Our mission
The work for our entrepreneurship was inspired in part by iGEM teams Leiden 2023, TU-Eindhoven 2022, and SDU-Denmark 2021.
Unmet needs
According to World Health Organization it's estimated that 1 out of 10 women in their reproductive age have Endometriosis (1). There are hardly enough treatment alternatives, and not all women benefit from them. For many, pain treatment, surgery, and hormonal therapy may not be sufficient to completely relieve their symptoms which can lead to ongoing pain and suffering as well as a worse quality of life (2). Endometriosis has a serious negative impact on mental health, including anxiety, despair, and loneliness, and this psychological toll can worsen physical symptoms and impair general well-being (3). To completely comprehend the causes of endometriosis and create better treatments, including non-invasive alternatives and long-term management plans, more studies are required. Many women's sufferings are prolonged due to the limited choices for managing their condition or relieving their symptoms because of the poor development in research.
A survey created by our team for women with endometriosis revealed an urgent need for a cure, highlighting the significant impact of the condition on their lives. The survey results emphasize the importance of finding more effective treatments to address the ongoing challenges and improve the well-being of those affected.
Technology
Our plasmid holds the potential to become the treatment women with endometriosis need. EndoERαSE will focus on Research and Development (R&D), aiming to optimize both the plasmid and its delivery method. However, assistance would be needed for the production and commercialization of the final product. A horizontal merger (4) would allow EndoERαSE to leverage the pre-existing facilities of another company while being able to offer them the most efficient, well-researched treatment available. This collaboration would accelerate bringing the solution to market, benefiting both organizations and advancing the fight against Endometriosis.
Provided we have found a gap in the market, developing and manufacturing any pharmaceutical product is expensive (5). Ideally, we want to patent our plasmid and set up the business to be purchased by a bigger pharmaceutical firm as part of our exit strategy, rather than taking the product all the way to market ourselves. This could be either after a solid proof of concept, during the drug discovery or later in clinical trials. After much consideration, we decided to focus on selling the patent after phase I clinical trials. This transition is optimal since the product, at this stage, has already undergone preliminary human safety testing (6), it has received enough validation to attract the interest of larger firms without incurring the high expenditures of future development. With this strategy, we may take use of the benefits of early-stage intellectual property and scientific validation without having to make a sizable extra expenditure in later-stage studies or obtain regulatory approval. By pulling out at this early point, we reduce the financial risks associated with taking a pharmaceutical product to full commercialization while also optimizing prospective rewards.
Opportunity
Due to organizations like Endometriose Fællesskabet (Endometriosis association) (7), research in women’s health conditions, particularly in Denmark, has been attracting greater attention. As a result, there has been a growing emphasis on developing diagnostic tests and treatments for diseases such as endometriosis. This increased attention has improved opportunities for securing funding and forming partnerships to support research efforts. As awareness grows, more individuals are likely to receive a diagnosis of conditions like endometriosis, which in turn creates a greater demand for improved and effective treatments. The combination of expanded research, better access to resources, and rising diagnoses highlight the growing importance of this field and the demand for solutions to improve patients' quality of life. Overall, the increased focus on these issues has been driving advancements in women’s health and creating a more supportive environment for progress in addressing diseases like Endometriosis.
Viability of Market (TAM, SAM, and SOM)
Total Addressable Market (TAM)
The Total Addressable Market (TAM) refers to the total potential revenue a product can generate if it captures 100% of the market share (8). In 2023, the TAM for endometriosis treatment was estimated at 1.4 billion USD (9). Projections indicate that the market will grow at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2034. By the end of this period, the market is expected to be worth 3.1 billion USD (9). The CAGR is an important metric for assessing how a company or market will expand over time, factoring in the effects of compounding. It provides a clear view of growth potential over a specific timeframe, making it a valuable tool for market forecasting and business strategy. This steady growth reflects increasing demand for effective endometriosis treatments, driving the market's expansion over the next decade.
Serviceable Available Market (SAM)
The Serviceable Available Market (SAM) represents the portion of the Total Addressable Market (TAM) that can be realistically targeted (8). Based on our timeline of key activities, as seen in Figure 3, it is evident that our treatment will not be market-ready by 2034. However, there is a possibility that by 2034 we may be able to sell part of the company. While our product might not yet be available, the potential for a strategic sale remains, aligning with our long-term goals despite the treatment's delayed market entry.
