Entrepreneurship

Overview of whole Entrepreneurship

Right from the beginning of our project, we embarked on an exploration of how we could effectively translate the concept of CellCare into a profitable reality. To achieve this goal, we identified our key target audience and engaged with them to gain insights into their needs and pains. We also collaborated with pharmaceutical industry experts to conduct a series of comprehensive assessments, covering aspects such as our customer base, the product itself, its market positioning, our strategy for commercialization, the financial aspects, and the composition of our team. Drawing upon the insights obtained from experts and integrating them with the results of our analyses, we formulated a business plan aimed at bringing the CellCare model to the market. We provide details and analyses of the consumer base, the offering, and our team within this page. We suggest reading our business strategy for a closer look into the specifics, reasoning, and basic assumptions that underlie these analyses.

Company

Overview of this page: Our company's goal and vision and review of the abilities of our crew are stated on this page. The programme for iGEM NU-Kazakhstan 2023 is presented. The SWOT analysis is carried out. The business strategy is summarized using a business model canvas, and then a financial projection and plan are discussed. Please read the business model for further details and assumptions.

Our mission: Our mission is to transform the landscape of cancer care, one breakthrough at a time.
Our vision: Empowering Precision Healing: Revolutionizing Cancer Treatment through Intelligent Solutions.
Our purpose: to create a localized smart and controlled anti-cancer drug release machinery against carcinoma using engineered bacteria embedded into the hydrogel system.

Our team

The iGEM NU-Kazakhstan 2023 team consists of eighteen master's and undergraduate students from a variety of academic backgrounds, including biological sciences, entrepreneurship, programming, web design, and graphic design. Expertise in various fields makes it possible to think creatively and transdisciplinary while critically evaluating outputs from several angles. These characteristics are necessary for new business venture creation and high-quality scientific research in the development of CellCare. The iGEM NU-Kazakhstan team is vital because it includes all nine of the Belbin positions listed in Table 1, which are essential for efficient decision-making and business procedures within a creative team. The team possesses the necessary knowledge and abilities to launch a new business, conduct R&D to improve CellCare, oversee a lengthy project, and hire additional partners.

Table 1. Belbin roles of iGEM NU-Kazakhstan team members.

SWOT analysis

A strategic management method employed for our new business venture is the SWOT analysis, which stands for identifying Strengths, Weaknesses, Opportunities, and Threats concerning business competition. This analysis is conducted in collaboration with representatives of AstraZeneca, Arlan BioTech startup, and the National Centre for Biotechnology. Further information about our advisers and their involvement in our project can be found on our Human Integrated Practices wiki page. We actively sought innovative approaches to overcome or leverage these weaknesses and threats to our advantage. The results of the SWOT analysis are illustrated in Figure 1.

Figure 1. SWOT analysis for iGEM NU-Kazakhstan.

Product

Our team sought a specific and targeted cancer treatment solution due to the challenges faced by conventional therapies like chemotherapy, which damages healthy cells. To tackle this, we utilized synthetic biology to create a unique drug delivery system. This system involves embedding engineered bacteria in a hydrogel, offering precise drug delivery to cancer cells. The hydrogel, initially liquid, solidifies upon administration, creating a mesh structure that contains bacteria. These bacteria self-destruct after reaching a specific concentration, releasing the natural anti-cancer toxin Colicin E1 into cancer cells, inhibiting their vital processes. The hydrogel acts as a timed toxin-release factory, eventually degrading into harmless materials. This approach induces anti-cancer immune responses and minimizes damage to healthy cells, making it a groundbreaking and safe cancer therapy.

Figure 1. Value propostion of CellCare. Value propostion canvas for CellCare that includes the gain creators, pain relievers of the product and the pains, gains and customer jobs of the customer.

Market analysis

Market overview:
From 2021 to 2026, the market for cancer therapies, which is projected to be worth $150 billion, is anticipated to expand at a CAGR of 7.2%. With an estimated 19.3 million new cases of cancer expected to be reported in 2020, the incidence of cancer diagnoses is on the rise globally. An increasing need for novel, accurate, and less hazardous remedies is reflected in the market's paradigm shift towards targeted and personalized treatments.

Figure 2. The expected global cancer therapeutics market size during the forecast period 2022 to 2030.

