Team:St Andrews/Entrepreneurship
Entrepreneurship
Contents
At the early stages of our project, we began realising that we had a unique value proposition and could meet unmet consumer demands. We thus started thinking of how Shinscreen could be bigger than just an iGEM project. We put a large focus on gathering insights into the market and pursuing business opportunities on top of the modelling and human practices work.
We have conducted a series of stakeholder interviews to explore our busines responsibilities and opportunities. As these results were promising, we conducted direct market research through surveying several target markets and consumer groups, conduct public sentiment analyses, and hosting a discussion forum. We then performed extensive market research and analysis to explore business opportunities and markets to break into, concluding that there are unmet consumer demands which Shinescreen could meet. We also consulted with several IP experts to explore patenting. Recently, we pitched our business proposition and won the St Andrews enterprise pitch event to fund our Entreprenurial ventures. Currently, we are at a stage where we are making a business development plan and in the process of setting up a company.
Unique value proposition
Our probiotic will use the non-chemically expensive feedstock glucose to provide a sustainable source of sun protection. The sunscreen gel, bacteria and UV-absorbing components are ensured to have no impact on aquatic environments as the components are either already present in the surrounding water or have been tested against coral microenvironments in vitro. The proposed natural ingredients for the sunscreen gel have been suggested to be both environmentally friendly and skin-promoting.
While there are existing mineral sunscreens (using zinc oxide) which are advertised as environmentally friendly, during our meeting with dr. Alice Tagliati, it was mentioned that new research shows these too have detrimental effects on the marine environment. Furthermore, such products leave a white cast on the skin making them unpopular with consumers, especially those with darker skin tones. The components used in our sunscreen would most likely be transparent, hence avoiding this issue. To add to this, it may be possible to consider adding pigmented compounds for a desirable effect, such as bronzing or even sparkling. Similarly, additional enzymes could be introduced to the system to give off different fragrant odours, such as vanilla or lavender.
The extraction procedure involved in isolating the UV(A)-absorbing compound shinorine is expensive and so past products containing this compound have had expensive shelf prices. However, by applying the bacteria directly onto the skin, and synthesising the shinorine in vivo, these extraction costs are minimised while allowing for much larger concentrations to be reached. Finally, since the bacteria will naturally proliferate in the presence of a nutrient source contained in our formulation, the sunscreen is essentially ‘renewable’ preventing the need for consistent reapplication throughout the day. Our killswitch design works to control the proliferation, acting both as a safety mechanism and an adaptable protection mechanism.
Sponsorship
The St Andrews iGEM team worked hard to set up two separate crowdfunding campaigns via Experiment.com and SaintsFunder which we will go live after the jamboree in order to raise money for the second phase of the project. In the process, we considered contributions that we could present to our donators. Our goal was to encourage donations, give back to our benefactors, and contribute to the environment accordance with our aim of marine conservation.
The coral adoption program implemented by the Coral Guardian -- a non-profit organisation focused on conserving coral reefs, based in Komodo National Park, Indonesia -- provided the perfect fit. The organisation has transplanted more than 38,000 corals, multiplying the surrounding marine biodiversity by 30 times, has taught the communities about sustainable fishing, and raised international awareness on the issue of coral bleaching.
On July 31st, wet with Ruxandra Toderasc, the Coral Guardian project manager and scientific co-director. We discussed how both the St Andrews team and Coral Guardian would benefit from the partnership. We agreed to promote the organisation via our social media pages, raising awareness about the Coral Guardian and its goals to other iGEM teams, members of our community, and even those who do not live nearby coral reefs. In return, the Coral Guardian would provide us aid with lab work, allow us to offer generous donators with the opportunity to adopt corals through the Coral Guardian at a reduced rate. As the partnership is continuing, we have signed a unilateral commitment to confidentiality to protect the information that is shared with the organisation and we are working with the Coral Guardians to promote marine conservation.
Stakeholder interviews
Researcher perspectives
We had a range of stakeholder meetings, which served a dual purpose to advance our human practices and to investigate the market potential of Shinescreen.
