Team:Stockholm/Entrepreneurship

iGEM Stockholm 2018 Wiki

Entrepreneurship

Executive Summary

iGEM Stockholm, formed by 20 bright entrepreneurs, has developed Biotic Blue, the new innovative enzymatic degradation solution to pharmaceutical pollution in the aquatic environment. Our team, based in Sweden, fights against the ecotoxicity and antibiotic resistance as a result of high concentrations of pharmaceutically active compounds in the Baltic Sea Region.

Aiming to develop our research project to the next level, we started our entrepreneurial journey. Among the different stakeholders, the Swedish Government, the Swedish Environmental Protection Agency (EPA), and municipal and private wastewater treatment plants (WWTPs) management were identified as major key players. Swedish WWTPs were determined to be the target markets, where we undertook a competitive analysis and a macroenvironmental factors study. Applying for a patent in Sweden through the Swedish Patent and Registration Office (PRV) and establishing the regulatory framework are fundamental aspects that we think will facilitate our business growth opportunities. Shaping our market entry strategy as well as the funding strategy will contribute to a successful business performance. Finally, we also present some industry perspectives towards Biotic Blue from the companies AstraZeneca and Pharem Biotech.

Problem Description

Consumption of pharmaceuticals has significantly risen over the past years. This trend will continue as lifespan increases, and pharmaceuticals become more available. Between 30 and 90% of orally consumed pharmaceuticals excreted in the urine, end up in the water reservoirs after going through the sewage system [1]. Lack of strong regulations prevents WWTPs from treating water from pharmaceuticals.

Development of antibiotic resistance is one of the major consequences of pharmaceutical pollution, posing human health in great danger. The presence of antibiotics promotes acquisition or independent evolution of resistance from bacteria that generally lack innate antibiotic capacity [2]. Eventually, these resistant bacteria reach humans either via food or direct exposure to animal hosts [3],[4].

In addition, pharmaceuticals also provoke ecotoxic effects on marine organisms. Some biological pathways are highly conserved in nature. Therefore, pharmaceuticals similarly intervene both in human and marine organisms’ pathways, exerting sign effects in their physiological functions [5].

The antibiotic sulfamethoxazole (SMX) presents one of the highest concentrations among Active Pharmaceutical Ingredients (APIs) detected in samples from rivers and effluent streams from WWTPs ending up in the Baltic Sea [6]. SMX poses an imminent threat to regional ecosystems as WWTPs are unable to remove it.

Therefore, we can define our need as it follows: a way to address the growing problem of antibiotics’ presence in the aquatic environment of the Baltic Sea Region by removing SMX from wastewater in order to prevent antibiotic resistance and minimize their ecotoxic effects.

Stakeholders Analysis

Stakeholders analysis is key to assess their needs and expectations as well as their potential project impact if the need is not met. Therefore, we map the interest and power of each player (Figure 1).

Figure 1. Stakeholders interest/power grid.

Market Analysis and Customer Discovery

The identification of customer’s needs, wants, and demands is a priority for us. In order to meet our clients’ needs, maximize the benefits and minimize the risks, a market analysis allowed us to select the most profitable and attractive segments to launch Biotic Blue. Through this analysis, we were able to identify our strengths, weaknesses, opportunities and threats and, consequently, we could define our business strategy and plan activities accordingly.

Market Segmentation

We will be serving different business markets, which at the same time have several customers and needs. We carried out a market segmentation in order to understand each segment behavior and identify which ones offer better opportunities. There are four types of segmentation: demographic, behavioral, psychographic and geographic [8]. In this case, we first performed a geographic segmentation. We decided to operate in the Baltic Sea Region, consisting of 9 countries: Denmark, Estonia, Latvia, Finland, Germany, Lithuania, Poland, Russia, and Sweden. The reason why we focused on this region was because of its ecosystem, which is particularly sensitive to pharmaceutical pollution due to its low biodiversity, low functional redundancy, the physiological stress many species experience as an effect of the brackish water environment and the slow water exchange rate, which means long retention time for pharmaceuticals [6].

We chose Sweden as the initial country to launch Biotic Blue. Its prosper economic situation, and strong environmental-friendly culture will presumably offer more implementation opportunities for our product. Moreover, Sweden is among the countries in Europe where the tertiary treatment is more established in their plants [9]. According to the Swedish EPA’s report in 2016, 95% of urban wastewater undergoes both biological and chemical treatment [10], which we assume will lead to a better acceptance of advanced treatments.