Market Demand:
The demand for cancer treatments that minimize damage to healthy cells while enhancing efficacy is significant. Market research indicates that over 40% of cancer patients are actively seeking targeted therapies with fewer side effects. Moreover, the market for immune-stimulating therapies, a vital feature of innovative bacteria-mediated therapy, is projected to reach $150 billion by 2025.

Market trends:
1) Personalized Medicine: The market for personalized cancer therapies is expanding at a CAGR of 10.2%, highlighting the product's alignment with this trend in personalized medicine.
2) Biotechnology Advancements: The synthetic biology sector of the biotechnology business, which is estimated at $800 billion, is mainly devoted to the study and treatment of cancer.
3) Focus on Minimally Invasive Therapies: A significant market trend favoring the product's localized, bacteria-mediated approach is indicated by the minimally invasive therapy market's 8.5% CAGR growth.

Market challenges:
1) Regulatory Compliance: Novel medication delivery systems and genetic engineering are subject to strict restrictions, although spending for compliance-related research and other activities has increased by 9.5% in the market.
2) Market Education: According to market surveys, 68% of oncologists feel that novel therapies have the potential to be effective; nonetheless, there is a need for widespread education and awareness campaigns among medical professionals and patients alike.

Market opportunities:
1) Partnerships: There is much potential for collaboration with pharmaceutical companies and academic institutions, given the $6.5 billion worldwide market for joint research in cancer medicines.
Global Expansion: There is a substantial market opportunity as cancer rates rise in emerging nations. 48% of all new instances of cancer are found in the Asian-Pacific area alone, which represents a sizable opportunity for growth.

Market forecasts:
By 2026, it is anticipated that the market for novel bacteria-mediated cancer therapies will rise at a rate of $3.5 billion. The product is well-positioned to take a sizable market share and help advance cancer treatment approaches globally, thanks to strategic collaborations, ongoing research activities, and market education programs.

Partnership

Astrazeneca

iGEM NU Kazakhstan boasts an extensive network and actively engages in collaborations with a diverse range of partners and stakeholders. The team maintains strong affiliations with Biopharma industry workers and receives guidance from several principal investigators, who are esteemed founders and researchers of companies. These experts specialize in synthetic biology, oncology, and biological startups. Furthermore, our team is closely linked to top pharma companies like AstraZeneca. These associations provide valuable opportunities for skill enhancement and knowledge enrichment within our team.

On the 8th of June, members of our iGEM team had the privilege of meeting with Zhalgas Daniyarov, a distinguished representative from AstraZeneca who is responsible for the management of Public Services, at the Astana International Forum of Foreign Investors chaired by the President of the Republic of Kazakhstan. The meeting served as a valuable opportunity to discuss our project, share ideas, and explore potential areas of collaboration. Since then, we have met with Zhalgas several times and discussed many aspects of our project.

Meetings with Zhalgas Daniyarov were crucial in establishing the moral framework for our initiative as well as in refining our methods for engaging stakeholders and developing the project.

The management of AstraZeneca stressed the value of ethics throughout our conversation about science. Our Human Practises component's foundational principle became being aware of the ethical consequences of our job. We addressed the appropriate conduct of research and examined the ethical issues surrounding the manipulation of biological systems to make sure our effort complied with the strictest ethical guidelines.

The conference also gave us a plethora of information about efficient communication techniques. We mastered the skill of explaining the crux of our research to scientists and stakeholders. This acquired information enabled us to write persuasive letters, present a convincing case for our proposal, and ask professionals in the industry for help.

Furthermore, Zhalgas Daniyarov's recommendations for transparency had a significant impact on our strategy. We understood how crucial it was to be open and honest about our approaches, objectives, and potential effects. In addition to promoting confidence among stakeholders, this transparency also encourages open communication, which stimulates cooperation and feedback.

The knowledge gained about the world of clinical trials was one of the main things to remember from the meeting. Our project's advancement became dependent on our ability to comprehend the nuances of this crucial stage of medication development. The management also suggested that we concentrate on starting an R&D firm based on our creative notion. We investigated the entrepreneurial components of our research and set our sights on real-world applications outside of the iGEM competition as a result of this strategic advice.

Discussions also focused on how to commercialize our ideas effectively. We investigated methods for commercializing scientific advancements while assuring availability and cost. This knowledge not only broadened our perspective but also equipped us with the skills necessary to transform our project from a theoretical concept into a practical, commercially viable solution.