Serviceable Obtainable Market (SOM)
The Serviceable Obtainable Market (SOM) refers to the portion of the Serviceable Available Market (SAM) that can realistically be captured (8). In this scenario, EndoERαSE is based in Denmark, a country with a well-established life science and medical industry. This strong foundation provides a promising opportunity for the company to capture a share of the market, making it possible to secure a portion of the available demand within the Danish life science sector.
Feasibility, scalability and inventiveness
Our treatment stands out from existing options, and there has been expressed a significant demand for it, as evidenced by the positive feedback we received from patients during our Human Practices research. To maintain our competitive edge in the field of endometriosis treatment, we conducted a thorough SWOT analysis as seen in Figure 1 (10), which can be seen in the next section. This assesses the strengths, weaknesses, opportunities, and threats associated with our approach. This comprehensive evaluation would allow us to strategically address potential challenges while maximizing the unique advantages of our treatment. By staying proactive and informed, we can ensure that we will be well-positioned to meet the growing demand and lead the way in innovative endometriosis care.
SWOT Analysis
Competition
Direct competitors:
At present, we have not identified any direct competitors, as our treatment is distinct in both its approach and its effects. Unlike existing treatments, which primarily focus on managing symptoms, particularly pain, our solution would innovatively address the condition of endometriosis by creating a treatment that minimally invasively reverses the condition. This uniqueness would give us a significant competitive edge in the market. However, as we continue to develop and promote our treatment, it is essential to monitor any emerging technologies or research that may pose competition in the future. Staying ahead of the curve will ensure that we maintain our unique position in this field.
Indirect competitors:
Several companies are currently offering treatments for endometriosis, although their focus has mainly been pain management rather than addressing the underlying condition. For example, Myovant Sciences and Pfizer have collaborated on a treatment approved by the FDA that manages to alleviate severe endometriosis pain in pre-menopausal women (9). Similarly, AbbVie Inc. has received FDA approval for a treatment targeting moderate to severe pain (11). Another company, TerSera Therapeutics, has developed a treatment approved by the FDA, which not only manages pain but also helps reduce endometriotic lesions (12). While these companies provide relief solutions, their treatments are limited to symptom management, leaving room for more comprehensive solutions like ours.
Future competitors:
As the focus on women's health issues, particularly diseases like Endometriosis, continues to grow, more funding is being directed toward R&D in this area. This increased attention is likely to lead to more companies entering the market in search of effective treatments. With advancements in synthetic biology and women's health receiving more support, it’s expected that future competitors will emerge. These companies may develop innovative treatments that could compete with ours. To remain competitive, we must stay agile and continue innovating while actively monitoring the industry landscape for new entrants and developments.
Product development plans
We have outlined our growth strategy and have conducted a thorough Business Model Canvas (BMC) analysis for EndoERαSE to visualize our business model and trajectory for future success. This can be seen in Figure 2. This framework helps ensure we cover all key aspects of our business while advancing our product development.
Business Model Canvas (BMC)
In line with the standard drug development process, we have established a detailed timeline with specific milestones to guide our progress. These goals will help keep our team focused and motivated throughout each phase of development.
Timeline
Key activities
iGEM
The iGEM competition served as the foundation of our project and provided the initial inspiration, and framework for our treatment's development. Our first steps in researching endometriosis and testing our treatment were conducted as part of our iGEM participation. It also offered us a platform to refine our scientific approach while gaining valuable feedback from experts. This experience laid the groundwork for our continued research, serving as a launchpad to push our project forward and establish its long-term potential in the field of Endometriosis treatment.
Access funding
Securing financial support is a crucial first step that enables the continuation and growth of our project. Funding allows us to participate in competitions like iGEM, conduct early-stage research, acquire necessary materials, and cover essential operational costs. During our iGEM journey, we received assistance through sponsorships, which not only supported our entry but also helped cover the costs of research. Moving forward, accessing sustained funding will be vital for scaling up our operations, conducting clinical trials, and ensuring the commercialization of our treatment.
Proof of concept
This stage involves validating our core scientific principle which is that our plasmid selectively can induce apoptosis in endometriosis cells while sparing healthy endometrium cells. Demonstrating this proof of concept is essential to prove that the treatment works as intended and has the potential to revolutionize endometriosis care. Successful validation will not only build confidence in our scientific approach but will also be critical for attracting future investments and partnerships, as it demonstrates that the treatment is both targeted and effective.
Register the company and patent
Registering the company is an important step in formalizing our operations and establishing ourselves as a legitimate entity. Alongside this, securing patents for our treatment is essential to protect our intellectual property and prevent competitors from duplicating our work. Patenting provides us with exclusive rights to the technology, allowing us to leverage our innovations in the market. This will ensure that we retain control over our treatment’s development while also safeguarding future revenue streams through licensing and commercialization opportunities.