Secondly, we undertook a demographic segmentation by the type of industry. Different industries were analyzed according to their suitability in regards to Biotic Blue implementation. These include municipal WWTPs, private WWTPs, non-municipal and individual wastewater treatment systems, and hospitals.

Market Targeting

After visiting and interviewing representatives from one private (BioPharmaceutical company AstraZeneca) and three municipal WWTPs (Henriksdal in Stockholm, Kungsängsverket in Uppsala and Lotsbroverket in Åland), we confirmed their role as potential customers. We were strongly recommended to implement Biotic Blue during the WWTPs processes (Study visit J Olsson 15 Aug 2018 and P Gruvstedt 18 Sept 2018). According to professionals from the industry, our product would not be feasible or controllable in initial steps since the water would not be clean enough, mainly because of sludge presence (Personal communication H Jönsson 15 Aug 2018).

Regarding municipal WWTPs with less than 2,000 people connected and non-municipal and individual wastewater treatment systems (up to 200 people connected), we understood they are customers with more complexity. Some of these systems do not meet the legal requirements [10], and also the implementation of advanced treatments are not under their main priority [11]. Investment costs and the ability to find workers with the appropriate skills are notable obstacles, whereas bigger municipal WWTPs possess the resources to welcome emerging techniques (Study visit J Olsson 15 Aug 2018 and P Gruvstedt 18 Sept 2018).

Different experts in the field also advised us to target hospitals, where the concentrations of pharmaceuticals are higher (Personal communication C Baresel 20 Jun 2018, study visit T Mörn 30 Jul 2018 and J Olsson 15 Aug 2018). Tomas Mörn, in addition, thought that by treating water at its source, the cost of WWTPs would be reduced. In our visit to Kungsängsverket WWTP, we also learned that the Uppsala University Hospital has a particular interest in solving this problem since they are currently running two projects to treat toilet water before it reaches the municipal WWTPs (Study visit S Svebrant 15 Aug 2018). On the other side, Huddinge Hospital representatives do not think hospitals are the source point for pharmaceuticals (Personal communication K Sonesson and S Rosenborg 10 Sept 2018). Although they would be willing to modify its working routines if a new solution could minimize their costs when disposing of patients' urine, they were still not sure about the need to implement a solution in a hospital setting (Personal communication K Sonesson, E Frank and S Rosenborg 10 Sept 2018).

After considering different customers, we conclude that both municipal (with more than 2,000 people connected) and private WWTPs (manufacturing sites of pharmaceutical companies) are our target markets in Sweden, being these customers more cost-effective due to its larger coverage area [12].

Market Size

Our market size (Table 1) is first presented through the calculation of our Total Available Market (TAM), specified through the estimation of our Serviceable Available Market (SAM) and finally described as our Serviceable Obtainable Market (SOM).

Table 1. Market size.

There has been a decrease in the number of municipal WWTPs due to the fact that smaller municipal WWTPs are replaced by pumping stations (facilities located before the WWTPs) [10]. However, as the number of households is increasing every year [14], we predict more people will be connected to municipal WWTPs, expanding the capacity of these. As a result, more plants might be built over time.

Regarding the private WWTPs, we also forecast a positive market growth. The Government requirements are getting tighter, resulting in more pharmaceutical manufacturing sites having to incorporate better treatment processes and facilities (Study visit P Gruvstedt 18 Sept 2018).

The market size was finally calculated to be 22 WWTPs. We believe this number represents a realistic result of the addressable market for Biotic Blue.

Competitive Analysis

In order to measure competition intensity, attractiveness and profitability, our analysis was based on the Porter’s Five Forces model (Figure 2).

Figure 2. Porter’s Five Forces model.