In essence, the encounter with the AstraZeneca manager in Kazakhstan was a life-changing event. In addition to strengthening our ethical basis, it gave us the information, skills, and strategic insights we needed to successfully negotiate the challenging terrain of scientific inquiry, ethics, and entrepreneurship. With this new knowledge at our disposal, we were better equipped to develop our iGEM project and make a significant contribution to the field of cancer research.

Arlan Biotech:

Dauken Seitkali, a co-founder of Arlan Biotech, met with us on September 5. Our meeting with Dauken Seitkali was a crucial turning point for our iGEM project. Mr. Seitkali gave us priceless insights into the world of entrepreneurship, strategic alliances, and finance options thanks to his vast expertise in the biotech sector.

Our conversations at this gathering mostly centered on the critical elements of forming strategic alliances with stakeholders. He imparted his knowledge on the art of networking, highlighting the significance of fostering connections with business leaders, academic institutions, and possible partners. His direction made it easier to forge deep ties, which we recognized as essential to the long-term success of our initiative.

Dauken Seitkali also gave liberally of his relationships with venture capitalists and investors. This information opened up avenues for prospective financing sources, which were crucial for the future growth and expansion of our enterprise. Understanding the nuances of working with venture capitalists gave us a road map for getting the funding required to move our ground-breaking anti-cancer medication release mechanism from the lab to practical applications.

Our encounter with Dauken Seitkali from Arlan Biotech not only deepened our awareness of the entrepreneurial environment but it also gave us more assurance that we could successfully negotiate the challenges of forming business partnerships and raising capital. With the knowledge and contacts we obtained from this meeting, we were better able to plan the growth and commercialization of our ground-breaking cancer therapy technique. This encounter acted as a spark for our initiative, advancing it towards a time when our creative idea can actually improve the lives of people with cancer all across the world.

National Center for Biotechnology

We gained important insights into the changing environment of biotechnology in our nation during our discussion with members of the National Centre for Biotechnology on September 6. The government's increased emphasis on human genome editing, which represents a paradigmatic shift in our country's scientific goals, was one of the most significant discoveries.

The reps were really enthusiastic about our concept throughout our talk, notably the novel application of hydrogel in our cancer therapy model. They acknowledged the potential of our strategy and emphasized how incredibly promising it is to include a hydrogel in the treatment of cancer. Their encouraging comments confirmed the viability of our initiative and emphasized the significance of our study in the context of national scientific endeavors.

We were inspired to continue working with this support and the knowledge that our project was in line with national interests. We looked forward to a time when our discoveries would considerably enhance cancer therapy and genetic research in our nation.

The intellectual property of CellCare

a. Existing technology

Within the Integrated Human Practices department, our team conducted internal research of Kazakhstan's market on the subject of present studies that focus on developing novel oncology therapeutic approaches with an overlook on possible legal processes and issues that our team might have to face by commercializing CellCare. It is crucial to note that at the most recent Ministry of Health official meetings on February 28th of 2023, the relevant issues in Kazakhstan's healthcare were discussed where Prime Minister Alikhan Smailov stressed the importance of developing solutions concerning domestic therapy and early diagnostics of oncological diseases [8]. Moreover, after numerous meetings and discussions with our collaborators from AstraZeneca and other collaborators from medicine or cancer research fields, it was determined that currently, there is no ongoing development of cancer therapy based on the use of a hydrogel delivery system and bacterioprotein release. Besides, despite the multiple studies conducted in the US, as they are already investigating the use and efficiency of bacteria-mediated localized cancer therapy, none of the conducted studies use the same bacteria backbone and modifications for localized carcinoma treatment as ours [9][10][11]. Thus, there are no issued patents globally and, specifically, in Kazakhstan. Since our business would primarily operate locally, we are confident about our ability to promote CellCare and operate in Kazakhstan's market with support from AstraZeneca's branch in Kazakhstan and Kazakhstan's Institute of Oncology located in Astana.

b. Protectability Plan

To ensure the protection of our intellectual property, our team plans to submit an application with a project description for a patent in 2 languages as required by governmental standards [12]. Based on the type of project, it is also required to select the category of the proposed patent - either industrial sample or invention [13]. Since there is a limitation for the therapeutic solutions applied on either humans or animals, our specific final product would be re-classified into 2 invention patents: hydrogel as the localized drug delivery system and environment-specific engineered E.coli model. Finally, to merge two patents, a separate application will be submitted for later cycles of the governmental вЂњGrant funding of the most promising commercialization projects of scientific innovationвЂќ program. More information about the scientific innovation of CellCare can be found in the Product section.

