institute. A large network of external experts will be engaged and become an asset for BII and its projects. The ability to call upon a broad network of expertise at any given time will also serve to decrease the time to market. BIIâ&#x20AC;&#x2122;s external network experts will, for example, serve as mentors in scientific and commercial matters, taking on roles as advisors, and be the sources of top-level positions and board members. One example of an important potential partner is the NOME network which is an NNF initiative. Other high-impact experts and networks to be cultivated are research and development institutions, public bodies, law firms, regional network organisations, investors, technology transfer offices and multiple industry contacts. Geographically, this should not be limited to Denmark; rather, close collaboration with research, industry or business partners should be sought internationally where the relationship would be of benefit. BII will also actively seek partnerships with other internationally renowned institutions such as ETPL, QB3, LabCentral and the Wyss Institute. These will take the form of staff exchanges, joint conferences, events and research activities. Furthermore, establishing close relationships with industrial partners will be of equal importance to BII. The value for industry will be in obtaining insights into new opportunities for acquisitions, as well as in providing opportunities to scout for new technologies and solutions. Close interactions with a large network will ensure a close and fluid interaction with the surrounding society and increase the number of successful exits from BII.

5 Infrastructure

LABORATORIES AND TECHNOLOGICAL PLATFORMS

5.1

Discovery Circle Investigators have the option to use their home laboratories for research conducted as part of Discovery but BII will house a number of technological platforms that cannot be found in investigators’ home institutions. These will be highly specialised and driven by the needs of the investigators and their projects, making BII a uniquely attractive location. There may be several distinct platforms or one focused research field with complementary platforms. Examples of potential platforms include: • CRISPR •

Robotics/medical micro-engineering Material science in synthetic biology/tissue repair • Human microbiome •

Alongside the technological platforms will sit specialist and general laboratories. The nature of these laboratories will depend on the scientific focus areas of the ongoing projects, and will likely evolve and grow over time as focus may change as the Institute expands. In addition, access to for example imaging facilities, computer clusters, software and hardware workshops, chemical storage and handling areas, as well as mechanical and electrical workshop facilities will be provided. In addition to a booking system to facilitate smooth collaboration and optimal use of laboratories, an affordable pay-per-use system will ensure teams remain commercially focused. Such systems are common at incubators across the globe with fair and transparent pricing structures enabling teams and businesses to make appropriate and efficient use of resources. BII will also facilitate access to existing specialised infrastructures via collaborations with universities and other research institutions. In addition to contributing to an efficient use of these facilities, and a way to avoid superfluous expenses for costly equipment, this will also be a way of expanding the collaborative network. External highly specialised laboratories and services, such as contract

research organisations, may also be used, especially for high-throughput screening and biologics/ antibody development. For projects such as medical technology projects, â&#x20AC;&#x2DC;Godkendte Teknologiske Serviceinstitutterâ&#x20AC;&#x2122; (GTS institutes), and other external development agencies will be used to test, validate and optimise the industrial design of a product.

Affordable Pay-per-use System: An Industry Standard LabCentral provides laboratory, office and event space in Cambridge, Massachussetts, USA. Fully functional laboratory space (shared or private), permits, waste handling and all common laboratory equipment required for life-science research are available through flexible, month-to-month agreements for up to 2 years. Access to conference rooms, event space and basic facilities is also included. In addition, LabCentral hosts an educational and networking programme specific to the interests of life-science start-ups. Charges include a basic monthly fee to LabCentral with additional costs depending on space needed, consumption of chemicals, the nature of the laboratories needed and whether the laboratories are private or shared. http://labcentral.org

OFFICES AND GENERAL SPACES

5.2

The design of the site and the physical infrastructure, including space allocation and interior, play an important role in addressing the need for both interdependence and independence of the project teams and start-ups. The site will allocate spaces where the various teams can work undisturbed on their projects. An interdependent, open and sharing culture across BII can be promoted by creating physical social areas such as coffee islands, break-out spaces and lounge areas. In addition, laboratories and offices will be shared. BII will apply the hot desk concept, which works well in terms of optimisation of capacity, eliminating empty spaces, and encouraging sharing and collaboration. At the same time, there will be an opportunity to store personal items in a dedicated area with locked shelves or booths. Exemptions to the hot desk concept will be made for researchers working primarily on their computers such as experts on computational biology, mathematical modelling, artificial intelligence and big data analysis. Standard meeting rooms allow for undisturbed discussion and larger event rooms will host events such as guest lectures and social activities.