Threat of new entrants: medium

  • Market is not regulated; however, an Environmental Impact Assessment (EAI) is needed
  • High research costs but sufficient funding in Sweden
  • Increased awareness of pharmaceutical pollution
  • Low competition and low brand equity barrier for enzymatic degradation
  • Strong Intellectual Property Rights (IPR)
  • High switching costs

Threat of substitutes: low

  • Great number of substitutes but with high energy consumption levels and use of chemicals
  • High customers’ switching costs and difficulties
  • Low customer’s propensity of substitution

Bargaining power of suppliers: high

  • Great variety of suppliers
  • High production switching costs
  • Suppliers are not dependant on this industry
  • Suppliers’ responsibility in unique components, which are highly dependant on the quality of the end product

Bargaining power of customers: high

  • Limited number of customers
  • Growing trend towards investing in new solutions
  • High price sensitivity customers
  • Need to provide evidence
  • High customer switching costs
  • Large-scale orders

Rivalry among existing competitors: medium

  • Low competition
  • New marketplace, high innovation and growth opportunities
  • Pioneering technology
  • Low information transparency

Once the profitability potential was considered to be medium, we could determine our competitive strategy. We want to focus on serving particular market segments (geographic markets and customer-size groups); therefore, we chose the market nicher strategy as our competitive position in the industry. Our objective is to genuinely know our customers in order to meet their needs better since we identified the bargaining power of customers to be significantly high.

Market Needs

Nowadays, there are other techniques available for the treatment of pharmaceuticals in wastewater. However, they also bring some disadvantages, such as an elevated cost, high energy consumption levels and use of chemicals. Launching a new solution that could overcome these disadvantages would presumably meet the market needs. The following graph (Figure 3) maps the existing solutions in relation to their cost and efficacy and allowed us to identify a gap in the market.

Figure 3. Gap analysis graph.

Willingness to Pay

Although the WWTPs are not legally required to treat their water from pharmaceuticals [10], some of them in Sweden have already decided to implement advanced treatment. Examples of this can be seen in the cities of Linköping and Uppsala, where they are implementing and planning to implement advanced techniques to treat wastewater, respectively (Study visit J Olsson 15 Aug 2018). Among the main drivers leading to this decision, we can identify the desire to be a front-runner, the willingness to help both the environment and society and the expectation of upcoming stronger legislation [11]. Regardless increased investment needs, their willingness to improve their services overweight their cost (Study visit J Olsson 15 Aug 2018). The estimated operating costs in Linköping seem to be justifiable considering the risk to the environment [11].

After presenting our idea to some professionals in WWTPs, they showed excitement but also skepticism towards the innovative Biotic Blue. They pointed out the need of supporting our solution with reliable evidence, testing it in a pilot plant in order to compete with advanced techniques (Skype call S Berg 29 Aug 2018) and have a proof of concept in large-scale validated by a third party (Study visit M Ryen 25 Sept 2018). If we are able to meet their requirements in the longer term, they will consider adopting our product (Study visit J Olsson 15 Aug 2018). On the other side, AstraZeneca representatives are open to newer and cheaper alternatives to be potentially implemented in their private WWTP (Study visit P Gruvstedt 18 Sept 2018).

Macroenvironment Analysis

In order to track the environment we are planning to operate, we conducted the following PESTLE analysis.

Political

  • National elections last September may influence the funding of projects aiming to solve this problem.
  • The Swedish Green Party (Miljöpartiet de Gröna) has current representation in the Swedish Parliament and could encourage the promotion of a cleaner environment. Environmental politicians can significantly affect the WWTPs’ procedures and the associated regulations.
  • The Government is aware of the situation; however, money seems to be the problem. Since the existing techniques to treat pharmaceuticals are expensive, politicians are not interested in developing any regulation. Municipal WWTPs would have to face big expenses when implementing these techniques (Personal communication M Ryen 7 Sept 2018).
  • The Swedish EPA was requested by the Government to investigate the prerequisites for using advanced treatment [11].
  • Over the Swedish history, the Government has granted environmental improvements [10]. In particular, there is sufficient funding available for advanced treatment (Personal communication M Ryen 7 Sept 2018). The Swedish EPA is responsible for the grant distribution process, and the funding is worth SEK 45 million for 2018, SEK 50 million for 2019 and SEK 70 million for 2020 [10].

Economic

  • National elections last September may affect economic trends and, therefore, change consumer spending and buying behavior.
  • WWTPs face high investments when introducing big modifications in their process (Study visit T Mörn 30 Jul 2018).
  • Municipal WWTPs’ finance comes primarily from loans and a variable tariff (depending on the size of the client, the amount of water they consume, etc.) charged to households and industries connected to their plants (Study visit E Kusoffsky 15 Aug 2018).
  • The income municipal WWTPs receive from these tariffs is spent in facilities expenses. If there is a new investment in the plant, there will not necessarily be an increase in the tariffs (Study visit E Kusoffsky 15 Aug 2018).