Commercialization strategies

As was described earlier, to commercialize CellCare, we will legally protect it to eventually license it as a separate technology and industrial sample to gain bargaining power for consequential partnership agreements on the market with pharmaceutical incumbents. To ensure competitiveness and legal competency in the market, as described earlier, we will legally protect the proof of concept of two main components of CellCare and proceed on possible partnership and funding discussions under a non-disclosure agreement. That is the best strategy for us to utilize as a team with limited financial and technical resources, and due to that, the maintenance of legal protection of IP is vital for the productвЂ™s eventual market sales. Thus, we developed the CellCare Customer Roadmap (Figure 1), where our primary customers are pharmaceutical companies, to provide our customers with a quality and concise representation of CellCare as an innovative product that emphasizes the contemporary needs (see Value Proposition) of users - Big Pharma customers.

Figure 3. CellCare Customer Roadmap developed based on Value Proposition with oversight on commercialization environments by Gans and Stern.

Based on Market Analysis, we determined that there are no complementary assets available in KazakhstanвЂ™s market to release CellCare products on the market since most of the assets are possessed and under the control of Big Pharmaceutical Companies, such as Pfizer, Merck Inc., etc. Consequently, according to Gans and Stern commercialization strategy environments table (Figure 2), since CellCareвЂ™s technology can be protected and the absence of access to complementary assets, CellCare would be best developed in Reputation Ideas Trading or Ideas Factories on local and global levels, respectively.

Figure 4. CellCare strategy as a Start-Up.

In the current commercial landscape, collaborating with market leaders is essential due to their vast assets and esteemed reputation. As a startup, CellCare must form partnerships with these incumbents, leveraging our legally protected innovations. Such incumbents often seek collaborations with startups to maintain their market dominance. Our primary objective is to foster these partnerships, enhancing our negotiation strength and facilitating licensing agreements with incumbent-backed deals.

Given that we do not have access to all the resources required for drug development, and considering the significant financial and technical barriers (absence of domestic incumbents and thus complementary assets, restricted governmental funding, and absence of suitable technical facilities for clinical trials), forming partnerships and outsourcing some technical duties with global incumbents is crucial for an effective commercialization approach. Therefore, our five-year commercialization strategy, which emphasizes these partnerships, is illustrated in a Gantt chart (Figure 3).

Figure 5. CellCare commercialization strategic Gantt Chart timeline. Estimated 7-year plan to successfully sell CellCare to primary consumers.

Pre-Clinical and Clinical Trials

CellCare's primary business operation target is Kazakhstan, which is located in the center of the Eurasian continent. Thus, KazakhstanвЂ™s eastern and most of the countryвЂ™s territory is located in Asian content, whereas the western region accesses the Caspian Sea and is located in the European continent. Due to this unique location, Kazakhstan can serve as a prospective clinical trials hub [15] due to the current political instability in Ukraine and Russia. However, currently, it is not feasible for CellCare to conduct pre-clinical trials and clinical trials I-III due to several limitations. First, Kazakhstan placed 92nd among 129 economies in the Global Innovation Index 2019 by the World Intellectual Property Organization, which underscores the overall countryвЂ™s economic underdevelopment. Second, apart from overall low ranking, there are 4 key weaknesses [16] that were identified in GII2022 that particularly convey detailed limitations for the Research and Development businesses such as CellCare. Those are Global corporate R&D investors, top 3, in mn US$, gross expenditure on R&D, % GDP, scientific & technical articles/bn PPP$ GDP, and university-industry R&D collaboration indicators that were identified as KazakhstanвЂ™s keen weaknesses. Thus, because of KazakhstanвЂ™s consistent underdevelopment and underperformance (2020-2022 yr.) in innovations, it is impossible to conduct clinical trials domestically merely because of an economically and scientifically unsuitable R&D environment. With the given circumstances, it was decided to choose a global pathway and plan to conduct clinical trials in the USA due to already established CellCare Partnerships. Therefore, to understand the limitations CellCare might face in conducting clinical trials in the USA, our team conducted thorough research supporting( entrepreneurship) on the National Cancer InstituteвЂ™s cancer clinical trial ethics and corresponding timeline. Based on the National Cancer InstituteвЂ™s various programs and initiatives, our team determined that the Experimental Therapeutics Clinical Trials Network is the most suitable program for CellCareвЂ™s development as our needs match ETCTNвЂ™s primary objectives. To successfully complete our 7-year commercialization strategy, we target the National Science Foundation Innovation-Corps [17] entrepreneurial training program as a major milestone (Figure 3) to transform CellCare from invention to real impact.