Initial meetings with researchers were incredibly promising: Dr Nicola Allison from the University of St Andrews thought stated that, “The idea that you produce a microorganism that naturally produced these compounds, I think that’s a really clever idea. When we talk about finding an alternative sunscreen, even when we talk about zinc oxide, we are talking about a chemical, albeit relatively inert, that’s going to come off and go into the water and something which is a relatively small particle, which by itself might have an impact. So the idea that if you had a natural organism which was literally going to degrade, it’s got potential.”
It was also emphasized that the topic is an important one which has been discussed in many recent conferences and research communities. She highlighted that the current benchmark for what qualifies as ‘reef-safe’ is unclear and misleading, and much more awareness needs to be raised on the issue. Nonetheless, some concerns were raised and further consideration of this motivated the design of our killswitch.
Dr. Hennige, an expert on the effect of sunscreen on corals from the University of Edinburgh, was equally enthusiastic and stated that our idea has an emerging market. Moreover, Dr. Alice Tagliati mentioned that new research shows that mineral sunscreens too have detrimental effects on the marine environment, suggesting a need for alternative reef-friendly sunscreens.
Meeting with Dr. Hennige and Dr. Tagliati
Industry Perspectives
To gain an industry perspective, we also conducted several interviews with reef-safe and probiotic sunscreen companies.
A recent meeting with Dr. Cornelia Schürch, head of developement at Mibelle Biochemistry (founders of Helioguard suncare products), provided insights into the complexity and difficulty of the sunscreen market. It was discovered Helioguard products are listed as ‘anti-photoaging’ rather than ‘sun-screening’, providing DNA protection against daily UV-A exposure rather any protection against prolonged, overexposure to erythemal UV-B radiation. Their research discovered that it was impossible to meet the required concentration or absorbance profile for comprehensive protection using natural extracts alone. While this naively sounds discouraging, our approach to production of natural UV-filters already offers the ability for much larger concentrations to be reached and has the potential for wide-spectrum absorbance once discovery of suitable non-pollutant UV-B absorbing compounds are unveiled.
An earlier meeting with Louise Laing, founder of people4ocean, emphasised that the market for conscious consumers is growing. It was highlighted that a synthetic biology approach has not been used before and could circumvent the need to clump zinc oxide into nanoparticles and the unpopular white cast. Furthermore, the very novelty of the product might be exciting enough to catch consumer attention.
Market Research and Analysis
While stakeholder interviews provide valuable insight, perspectives from prospective consumers are essential before pursuing with development. We conducted such research through three main approaches – a survey on the potential of consumer preferences and behavior in regard to bringing Shinescreen to the market, the full report which is available here, an online synthetic biology forum, and a twitter sentiment analysis, both found as part of Human Practices.
We analysed the relevant parts of our direct data collection to draw conclusions about Shinescreen’s market potential:
Market Summary
SWOT Analysis Summary of our Market Research
The Suncare market is growing globally and non-monopolised. With governmental policies oriented towards a more sustainable industry (e.g. bans on certain chemicals contained in traditional sunscreen) and the increasing awareness amongst well educated people of environmental degradation, the need for an alternative sunscreen which imposes or minimises risk for human health and the environment is becoming ever more urgent. Companies which produce reef-safe sunscreen (like People 4ocean in Australia) have attempted to meet the demand. But such mineral sunscreens still contain zinc nanoparticles, which although less damaging, are still harmful to coral reefs. Moreover, mineral sunscreens create a white cast on the skin surface, which consumers do not like (as stated by Louise Laing, founder of people4ocean). Our product offers a transparent chassis, therefore likely being more popular amongst consumers.
Moreover, the survey and our forum polls indicate that consumers are open to the idea of using our sunscreen. 82% of survey respondents stated being likely or very likely to buy Shinescreen if available at the same price as their current sunscreen. 50% of the forum attendees said that they would be willing to use GMO containing cosmetic products, while 50% said that they might, depending on the product. Moreover, since we surveyed several integral consumer locations in the world (Australia, Hawaii, China), as well as our local consumers (UK), we have a feel for the different sunscreen priorities across these regions, and an idea of how Shinescreen can meet different unmet needs. Thus, our research suggests that Shinescreen meets unmet consumer demands which consumers are willing to pay for. Overall, although there are of course hesitations amongst consumers about GMO use and our research has some limitations, our market research and stakeholder interviews do show a demand for our product. This suggests that Shinescreen could potentially be a viable competitor in the sunscreen market.
