Entrepreneurship

“Everyone can tell you the risk. But an entrepreneur can see the reward”- Robert Kyosaki

From the very start of our project, we investigated how we could transfer !MPACT into the real world in a lucrative way. To accomplish this, we defined our primary customers whom we approached to understand their values, needs, and pains. Together with experts in the pharmaceutical industry, we performed multiple analyses concerning our customers, the product, the product’s position in the market, our commercialization strategy, the financial plan, and our team. Combining insights, we gained from the experts and with the outcome of our analyses, we constructed a business plan to commercialize !MPACT. To validate our business plan, we participated in the TU/e Contest, where we pitched our project to business experts of large (pharmaceutical) companies, including Novartis, ThermoFisher Scientific, Organon, Medtronic, and other stakeholders. We reached the finals of this competition and won the Audience Award (Figure 1), emphasizing the potential of our business idea. On these pages we share information and analyses of the customer, product and our team. For more details, arguments, and assumptions that support the presented analyses we encourage you to read our business plan. If you would like to know more about how the business stakeholders helped us shape our business plan, please take a look at our Integrated Human Practices page.

Customer

Product

Company

Business plan

Problem statement

Opportunity

Customer

References

Customer

This page elaborates on the problem statement, the opportunity iGEM TU Eindhoven discovered, the targeted customer, relevant stakeholders, and the end-users of our product. For more detailed information and assumptions please read the Business plan.

Problem statement

Currently, 3-5% of the world population is affected by autoimmune diseases and this number is rising.1,2 The iGEM TU Eindhoven 2022 team focuses on the life-threatening autoimmune disease named antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).3 This is a collection of severe chronic disorders characterized by granulomatous and neutrophilic tissue inflammation causing necrosis of blood vessels.3–5 The necrosis of vessels leads to insufficient oxygen supply to the organs behind the vessels. Consequently, a decrease in tissue functioning or tissue death occurs.6

The current treatments for AAV are often immunosuppressive drugs i.e. drugs that suppress the immune system such as prednisolone (glucocorticoids), cyclophosphamide, and rituximab.7 These current treatments are often effective but due to the unspecific suppression of the immune system, burdensome side effects are associated and patients are more prone to infectious diseases.5,8 AAV damages organs, however, the cumulative exposure to glucocorticoids and immunosuppressive drugs of current treatments contributes to the organ damage as well.7 Additionally, the current treatments can only be used for a limited time span since longer use is not bearable for the patient. 10-30% of the patients do not respond to the current immunosuppressive drugs, 50% of the patients have relapses of the disease after 5 years despite the immunosuppression, the treatment-related toxicity contributes to morbidity and disabilities, and because of the high healthcare expenditures and workloads, there is a high unmet need in the treatment of AAV.7,9

More information about AAV can be found on the Project description page.

Opportunity

The problem described in the problem statement leads to the opportunity that iGEM TU Eindhoven discovered. The field of AAV should be heading towards a treatment that is less burdensome for the patient, prevents AAV relapses, and decreases healthcare costs and workload. A potential option is via personalized therapies. A personalized tailored treatment would reduce side effects since it only is active when the pathogenic disease markers (ANCAs) for AAV are present in the patient.10 With !MPACT, iGEM TU Eindhoven is designing a Modular Personalized Autoimmune Cell Therapy that consists of engineered patient cells that couple the presence of pathogenic biomarkers to an immunosuppressive response as a patient-tailored treatment for AAV symptoms.

It needs to be administered once, prevents relapses, has fewer side effects for the patient, and reduces the workload for hospitals. iGEM TU Eindhoven starts with designing this cell therapy for AAV, but eventually also aims to make !MPACT suitable for other autoimmune diseases. More information about !MPACT can be found in the Product Section.


Customer

Customer

Primary customer

The primary customers iGEM TU Eindhoven targets are large pharmaceutical companies that have at least 5,000 employees or an annual turnover of more than 1.5 billion euros and a balance sheet that is greater than 2 billion euros.11 Furthermore, these pharmaceutical companies should have the production facilities and expertise to produce advanced therapy medicinal products (ATMPs) or be willing to invest in such facilities. The industrial customer should be active in the field of immunotherapy but should not sell a cure against AAV, nor should they conduct research on a treatment for this disease. Moreover, they should have all required licenses to do clinical trials and their facilities should be in line with all GMO laws and regulations. Lastly, our customers should hold the same standards regarding safety and ethics on genetically engineered machines as iGEM TU Eindhoven. Extensive analysis, which can be found in the Business plan, showed that one of the stakeholders we engaged called Johnson & Johnson (Figure 2) is the ideal primary customer.

Figure 2 | Logo Johnson & Johnson. Johnson & Johnson is the first customer iGEM TU Eindhoven will try to contract.

Relevant stakeholders

Zorginstituut Nederland (National Healthcare Institute) showed us the triangle of stakeholders (the healthcare triangle) that is required to make !MPACT a successful product (Figure 3). These stakeholders are important members of the healthcare system in the Netherlands. The route to get !MPACT on the market can differ per country, but often similar stakeholders of the healthcare system are involved. Since each type of actor in this triangle plays an essential role, based on the advice of Zorginstituut Nederland, we tried to include all stakeholders of the triangle when developing !MPACT and shaping our business plan. For example, we engaged pharmaceutical companies such as Novartis, Johnson & Johnson, and Organon. We also engaged an advisory body of the government for reimbursement of new medicine called Zorginstituut Nederland (ZIN), clinicians, hospitals, and AAV patients. In the center of the triangle (not shown in the figure), the government is positioned that tries to represent the interest of all involved parties. By engaging all these stakeholders we learned what the market for new therapies looks like, which parties are relevant and what the road is towards a successful market entrance for our new therapy. For more information on how these stakeholders contributed to the development of !MPACT and the business plan, visit our Integrated Human Practices.

Figure 3 | Healthcare triangle. The healthcare triangle shows the important stakeholders and their relationships that are required for the successful market entrance of !MPACT (adjusted from Zorginstituut Nederland.

Product users

The health insurance companies will provide !MPACT to the health care providers in a health procurement market. These health care providers or clinicians are considered the product users and are closely involved in the development and reimbursement of !MPACT. In addition, patients to whom clinicians provide the therapy are also considered product users. The patients are often represented in patient organizations such as the Vasculitis Foundation in the case of AAV patients. We learned from them that the Vasculitis Foundation is also intimately involved in the development of new therapies for AAV and its reimbursement. For the business plan, we have applied a customer-driven approach, where we tried to design !MPACT based on the end-users needs. We learned about the values, needs, and pains of the patients through interviews that we processed in a patient journey (Figure 4) . The interviews are presented on the Integrated Human Practices.