Social

  • Demographics are changing towards a more environmentally concerned generation.
  • Society has different attitudes towards the environment. In particular, Swedish society is one of the most sustainable countries in the world.
  • Communities connected to the municipal WWTPs are concerned about the cost. There are available techniques to clean the water to the point of converting it into drinkable water; however, these communities are reluctant and assume they would have to economically assume the implementation of these techniques (Study visit T Mörn 30 Jul 2018).
  • Municipal WWTPs’ management shows a socially responsible behavior and wishes to offer better services as long as they do not feel they are wasting money (Study visit J Olsson 15 Aug 2018).
  • Experts in the field would like to see cheaper, more straightforward (Study visit P Gruvstedt 18 Sept 2018) and universal techniques in the market (Personal communication M Ryen 7 Sept 2018).
  • Around a quarter of a million households are not connected to the municipal water or sewage systems, 90% of these are houses for leisure purposes which are not used regularly [10].
  • There has been a suggestion of having an environmental marking or label on the pharmaceuticals packaging, or to influence their manufacturing to adapt it to some environmental protection actions (Personal communication S Rosenborg 10 Sept 2018).
  • Clinical Pharmacologist from Huddinge Hospital foresees a future regulation implementation during the upcoming 10-20 years (Personal communication S Rosenborg 10 Sept 2018).

Technological

  • Increasing R&D development.
  • Healthcare field is evolving with new treatment techniques that might decrease the use of pharmaceuticals.
  • There are emerging advanced techniques as well as technologies under development to treat pharmaceuticals [16].
  • There is a need for a cost-efficient technology that decreases the energy consumption levels and the use of chemicals in comparison with existing solutions (Study visit M Ryen 25 Sept 2018) [16].
  • The numbers of liquid/solid separation toilets are increasing as a measure to fight this problem [10].

Legal

  • Since Sweden entered European Union (EU) in 1995, EU directives have gradually been incorporated into national legislation, by the Swedish EPA and the Environmental Assessment Ordinance, within the framework of the Environmental Code and its ordinances and regulations [10].
  • The EU is currently reviewing the water regulations to unify them. In 5-10 years time, they are expected to show some changes and give more visibility to this topic (Personal communication M Ryen 7 Sept 2018).
  • The EU’s Water Policy considers the environmental pollution with pharmaceutical residues to be an emerging problem [17].
  • According to the Swedish Environmental Code, “wastewater shall be diverted and purified or treated in some other way to avoid detriment to human health or the environment” [18].
  • According to the Urban Waste Water Treatment Directive (UWWTD), “all wastewater entering the collecting system must before discharge be subject to at least secondary treatment”. Therefore, WWTPs are not legally required to treat water from pharmaceuticals [10].
  • The UWWTD is under evaluation. There is an Open Public Consultation on this directive opened until 19/10/2018 [19].
  • The Swedish EPA’s report in 2016 emphasizes the need for advanced treatment motivated by the risk of long-term effects due to the release of pharmaceuticals into the aquatic environment [10].
  • WWTPs have a special law which specifies they cannot have additional costs that are not required (Study visit S Andersson 10 Jul 2018). The Swedish EPA’s regulations have specific requirements for removal of nitrogen and biochemically degradable organic matter (BOD) whereas the WWTPs’ permits determine the requirements for phosphorus removal [10].
  • The Industrial Emissions Directive requires private WWTPs to use the Best Available Technology (BAT) (Email P Gruvstedt 5 Oct 2018).
  • The implementation of an environmental program during the next four years (2019-2022) will be presented this year by the Uppsala University Hospital to the Swedish politicians. After a thorough investigation of pharmaceuticals’ presence in water and their effects, the goal of this program is to solve the legal gap (Study visit S Svebrant 15 Aug 2018).