6 Stakeholder Management

BII will be a fundamentally new initiative in Denmark with a prime focus of turning new discoveries into products and solutions valuable to society. To foster and continuously strengthen an innovationbased entrepreneurial culture in Denmark, BII’s ambition is to become the natural host and centre of gravity, pulling together a large number of stakeholders. This calls for BII to engage in an open and outward flow of information on BII’s vision and mission, and the possibilities of collaboration with the Institute. Such dialogue serves to build long-lasting relationships with key stakeholders and secure alignment of interests. A range of activities will be initiated to engage with stakeholders. The types of activities will depend on the types of stakeholders in question and will expand as BII matures.

MAIN STAKEHOLDERS

6.1

Due to its offerings, size and potential impact, BII will be attractive to many different parties, including academia, public bodies and investors, as well as the media. BII will also be very open to collaboration with industry, particularly as that may bring strong experience and competencies into BII. Moreover, applications in response to open calls are as open to industry as they are to academia. It is of utmost importance for the long-term success of BII that users of the Institute are satisfied and feel that their interests – accelerating innovation and maximising value – are aligned with and actively supported by BII.

INTEREST GROUPS

INNOVATION HUBS AND INITIATIVES

HOSPITALS UNIVERSITIES PUBLIC ORGANISATIONS

INVESTORS

INVESTIGATORS, EXPERTS AND START-UPS INDUSTRY

BII BII AFFILIATES

ACTIVE PARTNERS

INNOVATION ECOSYSTEM

SOCIETY

Figure 12. Examples of the most important stakeholders of BII.

The relationship between BII and its stakeholders should be symbiotic. The project flow into BII will be from these institutions and companies, while BII will serve as a pipeline for new ideas for translational research and further pipeline building. Thus, it will be paramount for the individuals associated with BII to establish/maintain presence at the institutions to ensure close contact with potential project teams and to align on interests regarding issues such as terms, outcomes and joint initiatives. MAIN PRIORITIES

6.2

It will be critical for BII to actively engage with the stakeholders required to provide opportunities and expertise that can be leveraged by the start-ups. This must be especially prioritised during the initial phase. The stakeholder activities undertaken should: •

Ensure that BII is seen as an attractive partner and create excitement about the potential opportunities to translate research into new solutions • Actively scout for new talent and high-quality projects to enter BII • Catalyse and facilitate collaboration between stakeholders across the entire innovation ecosystem • Positively impact the entrepreneurial culture in Denmark and beyond

EXAMPLES OF ENGAGEMENT ACTIVITIES

6.3

Activities will be developed to engage BII’s diverse stakeholder community and to promote interaction, sharing and collaboration matchmaking. These activities will be tailored and include, for example, networking meetings to build personal relationships, arrangement of open and VIP seminars and courses, and showcasing of BII’s projects at symposia, conferences and workshops. Social media will be used to reach an even broader stakeholder community and draw attention to BII’s activities. External Programmes The Proof of Concept Grants and the Business Acceleration Academy are true outreach activities, reaching out to universities and hospitals and providing them with excellent entrepreneurial and business development opportunities as well as serving as scouting tools for BII. Open Seminars Many research centres and start-up hubs offer open educational modules to their entire ecosystem. This helps to develop broader competencies and promotes knowledge exchange. Meanwhile, open seminars give people from the outside a chance to get to know the institution and to interact with it as potential future BII affiliates, an engaged community member or as part of its value chain.

Open Seminars The Wyss Institute, Boston, USA, offers a number of free and public events. Relevant examples of recent activities are the Annual International Symposium 2017 entitled ‘Therapeutic Organ Engineering’, and frequent smaller symposia such as ‘The Diabetic Lower Extremity Symposium: From Innovation to Therapy’ and ‘28th Annual Warren Alpert Foundation Prize Symposium: Immune Checkpoint Blockade and the Transformation of Cancer Therapy’. Bio-X, Stanford, USA, offers open and semi-open events like Science Day, seminars, fellowships, poster sessions and symposia.