Figure 4 | Patient journey. A frequent journey AAV patients are going through.12
  1. Wang L, Wang FS, Gershwin ME. Human autoimmune diseases: A comprehensive update. J Intern Med. 2015;278(4):369-395. doi:10.1111/JOIM.12395
  2. Lerner A, Jeremias P, Matthias T. The world incidence and prevalence of autoimmune diseases is increasing. International Journal of Celiac Disease. 2015;3(4):151-155. doi:10.12691/ijcd-3-4-8
  3. Li J, Cui Z, Long JY, et al. The frequency of ANCA-associated vasculitis in a national database of hospitalized patients in China. Arthritis Res Ther. 2018;20(1):1-10. doi:10.1186/S13075-018-1708-7/TABLES/3
  4. Almaani S, Fussner LA, Brodsky S, Meara AS, Jayne D. ANCA-Associated Vasculitis: An Update. J Clin Med. 2021;10(7):10. doi:10.3390/JCM10071446
  5. Yates M, Wattsb R. ANCA-associated vasculitis. Clinical Medicine. 2017;17(1):60. doi:10.7861/CLINMEDICINE.17-1-60
  6. Smith RM, Jones RB, Jayne DRW. Progress in treatment of ANCA-associated vasculitis. Arthritis Res Ther. 2012;14(2). doi:10.1186/ar3797
  7. Lamprecht P, Basu N, Mohammad A. Mind the Gap: Balancing Remission and Risk of Relapse in ANCA-Associated Vasculitis. EMJ Rheumatol. 2021;8(1):36-42.
  8. Masiak A, Zdrojewski Z. Relapsing granulomatosis with polyangiitis with severe lung and upper respiratory tract involvement successfully treated with rituximab. Reumatologia. 2017;55(4):208-212. doi:10.5114/reum.2017.69783
  9. Kronbichler A, Lee KH, Denicolò S, et al. Immunopathogenesis of ANCA-Associated Vasculitis. Int J Mol Sci. 2020;21(19):1-27. doi:10.3390/IJMS21197319
  10. Insee. Definition - Large enterprise. Published November 16, 2020. Accessed September 6, 2022. https://www.insee.fr/en/metadonnees/definition/c1035
  11. AAV Patiëntenreis-Consultkaart - Vasculitis Stichting. Accessed September 20, 2022. https://vasculitis.nl/bibliotheek/aav-patientenreis-consultkaart/
  12. Scheller L, Strittmatter T, Fuchs D, Bojar D, Fussenegger M. Generalized extracellular molecule sensor platform for programming cellular behavior. Nat Chem Biol. 2018;14(7):723-729. doi:10.1038/S41589-018-0046-Z
  13. Iyer SS, Cheng G. Role of Interleukin 10 Transcriptional Regulation in Inflammation and Autoimmune Disease. Crit Rev Immunol. 2012;32(1):23. doi:10.1615/CRITREVIMMUNOL.V32.I1.30
  14. Chai W. What is a value chain and why is it important? TechTarget. Published February 2021. Accessed September 27, 2022. https://www.techtarget.com/searchcio/definition/value-chain
  15. Stenard BS, Thursby MC, Fuller A. Commercialization strategies: Cooperation versus competition. Advances in the Study of Entrepreneurship, Innovation, and Economic Growth. 2016;26:289-308. doi:10.1108/S1048-473620160000026010
  16. bidyutword. Value Chain –In Clinical Research Industry. Accessed July 23, 2022. https://bidyutword.wordpress.com/2016/07/04/value-chain-in-clinical-research-industry/
  17. nationalstemcellfoundation. Autoimmune Disease – National Stem Cell Foundation. Accessed July 23, 2022. https://nationalstemcellfoundation.org/glossary/autoimmune-disease/
  18. Kemna MJ, Damoiseaux J, Austen J, et al. ANCA as a predictor of relapse: Useful in patients with renal involvement but not in patients with nonrenal disease. Journal of the American Society of Nephrology. 2015;26(3):537-542. doi:10.1681/ASN.2013111233/-/DCSUPPLEMENTAL
  19. Coattrenec Y, Muller YD, Spoerl D, Lobrinus JA, Seebach JD. Prevalence of large vessel vasculitis in ANCA-associated vasculitis: a retrospective cohort study. Rheumatol Int. 2021;41(12):2147-2156. doi:10.1007/S00296-021-04993-2/FIGURES/4
  20. Statista Research Department - Statista. Health insurance in the United States - Statistics & Facts. Accessed July 23, 2022. https://www.statista.com/topics/7807/health-insurance-in-the-us/
  21. Toraman A, Gündüz ÖS. Predictors of renal and patient outcomes in anti-neutrophil cytoplasmic antibody-associated vasculitis: Our single-center, tertiary care experience. Arch Rheumatol. 2021;36(3):445. doi:10.46497/ARCHRHEUMATOL.2021.8687
  22. ANCA Vasculitis News. Treatment of ANCA Vasculitis. Accessed July 23, 2022. https://ancavasculitisnews.com/treatment-of-anca-vasculitis/
  23. Kapoor R. Competition and Disputes in the Patent Life Cycle.; 2017. https://www.researchgate.net/publication/317589286
  24. GAO. ORPHAN DRUGS FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue Report to Congressional Requesters United States Government Accountability Office. GAO analysis of Food and Drug Administration (FDA) documentation. Published online 2018.
  25. Gans JS, Stern S. The product market and the market for “ideas”: commercialization strategies for technology entrepreneurs. Res Policy. 2003;32(2):333-350. doi:10.1016/S0048-7333(02)00103-8
  26. Vasculitis Stichting. UMC Maastricht (MUMC+). Accessed September 24, 2022. https://vasculitis.nl/ziekenhuis/umcs/mumc/
  27. Erasmus MC Cancer Institute. Prof. J.E.M.A. (Reno) Debets, PhD - Principal Investigator - Erasmus MC. Accessed September 24, 2022. https://www.erasmusmc.nl/en/cancer-institute/research/researchers/debets-reno#16bb7751-18be-4fa1-8138-097ce1673c36
  28. Buffalo Biolabs. Nonclinical Contract Research Organization. Accessed September 24, 2022. https://www.buffalobiolabs.com/
  29. CHDR. Our building. Accessed September 24, 2022. https://chdr.nl/chdrs-story/our-building#building-finder
  30. Mostert NM. Belbin-the way forward for innovation teams. Journal of Creativity and Business Innovation. 2015;1. Accessed August 15, 2022. www.journalcbi.com
  31. Aranzabal A, Epelde E, Artetxe M. Team formation on the basis of Belbin’s roles to enhance students’ performance in project based learning. Education for Chemical Engineers. 2022;38:22-37. doi:10.1016/J.ECE.2021.09.001
  32. Choi J, Kim ST, Craft J. The Pathogenesis of Systemic Lupus Erythematosus – An Update. Curr Opin Immunol. 2012;24(6):651. doi:10.1016/J.COI.2012.10.004
  33. McIver B, Morris JC. The pathogenesis of Graves’ disease. Endocrinol Metab Clin North Am. 1998;27(1):73-89. doi:10.1016/S0889-8529(05)70299-1
  34. Ambagon Therapeutics. About • Ambagon Therapeutics. Accessed September 3, 2022. https://www.ambagontx.com/about/
  35. Ebinum M. How To: Business Model Canvas Explained | by Sheda | Sheda | Medium. Sheda. Published July 7, 2016. Accessed September 27, 2022. https://medium.com/seed-digital/how-to-business-model-canvas-explained-ad3676b6fe4a

Product description

Value chain

Market analysis

Competition

Intellectual property

Commercialization strategy & partnerships

References

Product

On this page, the product we designed is described. A value proposition canvas for the product and the position of the product in the value chain is shown. A market analysis is performed, the intellectual property for the product is explained, and a commercialization strategy is determined. For more detailed information and assumptions please read the Business plan.