Customers

Problem statement:

Cancer continues to be one of the most challenging problems in contemporary medicine, calling for creative ideas to improve treatment effectiveness and lessen side effects for patients. Around 10 million deaths from cancer are expected to be linked to the disease in 2020 alone, according to the World Health Organisation (WHO) [1]. Despite considerable medical science developments, existing cancer therapies, such as chemotherapy and radiation therapy, can have severe side effects because they target both malignant and healthy cells without discrimination [2].

Additionally, the cost of cancer therapy is exorbitant. The National Cancer Institute in the United States projected that the total cost of cancer treatment was $174 billion in 2018 [3]. This financial stress affects not only individuals but also the world's healthcare systems and economies, underscoring the critical requirement for effective and affordable cancer treatment methods.

By using a focused strategy that minimizes harm to good cells and lowers the possibility of negative consequences, the CellCare cancer therapy paradigm aims to solve these urgent concerns. Nevertheless, despite the potential of this ground-breaking approach, there is a significant need for safe and efficient cancer therapies, particularly for patients with advanced carcinoma. These patients frequently have few alternatives and a poor quality of life due to the fact that current medicines frequently need to deliver complete answers catered to their unique demands.

While the pharmaceutical sector makes significant investments in cancer research, it is still difficult and complicated to translate ground-breaking findings into patient-accessible and inexpensive medicines [4]. To close this gap and bring cutting-edge treatments like CellCare to market is crucial for research organizations, pharmaceutical firms, and healthcare providers to work together.

Our research intends to revolutionize cancer therapy by providing a safer, more precise, and more inexpensive substitute in light of these difficulties. We hope to pave the path for a time when cancer patients may receive adequate treatment without having to deal with crippling side effects or significant financial strain by working with experts and stakeholders from the healthcare and pharmaceutical industries.

Customers:

The CellCare cancer treatment model is designed to treat cancer in a new, safer way so it can be used in the treatment of cancer patients. Target customers are Oncologists and Cancer Treatment Specialists, Pharmaceutical Companies and Biotech Firms, Healthcare Institutions and Hospitals. Our innovative cancer therapy strategy serves patients who are battling the problematic third and fourth stages of carcinoma. Our model specifically targets easily accessible carcinoma types. The main advantage of the targeted approach is the minimization of damage to healthy cells. It reduces the risk of adverse effects, making it a promising avenue for future cancer therapy.

The healthcare triangle - a triangle of stakeholders necessary to the success of CellCare was demonstrated in Figure 1. These routes have a significant role in the healthcare system. Each nation may have a different process for bringing CellCare to market, but these steps frequently include the same healthcare system players.

Figure 1. Healthcare triangle of stakeholders necessary to the success of CellCare.

Business Model

1.1 Essential partners

Our primary stakeholders are going to be pharmaceutical companies that are based in Kazakhstan. They are capable of manufacturing large-scale production of our drug and, therefore, can introduce it to the public market. Oncologists and medical professionals in medical institutions will be the primary users, with end beneficiaries being cancer patients of all types.

1.2 Key activities

At Cellcare, our first part was R&D, which makes up a big chunk of the Non-clinical development. It consists of two parts, the first being pre-discovery and finding what needs the market has as of now. Its needs are medications for the diseases that now are treated sub-optimally, whether it is the environmental unfriendliness, side effects, or the expensive price. That is currently applicable for carcinoma since chemotherapy, one of the popular options on the market, is hard to produce due to scarcity of its components on the market, takes a severe toll on the body, and is unaffordable to many people. Having that in mind, we have understood what our goal will be and what we have to do. After that, we moved on to Non-Clinical development, which was made possible thanks to the Nazarbayev UniversityвЂ™s facilities.

Our first step was research on the best ways to find and attack cancer cells. After carrying out the research, pH-based lactate search was chosen as a safe and accurate method.

Our second step of non-clinical development was determining which bacteria to use and how to transport it safely. It was vastly important for us to find the safest options for both the body and ecology, so we came to the conclusion that the most viable options are Collicin and hydrogel, which are safe, eco-friendly, and in abundance on the market.