Employee Exchange and Intern Programmes Exchange programmes can have a tremendous impact on knowledge sharing and are a useful way of gaining new perspectives and developing valuable professional networks. The exchange programmes may be arranged among similar institutions which have a different scientific focus (research institute to research institute) or among different types of institutions but within a similar focus area (research institute to incubator, company or hospital). Case Competitions A way for corporate environments to gain new inspiration and energy can be to arrange competitions within their area of interest. BII could set up similar activities, potentially in collaboration with an external host or sponsoring organisation such as an academic or industry partner. For example, the “annual BII award” would serve to attract talent and high-quality project ideas while also facilitating networking opportunities with relevant groups.

Start-up Competition The â&#x20AC;&#x2DC;Lyfebulbâ&#x20AC;&#x201C;Novo Nordisk Innovation Awardâ&#x20AC;&#x2122; is a part of the annual Innovation Summit. The competition is aimed at emerging Patient Entrepreneurs, who get the chance to pitch their invention or idea to Lyfebulb founders, Novo Nordisk R&D device leadership, researchers and engineers, and venture capitalists.

International High-profile Events Participation in high-profile international events and conferences is a way of increasing the visibility of an institution or a certain technological/scientific advance. Such events often reach a broader public and can be a useful opportunity for high-level networking. They are usually held annually for an international audience with globally recognised speakers of high status. Often, high-impact events have themes that are more general, deal with field-specific challenges, or address political and policy issues. In addition, investor and corporate events provide opportunity to expose BII and its innovator teams to the venture capital and corporate investment/acquisition community. Public and Social Events BII will host frequent informal events, either at BII or at partner institutions, to build knowledge about BII and ignite excitement around the culture of innovation, entrepreneurship and life sciences. In addition, BII will arrange events for invited audiences, such as hosting internationally acclaimed speakers. These events would support the position of BII as the natural place for new thinking and a centre of gravity for research and innovation in life science.

7 Key Performance Indicators

Performance measurements are essential in order to assess the impact and outcome of the grants and convertible loans, build the reputation and brand, justify continued donations to BII, and effectively design and manage the Institute.

CRITICAL SUCCESS FACTORS AND KEY PERFORMANCE INDICATORS

7.1

To measure performance, a set of critical success factors (CSFs) and a number of key performance indicators (KPIs) linked to these CSFs have been defined for BII as a whole as well as for each of its phases. These KPIs have been developed and inspired by discovery centres and incubators such as the Wyss Institute and LabCentral. The outcome of the assessments will be used by the Leadership Team to demonstrate progress and/or act upon lack of progress, but also used externally to attract new investigators, companies and funding. Some CSFs and KPIs will be monitored from BIIâ&#x20AC;&#x2122;s inception, while others will not be relevant for some years, such as monitoring company exits. BIIâ&#x20AC;&#x2122;s mission is to promote collaborative research-based innovation and translate this into novel solutions to benefit the life sciences through the establishment of financially stable start-up companies. A set of CSFs and KPIs will therefore address the high-level activities of the BII (see Table 1), while the four phases will each be measured in terms of their expected activities in a similar fashion.

CRITICAL SUCCESS FACTORS

KEY PERFORMANCE INDICATORS

BII 1

Translate research findings and discoveries into innovations, products and companies within biomedicine, medical technology and biotechnology

Provide a well-functioning start-up ecosystem for sustained growth and job creation

Promote internationalisation and a collaborative culture

Number of patents and product innovations derived from BII activities

Number of scientific journal articles and the share of journal articles among the worldâ&#x20AC;&#x2122;s top 1% and top 10% most-cited journal articles

Number of national and international research and industry collaborations

Number of start-up companies established in and exited from BII, and the survival rates of these companies

Total external funding and investments in start-up companies and/or in innovations and products which have been created and/or developed by BII

Number of jobs created in start-up companies as well as in graduated companies

Table 1. Initial critical success factors and key performance indicators for BII.

8 Finance Models

The offering of grants and convertible loans to successful project teams, alongside the broad scientific and commercial support it offers, will be key to BIIâ&#x20AC;&#x2122;s magnetism and thus its success. The kind of financial support offered will depend on the developmental stage of the projects in question. Investigators in the Discovery and Transition phases will be supported with grants, whereas the more developed start-up projects of Incubation will be offered convertible loans.