Product description

To meet the shortcomings of the current therapies against ANCA-associated vasculitis (AAV), we designed !MPACT (Figure 6): a Modular and Personalized Autoimmune disease Cell Therapy. This cell-based therapy detects the pathogenic autoantibodies associated with AAV called ANCAs. In the presence of ANCAs, interleukin-10 (IL-10), an anti-inflammatory cytokine, is produced by the cells themselves resulting in suppression of the autoimmune response.


Figure 6 | !MPACT logo. !MPACT, a Modular & Personalized Autoimmune Cell Therapy, is developed by iGEM TU Eindhoven 2022.

!MPACT is based on the Generalized Extracellular Molecule Sensor (GEMS) platform described in Scheller et al. (2018). 13 This modular synthetic receptor allows the coupling of an extracellular input to an intracellular signaling pathway. In our case, binding of the pathogenic ANCA autoantibodies to the receptor leads to receptor dimerization and activation, starting a signaling pathway that results in the production and local release of anti-inflammatory cytokine IL-10 (Figure 7).

Figure 7 | Working mechanism of !MPACT. ANCAs activate the receptor upon binding which eventually results in the production of IL-10.

The activity of !MPACT is dependent on the concentration of ANCAs present. Higher ANCA concentrations, i.e. higher disease activity, will lead to more IL-10 production, resulting in stronger suppression of the inflammation. Furthermore, the presence of ANCAs is strictly necessary for IL-10 production. When no ANCAs are present, that is when there is no disease activity, the cells are “sleeping” and thus will not release IL-10. It is desired to only have IL-10 production when ANCAs are present since no anti-inflammatory effects are necessary in the absence of the disease and elevated concentrations of IL-10 could then lead to side effects, like hindering host response to pathogenesis. 14 In case of a relapse of the disease, the increase in ANCA concentration again activates the IMPACT cells. This way, the relapse of the disease is prevented before it gets problematic. !MPACT is thereby temporarily active, more adjusted to the disease activity, and can intervene early on in relapses. 

 

!MPACT is innovative and powerful since its therapeutic effect is personalized to the patient, i.e. that the amount of IL-10 production adjusts to the disease activity. Consequently, fewer burdensome side effects are expected than for current treatments. In addition, !MPACT can detect and intervene relapses early on, which is not possible with the current treatments. Both prevention of relapses and fewer side effects will reduce organ damage and will thereby reduce both healthcare costs and workload. Therefore, we are convinced that our design will greatly contribute to a better treatment of ANCA-associated vasculitis.


Figure 8 illustrates the implementation of the previously described concept into a therapy that may be used by physicians and other end users. 1) A clinician will begin the treatment by collecting immune cells from the patient. Subsequently, the cells will be transported to the manufacturing lab, where they will undergo genetic engineering 2). After the number of cells has increased 3), the patient is injected with the modified cells 4). Finally, the cells will engage with the auto-antibodies and temporarily and locally produce IL-10 to treat the signs and symptoms of AAV.

Figure 8 | Cell therapy cycle. The cycle that shows how treatment with !MPACT looks like.

Our main product will be the patented proof of concept of !MPACT supported by preclinical and clinical phase I and IIa data, which we will be licensed to a primary customer. Our customer will have to complete the clinical trials and needs to produce, market, distribute and sell the product.

Our therapy can be made applicable to other autoimmune diseases since !MPACT is based on platform technology that is considered modular.13 The underlying technology of !MPACT is based on different structural parts that can be modified to bind different disease-associated molecules/antibodies. The potential of this method lies in the fact that many autoimmune diseases have similar parthenogenesis; the body's natural defense system cannot distinguish the patient's own cells from foreign ones, causing the body to mistakenly attack healthy cells. Only a very small element of the cell, namely the recognition part of the same receptor, needs to be changed for the cell-based therapy to work for another autoimmune disease. More information about !MPACT and its background information can be found on the Project description page.

As previously explained on the Customer section, we used a customer-driven approach to design !MPACT. A Value Proposition Canvas is a framework that helped us to ensure that !MPACT is positioned around what the customers and end-users value and need. It clearly shows the pains associated with the current therapies and the pain relievers and gains that !MPACT brings. The value proposition for !MPACT is summarized in Figure 9.

Figure 9 | Value proposition !MPACT. Value proposition canvas for !MPACT that includes the gain creators, pain relievers of !MPACT (left) and the pains, gains and customer jobs of the customer (right). A fit is achieved since the value proposition of !MPACT addresses the most significant pains and gains of the customer profile.

Value chain

A value chain is a tool that describes the complete chain of all business activities in the development of a product or service.15 Together with Novartis, a large pharmaceutical enterprise, we discussed the value chain of !MPACT and our position in it as a business. It helped us to summarize and evaluate the cost efficiency of each stage in the drug development process. The value chain for !MPACT is visualized in Figure 10.

Figure 10 | Value chain !MPACT. The value chain for !MPACT shows all business activities required during the entire drug development process. It shows the drug development process, operations and secondary activities.

