Project

Design Safety Implementation

Wet Lab

Engineering Construction Protocol Parts

Dry Lab

Hardware Software Model

HP

Overview Intergrated human practice Education Entrepreneurship

Team

Member Attributions Contribution

In the past month, we created super eco, which acts as a probiotic that colonizes the gut and can efficiently target the secretion of antimicrobial peptides to specifically kill Staphylococcus aureus. To take super eco from the lab to the market, our entrepreneurial work also required extensive research across multiple areas, including patents, marketing, merchandising, and business plans. Our entrepreneurial research culminates in a sound business plan that drives our products to the global market.

In the future, in order to accelerate the speed of technology transformation, we plan to submit patent applications to achieve patent protection; We hope to provide solutions for unbalanced medical resources. After the multi-line products provide effective cash flow, we can bring the products to the grassroots level to solve the problem of medical resourcessolve the problem of medical resources. We hope to make the products more acceptable to patients and doctors at the grassroots level, and reduce the difficulty of product promotion.

On this page, we divide the work of entrepreneurship into three parts: market research, product, and company.On this page, we divide the work of entrepreneurship into three parts: market research, product, and company. For more detailed information, please start our journey.

Market Research

Keeping in mind the biopsychosocial paradigm of health1, the roots of every disease lie not only in biology, but in social, psychological and environmental aspects. Therefore, it is important to understand the context of existing treatment options and to raise awareness of our solutions and prevention, where knowledge of social, economic, political, cultural behaviors related to the disease can bring new external insights to the implementation of product design. This way, we can customize our prototypes so that they function optimally and meet the needs of the end user.

Because market research requires less funds and time, it is a work that can help us quickly understand the market and determine the advantages of product positioning. Therefore, in the early stage, we conducted extensive investigation and research on the market conditions, competitors' behaviors and our own products, and we realized that our project has advantages and huge application market, but also has many defects.

Problem Statement

Reports of food poisoning caused by Staphylococcus aureus are numerous, and Staphylococcus aureus accounts for about 25% of foodborne microbial food poisoning incidents2. Its drug-resistant strain, MRSA, can cause severe illness in the gut and is a focus of infection control worldwide.
Due to drug resistance, the treatment of MRSA has many limitations. The current treatment methods are mostly antibiotics, such as vancomycin, teicoranin, linezolid, etc. Linezolid and vancomycin are relatively expensive, and long-term use may cause bone marrow suppression. Teicoranin has lower otorenal toxicity than vancomycin, but its effect is slow, so it cannot become a first-line drug for severe infections3. Given the many limitations, the clinical need for a safe and effective treatment of MRSA is unmet and is an area of potential new drug development.
After background investigation, we believe that the current treatment for MRSA should be in the direction of improving treatment effect, reducing medical costs, and reducing side effects. The super eco we are designing has the potential to meet these points, and it has a huge application prospect.
For more information about MRSA, please visit the project description page.

Customer Analysis

We hope to obtain more first-hand information when analyzing customer groups and understand customers' purchase wishes and needs. During the background investigation, we made a questionnaire, and the questionnaire results told us the thoughts of many customers. For example, some people said that the current drugs for the treatment of drug-resistant bacteria are relatively expensive, and a course of treatment costs up to thousands of yuan. Therefore, we take the cost into account in the design, so that the production of drugs can be as low as possible to meet the needs of customers; Some people also reflect that the current treatment methods of food poisoning are too troublesome, and they need to go to the hospital for infusion. We consider making the project into a convenient capsule that can be taken, so that people can easily treat the disease at home without delaying work or study; We also found that people have a good acceptance of GM drug products and are willing to use them if they are confirmed to be safe and have good therapeutic effect. In order to make our GM drugs accepted by more people, we should strive to achieve good therapeutic effect and ensure their safety through a variety of biosafety measures.
We also conducted in-depth interviews with target groups to understand the product process from the perspective of users and find out their pain points in the process of using the product, so as to meet their needs as much as possible. Please refer to the intergrated human practice for the specific interview process.
From this, we have identified our customer groups and corresponding value propositions. In the process of product design, we will try to meet these needs to promote cooperation. Please see Figure 1 for details.
Figure 1 Analysis of key customers and value proposition.