Alternative Markets
To ensure our product has the most market potential, it is integral to also explore other possible markets that our product could enter. The sunscreen market is strict, complex, and has numerous regulations on shelved products and complications in application such as broad-spectrum absorption and water resistance. It is for this reason, we believe, that such a product as ours is relatively under-explored. The meeting with Dr Cornelia Schürch reiterated this conviction.
Nevertheless, this prompted us to initially reconsider our technology applied as an anti-photoaging remedy. This may be more realistic in the short-term and opens further avenues to pursue using the modular nature of our probiotic. This market has the added benefit of easier regulations and crucially has no requirement for UV-B absorption.
While the market of the product might be restrained by GMO regulations in different countries, the biosafety measures considered by the modular kill switch design offers potential for meeting the strictest requirements.
Finally, following research which suggested the health benefits of probiotic skin treatments, we explored the medical industry. We have had a meeting with a highly regarded professor of dermatology with a specialisation in photo biology and a member of the British Association of Dermatologists. The Professor was enthusiastic about the possibilities of the photo-sensitivity patient treatment angle for our invention, as photo-sensitivity patients are most often sensitive to UV(A), which our product would absorb. This is very significant, as 5-20% of the global population is affected by photosensitivity disorders. She saw permanent integration of our probiotic into the microbiome as an opportunity, rather than a safety concern, as it could benefit people with photosensitivity disorders such as porphyria and polymorphic light eruption, for whom current treatments are limited. This was particularly interesting considering our extensive focus on developing a killswitch to prevent such integration. Using a different control mechanism such as an auxotrophic organism – one that is reliant on an artificial substrate and unable to survive without it – could allow prolonged survival on the skin while maintaining safety. This potential design modification should be explored in phase II testing.
Intellectual Property Protection
Although challenges will be inevitable and abundant, our market research and analysis led us to conclude that our invention is possible, scalable, and inventive. Thus, we decided to take the next step and explore ways of protecting our intellectual property.
Initially, we had a meeting with Thomas Storey, a current Patent-lawyer trainee who was part of last year’s St Andrews iGEM team. Following this, we had a meeting with Mewburn Ellis Patent Attorneys Paul Misselbrook and Frances Salisbury, which our partner Manchester who kindly organised and invited us along. This made us realise we would ideally need to register a patent before the Jamboree, which we previously were not aware of.
Meeting with Patent Lawyers form Mewburn Ellis
To follow up, we met with Will Wright, director of entrepreneurship at iGEM, to gain his insights into starting a business and pursuing a patent application. He expressed his approval of our project, acknowledging that the market for skin care and sustainability are both growing. In particular, we expressed our concerns about the conflict of interest between protecting our idea alongside complying with iGEM core values of openness and shared research. We were relieved to hear that these were familiar concerns, and we were ‘ahead of the game’ by considering this before a significant amount of information had already been released publicly. He detailed that iGEM is a ‘closed’ organization and any information which was detailed in a private setting exclusive to iGEM members would not technically qualify as ‘disclosure’. However, the impending wiki freeze deadline put us on the clock as we were unwilling to detriment any aspects of our iGEM responsibilities. The complexity and expense of patent applications was detailed, and it was clear that a qualified patent attorney would be required to complete this effectively.
At his suggestion, we set up an urgent meeting with the IP team of St Andrews, who laid out steps for registering a patent with the university. This clarified our doubts on ownership of the intellectual property. As a project funded by and associated with the university, it was their decision whether they would like to own the IP and support further development of the research. This was of course desired, as the resources and expertise the university could provide would be vital for progression towards the shelves, even if this meant sacrificing rights to the IP. During our meeting, the team expressed their concerns about our lack of lab work and resulting lack of evidence for the idea. As was already known, committing to such a project without solid proof of concept was a risk. Nevertheless, the team remained interested in our idea, and provided us with a review form to fill out for a potential patent draft application.