From the analysis of the value chain (see Business plan), it can be concluded that iGEM TU Eindhoven possesses or has easy access to the assets necessary in the drug discovery phase. In all other phases, however, not all assets are in-house or freely available which means that large investments or collaborations with third parties are needed to acquire them.16 It is therefore decided that iGEM TU Eindhoven only performs the part of the value chain where it expertise lies. This means that iGEM TU Eindhoven focuses on the drug discovery part of the drug development until the phase IIa clinical trials since a successful clinical IIa clinical trial serves as a golden standard for a proof of concept in clinical research.17



Market analysis

iGEM TU Eindhoven targets a small niche of the 400 million patients in the world that suffer from autoimmune diseases.18 The team focuses on patients suffering from AAV, which comes down to around 2-3 million patients in the world. This results in a potential addressable market of around 550-825 billion euros assuming an annual contract value per patient of 275.000 euros.4 Since laws and regulations for market entry with a cell therapy differ between countries and because reimbursement of !MPACT is of critical importance, first two major, well-developed, and well-known market niches are targeted that include the US and Europe. The number of patients with AAV in the US and Europe adds up to 215.000 – 430.000 patients and a total addressable market of 60-118 billion euros.4 Additionally, !MPACT is designed for PR3-ANCA positive patients and patients with renal involvement since it is proven that ANCA rises correlated with relapses in patients with renal evolvement.19 It is found that 36% of all AAV patients that are PR3-ANCA positive, 59% have renal involvement.20 Moreover, only around 90% of the citizens of the USA have health insurance.21 The size of the market iGEM TU Eindhoven is hoping to obtain with the cell therapy within 12 years (return on investment time as a consequence of IP expiring) is eventually 35% of the serviceable addressable market because a total of 35% of the patients with renal involvement progressed to end-stage renal disease (ESRD) associated with lifelong dialysis and intensive care.22 It is expected that all patients who have lifelong dialysis are willing to undergo the cell therapy and get prescribed the new therapy that is significantly more effective and cheaper than current treatments. Taking all these factors into account, this eventually leads to a market share (SOM) of around 4.4-8.8 billion euros within 12 years. The PAM, TAM, SAM, and SOM are summarized in Figure 11 and further explained in the Business plan.

Figure 11 | Market analysis. The expected PAM, TAM, and SOM for !MPACT presented in number of patients and euros.

Competition

The current treatments for AAV and corresponding manufacturers are compared with !MPACT based on the costs, persistence (how long the drugs remain in the body), effectiveness, side effects, the workload for hospitals, and usage duration (how long the treatment takes) in Table 1. In addition, the possibility of a relapse of AAV is indicated for each therapy. A more extensive analysis of all competitors can be found in the Business plan.


Table 1 | Competition. Benchmarking !MPACT to indirect competitors



Based on Table 1, we can identify several selling points of !MPACT compared to the competitive treatments. The two most significant advantages of !MPACT are visualized in the Unique Selling Point (USP) diagram (Figure 12).

Figure 12 | USP table. Unique Selling Point (USP) of !MPACT compared to the main competitive treatments for AAV.


Intellectual property

Existing technology

The Gate, an association that supports tech start-ups, assisted us in identifying the legal issues pertaining to the current technology that we utilize with !MPACT. Look at our Integrated Human Practices wiki page for further details on the Gate and their role in our project. After we performed our research with their help we discovered that the Generalized Extracellular Molecule Sensor (GEMS) platform is the subject of an ETH Zurich patent application published in the US and Japan.13 However, there are now no granted patents anywhere, and our business will be located in Europe, where there is certainly freedom to operate.


Protectability and claims

For reasons of protectability, our team plans to submit a patent application in the US and in Europe for the technology of !MPACT. In the application description, antibody binding to a synthetic receptor with the efficient output of IL-10 in a human cellular system is described in detail. More detail on the technology of !MPACT can be found in the Product Section. The claims included contain the intracellular pathway, associated linkers, antibody affinity domain sequences, and relevant mammalian cell implementation methods.


Protectability plan

Through the United States patent and trademark office (USPTO), !MPACT will apply for a utility patent in the US. At the same time, we will apply for a European patent because it is an easier and cheaper alternative for obtaining individual patents in countries that are members of the European Patent Convention (EPC). 24 After six months, the European patent application will be published where both patents are valid for 20 years. The simplified timeline of a European patent application is shown in Figure 13.

Figure 13 | European patent application. Simplified timeline of the European patent application of !MPACT for the first patent. The figure is adjusted from Kapoor et al. 24

According to the definitions of the EMA and FDA, ANCA associated vasculitis qualifies as an orphan disease. 25 In the drug discovery phase, we will file an application for orphan drug classification, which provides patenting benefits after the clinical trial phases. Once the drug is on the market, benefits include 10-year market exclusivity and protocol support. Figure 14 shows this procedure in a graphical way. Additional strategic benefits as well as the considerations that make !MPACT acceptable for this application can be found in the Business plan.

Figure 14 | European patent application. Simplified timeline of the European patent application of !MPACT for the first patent. The figure is adjusted from Kapoor et al. 25

Although we have reached out to experts for legal protection of the technology of !MPACT, we did not manage to achieve a patent for !MPACT before the Grand Jamboree. We have decided to disclose the technology of !MPACT during the Grand Jamboree and with relevant stakeholders such that we can present our project in the best way possible. Moreover, we wanted to get the most relevant feedback on how to improve our design to make it more feasible, desirable, and responsible. On contrary, as discussed in the Proposed implementation we aim to expand and optimize the mechanism underlying !MPACT after the Grand Jamboree even further. Through non-disclosure agreements, we will discuss with relevant stakeholders on the technical details of these optimizations and file a utility patent for the improved design through the process described in the previous section Intellectual Property. Our experience has taught us the value of intellectual property, and we would advise future iGEM teams to consider legal protection as early as possible in the project.

Commercialization strategy & partnership

As explained previously, to commercialize !MPACT it will be legally protected to license it on the technology market to large pharmaceutical companies. In addition, it is described that the proof of concept and the technology that underlies !MPACT can be thorougly protected. On the other hand, the complementary assets to bring the cell therapy to the market are not freely available and are mainly in hands of large pharmaceutical companies. Based on the commercialization environments described by Gans and Stern (Table 2) this means we are dealing with the "Ideas Factories" situation.26 In this situation you have to collaborate with external parties because complementary assets are tightly held by them. However, since there is high bargaining power as a result of the well-protected technology, it is possible to make contract agreements.16 The incumbents have high bargaining power because of the complementary assets they own and iGEM TU Eindhoven has high bargaining power because of the strongly protected technology.

The goal is thus to search for the incumbents that are most in need of the technology since this optimizes the bargaining power of iGEM TU Eindhoven to make an attractive deal for licensing the proof of concept to these external parties.


Table 2 | Commercialization environments. Commercialization environments as described by Gans and Stern. In case of !MPACT, we are dealing with the “Ideas Factories” quadrant. 26


Since not all assets along the drug development process are available, as extensively described in the value chain (Figure 10), or are inherent to large investment barriers, partnerships are inevitable for a successful commercialization strategy. The commercialization strategy with partnerships for the next five years is visualized in a Gantt chart (Figure 15).

Figure 15 | Gantt Chart commercialization. 5-year plan to successfully license !MPACT to a target customer.



Partnerships

Click on the required partnerships below to learn about them!