Competitor Analysis

We carried out 4Ps analysis on The marketing theory of three companies producing drugs to treat MRSA interference in the market, and analyzed and compared them in four aspects: product, price, place and promotion. The marketing theory of 4Ps, put forward by Professor Jerome McCarthy, formulates marketing work to facilitate memory and dissemination. The theory studies market demand and changes from the supplier side to help enterprises win in competition. Please See Figure 2 for details.
Figure 2 The marketing theory of 4Ps.
After analysis, we find that even though these three companies are old companies and some of them are leading international pharmaceutical companies, there are some problems behind them more or less. Among them, Pfizer Pharmaceutical Co., Ltd. is facing the threat of the upcoming patent expiration. In addition to the increasing competition from generic drugs, national policies will be inclined to new technology drugs. Yiteng Pharmaceutical Co., Ltd. has no independent research and development products, heavy marketing light research and development; The North China Pharmaceutical Co., LTD., once a giant of domestic pharmaceutical companies, is heavily indebted, and their market is not irreplaceable. As a result, super eco can better adapt to the market and fill the gap in MRSA treatment today. Please see Figure 3 for specific comparison results.
Figure 3 4P analysis of competitors.

Dominance Discovery

After doing the above three parts of the work, we found that super eco has a unique advantage.
First of all, in terms of cost, due to the high killing efficiency of super eco against MRSA, we only need a small amount of bacteria, which greatly saves costs. Secondly, in the biosafety module, we adopted a biphasic steady-state switch, which does not activate the suicide mechanism in the production process and effectively reduces waste. In terms of production and transportation, the enteric capsules we adopted are simple and easy to produce, and the current lyophilization process is mature, and the storage and transportation costs are low. A combination of factors will result in super eco's final price tag being lower than most existing treatments.
Secondly, safety, we design biosafety modules based on different safety purposes, from transcription of gene pathways to protein synthesis, to suicide mechanisms at the individual level, and finally to quorum sensing mechanisms in populations. A wealth of regulatory tools to ensure that our drug system does not impose additional burdens on the human body; At the same time, the selection of the only probiotic in E. coli as a carrier also greatly reduces the possibility of heterogenic colonization, reducing the risk of bacteria escaping to other parts of the body. Super eco also has the potential to apply for over-the-counter medicines, making treatment easy and safe for patients at home. direction of improving treatment effect, reducing medical costs, and reducing side effects. The super eco we are designing has the potential to meet these points, and it has a huge application prospect.
However, as an immature product, super eco is still faced with many weaknesses and challenges. We explore our strength, weakness, opportunities and threats through SWOT analysis. Based on the situation analysis of internal and external competitive environment and competitive conditions, It can help us to better analyze according to the conditions of the enterprise itself within the given situation. For specific analysis, please see the company section.
Gaining a competitive edge in drug development requires paying close attention to the current R&D process, but also to the future. Maintaining this comprehensive vision is challenging, so it is necessary to investigate the entire development landscape, we use the powerful database cortellis market analysis, comprehensive analysis to predict trends, threats and opportunities, one step ahead of the competitors, through market research work, we see a huge market space in the MRSA treatment field.

Product

Product Introduction

Capsule live bacteria is the main product of our team. After taking capsules, super eco will gradually dissolve into the intestine, secrete antimicrobial peptides when encountering MRSA, accurately target MRSA to kill, prevent disease deterioration, and also play an effective preventive role to reduce the risk of infection and avoid zoonosis. We position the product as a health care product and recommend users to take it every once in a while. Escherichia coli is a probiotic naturally existing in human body, which can maintain nutrient absorption, maintain intestinal flora balance and inhibit intestinal bacterial proliferation. If users have intestinal flora disorders such as staphylococcus aureus enteritis and other symptoms, the product can also play a certain therapeutic effect. More information about super eco can be found on the project description page.

In order to solve the current deficiencies of MRSA therapeutic drugs, we will conduct multi-dimensional development such as research and development, data modeling, and marketing. At present, the product still lacks clinical data support, and we plan to conduct clinical trials after animal experiments to determine the safety, which will become a feasible cutting-edge new technology for clinical transformation. In addition, in order to expand the product line, timely develop low-cost, popular products with high selling points, and provide personalized services, we will also develop sensors that can detect the type of food poisoning and treatment drugs for different bacteria, which will help patients to use the right medicine

Value Chain

"Every business is a collection of activities in the process of designing, producing, selling, distributing and assisting its products. All these activities can be represented by a value chain." The competition between enterprises and enterprises is the competition of the entire value chain. In order to better understand the value impact of each value activity on enterprises and find our advantages in some specific strategic value links, we discussed the value chain of super eco. By strengthening the key links in the value chain, the competitive advantages of enterprises in the industry can be formed. The value chain of super eco is shown as Figure 4.

Figure 4 the value chain of super eco.

In addition to the enterprise activities displayed in the above value chain, there are still some basic activities and supporting activities that are not displayed, such as marketing, human resource development, enterprise basic system, etc. The advantages of enterprises in some specific strategic value links of the value chain may become monopoly advantages in the industry. If these key links are seized, the entire value chain will be seized. Through the analysis of the value chain, we found that although super eco has the technology at the R&D and innovation stage, it lacks a large amount of upfront funding, which means that we need to invest heavily or partner with third parties. In addition to strengthening research and development innovation, we will conduct animal and clinical trials in the later stage to determine the efficacy and safety of the drug. We will establish good practices throughout the value chain so that medicines reach patients smoothly.