Environmental

  • Municipal WWTPs obtain their permits from the Environmental Assessment Ordinance depending on their environmental footprint (amount of connected communities) (Study visit J Olsson 15 Aug 2018), the water status and the environmental quality standards [10]. These environmental permits and the Swedish EPA regulate discharges from WWTPs [10].
  • Private industries have operational permits considered by the Environmental Courts and issued by the Government [18]. In the permit application, a description of the activities must be provided as well as the environmental impact that might occur and the protection measures to be undertaken to minimize the impact (Study visit P Gruvstedt 18 Sept 2018).
  • Emission requirements differ depending on the type of industrial activity. Therefore, municipal and private WWTPs do not have exactly the same requirements for individual parameters (Email P Gruvstedt 5 Oct 2018).
  • The municipal WWTPs with permits carry out “operator self-monitoring”, which includes the inspection of the facilities themselves, the management of chemicals and waste, measurements in the recipient and further analysis of the environment [10].
  • The operating permit of a private WWTP requests sampling and analyzing procedures. As a result, the environmental risk assessment is sent to the Government (Study visit P Gruvstedt 18 Sept 2018).
  • The Swedish EPA and the Swedish Agency for Marine and Water Management (SwAM) coordinate national environmental monitoring to document changes in the environment. County councils are, on the other side, coordinating the regional and local level [10].
  • Specifically, the Swedish EPA has a screening programme for pharmaceuticals that performs occasional sampling surveys and analysis [11].
  • Stockholm Vatten och Avfall, the institution producer of drinking water and responsible for treating wastewater, annually writes environmental reports.
  • SwAM will be publishing during 2018 a report related to the advanced treatment of pharmaceutical residues [11].
  • The Baltic Sea Action Plan (BSAP), in collaboration with the Helsinki Commission (Helcom), aims to restore a healthy ecological status in the marine environment by 2021 [11].
  • Big changes in WWTPs imply the need for better resources, such as space (Study visit J Olsson 15 Aug 2018). According to the Swedish Water and Wastewater Association, “resources are lacking for long-term strategic efforts” [12]. However, some plants have the space to introduce modifications in infrastructure (Skype call S Berg 29 Aug 2018 and study visit P Gruvstedt 18 Sept 2018).
  • There is an increase of population causing an increase in pharmaceuticals’ consumption.
Our Solution - Biotic Blue

To protect the environment from pharmaceuticals, we developed Biotic Blue. Our product consists of an enzyme (fungal laccase), capable of degrading SMX in wastewater. This enzyme is immobilized on magnetic beads which are recovered from the water and re-used during the prebiological step of WWTPs. Our mission, therefore, is to prevent SMX from reaching the aquatic environment minimizing its ecotoxic effects and slowing down the progress of antibiotic resistance in bacteria.

Biotic Blue can be used as an advanced treatment technique in WWTPs. Our vision is to become a platform technology that targets a variety of active pharmaceutical compounds and tackles the emerging problem of pharmaceutical pollution in water.

Overall, Biotic Blue’s unique value proposition resides in its ability to degrade specific pharmaceutically active substances in wastewater. We offer an energy cost-efficient product that does not need specialized personnel to be run. In addition, unlike other advanced solutions taking place at the effluent treatment, Biotic Blue has a unique approach since it will be implemented in a prebiological step of WWTPs. This will prevent the development of antibiotic resistance, inhabiting the activated sludge.

Intellectual Property

The core of every innovation is knowledge, and it can be used to create market advantage. Intellectual Property (IP) will become a key asset for Biotic Blue because our invention will be protected by law after filing a patent and applying for a trademark. By protecting these IP rights, we will add extra value to our creation, improve our chances of finding business partners and potentially attract investors to support our future activities. Moreover, we will be able to defend Biotic Blue against competitors.

Patentability

We ensured the patentability criteria through conducting an extended Google search, reading of scientific reports, attending conferences and searching for existing patents (landscaping). After all this investigation, we can confirm that our invention does not hinder its patent eligibility and, therefore, shows novelty, nonobviousness and industrial applicability.

Landscaping

The landscape analysis brought us direction, clearance to our product potential and minimized the risk of patent infringement.

We used the database Espacenet from the European Patent Office (EPO) to conduct the patent search. In each search, we wrote a combination of a minimum of three keywords, which were: magnetic particle(s), magnetic bead(s), degradation, enzymatic, protein, enzyme, pharmaceutical(s), antibiotic(s), water, water purification and wastewater. We identified a total of five patents which needed to be deeply analyzed in order to avoid infringement on existing inventions.

The first patent, “Laccase- Laccase encapsulated magnetic Cu-alginate beads and the method of bioremediation of water pollutants using the same (KR20170143114)”, was rejected on 06/02/2018. The claims referred to a method for treating wastewater in which a magnetic substance-copper-alginate particle had a laccase immobilized [22].