Development proof of concept

Pre-clinical trials

Clinical trials I and IIa

Clinical trials IIb- Market entrance

  1. Wang L, Wang FS, Gershwin ME. Human autoimmune diseases: A comprehensive update. J Intern Med. 2015;278(4):369-395. doi:10.1111/JOIM.12395
  2. Lerner A, Jeremias P, Matthias T. The world incidence and prevalence of autoimmune diseases is increasing. International Journal of Celiac Disease. 2015;3(4):151-155. doi:10.12691/ijcd-3-4-8
  3. Li J, Cui Z, Long JY, et al. The frequency of ANCA-associated vasculitis in a national database of hospitalized patients in China. Arthritis Res Ther. 2018;20(1):1-10. doi:10.1186/S13075-018-1708-7/TABLES/3
  4. Almaani S, Fussner LA, Brodsky S, Meara AS, Jayne D. ANCA-Associated Vasculitis: An Update. J Clin Med. 2021;10(7):10. doi:10.3390/JCM10071446
  5. Yates M, Wattsb R. ANCA-associated vasculitis. Clinical Medicine. 2017;17(1):60. doi:10.7861/CLINMEDICINE.17-1-60
  6. Smith RM, Jones RB, Jayne DRW. Progress in treatment of ANCA-associated vasculitis. Arthritis Res Ther. 2012;14(2). doi:10.1186/ar3797
  7. Lamprecht P, Basu N, Mohammad A. Mind the Gap: Balancing Remission and Risk of Relapse in ANCA-Associated Vasculitis. EMJ Rheumatol. 2021;8(1):36-42.
  8. Masiak A, Zdrojewski Z. Relapsing granulomatosis with polyangiitis with severe lung and upper respiratory tract involvement successfully treated with rituximab. Reumatologia. 2017;55(4):208-212. doi:10.5114/reum.2017.69783
  9. Kronbichler A, Lee KH, Denicolò S, et al. Immunopathogenesis of ANCA-Associated Vasculitis. Int J Mol Sci. 2020;21(19):1-27. doi:10.3390/IJMS21197319
  10. Insee. Definition - Large enterprise. Published November 16, 2020. Accessed September 6, 2022. https://www.insee.fr/en/metadonnees/definition/c1035
  11. AAV Patiëntenreis-Consultkaart - Vasculitis Stichting. Accessed September 20, 2022. https://vasculitis.nl/bibliotheek/aav-patientenreis-consultkaart/
  12. Scheller L, Strittmatter T, Fuchs D, Bojar D, Fussenegger M. Generalized extracellular molecule sensor platform for programming cellular behavior. Nat Chem Biol. 2018;14(7):723-729. doi:10.1038/S41589-018-0046-Z
  13. Iyer SS, Cheng G. Role of Interleukin 10 Transcriptional Regulation in Inflammation and Autoimmune Disease. Crit Rev Immunol. 2012;32(1):23. doi:10.1615/CRITREVIMMUNOL.V32.I1.30
  14. Chai W. What is a value chain and why is it important? TechTarget. Published February 2021. Accessed September 27, 2022. https://www.techtarget.com/searchcio/definition/value-chain
  15. Stenard BS, Thursby MC, Fuller A. Commercialization strategies: Cooperation versus competition. Advances in the Study of Entrepreneurship, Innovation, and Economic Growth. 2016;26:289-308. doi:10.1108/S1048-473620160000026010
  16. bidyutword. Value Chain –In Clinical Research Industry. Accessed July 23, 2022. https://bidyutword.wordpress.com/2016/07/04/value-chain-in-clinical-research-industry/
  17. nationalstemcellfoundation. Autoimmune Disease – National Stem Cell Foundation. Accessed July 23, 2022. https://nationalstemcellfoundation.org/glossary/autoimmune-disease/
  18. Kemna MJ, Damoiseaux J, Austen J, et al. ANCA as a predictor of relapse: Useful in patients with renal involvement but not in patients with nonrenal disease. Journal of the American Society of Nephrology. 2015;26(3):537-542. doi:10.1681/ASN.2013111233/-/DCSUPPLEMENTAL
  19. Coattrenec Y, Muller YD, Spoerl D, Lobrinus JA, Seebach JD. Prevalence of large vessel vasculitis in ANCA-associated vasculitis: a retrospective cohort study. Rheumatol Int. 2021;41(12):2147-2156. doi:10.1007/S00296-021-04993-2/FIGURES/4
  20. Statista Research Department - Statista. Health insurance in the United States - Statistics & Facts. Accessed July 23, 2022. https://www.statista.com/topics/7807/health-insurance-in-the-us/
  21. Toraman A, Gündüz ÖS. Predictors of renal and patient outcomes in anti-neutrophil cytoplasmic antibody-associated vasculitis: Our single-center, tertiary care experience. Arch Rheumatol. 2021;36(3):445. doi:10.46497/ARCHRHEUMATOL.2021.8687
  22. ANCA Vasculitis News. Treatment of ANCA Vasculitis. Accessed July 23, 2022. https://ancavasculitisnews.com/treatment-of-anca-vasculitis/
  23. Kapoor R. Competition and Disputes in the Patent Life Cycle.; 2017. https://www.researchgate.net/publication/317589286
  24. GAO. ORPHAN DRUGS FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue Report to Congressional Requesters United States Government Accountability Office. GAO analysis of Food and Drug Administration (FDA) documentation. Published online 2018.
  25. Gans JS, Stern S. The product market and the market for “ideas”: commercialization strategies for technology entrepreneurs. Res Policy. 2003;32(2):333-350. doi:10.1016/S0048-7333(02)00103-8
  26. Vasculitis Stichting. UMC Maastricht (MUMC+). Accessed September 24, 2022. https://vasculitis.nl/ziekenhuis/umcs/mumc/
  27. Erasmus MC Cancer Institute. Prof. J.E.M.A. (Reno) Debets, PhD - Principal Investigator - Erasmus MC. Accessed September 24, 2022. https://www.erasmusmc.nl/en/cancer-institute/research/researchers/debets-reno#16bb7751-18be-4fa1-8138-097ce1673c36
  28. Buffalo Biolabs. Nonclinical Contract Research Organization. Accessed September 24, 2022. https://www.buffalobiolabs.com/
  29. CHDR. Our building. Accessed September 24, 2022. https://chdr.nl/chdrs-story/our-building#building-finder
  30. Mostert NM. Belbin-the way forward for innovation teams. Journal of Creativity and Business Innovation. 2015;1. Accessed August 15, 2022. www.journalcbi.com
  31. Aranzabal A, Epelde E, Artetxe M. Team formation on the basis of Belbin’s roles to enhance students’ performance in project based learning. Education for Chemical Engineers. 2022;38:22-37. doi:10.1016/J.ECE.2021.09.001
  32. Choi J, Kim ST, Craft J. The Pathogenesis of Systemic Lupus Erythematosus – An Update. Curr Opin Immunol. 2012;24(6):651. doi:10.1016/J.COI.2012.10.004
  33. McIver B, Morris JC. The pathogenesis of Graves’ disease. Endocrinol Metab Clin North Am. 1998;27(1):73-89. doi:10.1016/S0889-8529(05)70299-1
  34. Ambagon Therapeutics. About • Ambagon Therapeutics. Accessed September 3, 2022. https://www.ambagontx.com/about/
  35. Ebinum M. How To: Business Model Canvas Explained | by Sheda | Sheda | Medium. Sheda. Published July 7, 2016. Accessed September 27, 2022. https://medium.com/seed-digital/how-to-business-model-canvas-explained-ad3676b6fe4a
X