Horizontal merger, research, and development >
Forming strategic partnerships or pursuing mergers with companies that specialize in complementary technologies can significantly boost our R&D efforts. Collaborating with industry leaders could provide access to cutting-edge knowledge, specialized tools, and additional resources, which would help us accelerate progress. By pooling expertise, we could streamline research, reduce development timelines, and more effectively tackle challenges. These collaborations would also open the door to broader market access and potentially faster routes to commercialization.
Clinical Trials
Successfully completing clinical trials is a vital step in ensuring the safety and efficacy of our treatment. Before scaling up, it is essential that our treatment undergoes rigorous testing to meet regulatory requirements and establish trust within the medical community. Clinical trials will provide the data necessary to demonstrate that our treatment is both safe for patients and effective in addressing the underlying condition of endometriosis.
Phase I will remain the main focus where we aim to assess safety by monitoring for potential immune reactions, efficacy in reducing endometriosis symptoms, and determining the optimal dosage. We will also look for side effects such as tissue inflammation, unintended genetic effects, or hormonal imbalances, as the treatment is targeting estrogen receptors. Additionally, the tracking of long-term effects and the treatment’s impact on quality of life for patients could occur after a big pharma company purchases our company and finalizes the remaining clinical trials. These trials will also play a key role in securing approval from health authorities, paving the way for widespread use.
Access facilities
Securing access to larger research and production facilities is crucial for optimizing the development and manufacturing of our plasmid. However, our project is still in the early stages, so larger research facilities are not necessary at this time, and the facilities at SDU are sufficient for our needs. The SDU startup station can assist in the finding of affordable office spaces, meeting facilities, lab facilities, and more. Additionally, organizations like Life Science Fyn offers entrepreneurs in the life science field affordable access to laboratory facilities, which we could use in the future. As we progress toward commercialization, transitioning to larger facilities will eventually be essential for refining our processes, improving efficiency, and reducing costs. By leveraging state-of-the-art infrastructure, we can ensure our production methods meet industry standards and effectively handle the increasing demand for our treatment as we prepare for market entry.
Upscaling
Upscaling our production capacity is an essential step to meet the growing market demand and make our treatment widely available. Transitioning from small-scale laboratory production to industrial-scale manufacturing will not only allow us to produce larger quantities of our plasmid but also improve cost efficiency. This will involve optimizing our production process to reduce costs, increase yield, and ensure the highest quality standards are maintained. Upscaling will be key to ensuring that we can supply hospitals, clinical trials, and eventually pharmaceutical companies with our treatment.
Establish distribution channels
Building strong distribution networks is critical to ensuring that our treatment reaches the healthcare providers and patients who need it. Establishing partnerships with distributors, hospitals, and pharmaceutical companies will facilitate the smooth delivery of our product to end users. We will need to develop reliable and efficient logistical solutions to ensure our treatment is accessible on a global scale. A well-structured distribution network will also help us build relationships with healthcare professionals, making it easier to expand our market reach and drive future growth.
Marketing of our treatment
Effective marketing is key for promoting our treatment and raising awareness among healthcare professionals and patients. Highlighting the benefits of our treatment, such as its minimally invasive nature and its ability to target a specific cell type, will help differentiate us from existing options. A strong marketing campaign will build trust in our product and communicate its safety and effectiveness. By leveraging scientific publications, industry conferences, and direct outreach, we aim to establish our treatment as a breakthrough solution for Endometriosis and position it as the preferred choice for managing the condition.
Key partners
For the growth and development of our company, we need to collaborate with several key partners. One of the most crucial is SDU RIO, the University of Southern Denmark’s Research & Innovation Organization. SDU RIO offers support to students at SDU in areas like patenting, which will be essential for protecting our intellectual property. Additionally, SDU RIO's Startup Station, a subdivision of the organization, could prove invaluable by providing us with insights into securing funding and offering other resources that are critical for a new startup. We have also spoken with Knud Engbjerg, a business developer from SDU RIO, who gave us useful advice on the steps needed to establish our company. He introduced us to Liv Thomsen, a Specialist Consultant from SDU RIO, further strengthening our network within the institution. We have already engaged with Liv Thomsen to discuss the potential of securing a patent for our treatment. She advised that while our plasmid needs further optimization and refinement, especially after presenting at the iGEM competition, she was optimistic about its prospects. Another key need for our development is lab space. We are hopeful that the Department of Biochemistry and Molecular Biology at the University of Southern Denmark, where we conducted much of our work during iGEM, could provide us with the laboratory facilities necessary for continuing our R&D or help acquiring for affordable lab space. Additionally, LifeScience Fyn, a Danish association located in Funen, would be fundamental for assisting us in the beginning of our start-up. Finally Preflight Odense is a free program that consist in the meeting of experts and speakers to help kickstart your start-up. Their support would allow us to further optimize our plasmid and carry out the essential experiments required to advance our treatment.