Two of these five patents, whose applications were filed in China, are currently under examination. The pending patent “Method for preparing nanometer-magnetic-particle immobilized aniline degrading bacteria and application thereof to degradation of chlorophenol (CN105624141)” has its priority date on 19/02/2016. The claims are focused on the preparation method of particles immobilized on carrageenan to degrade chlorinated phenol and their recovery method by magnet adsorption [23]. On the other side, the pending patent “Preparation method of chitosan/mesoporous molecular sieve immobilized laccase and degradation method of phenolic wastewater (CN106191023)” was filed on 14/07/2016. The claims protect a method for preparing a chitosan/micromolecular sieve immobilized laccase to degrade phenolic wastewater [24].

The US patent “Chloroperoxidase-catalyzed degradation of pharmaceutical pollutants in wastewater (US9938176)” was granted on 10/04/2018. The claims describe an enzymatic method for the degradation of compounds selected from acetaminophen, carbamazepine, sulfamethazine, diclofenac and naproxen [25].

Lastly, the European patent “Method of degradation and inactivation of antibiotics in water by immobilized enzymes onto functionalized supports (EP3034186)” was granted on 19/09/2018 and with Sweden being one of the Designated Contracting States. The claims include antibiotics such as amoxicillin or sulfamethoxazole to be degraded in an aqueous medium by a laccase enzyme, from Pleurotus ostreatus or Pseudomonas aeruginosa, immobilized on moving bed carriers [26].

Overall, the first four patents do not pose a risk of infringement either because they were rejected, they are still in the application process and under evaluation or they are targeting a different market once they were granted. On the other side, in regards to the last patent, we are confident when we claim our invention has differences. We are using a different organism and substrate, and our immobilization surface is broader defined (magnetic particles).

Intellectual Property Strategy

After confirming the patentability criteria and dismissing the risk of infringement, we discussed our IP strategy with experts in the field from the patent company, Groth & Co, and KTH Innovation (Figures 4 and 5).

Figures 4. Andreas, Blanca, Joanna (European Patent Attorney), Helena (European Trademark and Design Attorney), Stamatina and Chrismar after the meeting at Groth & Co.

Figure 5. Discussing our Intellectual Property strategy at KTH Innovation office with an European Patent Attorney.

We decided to apply for a patent in Sweden through PRV (Figure 6). Since Biotic Blue is a product invented by 20 students, the patent application was filed in the name of every single member in iGEM Stockholm. Therefore, the ownership belongs to the entire team, producing fair and equal grounds. Prior to the patent filing, all members signed a Non-Disclosure Agreement (NDA) to ensure confidentiality and compliance of the invention.

Figure 6. iGEM Stockholm patent registration.

Within the 12-month period after the filing date (the priority year), we will be able to add new findings to the original application. We also intend to file an international application through the Patent Cooperation Treaty (PCT) to possess simultaneous protection in a large number of countries [27].

Once the invention is more developed, we will be able to conduct a Freedom To Operate (FTO) analysis. It is important to perform several evaluations in different stages of the project since FTO is not static and suffers changes over time. We will continue monitoring for emerging inventions that may be within the scope of Biotic Blue to ensure that no other party is infringing our protection rights.

Trademark Strategy

In addition to filing a provisional patent for Biotic Blue, we also aim to protect its trademark. A registered trademark will give us legally exclusive right of using the mark (Personal communication H Perneborg 15 Jun 2018) and will extensively help us build a valuable brand among our customers. Therefore, we conducted an initial search for trademark rights on the Swedish Trademark Database from PRV as well as on the European Union Intellectual Property Office (EUIPO) trademark search. The search gave us the result of no existing trademark rights in the process, or in the current registration for “Biotic Blue”. Furthermore, to be eligible for registration, our trademark must be distinctive, must not be confused with another and must not describe what we sell [28].

Once we confirm Biotic Blue is accepted for protection, the trademark will consist on a figurative mark containing word elements (Figure 7). Although our target market is Sweden, we would like to expand our business to other Baltic countries in the future. That is why we will apply for the EU trademark from EUIPO which will give us protection in all the EU Member States. The application will indicate our product class based on the Nice Classification, which is class 1 “enzymes for use in water treatment” [29]. It will be filed in just one language, and once it is registered and reviewed, we will be able to renew it indefinitely every ten years [30].

