Abstract

Biotechnology entrepreneurship is important for bringing beneficial scientific discoveries to the awareness and use of society. Although iGEM is an open source competition that does not in itself focus on business creation, it begs to question what the possibilities could be if it did. Entrepreneurship uses the market to find a problem and solve it. By using business methods as a scaling method, biotechnology can provide solutions for a larger variety of problems and to a greater number of people. In sum, biotech entrepreneurship is a mechanism for spreading good ideas and making useful products available to those that need them.

Furthermore, understanding enabling factors in biotech entrepreneurship can help bring awareness to biotech and promote entrepreneurship for iGEM participants and scientists everywhere. Therefore, the aim of this research is to establish the most significant enabling factors in relation to biotech and synthetic biology (SynBio). From there, future steps can be made to promote entrepreneurship in the scientific realm.

The analysis will begin with a presentation of the hypothesis, research model and objectives. The next sections provide a qualitative and quantitative analysis of the research. The concluding sections involve a list of suggestions and next-steps on how the data can be used for entrepreneurship.

Research Question, Research Objective and Research Design

Our theory holds that if certain enabling factors exist for biotech business creation and success, then biotech businesses will be founded. If this is true, then further research is needed to understand the enabling factors in biotech entrepreneurship in order to further promote its success. We assume that the factors that facilitate business creation and biotech innovation also extend to the realm of biotech entrepreneurship.

Research Objective 1: Establishing a theoretically grounded framework to understand the enabling factors that facilitate entrepreneurship in biotechnology.

Research Objective 2: Substantiate the theoretical framework and investigate the motives, barriers and decision criteria that leads to business creation in biotechnology and SynBio.

Research Objective 3: Establish the most important factors that lead to or prevent business creation in biotechnology and synthetic biology within the context of iGEM.

Research Model

To answer the objectives, this research draws on a combined multi-method empirical study, linking a qualitative and quantitative approach to understand entrepreneurship in biotechnology and SynBio. By combining qualitative and quantitative data, the research benefits from the advantages of both approaches. Qualitative data can capture the causal process of a certain phenomenon and substantiate the hypothesis derived from literature in order to answer research questions behind the enabling factors in biotechnology entrepreneurship (Eisenhardt 1989, Eisenhardt and Graebner 2007, Miles and Huberman 1994, Yin 1984). On the other hand, quantitative data allows testing on a large scale as a greater spectrum of observations can be tested. This strategic combination will create a better understanding of significant factors in biotech entrepreneurship.

The next sections will establish 1) the background research used to develop the theory and structure the data collection, including literature and advising, 2) a qualitative research approach, 3) a quantitative research approach, 4) an analysis of the combined qualitative and quantitative data, a 5) a conclusion and discussion regarding enabling factors in biotech plus 6) suggestions for the biotech industry and iGEM to enable more scientists to found a company.

- MODEL 1: Research Model**

Literature analysis

A number of papers and books related to entrepreneurship and biotechnology were reviewed to design the survey and interview guidelines. The main literature sources include:

Literature	Description
Engel, Jerome S. Global Clusters of Innovation: Entrepreneurial Engines of Economic Growth around the World. 2014	An in-depth review and description of various entrepreneurship ecosystems around the world, as well as the enabling factors that allow startup success.
Steinmetz, Max. Success Factors of Startups from the Founders Perspective. 2011	Research on success factors of startups from the point of view of business founders.
Kananen, Johannes. Success factors of Start-up companies from the investors’ perspective. 2011	Research on success factors of startups from the point of view of investors.
Journal of Comparative Policy Analysis: Research and Practice: “Where science comes to life: University bioscience, commercial spin‐offs, and regional economic development” 2014	Biotech entrepreneurship, university spin-offs and how they are created.

From these sources, 11 main paradigms were established to distinguish enabling factors relevant to business creation. These paradigms cover most important influences on business creation.

Table 1: Paradigms of Entrepreneurship
Team	Entrepreneurial experience, background, education, team spirit, risk-taking, team functionality
Product/Project	Characteristics of the product/project, prototyping, proof of concept, marketability of product
Academic Mentorship	Mentorship related to project creation, advising in biotech and in entrepreneurship, access to information, knowledge exchange, technology transfer, collaboration
Entrepreneurial Mentorship	Access to personal network of contacts/business angels, venture capitalists
Access to Resources and Product Development	Material and laboratory access, quality of test environment
Access to Customer Feedback	Access to feedback by potential users and customers of the product
Access to Financial Support	Funding via venture capitalists, accelerators, research funds, banks, university support, etc.
Access to Legal Advice	Advising for patenting or legal issues
Unique Market Opportunity and Access	Market characteristics (market competition, industry life cycle), timing of product, partners in the industry, etc.
Environment	Cluster for entrepreneurship and/or biotechnology, political/regulation situation
Founder	Characteristics of entrepreneurs, more specifically, their abilities and skills, personal motivation, vision, gender, education and work experience. *It should be noted that most of our analysis is on a “team” basis with less focus on individual founder characteristic, therefore, enabling factors related to individual characteristics are omitted in this study.