Key resources
The resources available to us will significantly impact the success of our business. The most critical resource is our team that developed the foundational aspects of EndoERαSE. The teams collective experience along with the dedication of our supervisors, and principal investigators (PI’s), is a strong foundation that will be crucial in advancing our treatment to the market. Our combined efforts and insights will play a pivotal role in ensuring that we can navigate the challenges ahead and bring our solution to those who need it.
Research and development
We plan to conduct different experiments to develop our plasmid and introduce measures to make the treatment safer and reduce off-target effects. We are already researching methods to deliver the plasmid in vivo.
Value proposition
Our treatment's value lies in its difference from all other treatments on the market. Additionally, it may be possible to turn our plasmid into a diagnostic tool.
Customer relations
Our interactions with pharmaceutical companies will be managed through dedicated personal support, ensuring that each pharmacist communicates directly with a designated contact from our company. Building a strong, positive relationship is essential, as our goal is to collaborate closely with these companies to further develop and advance our treatment. Establishing this connection will foster trust and cooperation, paving the way for successful long-term partnerships in the pharmaceutical industry.
Channels
We plan to reach potential pharmaceutical customers by directly engaging with companies that specialize in plasmid development and upscaling, as well as its delivery. Our approach involves targeting these specialized pharmaceutical companies to foster interest in our treatment. Additionally, we will raise awareness of our solution through our participation in the iGEM competition, which serves as a platform to showcase our innovation and attract the attention of relevant industry players for future collaborations.
Customer segment
Our primary customer segment includes major pharmaceutical companies, such as Pfizer, through which we aim to distribute our treatment to healthcare providers. The treatment is intended to be prescribed and administered by qualified healthcare professionals, including physicians, ensuring its proper medical use. Additionally, pharmacies could serve as a potential distribution channel to facilitate access for healthcare providers. By partnering with key players in the pharmaceutical industry, we seek to ensure wide-scale distribution and support as our treatment advances through the development and commercialization stages, with an emphasis on professional oversight in its administration.
Cost structure
Our primary costs will be focused on R&D to optimize our treatment. Following that, clinical trials will represent a significant expense due to the rigorous testing and approval process required to ensure safety and efficacy.
Revenue streams
In the short term, our company will rely on grants for funding. Additionally, partnering and collaborating with universities, research institutions, or similar organizations may provide opportunities to generate revenue and further support our business. These collaborations could offer valuable resources and financial contributions, helping us sustain operations and advance our treatment development. By leveraging these partnerships, we aim to secure both funding and expertise for our ongoing growth and innovation.
Intellectual property
To establish EndoERαSE as a fully operational company, we will register it through Virk, the official registration platform for businesses in Denmark (15). Additionally, once we have sufficiently optimized our Treatment Plasmid, we intend to file for a patent for our Treatment Plasmid to protect our intellectual property and secure our innovation. After filing for a patent for our treatment, we will document our processes and maintain confidentiality through non-disclosure agreements. We will prepare for potential sale, possibly after phase I of clinical trials, by compiling financial statements, organizing legal documents, and creating a business summary. Finally, we will engage advisors to negotiate terms and ensure a smooth transition.