At the encouragement of the technology transfer center, we completed a thorough invention disclosure form about the inventiveness and market possibilities of our sunscreen. The TTC was enthusiastic about the potential of this invention, and we had subsequent meetings about the process of filing this patent.
However, in the end, the TTC recommended to not go forwards with the filing at this time. They believed that there is currently insufficient data present to form substantive claims regarding the invention. In essence, this was due to our inability to proof our concept in the wetlab, as we have no laboratory access due to the pandemic. There is thus no proof that the methodology of adding the bacteria to skin would provide an effective mechanism for protection of UV. The concept of adding a gene to a bacterium is not sufficiently inventive without a reduction to practice. They highlighted that should we put in a priority application without evidence, the patent would most likely be rejected, which would then invalidate any further attempt to file a new patent. This could then harm our chances of filing a patent in phase II of the project.
Nevertheless, this result is still encouraging for the possibility of intellectual property protection during phase two of our project. The TTC stated that “once the wet work has been completed and evidence to exemplify what is being claimed, we may be in a position to file a composition of matter patent that would have the specifics of the sun cream formula”. They highlighted that although we will be disclosing the gene sequence and the idea at the jamboree, they strongly feel that with reduction to practice, a composition of matter with the probiotic formulation would be a far more financially viable patent. They are thus more than happy to continue to support the project during the phase II and engage with potential filings at a later stage when the wet work is underway.
Although it is of course disappointing that our lack of laboratory access this year prevents us from protecting our IP, we’re sure we’re not the only iGEM that would've liked to prove their theories in the wetlab. Moreover, the TTC’s interest and thorough engagement with the potential filing does suggest our project has real market potential, seeing as filing a patent for us would bear significant costs for the university. As we successfully pitched our business idea to investors (as explored in the next section), we now have the funds to pay for our lab costs to prove our concept, and will then hopefully be in a stronger position to patent our work.
Lastly, it cannot be underestimated how valuable this journey was in expanding our knowledge on intellectual property protection. A common problem with iGEM teams is that they realise too late that they want to protect their IP, after they have already disclosed too much. We will be in an excellent position in phase II, ready to protect any inventions that we have not yet been disclosed in phase I. Moreover, we will have built the connections to help us do so through our meetings with Mewburn Ellis Patent Lawyers, iGEM entrepreneurship, and our relationship with the St Andrews Technology Transfer Centre. Thus, overall, this IP protection journey has been extremely valuable in setting a strong foundation and enhancing our knowledge, and we are enthusiastic to pursue this further in the future.
Pitching to Investors
We recently put our business proposition to the test by participating in the St Andrews Enterprise Week Pitch Event sponsored by Santander universities. Out of 15+ competitors, the judges decided to grant us the full prize fund of £980, giving expert accreditation to our plan. This money can be used to carry the bulk of our lab cost, so that phase II testing has the resources to commence. If theory is upheld in the lab, this gives our endeavor more credibility for future investors and allows us to successfully pursue intellectual property protection.
Company Formation and Future Steps
To ensure continuation of the team beyond the iGEM competition, we have started consultations with Stephen McCallion, who is kindly advising us on setting up a business. Following analysis of a personality questionnaire, it was discovered that most of the team were development-oriented: focused on the positive social impact our product could have and, as a result, getting it to the shelves as soon as possible. While this is of course a positive in many respects (and perhaps expected considering the very nature of those who participate in iGEM), a business needs a varied skillset. Within the development side of the business, our multi-disciplinary team of biologists, physicists, mathematicians, and computer scientists certainly provides this, but we are perhaps lacking in commercial mindset needed to fund the R&D process -- regardless of whether our organisation looks to be charitable or profitable in the future.
After some internal discussions, we proposed suitable team members to take the four main positions within the business: head of operations, head of development, head of strategy, and head of finance. However, Stephen emphasised that a business cannot be made of a team of leaders, balance is key and each position within these departments are equally important to the effective functioning of the company. Recently, we have begun discussions on setting up a private limited company, with how shares and ownership may be distributed. While such conversations within a team of equal status individuals are difficult, experience and shared wisdom has indicated that such an arrangement does not work in a formal business environment. All decisions made hitherto are preliminary and subject to change after the jamboree.