(Steinmetz 2011, Kananen 2011, Engel 2014)

Advising

Once the paradigms of important factors were established for entrepreneurship, experts in biotech and entrepreneurship were contacted for further consultation. The advisors included academic advisors and professors in synthetic biology, representatives of BioM (the biotech cluster in Munich, Germany), entrepreneurial advisors from the startup accelerator TechFounders and current and past participants of iGEM. All of these advisors contributed to the research methodology as well as the quantitative survey and qualitative interview design.

Research Approach

First, 11 of qualitative interviews were held to better understand the factors that affected Founders and non-Founders from the iGEM population. Second, a quantitative survey was designed to analyze the significance of different variables in business creation in biotech (specifically in iGEM). From the survey a statistical analysis was performed to measure the degree to which the variables affected founding a business.

The survey analyzes current and past iGEM participants, who are working in relatively the same, with similar education levels, time frames and resources.

Potential Limitations of the Data

Although the sample size (n = 140) is decent for data analysis, a larger sample size could potentially provide better results. Furthermore, as there were only a handful of business founded from iGEM (less than 20), the sample size of Founders from iGEM remains small due to this limitation. However, this only strengthens the reasoning for conducting research on this topic, to understand why so few teams have founded businesses and what can be improved to make it more common in the future.

Qualitative Data Approach

For the qualitative data, 11 past iGEM participants were interviewed, 4 of which founded a business (Founders) and 7 who had not (non-Founders). The goal of the interviews was to understand the Founders/non-Founders decision process and the factors that influenced or barred the way to business founding. The chapter is organized 1) a list of interviews with Founders, 2) a table of the core questions and responses from the Founders, 3) a list of interviews with non-Founders and 4) a table of the core questions and responses from the non-Founders.

Founder Interviews

TABLE 2: LIST OF FOUNDERS INTERVIEWED
INTERVIEWEE	COMPANY	UNIVERSITY/IGEM YEAR	INTERVIEW DATE
Cindy Wu	Experiment	U. Washington 2010 and 2011	September 13^th, 2016
Danny Cabrera	BioBots	U. Pennsylvania	September 20th, 2016
David Lloyd	FredSense	U. of Alberta, U. of Calgary	September 20th, 2016
Eva-Maria/	Gene Advisor	Edinburgh 2006	September 15th, 2016

The following table gives a snapshot of the core questions the Founder interviews sought to establish: 1) what are the enabling factors for founding a company, 2) were there adequate resources, including enough time, advising and funding to build a company, and 3) was there any knowledge or technology exchange or support from related industries.

TABLE 3: CORE QUESTIONS AND RESPONSES FROM FOUNDERS
Interviewee	What were the main reasons for founding a company?	Did you have adequate resources? (tools, academic advising, entrepreneurship advising, time, funding)	Did you have knowledge or technology exchange with industry members? Were you in a biotech cluster?	Other comments on entrepreneurship in biotechnology/ synthetic biology?
Cindy Wu	The proof of concept at iGEM and in general was successful Initially the idea was a solution to fix their own problem Accelerators and investors were supportive	Had adequate funding from the university during iGEM After iGEM, had very low funding until joining Y-Combinator, an accelerator in San Francisco Raised money from investors A lot of mentorship, but not business mentorship until after iGEM	Yes. Lots of help with many CEOs, founders, universities Mentors and alumni from Y- Combinator	At the beginning, had no business, website, sales experience. However, they were able to develop and entire project and eventually a startup from scratch and learning everything new. iGEM was definitely an enabling factor Their advantage with earning investors trust was their huge vision for their product Almost did a PhD, but glad she did not so she could do her business
David Lloyd	Grant funding from Deep Starter, a program for SynBio companies Good team, smart people	Yes, enough resources and funding A lot of entrepreneurial/business advising	Yes, a ton of knowledge exchange, less technology exchange	iGEM was definitely an enabling factor
Danny Cabrera	Good business opportunity More influence founding a business than academia – ended up deferring PhD Good mentorship Funding from DreamitHealth accelerator	Yes, very good advising in academia and business	No, not really	Today it is much cheaper to do biotechnology than ever before, and in some ways the barriers are much lower
Eva-Maria/Jelena Aleksic	Research and access to high tech, plus a good idea of a market need Industry knowledge exchange	Not enough funding. Took bank loans to support the project	Yes, from the Accelerate Cambridge program, the industrial community and the academic region	The business did not really take off until finishing their PhD’s. But once they did, they switched to the business side and founded a startup.