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Entrepreneurship
During the development of our 50S.O.S. bacterial cell stress screening kit we have come to the conclusion that a company would be the best method for the distribution of 50S.O.S., based on conversations with a variety of researchers
currently researching novel antibiotic therapy approaches. This page will showcase how we would approach the development of this company. 50S.O.S. will be sold as an easy to use kit, which we will develop ourselves. The first years of
research
will be used for product development, after which we will begin a start-up and start producing the 50S.O.S. kit. With the revenue we will pay back our investors and simultaneously invest in our own research into new antibiotics, thereby
creating a hybrid business.
Why a commercial product?
There are many options for distributing our stress detection system to future users. Whilst we worked on the development of our stress receptor cell lines, we realised that to simplify the use of our system, creating Read more about this decision on our Integrated Human Practices page a kit would be the best option. The main advantage
of a kit is that it requires little preparation before use by a researcher, contrary to for example just a cell line. After our visit to the start-up company Karveel, we realised that the kit should be easy to use, compatible with current
devices, and affordable. Based on these requirements, we have developed Read more about our 50S.O.S. kit on our Product
Design page the 50S.O.S. stress detection kit. Selling this kit would make it available for researchers all over the world and simplify the search for antibiotics.
After patenting the kit, we have several options. We can sell the patent to an established company which already has the means to produce the kit or we can keep the patent rights to produce the product ourselves. We prefer the latter
option since the chance that a large company will buy patent rights in this early stage of development is very small and because our technology is very innovative, it has the capacity to grow from a small start-up to a large company.
Unique selling point and Patenting
Current antibiotic discovery methods
There are currently only a few methods to test compounds for their ability to function as an antibiotic. For natural compounds, such as those originating from fungi or streptomyces, screening focuses on bacterial lethality or growth
inhibition. For example, to discover antibiotics produced by streptomyces, streptomyces are dotted onto a plate. After a colony of streptomyces has formed, a layer of soft agar is added which contains the bacteria to test the antibiotic
potential. Similar to disk diffusion, a dark halo will form if the streptomyces produce a compound which kills surrounding bacteria[1].
Alternatively, specific compounds can be tested by adding them to a growth culture of bacteria. Subsequently, growth of these bacteria is measured to determine whether growth is being inhibited or if bacteria are being killed by the added
compound. Such methods are often used to test slightly altered versions of existing bactericidal compounds, with the goal of improving effectiveness. Once a candidate antibiotic is found, the minimal inhibitory concentration can be
determined as a measure of bacterial susceptibility to this compound[2].
The considerable downside to both methods is that only death and growth inhibition are measured. If there is only minor damage - which does not inhibit growth -, it does not show in the tests. Although these damaging compounds may not be
lethal, they could still contribute to the effectiveness of other antibiotics or be lethal together with another stressful compound. Additionally, the previously discussed methods are either relatively simple and do not require special
compounds, or require a large variety in specific life forms - such as streptomyces -, making kits for these tests ineffective.
Unique selling point
Contrary to existing systems, 50S.O.S. uses specific components, namely our stress detecting cell lines, which are easier to use when prepared in a kit. This will aid in the discovery of new antibiotics which is needed in order to
decrease the rate of resistance. The unique selling point of our kit is the ability to not only detect bacterial death or growth inhibition, but also bacterial stress. This allows for the detection of much lower concentrations of lethal
compounds and the identification of non-lethal, stressful substances, which can be used in lethal combination therapies. Additionally, our kit indicates the type of stress being experiences by the bacteria. Knowing the specific form of
stress gives an insight into the mode of action of the compound, thereby accelerating drug development pipelines. As such, 50S.O.S. can be used in both research and drug development.
Patents
To obtain information regarding the legal aspects of our product development, we spoke to Luris is a department of Leiden University which aims to connect
the university to the market and helps researchers with the legal challenges that come with patenting and start ups Luris. After this meeting, we learned that in order to keep kits such as 50S.O.S. free for use,
it is
common practice to patent the kit in order to protect it's free use. This would ensure that the use of the cell line in the form of a kit is protected, while the cell line itself is still open source. Because the patent would not be
defended or
upheld, it will prevent others from patenting our product. This allows companies to freely use our product, while at the same time allowing us to keep producing the kit. The patenting will be done in consultation with Luris, which is
specialised in patents.
References
[1]: Shetty et al.(2014). Production of polypeptide antibiotic from Streptomyces parvulus and its antibacterial activity. Brazilian Journal Of Microbiology, 45(1), 303-312. doi: 10.1590/s1517-83822014005000022
[2]: Dafale et al. (2016). Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance. Journal Of Pharmaceutical Analysis, 6(4), 207-213. doi:
10.1016/j.jpha.2016.05.006
Support and Partners
Any good product needs support to get onto the market. Our main partner would be Leiden University through university programmes such as Luris, which help start-ups from the university and can be very useful in the initial stages.