GRANTS AND CONVERTIBLE LOANS

8.1

All grants will be considered as donations to the awardees, with no repayments to BII. Conversely, the convertible loans provided imply a return on investment. As early-stage financing involves high risk, only a fraction of the convertible loans awarded is expected to generate a return; in the case of failed projects, any loan will thereby be considered a donation. Project teams will also apply for external funding, as will BII itself to ensure the continuation of the Institute. Collaboration with industry will be an important factor for BII. Allocation of funding within the Institute will be decided by the Board of Directors, who, together with the Leadership Team will also set the strategy for attracting external funding to the projects and to BII in general. BIIâ&#x20AC;&#x2122;s granting and loan structure is targeted and tailored to fit people, projects and start-ups in Discovery, Transition and Incubation. The companies in Growth will be self-sustainable economic entities.

The achievement of mutually agreed milestones will be required to receive further financial support to ensure the most promising projects and committed teams will receive continued funding and support. This support will be provided in tranches according to need, and only upon the achievement of the mutually agreed milestones, providing an incentive for progress. As project teams will be encouraged to apply for supplemental external financing, supported by BII experts, the Institute’s grants and loans will, in many cases, be complementary to other sources of finance. An overview of the characteristics, limits and requirements of BII’s different grant and loan categories is provided in Table 2.

INVESTIGATOR PROGRAMME

PROOF OF CONCEPT

BUSINESS ACCELERATION ACADEMY

CREATION HOUSE

TRACTION FACTORY

Discovery Evaluation Committee

Director and Heads

Incubation Evaluation Committee

INSTRUMENT

Grants

Convertible loans

DURATION

5 years

6–12 months

3 months

12–18 months

PHYSICAL LOCATION

Host institution/ BII

Host institution

Host institution/ BII

BII

AMOUNT IN DKK

Up to 10 million paid in tranches

Up to 1 million

Up to 0.6 million

Up to 10 million paid in tranches

Up to 5 million paid in tranches

DECISION MAKERS/ APPROVERS

STAGE-GATED PAYMENT COVERED COSTS

Yes

50% for research and 50% for optional new translational research (e.g. salary, equipment, travel, experiments)

Researcher and supervisor salaries, equipment, travel and experiments

Salary, travel and consultancy

Salary, product development, IP, regulatory and education

Salary, product development, manufacturing, clinical design, toxicology, regulatory, IP and BD consultation

Table 2. Overview of programmes and funding instruments at BII. BD: business development

Discovery Grants Based on open calls, Discovery Grants will be given to investigators to support their ongoing research at their home institutions and the development of interdisciplinary research ideas as described in Section 3.1.

Discovery Grants will be up to DKK 10 million and last for a period of 5 years.

Proof of Concept Grants The Proof of Concept Grants will be awarded to projects developed within Discovery but will also be available via open call to projects developed outside the Institute, thus serving as an outreach tool. The Proof of Concept Grant provides an element of de-risking, both for the researchers receiving the grant and for BII, by serving as a translational tool.

Proof of Concept Grants will be up to DKK 1 million.

Accelerator Grant The Accelerator Grants will target projects just beyond proof of concept. They are used to probe commercial potential of these early-stage projects and the teams behind them via the Business Acceleration Academy. The main focus of the Business Acceleration Academy is to help the project teams develop solid business plans.

Accelerator Grants will be up to DKK 0.6 million.

Incubation Convertible Loans Projects entering Incubation (from within or outside BII) will be increasingly de-risked. For these start-up projects, financial support will be given as convertible loans and will be attached to the BII Incubation programmes: the Creation House and the Traction Factory. The loans will be issued unsecured, leaving the start-up team free from repayment if their project fails to succeed. Such favourable loaning conditions will make the Incubation convertible loans very attractive to start-up teams.

Creation House loans will be up to DKK 10 million over a period of up to 18 months.

Traction Factory loans will be up to DKK 5 million over a period of up to 18 months.

Depending on the success of the start-up companies in question, convertible loans issued by BII will eventually lead to either debt cancellation in case of failure/lack of progression, or conversion of the loan into equity in case of success. While there is no financial downside for the investigators and innovators, loans provided to unsuccessful projects will leave BII with a net loss. BII can try to liquidate achieved, intangible assets, but this will be highly unlikely to have any financial effect. In cases of success, BII will have the prerogative of choosing the repayment of the loan. Repayment can occur by two different means: either the start-up can repay the loan to BII or BII can convert the loans into equity. Financing BII start-up teams is associated with a high financial risk and when entering, BII teams may have no other sources of finance beyond BII. By converting loans into equity for successful start-ups, BII may ensure a small stake in the futures of those companies.