Step three was the lab work, which included determining the right proportions, researching the process of reactions, and the average response rate.
After finishing the lab work, the next step is patenting the results of our work to be able to protect intellectual property. Hence, patenting is another step displayed among the key activities. That will allow us to have protection over the results of the work. However, it requires a complex knowledge of the process of patenting, and professional help might be needed.

The cost of development production will require investments that allow production and testing on an industrial scale. Therefore, considerable investments should be attracted from both the government and the private sector. To acquire both types of investment, connections have to be established and result in successful partnerships through event organization. We will explore all possible investments, funds, and grants from the government of Kazakhstan. During the process, the best effort will be made to display the effectiveness and helpfulness of our drug to society. It is crucial to show that we have developed a medicine that is smart, localized, safe, and cost-effective. We need to show to both government and private investors that our drug is going through the process of approval from both the Ministry of Health of Kazakhstan and the FDA. If steps are carried out correctly, pharmaceutical companies will see the potential of the drug and consider the purchase of it.

1.3 Vital resources

Throughout the whole process, we were able to have access to the labs of Nazarbayev University, which is pivotal at the beginning of R&D. Being able to use the lab allowed us to have the opportunity to develop, test, and modify the medicine, consequently improving our Wet-lab. When it comes to the Dry Lab, access to all types of software and hardware was essential for the conduction of work, let alone iGEM NU-Kazakhstan organizations room, which accommodated the whole team for meetings and brainstorms of all kinds. Thanks to the advisory of Ivan Vorobyev and Ellina Mun, we received the much-needed advice and feedback to improve our project. Advisors in the lab have also made a significant impact during the lab work.

1.4 Customer Relationship

Relationships with both the pharmaceutical and the government structures are going to be set through accurate descriptions, presentations on the proper implementation of the drug, and clear instructions on the functionality. There will be a heavy focus on long-term relationships to be able to improve both the scale and the quality of the drug.

1.5 Channels

To effectively target potential pharmaceutical clients, our primary approach involves direct engagement with pharmaceutical firms specializing in the development and scale-up of cell-based treatments. Our brand visibility within these companies is enhanced through:
Awareness Creation: We disseminate information about our therapy via scholarly paper publications and gain exposure through platforms like TU/e and the iGEM contest.
Interest Generation: Hosting camps and events, such as the upcoming Bio art exhibition, which we are spearheading, serves as a pivotal avenue to pique interest in our therapy.
Desire Cultivation: Active participation in research trials fosters a more profound desire and trust in our therapeutic solutions.
With the proper use of those strategies, we plan to solidify our position in the pharmaceutical market and prolong lasting partnerships.

1.6 Cost Structure:

This therapy is designed to be cost-effective, offering a value-driven approach that prioritizes therapeutic benefits but still effectively minimizes production costs. In fact, it is anticipated to be approximately six times more affordable than treatments like chemotherapy. Critical expenses in developing our proof of concept therapy related to cancer encompass product materials, R&D, lab facility rentals, taxes, and technician wages. Notably, many resources, including the initial lab access, are generously provided by Nazarbayev University, which significantly reduces the overall cost. Additionally, there are budgeted expenses for patent applications, marketing, and general activities like events and conferences. A crucial point to highlight is the low cost, making it a standout feature. Required costs are described in 1.7 Business canvas model.

1.6.1 Cost Structure for Pharmaceutical

At the current day, our work is in the stage of development and is yet to receive approval for clinical use. As a result of that, various costs are involved in refining and perfecting it before it can be introduced to the market. Gaining approval from regulatory bodies like the Food and Drug Administration and the Ministry of Healthcare of Kazakhstan requires the attraction of significant financial investments. This comes from the fact that the therapy needs to undergo four distinct clinical trial phases before being reviewed by the FDA or the Ministry of Healthcare of Kazakhstan. However, our strategy involves selling our proof of concept therapy to pharmaceutical firms prior to these clinical trials, making these costs irrelevant to our business model.

Nevertheless, we intend to sell our proof-of-concept drug to pharmaceutical companies ahead of such trials, hence making this a cost outside our business model. Still, our investors need to recognize those potential costs. Ballpark's estimate gives us numbers indicating that the trials may take around five to seven years, with approximately $10 to $80 million for budgeting. A breakdown of the trial phases is as follows: The stages include Phase 1 (a few months); Phase 2 (a few months to two years); Phase 3 (1-4 years), FDA approval, and finally, Phase 4.

1.7 Business canvas model

Figure 1. Business Model Canvas for iGEM NU-Kazakhstan project.

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