The first phase of R&D is to design, develop, test, and optimize the proof of concept of !MPACT. Proof of concept development will be carried out in partnership with Maastricht and Erasmus University Medical Center (UMC). To be specific the Vasculitis Expertise Centrum (VEC) of Maastricht UMC and the laboratory of immunology of Erasmus UMC.27,28 These partners have respective expertise in the pathogenic mechanism of AAV and in the development of T-cell therapies to tune the immune system. Moreover, they bring in more resources to do high-quality research, have a close relationship with the clinic, and have access to patients. They benefit since they will be part of state-of-the-art research in their field and because they will obtain a share of our new venture. Resources are shared in the partnership and include expertise, clinical data, laboratories, lab equipment, lab consumables, biological agents, and human tissue. In the past year, they already provided many insights which we implemented in our project, of which more information can be found on the Integrated Human Practices page.

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Resources for pre-clinical trials are only partly in-house but relatively easy to access. Since not all resources are in-house and since large investments are required to obtain them (e.g. advanced lab equipment, animal care, appropriate lab environments, in-silico models) we will outsource most of these activities to a company specialized in preclinical research such as Buffalo Biolabs. They are specialized in immunotherapy, offer in-vivo research, offer support services, and have all the required resources. They own in-vitro laboratory spaces including tissue/cell culture labs. In addition, they offer histology & hematology services, and bioanalytical services. They have the required imaging techniques and licenses to perform animal studies in multiple species from monkeys to pigs to mice.29 Therefore, they are considered the perfect candidate for a partnership to perform pre-clinical trials.

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Clinical trials require a huge amount of expertise, licenses, large facilities, tons of equipment, trained work staff, analysis tools, etc. The required resources are, therefore, very hard to acquire yourself and have a large barrier to entry. Hence, a partnership is essential. We outsource the clinical trials I and IIa to the Centre for Human Drug Research (CHDR) which is an independent institute that specializes in cutting-edge early-stage clinical drug research. 30 We visited the CHDR to discuss what a partnership with them looks like, what it costs, what resources clinical studies require, ethical issues, laws & regulations, and what type of clinical studies they perform. Since we only have to perform clinical trials phases I and IIa, the CHDR is the ideal candidate to help us with our clinical studies. The CHDR offers state-of-the-art facilities to accommodate early-phase clinical trials. They own a First-in-Man unit and top-notch volunteer accommodation, dedicated research rooms, and efficient sample management.30 During our visit to the CHDR, we learned a lot about clinical trials which can be found on the Proposed implementation page in detail. Moreover, it was very impressive to see their facility and equipment for clinical studies.

X


Large pharmaceutical companies to which we license the proof of concept !MPACT have the required resources to do large clinical studies (phase IIb and III), they own large business units and have a well-known brand name to market the new therapy. They have production facilities or enough financial resources to invest in them and they own the required distribution channels and infrastructure. They have regulatory units to file for market authorization and they know the laws and regulations for market entrance in different countries as they have multiple branches (geographical reach). They have close relationships with hospitals and doctors. Moreover, they have experience in bargaining with governments for the price of a new therapy to ensure successful market access (reimbursement). For iGEM TU Eindhoven, it is impossible to acquire all these resources in the limited amount of time (patent period). Hence, we mustn’t perform this part of the value chain ourselves and instead license our product to large pharmaceutical companies who perform the drug development process from a clinical phase IIb until the market entrance.

Mission & Vision

The winning team

SWOT analysis

Growth and exit

Financial analysis

Business model canvas

References

Company

On this page, the mission and vision of our company are presented. Our team and its skills and characteristics are reviewed. A roadmap for the future of iGEM Eindhoven 2022 is shown. A SWOT analysis is performed. A business model canvas is used to summarize the business plan and finally, a financial forecast and plan are described. For more detailed information and assumptions please read the Business plan.

Mission & vision

The winning team

The iGEM TU Eindhoven 2022 team consists of nine ambitious master's and bachelor's students with varied backgrounds ranging from expertise in biomedical engineering (modeling, programming chemical biology, synthetic biology, and organic chemistry) and experience with entrepreneurship, stakeholder co-creation, and graphic design. This enables interdisciplinary, creative thinking and critically assessing deliverables from different perspectives. These qualities are required for high-quality scientific research in the development of !MPACT and for new venture creation. The team members and their roles in the iGEM TU Eindhoven team are shown in Figure 16. What is more, is that iGEM TU Eindhoven has a strong team since the team contains the complete nine Belbin roles Table 3, which are crucial for effective decision-making and business processes within an innovative team.31, 32 These Belbin roles go together with a clear division in tasks and responsibility for every team member. The wide variety in knowledge, experience, skills, character traits, and responsibilities allow for very efficient business processes such as project management, human resource management, and business development. iGEM TU Eindhoven has a large network as it has close relationships with research groups and institutes at the university, with many stakeholders relevant for Human Practices, and iGEM TU Eindhoven is located in the innovative environment of the TU/e campus and BrainPort region of Eindhoven. In conclusion, the team has the required competencies and skills to start a new venture, perform R&D to optimize !MPACT, manage a long-term project, and contract new partners.

Figure 16 | Team members. iGEM TU Eindhoven 2022 team members with their team roles.




Table 3 | Belbin roles. iGEM TU Eindhoven 2022 team members with their Belbin roles.
Belbin role #1 #2
Elisa Passet Implementer Monitor evaluator
Wouter Langers Plant Specialist
Famke Klop Team worker Completer/Finisher
Jolien Marcelis Co-ordinator Shaper
Floor van Boxtel Resource investigator Shaper
Femi Hesen Team worker Completer/Finisher
Kim Wintraecken Plant Implementer
Jakob Scheele Monitor evaluator Shaper
Rian Driedijk Shaper Implementer



SWOT analysis

A SWOT analysis is a strategic management technique used to help our new venture identify Strengths, Weaknesses, Opportunities, and Threats related to business competition. The SWOT analysis is performed together with the pharmaceutical company Organon. Look at our Integrated Human Practices wiki page for further details on Organon and their role in our project. We learned from Organon that threats and weaknesses do not have to be something bad but can be seen as opportunities. For every weakness and threat, we searched for new ways how we could circumvent them or use them to our advantage. The SWOT analysis is visualized in Figure 17.