R&D work required
All work until now has been with the engineering and computational design of the product according to theory and existing literature. The next major bottleneck in accomplishing a proof-of-concept prototype is the laboratory research which will be carried out in phase II of the project during the summer of 2021. The 10-week period set aside for this experimentation is deemed necessary to identify whether all the proposed components of the system function effectively. Further time will be taken to improve the efficiency of the system and to build upon the prototype design.
Following permission, in vivo testing will commence phase III of the project. The product effectiveness in providing protection across a wide-range of required wavelengths will need be put to the test. It will be determined whether predictions from phase II in vitro testing are upheld under realistic application. Due to the regulations associated with releasing a new product in the market, probiotic phase trials can take an extended period of time, and will depend on the eventual, initial application of our technology as well as the country of release. The sunscreen domain, in particular, has strict regulations, where in the US it is overseen by the FDA.
Business Development Plan
While a successful business is built upon passion, focus and expertise, we realise that without a practical framework for staying on track, it is far too easy to fall astray during the business development process.
A business plan serves many purposes for both new and existing companies: it maps the route towards commercialization and growth; it provides a time-based schedule for the process providing drive and urgency to meet deadlines; it clarifies the unique selling proposition of the business, the marketplace and the industry competition; and it gives potential investors a means of immediately evaluating the business, endowing credibility to the company if done well.
During discussions with Stephen, we began drafting our business development plan. The document aims to cover:
- Executive summary: providing an overview of the entire plan, much like the abstract of a scientific research publication
- Business summary: outlining the history of the business, the problem it aims to solve and the company’s unique value proposition
- Goals: detailing clearly what the company is trying to achieve with the SMART protocol
- Market: research-based considerations of prospective customers and key competitors using the; considerations on the best approaches for marketing and promotional activity based on this; monitoring the dynamics of the market using PESTLE analysis
- Services: detailing all potential applications of the technology we aim to develop, the compelling characteristics, potential threats to the services requirement, challenges with the development or expansion, and relevant patent conflicts or needs
- People: describing the internal structure of the business, informing on the expertise, skillset, and credentials of each team member (or at least each senior member); investors invest in the people as much as the business, so it is important to convey personalities; highlighting skill gaps and how it is planned to address them as well as areas of strength
- Finance: a comprehensive overview of the figure associated with the plan; sub categorised into sales projections, costs, cash flow summary, profit and loss summary and funding sources; with assumptions behind the growth forecast justified
Much of the content for this is detailed in the above sections, however, the financial aspects require more comprehensive and quantitative considerations . What remains to be completed is presenting the information in an organised, logical, and clear document. Currently, we are using a template provided by sage.com adapted with guidance provided by Innovate UK.
We realise the business plan should not be a static document. Much like a CV, it should be re-evaluated at every milestone or whenever any changes are made within the company. Head of strategy will likely take on the responsibility of the business plan, arranging bi-weekly or monthly meetings with the rest of the department to update it.
Thus, as soon as the jamboree is over, our priorities are to finalise the business plan, make decisions regarding leadership positions and shares, and set up the company. We will carefully consider how this can best be combined with the second phase of our iGEM project.
Discussion
Throughout our iGEM journey, we were lucky to have learned so much about entrepreneurship. We learned how to explore the potential business success of our project, conduct extensive market research, gained in depth knowledge of intellectual property protection, and even had a go at giving a successful business pitch. No matter where our business leads us, this is invaluable knowledge for any future endeavors we pursue.
From here onwards, we plan to align our company formation closely with iGEM where possible. As we will continue with iGEM as a two-phase project, we hope to use St Andrews iGEM 2021 team’s wet lab work to develop our business proposition further. Moreover, talking to Will Wright made us very enthusiastic about the possibility of working with EPIC and after iGEM. We are thus very excited about the business opportunities in store for us following the jamboree, and are excited to see how we can remain partnered to iGEM in our entrepreneurial journey.