Competitive Product Analysis

Currently, anti-MRSA drugs commonly used in clinic include vancomycin, teicoranin and linezolid. We compared these three drugs with atropine, which is used to relieve symptoms, in terms of price, application method, side effects and whether resistance will occur. Atropine cannot completely treat MRSA, while vancomycin and Teicoranin are both at risk of causing resistance. Linezolid is a new type of drug, the way of action is completely different from antibiotics, the treatment effect is good, but the treatment is expensive. Super eco can make up for many deficiencies. It has a low production cost, uses antimicrobial peptides to kill MRSA, and has good therapeutic effect without drug resistance. Through the analysis of competitive products, we found the Unique Selling Proposition of super eco: High lethality will not produce resistance at the same time, the cost is low.

Figure 5 Competitive product analysis chart.

The Creativity of Super Eco

Market potential:

With the gradual evolution of microbial pathogens and the overuse and misuse of some drugs, antimicrobial resistance (AMR) has become one of the major public health threats of the 21st century. Globally, MRSA directly caused more than 100,000 deaths in 2019,

According to GlobalData, a data analytics and consulting firm founded in 1999, the MRSA treatment market will experience limited growth over the next decade, growing from $1.4 billion in 2014 to $145 million in 2024. Many of these new products will establish niche positions in MRSA therapeutics and will also realize their potential outside of MRSA therapeutics.

Solve the problem of unequal medical resources:

A major challenge in tackling drug-resistant bacteria is understanding the true burden of resistance, especially in areas where surveillance is minimal and data scarce. However, until now, no comprehensive evaluation study covering all regions and a wide range of pathogens and drug combinations has been published. This is why we are concerned about the vast rural areas, the hidden corners of many people suffering from illness.

Super eco's production costs are lower, and we plan to adopt an intermediate pricing strategy to eliminate competitors while achieving a fair profit margin. In the future, we also plan to develop a series of supporting facilities such as sensors to detect types of bacterial food poisoning and give the right medicine, which will help us to provide low-cost supporting products for people who do not want to pay too much for treatment. Super eco's live bacteria capsules are easier to promote than injectable liquid, and the publicity form of health care products is conducive to its acceptance by the public. People with bad stomach and health care workers who are easily exposed to MRSA environment are our audience, especially in rural areas. Low price and convenient use form are easier to spread, overcome backward medical resources, and protect everyone's intestinal health in the most harmless way.

While high-income countries also face alarmingly high levels of antibiotic resistance, its impact is most severe in low - and middle-income countries, highest in sub-Saharan Africa and South Asia, at 24 per 100,000 and 22 per 100,000, respectively. In sub-Saharan Africa, AMR indirectly causes 99 deaths per 100,000 people; In South Asia, AMR is indirectly responsible for 77 deaths per 100,000 people4. We hope that by working with foreign governments, regional and international organizations, super eco can help them as well.

In the future, we plan to cooperate with the government to promote super eco to grassroots hospitals, pharmacies, and health centers to help more areas lacking medical resources and alleviate the problem of inequality.

Promote employment:

We plan to set up a start-up company, as the company continues to grow, it will directly bring employment in the development, and drive indirect employment through its influence on the upstream and downstream of the industrial chain. In the middle stage of development, the company's scale expands rapidly, and the demand for jobs rises. In the later stage of development, the company implements a steady expansion strategy, and the production, sales and operation match. The employment growth we can bring is considerable.

Intellectual Property

Considering the legal protection of the project, we plan to apply for a patent for our drug in China, and when the technology progresses, the patent should be extended accordingly, so as to prove the feasibility of super eco, increase its competitiveness, and make it easier to attract investors and persuade them to cooperate with us. After studying the Patent Law of China, we determined that super eco meets the requirements of the patent of pharmaceutical products, belongs to the invention patent, and has the novelty, creativity and practicability stipulated in Article 22 of the Patent Law. We have manufactured super eco by synthetic biology method, which can effectively kill MRSA. No one had ever patented anything like this before.

At the same time, because our design uses some patented technologies of others, the process of commercialization of the project also involves patent transfer and patent implementation. Patent transfer means that the patentee, as the transferor, transfers the ownership or holding right of its invention and creation patent to the transferee, and the transferee pays the agreed price. In the future, we will consider conducting patent transactions when necessary. You may also consider working with the patentee to obtain a license to enforce the patent.