8.2

ALLOCATION OF FUNDING

On a yearly basis, the Board of Directors approves the overall distribution of appropriations for BII Discovery, Transition and Incubation, based on the annual business plan issued by the BII Leadership Team. A shortlist of applications submitted in response to open calls for grants or convertible loans will be reviewed by the evaluation committees for Discovery and Transition/Incubation and by the BII Leadership Team on a frequent basis. Upon recommendation from the evaluation committees, approval is given by the Director together with the Head of Science and Technology or with the Head of Business and Entrepreneurship. In cases of grants or convertible loans above DKK 15 million, approval will be provided by the Board. Debt cancellation of defaulted loans, cancellation of unpaid interest, changes in conditions of loans over DKK 15 million and exits require Board approval. The funding allocation process is described in Figure 13. GRANTS AND LOANS WITHIN LIMITS SET BY THE BOARD APPROVAL: BOARD OF DIRECTORS

Distribution of funding for the Discovery and Incubation phase

DIRECTOR HEAD OF SCIENCE AND TECHNOLOGY HEAD OF BUSINESS AND ENTREPRENEURSHIP

EVALUATION COMMITTEE

Specific mandate

INFORMATION

on funding appropriations

APPROVAL

of project applications and related funding

EVALUATION AND PRIORITISATION

of applications

Figure 13. Funding allocation process.

QUALITY ASSESSMENT AND PROGRESSION MANAGEMENT

8.3

To secure continued success of BII, the quality and progression of projects and teams in Transition and Incubation will be monitored carefully in formal, regular evaluation processes, in addition to continued informal review of participation established in Discovery. Regular constructive feedback, agreement on milestones and payment of grants and convertible loans in tranches will be some of the tools used to facilitate progression of projects and commitment of BII investigators and incubees. The Head of Science and Technology will be ultimately responsible for evaluating Discovery Circle Investigators and their projects to release additional tranches of the Discovery Grants, while the Head of Business and Entrepreneurship will be ultimately responsible for evaluating BII start-up teams and projects. In cases of critical lack of progression or commitment, the Director will also be involved.

FUNDING THE BII CORE AND FINANCE OPERATIONS

8.4

Whereas the grants and loans described above serve to co-finance the BII people, projects and start-ups, the running, performance and activities of the entire Institute will also need funding and financial support. BII will seek to attract further funding alongside the donations from NNF. Such external funding could come from other national or international private foundations or public national or international initiatives, such as the EU. Some external instruments may be directly connected to specific activities within BII, for example, donations targeting BII Discovery from research councils or loan guarantees from the European Investment Fund, partly covering losses on BII Incubation loans. Potential revenue streams from exits and licences are uncertain and may not be relevant for many years. However, in the long term, a combination of potential returns on investments and external funding could lead to BII being less dependent on donations from NNF. A finance operation entity will be required to ensure a professional and transparent setup. Standard legal documents will be developed and an appropriate IT platform will be implemented.

9 Principles for Ownership of Intellectual Property Rights

The interdisciplinary approach and the multitude of collaborations at BII between researchers, entrepreneurs, research institutions and companies may complicate ownership of ideas and inventions. To ensure joint ownership and support for this, a joint Memorandum of Understanding (MoU) outlining a transparent IP regime to protect the IP fostered through projects supported by grants or convertible loans from BII was developed among BII’s most important stakeholders. This includes all eight Danish universities, who became signatories of this MoU on November 11, 2017. The following principles form the significant elements of the IP regime at BII: •

IP generated through BII-funded research and Transition activities, e.g. Discovery and Proof of Concept Grants, will be owned by the institution(s) where the inventor(s) is employed, following usual Danish practices

•

Admittance to BII Incubation requires that the individual start-up teams have obtained the necessary rights from the institutions owning the IP, either through licences or ownership, in order to facilitate progression of projects in the Incubation phase

•

IP generated by the start-up companies through activities in the BII Incubation and Growth phases will be owned by these companies

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