Figure 17 | SWOT analysis. SWOT analysis was conducted together with Organon to identify the business’ strengths, weaknesses, opportunities, and threats.

Growth and exit

This year iGEM TU Eindhoven focused on the design and development of the proof of concept of !MPACT. We tested the mechanism of the proof of concept in-vitro. For the next year, we aim to optimize the proof of concept and product design of !MPACT to make it potentially safer and more effective. Moreover, the goal is to translate the proof of concept to the actual therapy. In 2024, this therapy will be tested in-vitro and with in-silico models to obtain basic information about its safety and biological efficacy. The next step will be to test !MPACT in-vivo in a variety of animal models. The pre-clinical tests have a goal to delineate the pharmacokinetic profile, general safety, and toxicity. In addition, the drug’s mean residence time will be determined which depends on the metabolism, absorption, excretion, and distribution of the therapy. In 2026 we aim to start with the first phase of clinical trials and in the last year, the clinical trial IIa will be conducted after which !MPACT will be licensed to our target customer. In Figure 18 the roadmap for the next five years is summarized. After we successfully licensed !MPACT as therapy for AAV, we will adjust our developed platform technology to develop new therapies for auto-immune diseases such as Grave’s disease or Systemic lupus erythematosus (SLE) that have similar pathogenic mechanisms as AAV. 33,34

Figure 18 | Roadmap. The 5-year plan of iGEM Eindhoven 2022 is visualized in a roadmap.


Multiple growth strategies for iGEM TU Eindhoven 2022 in the long term are possible. The strength of our project lies in the fact that we have developed a modular platform technology that can be adjusted for multiple autoimmune diseases, as explained in the Product Section. With the same technology, we can therefore enter new markets, known as “Market development” (Figure 19). In addition, since we start in the US and Europe we can also try to reach more geographical areas which is also an example of “Market development”. Lastly, by partnering with large pharmaceutical companies such as Johnson & Johnson, the credibility and reputation of iGEM TU Eindhoven gets increases, which enables us to obtain a stronger position in the market called “Market penetration”.


Figure 19 | Growth strategies. Different growth strategies taking into account the market and the product/service.


The exit options of the founders of !MPACT is considered a sell-out or initial public offering (IPO). Both options have the same basis exit motive; the increasing role of stakeholders and their pressure to develop the exit strategy. More information about the growth and exit strategies can be found in the Business plan.



Financial analysis

To execute the business plan of the firm, a financial plan and forecast needs to be developed. Therefore, assumptions were made on the expected cost structure and revenue streams.

The fixed costs include human resources expenditures, training expenses, services rendered by third parties, infrastructure & operational costs, and marketing costs. In addition, costs to legally protect !MPACT, costs to draw up a license for the IP of !MPACT and the R&D expenses to develop !MPACT is also considered fixed costs since iGEM TU Eindhoven will not be a production company. Therefore, we have excluded direct variable costs. The revenue hypothesis is based on the expected license fee that pharmaceutical companies have to pay to exclusively further develop and market !MPACT.

iGEM TU Eindhoven worked out the financial plan together with Ambagon Therapeutics, a new venture from the Eindhoven University of Technology (TU/e) (Figure 20). Ambagon therapeutics started as a spin-off company of the TU/e in 2020 and aims to develop a new class of medicines that can modulate previously undruggable targets and influence currently accessible ones in new ways.35 Ambagon Therapeutics has experience in starting a new life science venture as a spin-off from the TU/e. Hence, they form the perfect partner to discuss revenue and cost assumptions. In the PDF the financial plan and forecast are documented. To learn more about the revenue and cost assumptions, and financial analyses please take a look at our Business plan.


Figure 20 | Visiting Ambagon Therapeutics. Company visit at Ambagon Therapeutics to discuss the financial plan for our new venture



Financial analysis

If the preview does not work, you can download the financial analysis here: Financial analysis


Based on all analyses, it can be concluded that iGEM TU Eindhoven will have a bright financial future when we find the right investors. There will be a near-five-year period in which there will be losses, but this is common for life science start-ups. Additionally, there are no significant liquidity issues, and the firm will eventually make a net profit in 5 years. These facts, combined with the fact that investors can decide to make a performance-based deal with lower investment risks, makes it very attractive for venture capitalists to aid this new venture as well.

Business model canvas

A business model is an easy tool to visualize all fundamental business building blocks and to quickly define and communicate our business idea. The left side of the Business Model Canvas focuses on the customer (external) and the right sight on the business (internal). The internal and external business building blocks combine at the center that show the value proposition of our product !MPACT. 36 The value proposition describes the exchange in value between our venture and the customer. We use the Business Model Canvas as a summary of our complete business plan (Figure 21).


Business model canvas link
Figure 21 | Business model canvas. The business model canvas of !MPACT summarizes the complete business plan of iGEM TU Eindhoven 2022