Company

Mission and Vision

Our team consists of 12 enthusiastic undergraduate students from different disciplines, including biological sciences, clinical medicine, agronomy, biomedical engineering, plant protection, ecology, industrial design, and the intersection of disciplines allows us to come up with many creative ideas and make it possible to realize them. Our vision is to be a leading pharmaceutical company that "thinks globally and serves the world," and we hope that the emergence of super eco will make a difference in the field of MRSA treatment.

Figure 6 our super eco.

SWOT Analysis

SWOT analysis is a situation analysis based on internal and external competitive environment and competitive conditions, which can help us better understand the advantages, disadvantages, opportunities and threats of enterprises. It has significant structural and systematic characteristics. We perform the analysis within the framework of super eco's own conditions. The SWOT analysis is shown in Figure 7.

Figure 7 SWOT analysis. External environmental factors include opportunity factors and threat factors, while internal environmental factors include strength factors and weakness factors.

After completing the construction of the SWOT matrix, the corresponding action plan can be formulated and a series of alternative countermeasures for the future development of the company can be obtained. We decided to give full play to the advantages to take advantage of the opportunity, with live bacteria capsules as the main product, give full play to the modular idea and academic advantages to accelerate the diversified layout, and adopt an intermediate pricing strategy to accelerate capital recovery and supplement cash flow; Regarding weakness, I can seek opportunities to cooperate with large pharmaceutical companies and supporting facilities factories to overcome the problem of insufficient funds in the early stage and establish myself in the market more quickly. In order to resolve threats, after the industrialization of products in the later stage, we also need to gradually improve corporate awareness, increase our competitiveness in the market, and use the brand effect to spread the product more widely. We consider the past, based on the present, with an eye to the future, and carry out a thorough analysis and explanation of the "possible" aspects of super eco with SWOT analysis.

Fund Analysis

Super eco will become a pharmaceutical company. In order to implement the company's business plan, we also need a large amount of funds for experimental, late-stage clinical and operational purposes, of which R&D costs account for the majority. Since there are no offline experiments and human resource expenditures are difficult to estimate, we cannot accurately determine the costs. Therefore, we have a preliminary idea of the expected cost structure and funding sources in order to develop our financing plan and establish an effective funding chain.

Zhejiang University Education Foundation has a special funding support of about 300,000 for iGEM, and we have sufficient funding sources in the early research and development stage. In addition, entrepreneurial competitions organized by schools or governments, such as srtp and Internet +, can provide some financial support for entrepreneurial teams in the early stage of project establishment and research and development.

In order to obtain more funding for research and development projects, we can participate in roadshows and fundraising events, which can effectively obtain feedback and support from venture capitalists, who will become our first investors and customers. As a life sciences startup, we knew we were going to lose money in the beginning, From the research and development stage to the consumer market, the product should at least go through the design and development, registration testing, clinical trials, registration application, production license application and other long and profitable process, it's a 10K race, but based on SWOT analysis and financial analysis, We are confident that we can achieve net profit in 5 years. In the later stage of the project, we will make a complete financing plan to strengthen the company's financial support.

Figure 8 Initial capital investment.

Business Model

Business Model Canvas can not only provide more flexible plans, but also more easily meet the needs of users. It can standardize the elements in the business model and emphasize the interaction between the elements. We drew a commercial canvas based on super eco's characteristics, as shown in Figure 9.

Figure 9 Business model canvas of Super eco—— AMP-based intestinal symbiotic bacteria targeting MRSA.

Business Plan

The business plan is a written material compiled by the company, enterprise or project unit in order to achieve investment, financing and other development goals according to certain format and content requirements to comprehensively show the current status and future development potential of the company and project to the audience. In order to successfully commercialize our project, we completed the business plan with the help of many stakeholders.

See the intergrated human practice section for more on communicating with stakeholders.

In order to verify our business plan, we can also participate in creative competitions, such as Internet +, Challenge Cup, and present our projects to everyone; We can also participate in the industry expo, meet many excellent peer pharmaceutical companies, exchange industry news with them, and seek potential partners. We plan to open up the application and charging channels of new clinical technologies in hospitals in the future to obtain sufficient order protection; Establish sales agents and advertising marketing channels for biomedical enterprises to obtain sufficient marketing guarantee; Cooperate with government and science parks to obtain policy support. Let's look forward to the future of super eco!

Reference

  1. Engel, G. L. (1977) The need for a new medical model: a challenge for biomedicine, Science 196, 129-136.
  2. 张从超. (2017) 生牛乳中金黄色葡萄球菌的快速检测及耐药性研究, 齐鲁工业大学.
  3. 容冬丽, 吴清平, 吴诗, 张菊梅, and 徐明芳. (2018) 我国部分地区即食食品和蔬菜中金黄色葡萄球菌污染分布及耐药和基因分型情况, 微生物学报 58, 314-323.
  4. (2022) Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis, Lancet 399, 629-655.