In order to finance our research, we have looked into different funds. The NWO - a dutch organisation for scientific research - funds many different universities and companies which aim to solve societal problems. The maximum amount of
the fund is € 2.500.000,-. Our company would be a perfect fit for this fund, since antibiotic resistance is a rapidly growing problem. Investing in a solution now will save a lot of money in the future[3].
Further funding could be received from the Egberts Stichting, which funds medical research[4]. In addition to this, the RIVM has informed us that the Dutch government intends to invest more money in the future, to help solve the
antibiotic resistance crisis. Also, Read more about our dialogue with the Dutch ministry of Healthcare on our Integrated
Human Practices page the Dutch ministry of Healthcare has expressed the intent to invest in projects like ours.
[3]: NWA Startimpuls. (2018). Retrieved from https://www.nwo.nl/financiering/onze-financieringsinstrumenten/nwo/nwa-startimpuls/nwa-startimpuls.html
[4]: Egbers Stichting. (2018). Retrieved from https://www.finportal.nl/egbers-stichting-stimuleringsfonds-voor-medisch-wetenschappelijk-onderzoek
Marketing
Market assessment
Potential buyers of 50S.O.S. are businesses and researchers who are interested in the development of novel antibiotics, combination therapies or those who want to improve their previously developed drugs. As it is expensive to look for
entirely novel drugs, it is expected that companies will mostly use the kit to improve previously discovered drugs. Additionally, researchers can use 50S.O.S. to study stress in bacteria and the development of resistance.
Market interest
50S.O.S. is a simple kit that can be used by any modern lab. Any lab that aims to detect stress in bacteria may buy our kits. This might apply to academic, commercial or educational laboratories. Pharmaceutical companies will want to
determine the effect of antimicrobial compounds on bacteria. Similarly, academic researchers investigating antimicrobial compounds and peptides will want to use 50S.O.S. to easily determine bacterial stress being induced by their
substances of interest. We have already spoken to a variety of such researchers, Read more about these researchers on our
Integrated Human Practices page who have expressed their interest in our technique.
Exploitation Strategy
During the development of an exploitation strategy for our company, we discussed our approach with Luris is a department of Leiden University which
aims to
connect the university to the market and helps researchers with the legal challenges that come with patenting and start ups Luris. Based on these discussions, we decided that the company should work with a
hybrid business plan for the sale of 50S.O.S. This means the company will consist of two main elements. The first is the production of the kit itself, which will be the company’s main source of income. This element includes further product
development, finding the necessary machinery and a suitable company site. After these stages of business development have been completed, production is initiated and income will be generated. The next two steps are continuous improvement
of our 50S.O.S. stress detection kit and initiating the second aspect of our company.
This second element will be research into new antibiotic combinations therapies. With our own stress detection technology, we will try to find new antibiotic compound combinations which can serve as novel antibiotics. A share of the
company’s income will be used to finance this research. Once such a combination is found, this will again contribute to the revenue to support further research.
We have chosen this particular strategy for multiple reasons. First of all, we want to distribute our stress detection system around the globe and in order to achieve this, a company was the best option. This way we make sure that 50S.O.S.
reaches the market and is not lost among the other ideas of large companies. The second element of our business strategy to discover new antibiotic compound combinations originates from the idea that we want to solve the antibiotic
resistance crisis. Established companies are hesitant to invest in research towards antibiotics because they are afraid their investment will not be returned. The two reasons for this are the fear that the company is obligated to keep the
antibiotic at a low price and the significant chance that novel antibiotics will be shelved and only used as a last resort drug, thereby leading to low sales figures. Therefore, we intend to engage in the search for new antibiotic compound
combinations ourselves, to help ensure that the antibiotic resistance crisis is averted.
Realisation Schedule
We have estimated a realisation schedule for the first years of the company. The first important task will be product development, this will take approximately two years. The product will be further developed in a lab supplied by our
partner, Leiden University. Simultaneously, the patent rights for the system will be acquired.
The third and fourth year will be the transition time from a small lab at Leiden University to a larger production location. At the same time, the marketing will be started. After a total of four years, the facilities should be ready for
production. From here on, we will sell our kits while continuing development of 50S.O.S. and starting research into finding novel compound combinations.
The time it will take to find a new compound combination is hard to predict. We estimate it will take around 4 years of research.
SWOT Analysis
Internal analysis
Strengths
Our product is easy to use in any laboratory
The kit is quantifiable and more sensitive than current techniques, while also providing information on the mode of action of tested compounds
It is an innovative system
A strong proof of concept already exists
Weaknesses
A third party will be needed to upscale production of 50S.O.S. kits
Further development to improve the kit is still needed
External analysis
Strengths
Governments are investing increasing amounts of money into antibiotic research
A lack of novel antibiotics combined with a growing need for new antibiotics results in a growing market for this kit
The kit can be used for other research focused bacterial cell stress
Weaknesses
Companies are withdrawing from antibiotic research and development
The stress detection cell lines will be open source
Conclusion
50S.O.S. is a sensitive and easy to use product. Our market research has shown that there is substantial interest in the product and with the help of various funds, as well as national and international support, our product can aid in
the
battle against antibiotic resistance.