Figure 7. Biotic Blue logo.

Regulations

In order to fully comply with the specific regulations, it is necessary to analyze the Swedish directives and codes that are relevant to Biotic Blue.

The Swedish Environmental Code Ds 2000:61 is a major piece of legislation that promotes sustainable development by fundamental environmental rules [18]. In addition, the Swedish EPA, responsible for advising county administrative boards, municipalities and plant operators on sewage systems and treatment facilities designed for more than 200 people [10], clearly presents two of the most critical directives in this area:

  • Urban Waste Water Treatment Directive (91/271/EEC) concerns urban wastewater treatment and discharges from domestic and industrial sectors [31]. It has been incorporated both in the Environmental Code and in the Swedish EPA’s regulation.
  • EU Water Framework Directive (2000/60/EC), whose two main objectives are getting cleaner water in Europe and having the citizens more involved [32].

The EU’s Water Policy emphasizes the need for environmental assessments for specific projects planning to produce significant new changes to water bodies [17]. The Environmental management ISO 14046:2014 also provides guidelines for a water footprint assessment [33].

In particular, the purpose of an Environmental Impact Assessment (EIA) is to identify, predict, evaluate and mitigate the direct and indirect impact of a planned activity [18]. According to the Environmental Code, in an EIA, “manufacturers of chemical products or biotechnical organisms shall ensure that an appropriate investigation is carried out as a basis for assessment of the damage to human health or the environment that the product or organism is liable to cause”. The assessment shall specify the substances or organisms, the nature and degree of dangerous characteristics and any necessary measure in order to protect human health or the environment [18].

Lastly, the following acts, ordinances, regulations and directives are also important to consider:

  • Public Water Supply and Wastewater System Act (SFS 2006:412)
  • The Water Act (1983:291)
  • Containing Special Provisions concerning Water Operations Act (1998:812)
  • Environmental Assessment Ordinance (2013:251)
  • Regulation on environmentally hazardous activities and health protection (1998:899)
  • Groundwater Directive (2006/118/EC)
  • Industrial Emissions Directive (2010/75/EU)
  • Integrated Pollution Prevention and Control (IPPC) Directive (96/61/EC)
  • Environmental Quality Standards Directive (2013/39/EU)

As previously mentioned, WWTPs are not legally required to treat water from pharmaceuticals [10]. This fact inspired us to propose a Work of Conduct. Extensive regulatory research, as well as discussions with experts within the field, resulted in the suggestion of a suitable Work of Conduct for the municipal and private WWTPs in Europe. This can be found here.

Business Plan

We believe our idea has promising potential to be moved into a business level. We want to plan our future by defining the team structure, market entry strategy, funding strategy and Lean Canvas.

Team

The team consists of 20 members from 11 nationalities and different academic backgrounds divided into five departments: fundraising and business development, research and development, communications and engagement, marketing and visibility, and information technology (Figure 8). To know more about us, visit our website: igem.se

Figure 8. iGEM Stockholm organogram.

Market Entry Strategy

We want to achieve profitable growth; thus, product marketing is utterly important. By using the Ansoff Growth matrix, we were able to select our market opportunities and establish relevant strategies. In our case, as a Business-to-Business (B2B) selling model, we are offering a new product in a new market, which means we are following a diversification strategy. This type of strategy requires both product and market development to create value for customers and build profitable relationships.

Following this marketing strategy and paying equal attention to both customers and competitors, we also designed an integrated marketing mix program to accomplish our objectives and establish strong positioning in our target markets.

Product: Biotic Blue is described using the following SWOT analysis (Figure 9).

Figure 9. Product SWOT analysis.

Price: based on the cost-based pricing strategy, the break-even pricing is the approach that will better determine our final price. Therefore, after designing Biotic Blue and determining its costs, we will set the price at which it will break even, and finally, we will convince buyers of our product’s value. We aim to gain a long-term relationship with our customers; thus, our model will not be based on one initial payment but instead on smaller payments over time set by their demands.

Place: initially, we will be operating in Sweden, and our strategy to make Biotic Blue available to customers will rely on personalized interaction, employees specially trained to demonstrate Biotic Blue value to potential buyers.