  1. Wang L, Wang FS, Gershwin ME. Human autoimmune diseases: A comprehensive update. J Intern Med. 2015;278(4):369-395. doi:10.1111/JOIM.12395
  2. Lerner A, Jeremias P, Matthias T. The world incidence and prevalence of autoimmune diseases is increasing. International Journal of Celiac Disease. 2015;3(4):151-155. doi:10.12691/ijcd-3-4-8
  3. Li J, Cui Z, Long JY, et al. The frequency of ANCA-associated vasculitis in a national database of hospitalized patients in China. Arthritis Res Ther. 2018;20(1):1-10. doi:10.1186/S13075-018-1708-7/TABLES/3
  4. Almaani S, Fussner LA, Brodsky S, Meara AS, Jayne D. ANCA-Associated Vasculitis: An Update. J Clin Med. 2021;10(7):10. doi:10.3390/JCM10071446
  5. Yates M, Wattsb R. ANCA-associated vasculitis. Clinical Medicine. 2017;17(1):60. doi:10.7861/CLINMEDICINE.17-1-60
  6. Smith RM, Jones RB, Jayne DRW. Progress in treatment of ANCA-associated vasculitis. Arthritis Res Ther. 2012;14(2). doi:10.1186/ar3797
  7. Lamprecht P, Basu N, Mohammad A. Mind the Gap: Balancing Remission and Risk of Relapse in ANCA-Associated Vasculitis. EMJ Rheumatol. 2021;8(1):36-42.
  8. Masiak A, Zdrojewski Z. Relapsing granulomatosis with polyangiitis with severe lung and upper respiratory tract involvement successfully treated with rituximab. Reumatologia. 2017;55(4):208-212. doi:10.5114/reum.2017.69783
  9. Kronbichler A, Lee KH, Denicolò S, et al. Immunopathogenesis of ANCA-Associated Vasculitis. Int J Mol Sci. 2020;21(19):1-27. doi:10.3390/IJMS21197319
  10. Insee. Definition - Large enterprise. Published November 16, 2020. Accessed September 6, 2022. https://www.insee.fr/en/metadonnees/definition/c1035
  11. AAV Patiëntenreis-Consultkaart - Vasculitis Stichting. Accessed September 20, 2022. https://vasculitis.nl/bibliotheek/aav-patientenreis-consultkaart/
  12. Scheller L, Strittmatter T, Fuchs D, Bojar D, Fussenegger M. Generalized extracellular molecule sensor platform for programming cellular behavior. Nat Chem Biol. 2018;14(7):723-729. doi:10.1038/S41589-018-0046-Z
  13. Iyer SS, Cheng G. Role of Interleukin 10 Transcriptional Regulation in Inflammation and Autoimmune Disease. Crit Rev Immunol. 2012;32(1):23. doi:10.1615/CRITREVIMMUNOL.V32.I1.30
  14. Chai W. What is a value chain and why is it important? TechTarget. Published February 2021. Accessed September 27, 2022. https://www.techtarget.com/searchcio/definition/value-chain
  15. Stenard BS, Thursby MC, Fuller A. Commercialization strategies: Cooperation versus competition. Advances in the Study of Entrepreneurship, Innovation, and Economic Growth. 2016;26:289-308. doi:10.1108/S1048-473620160000026010
  16. bidyutword. Value Chain –In Clinical Research Industry. Accessed July 23, 2022. https://bidyutword.wordpress.com/2016/07/04/value-chain-in-clinical-research-industry/
  17. nationalstemcellfoundation. Autoimmune Disease – National Stem Cell Foundation. Accessed July 23, 2022. https://nationalstemcellfoundation.org/glossary/autoimmune-disease/
  18. Kemna MJ, Damoiseaux J, Austen J, et al. ANCA as a predictor of relapse: Useful in patients with renal involvement but not in patients with nonrenal disease. Journal of the American Society of Nephrology. 2015;26(3):537-542. doi:10.1681/ASN.2013111233/-/DCSUPPLEMENTAL
  19. Coattrenec Y, Muller YD, Spoerl D, Lobrinus JA, Seebach JD. Prevalence of large vessel vasculitis in ANCA-associated vasculitis: a retrospective cohort study. Rheumatol Int. 2021;41(12):2147-2156. doi:10.1007/S00296-021-04993-2/FIGURES/4
  20. Statista Research Department - Statista. Health insurance in the United States - Statistics & Facts. Accessed July 23, 2022. https://www.statista.com/topics/7807/health-insurance-in-the-us/
  21. Toraman A, Gündüz ÖS. Predictors of renal and patient outcomes in anti-neutrophil cytoplasmic antibody-associated vasculitis: Our single-center, tertiary care experience. Arch Rheumatol. 2021;36(3):445. doi:10.46497/ARCHRHEUMATOL.2021.8687
  22. ANCA Vasculitis News. Treatment of ANCA Vasculitis. Accessed July 23, 2022. https://ancavasculitisnews.com/treatment-of-anca-vasculitis/
  23. Kapoor R. Competition and Disputes in the Patent Life Cycle.; 2017. https://www.researchgate.net/publication/317589286
  24. GAO. ORPHAN DRUGS FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue Report to Congressional Requesters United States Government Accountability Office. GAO analysis of Food and Drug Administration (FDA) documentation. Published online 2018.
  25. Gans JS, Stern S. The product market and the market for “ideas”: commercialization strategies for technology entrepreneurs. Res Policy. 2003;32(2):333-350. doi:10.1016/S0048-7333(02)00103-8
  26. Vasculitis Stichting. UMC Maastricht (MUMC+). Accessed September 24, 2022. https://vasculitis.nl/ziekenhuis/umcs/mumc/
  27. Erasmus MC Cancer Institute. Prof. J.E.M.A. (Reno) Debets, PhD - Principal Investigator - Erasmus MC. Accessed September 24, 2022. https://www.erasmusmc.nl/en/cancer-institute/research/researchers/debets-reno#16bb7751-18be-4fa1-8138-097ce1673c36
  28. Buffalo Biolabs. Nonclinical Contract Research Organization. Accessed September 24, 2022. https://www.buffalobiolabs.com/
  29. CHDR. Our building. Accessed September 24, 2022. https://chdr.nl/chdrs-story/our-building#building-finder
  30. Mostert NM. Belbin-the way forward for innovation teams. Journal of Creativity and Business Innovation. 2015;1. Accessed August 15, 2022. www.journalcbi.com
  31. Aranzabal A, Epelde E, Artetxe M. Team formation on the basis of Belbin’s roles to enhance students’ performance in project based learning. Education for Chemical Engineers. 2022;38:22-37. doi:10.1016/J.ECE.2021.09.001
  32. Choi J, Kim ST, Craft J. The Pathogenesis of Systemic Lupus Erythematosus – An Update. Curr Opin Immunol. 2012;24(6):651. doi:10.1016/J.COI.2012.10.004
  33. McIver B, Morris JC. The pathogenesis of Graves’ disease. Endocrinol Metab Clin North Am. 1998;27(1):73-89. doi:10.1016/S0889-8529(05)70299-1
  34. Ambagon Therapeutics. About • Ambagon Therapeutics. Accessed September 3, 2022. https://www.ambagontx.com/about/
  35. Ebinum M. How To: Business Model Canvas Explained | by Sheda | Sheda | Medium. Sheda. Published July 7, 2016. Accessed September 27, 2022. https://medium.com/seed-digital/how-to-business-model-canvas-explained-ad3676b6fe4a

Business plan

A business plan is a document that describes our new venture goals, operations, industry standing, commercialization strategy, marketing objectives, risk analysis, and financial forecast. The pdf of our business plan shows all entrepreneurial efforts of iGEM TU Eindhoven 2022. The business plan was discussed with an associate professor Industrial Engineering & Innovation Sciences at Eindhoven University of Technology. Her areas of expertise include strategy, technology entrepreneurship, learning methods and technology and knowledge transfer. Her research focuses on the strategic management of young technology-based firms and entrepreneurial exit. She taught us that for our business, having well-protected technology is of critical importance. Moreover, she explained that we need to clearly define where we are now as a business and what the next steps should be in terms of partnerships and business operations. For partnerships, we should clearly define why we need the partnership, what is in it for our partner, and what the partnership looks like. She explained how we need to make a financial plan. For that purpose she stressed that because we are not a production company and because it takes six years before we start making a profit, the cash flow (treasury position) in the next five years is the most essential part of our financial forecast. Lastly, she explained the type of investors we need to attract. We implemented all her feedback and the feedback of the other stakeholders we engaged in our business plan. Scroll in the preview below or download the pdf of our business plan.


Financial analysis

If the preview does not work, you can download the pdf here:

Business Plan link
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