Financials
Risk assessment
Table 1: Risk Assessment
| Phase | Risk | Solution |
|---|---|---|
| Access Funding | Inability to acquire grants or loans. | Secure diversified long-term funding through private investment, strategic partnerships, or EU grants. |
| Proof of concept | Our plasmid does not work as intended. | Have multiple plasmid designs to increase the chances of one of them working. |
| Horizontal merger, research, and development | No suitable company. | Broaden search criteria, explore partnerships, and consider international or early-stage companies. |
| Clinical Trials | Trial failure due to safety or efficacy issues. | Mitigate risks by conducting thorough preclinical studies, adaptive trial designs, and using biomarkers to improve patient selection and outcomes. |
| Access facilities | Limited access delays production and scaling efforts. | Establish partnerships with research institutions or pharmaceutical companies. |
| Regulatory Approval Delays from the European Medicines Agency (EMA) | Regulatory delays from EMA postpone product launches. | Stay in close contact with regulators and ensure trial designs and results align with EMA requirements. |
| Upscaling | Scaling production may face technical and supply challenges. | Invest early in scalable manufacturing processes, ensure technology transfer is efficient, and validate production techniques. |
| Production Demands | Failure to meet demand causes supply shortages. | Secure production capacity through partnerships or in-house expansion and maintain flexibility to quickly ramp up manufacturing. |
| General Data Protection Regulation (GDPR) | GDPR non-compliance risks penalties and reputation. | Ensure GDPR compliance through strong data protection systems, secure data storage, and privacy protocols. |
| Distribution channels | Weak distribution channels limit patient access and efficiency. | Develop strong partnerships with distributors and logistics firms. |
| Intellectual Property (IP) and Patent Expiration | Patent expiration invites competition, reducing market share. | Utilize supplementary protection certificates (SPCs) and ensure strong IP strategies, including continuous innovation to extend exclusivity. |
| Marketing | Negative publicity could harm reputation and sales. | Ensure transparent marketing and rigorous evidence support to build trust and credibility with stakeholders. |
| Regulatory Changes | EU regulatory changes impact market access or pricing. | Stay agile by closely monitoring EU policy changes and remaining flexible in responding to shifts in regulatory environments. |
Estimated finance
The cost of developing a new drug has reached astronomical height, often cited to be in the range of $1.5 billion and $2.9 billion. This Figure covers both successful drugs and those that fail during testing (5). Larger pharmaceutical companies face these high costs due to extensive research facilities and the need to recover investments across various projects (16).
In contrast, smaller biotech firms can potentially limit R&D expenditures to the thousands or hundreds of thousands of dollars annually by operating on lean budgets and leveraging partnerships. For example, Intellia Therapeutics reported total expenses of approximately $19.453 in 2015, which increased to $551.566 by 2023 (17). Despite this growth, smaller firms can still find ways to manage and minimize their R&D costs (18).
To fund our project, we have several promising opportunities to explore. We could pursue investment from Sunstone Life Science Ventures, a venture capital firm that specializes in supporting innovative biotech projects. Notably, they have a dedicated fund, Fund IV, that focuses exclusively on therapeutics, making them an ideal partner for our initiatives. Furthermore, it is worth mentioning that Sunstone Life Science Ventures is located in Copenhagen (CPH), enhancing the potential for local collaboration and support (19).
We also have the option to approach Novo Nordisk, our current sponsor, which previously provided us with 200,000 DKK. Notably, they also offer the “Tandem Programme – Translational research collaboration between Basic and Clinical Researchers” which provides funding of up to 10,000,000 DKK, for which we could apply later on in our research. To be eligible the grand must be applied with the main applicant having their primary employment at a university or hospital, so that should be kept in mind (20).
At our meeting with Knud Engbjerg, he mentioned “Den Lyse Idé” (The Bright Idea), as a fund we could apply for. The Bright Idea is a price that is given out by “Otto Mønsteds Fond” to two different Danish start-ups, one at their early stages of development and the other at their later stages of development. There is 250,000 DKK for both prices. The judges are looking at the following criteria when deciding who should get the price (21).
- Excellence in thought, communication, analysis and documentation.
- The degree of business vision and understanding.
- How possible it is for The Bright Idea to be implemented.
- The idea’s value and significance for Danish business.
(21)
Applying for this prize after the iGEM competition could benefit in the growth of our business, as we are still on the early stages of the development of our Treatment Plasmid.
Additionally, Dr. Martin Rudnicki, Professor and Doctor in Gynecology and Obstetrics at OUH, Director of Minimal Invasive Surgery, has expressed his willingness to assist us in obtaining grants of up to 2,000,000 DKK. Lastly, the University of Southern Denmark can offer us help with affordable facilities and equipment for a bench fee, further reducing our operational costs.
These diverse funding sources will create a solid financial foundation to advance our project and enhance our research and development capabilities.
Through our participation in iGEM, we have already engaged in extensive communication and documentation throughout the development of our idea. Additionally, as part of our Human Practices, we have had the opportunity to speak directly with patients. These conversations have deepened our understanding of the significant impact treatments like ours could have for improving their quality of life. Many patients have expressed strong interest in a solution like ours, reinforcing the importance of continuing our work.
Long-term impacts
Our long-term goal is to bring substantial improvements to the lives of women affected by endometriosis. We aim to provide a more effective solution that offers enhanced access to care, ultimately improving their overall well-being. By targeting the root cause more precisely, our approach seeks to deliver lasting relief and a meaningful boost in quality of life for those who suffer from endometriosis.