Promotion: personal selling will be an essential advertising channel for us. In addition, we will establish our brand by actively using digital marketing and social media platforms. Engagement of future buyers will be possible by associating the brand with a desirable benefit, which is to achieve cleaner water.

Funding Strategy

Financial support becomes crucial to succeed in the industry and helps out when needing the resources to maintain our position in the market. Our financial strategy is based on the bootstrapping method. We will be using internal financial sources (personal savings, loans and investments from family and friends) as well as public support (student grants and university support).

This way, we will be able to maintain control over all decisions by not sharing ownership between investors. This method will eventually attract Angel Investors (AI) who will perceive us as self-confident entrepreneurs. On the other side, the reason we are not considering Venture Capital (VC) funding is that VC firms are mainly driven by technology and product attractiveness, which means that this kind of funding is more focused on advanced projects. They also tend to be very selective and often demands exclusivity (Lecture A Mohammadi 26 Jan 2018), therefore, this option will be studied in the future. We will also consider a possible application to the Water Innovation Accelerator program run by the non-profit organization WIN.

We are happy to say we were greatly funded by two of the most renowned universities in Stockholm, Karolinska Institutet (KI) and KTH Royal Institute of Technology. In addition, we also received support from the following sources: KI Innovation Office and student grants from Medicinska Föreningen union at KI and KTH Opportunities Fund.

We joined, as one of the first members, the Open Innovation platform HelloScience created by Novozymes. The platform offers microgrants up to 1000 $ USD and aims to encourage collaboration between students and incubators, so our early stage product can come to life [36].

We also believed in crowdfunding as an effective platform to fund our project. In order to gain a broader perspective on this new trend, we attended an event hosted by Daniel Daboczy, CEO and co-founder of FundedByMe. He highlighted the astonished switch suffered during the last decade. While crowdfunding was only used as a desperate option to seek for funding, nowadays many companies widely believe in this movement. Lastly, his key advice to newly formed companies was to gain exposure and attract investors (Public event D Daboczy 21 Aug 2018).

We want to grow professionally by seeking inspiration and expanding our network. We attended the launching event of the Startup Guide Stockholm Vol. 2. founded by Sissel Hansen (Figure 10). Its content allows entrepreneurs to expand their network and empowers their business. We also attended the Sthlm Pitch Meetup event where we could mingle with many investors and experienced entrepreneurs.

Figure 10. Josephine and Stamatina during the Startup Guide Stockholm Vol.2 launching event.

Regarding the private funding, we are delighted to mention that reputable pharmaceutical companies such as Johnson & Johnson and Merck have highly contributed and helped us from the beginning.

Lean Canvas

As mentioned before, the Lean Canvas model helped us summarizing our key business principles (Figure 11).

Figure 11. Lean Canvas model.

Time Plan

The project schedule for the next two years is presented in the following Gantt Chart (Figure 12).

Figure 12. Gantt Chart.

Industry Perspectives

AstraZeneca

AstraZeneca is a Research-Based BioPharmaceutical company. Their operational facility possesses a private treatment system for the water coming from their equipment. While visiting the company (Figure 13), Peter Gruvstedt and his colleagues showed great interest in our approach. They are indeed open to better cost-efficient alternatives.

Figure 13. Andreas, Vilma, Josephine, Peter (Process Engineer) and Blanca during AstraZeneca visit.

Discussing the different implementations of Biotic Blue, Peter proposed their fungal department as a valid option since the conditions are optimal for our enzyme. He was positive and receptive about our closed system concept. Biotic Blue can potentially build the right expectations in the market, considering that further research and improvements will be needed.

Pharem Biotech

Pharem Biotech is a company focused on advanced enzymatic degradation in the field of water treatment. In our visit, we were welcomed by Martin Ryen and Domenico Palumberi (Figures 14 and 15).

Figure 14. Blanca, Martin and Stamatina after the meeting with Pharem’s owner and CEO.

Figure 15. Blanca, Martin (owner and CEO), Nicolai, Domenico (Head of Enzyme Development), Andreas and Marit during Pharem visit.

As a pioneer company, they differ from competitors by offering cost-efficient wastewater solutions. They showed interest in Biotic Blue since we pursue the same objective: to remove harmful organic compounds from the aquatic environment. They were unsure about our enzyme choice considering the target antibiotic. However, they would be interested in our approach if the long-term results show enough evidence.

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