To develop a product that embodies global responsibility and addresses the needs of the designated population, we must consider the interests of all stakeholders who are affected by or can influence XPCures. Central to this effort is our commitment to providing humanitarian care for XP patients by prioritizing their well-being and quality of life.

In order to fully understand the values and concerns of stakeholders, especially XP patients and their families, we have engaged in meaningful conversations and interviews with individuals from various organizations and communities. Together, we explored the technological, ethical, safety, societal, and legal aspects of XPCures. Through these interactions, we gained invaluable insights that allowed us to integrate these values into the design of our project, ensuring it not only meets clinical and scientific standards but also reflects a deep commitment to the humane treatment of XP patients.

This section highlights the work of the Human Practices group, leading to a deeper exploration of the essential question: How does XPCures embody compassion and improve the lives of XP patients while benefiting society as a whole?

The Silver Human Practices page shows that XPCures is overall beneficial to the society and has a promising future. The page starts with an identification of the key issue addressed by XPCures along with a patient journey timeline that shows the common experience of XP patients, an continues to include a stakeholder identification map which categorizes the major stakeholders involved in the development of XPCures into 6 distinct categories, a value-sensitive analysis which derives necessary criteria that our design needs to meet from the key values of important stakeholders, and a power-interest map that indicates the different strategies we will use to manage each sector of stakeholders.

The Integrated Human Practices page thoroughly explains how we incorporated information from the stakeholders into our design through interviews and cooperations. We referenced the Integrated Human Practices page of iGEM TU-Eindhoven in 2022 and developed an interactive timeline to visualize the gradual progress of our Human Practices. The timeline continues all the conversations/interviews we had with crucial stakeholders as well as milestones we have achieved throughout the course of interacting with them. This page explains how we have taken suggestions from society to create a design that is socially desirable and responsible.

The Proposed Implementation page describes how our team plans to implement XPCures in reality. Here we discuss the R&D process, clinical experiments, licensing, and final marketization of the entire implementation of XPCures. The proposed implementation is designed with the help of some of the stakeholders we have engaged with.

The Entrepreneurship page shows the contribution of Human Practices to building a business plan for XPCures. The business plan discusses the target customer segments, financial plan, market potential, and multiple other aspects of our future “company” that would focus on further developing XPCures. A business model of our product is also included to visualize the prospects of XPCures in the future medical market.

On this page, we show how XPCures is good and responsible for the world. We identified the problem with the support of a Patient Journey Timeline. All relevant stakeholders are identified, and we engage with all stakeholders to gather their needs, perspectives, and suggestions for our project. A comprehensive Stakeholder Identification Map was created, illustrating the relationships between various stakeholders. Besides, a Power-Interest Matrix is positioned to illustrate the relative level of interest and power of stakeholders regarding XPCures. Then we applied Value-sensitive analysis as iGEM TU Eindhoven 2022 employed, analyzing the design requirements based on the values, interests, and ethical considerations of each stakeholder to ensure that our project aligns with their needs and expectations. At last, we reflected on the potentials and challenges of XPCurs from six aspects.

Whilst brainstorming for a topic of our research, a name none of us has ever heard of popped up on the screen. Xeroderma Pigmentosum, or XP, is an extremely rare genetic skin disease, with a global incidence of only 0.004%. As we dig deeper into the illness, a horrendous truth striked all the team members: XP patients may possibly die from simply walking under the sun. Their particular biological mutation, a defect in one of the XPC gene for XPC (a subtype of XP)^[1] patients, for example, causes them to be significantly susceptible to UV light. That is, no sunshine, no outdoor activities, no regular socializing, no freedom. Through close interviews with XP patients and their family (since most patients are underaged), we learned that people diagnosed with XP will suffer a life-time of more than simply departure from sunlight. Imagine being fully “armed” with a heavy UV-proof face mask and a one-piece UV-proof clothing that covers you from head to toe whenever you are outside, especially during torrid summers when UV rays are the strongest on earth. The sweltering heat is not the worst. People on the street will be judging, not only for the peculiar outfit, but also for the dark brown spots on your face. You are always known as the weirdo; kids in school would never speak to you, and colleagues at work never take you seriously. Imagine never being able to live like a normal person does. Even worse, with a 100% risk of getting skin cancer, two-thirds of XP patients die before the age of 20, according to National Center of Biotechnology Information.

Currently, there is no cure for XP. During one interview, the patient describes that she is practically waiting for death, as the symptoms only get worse and worse without any way to inhibit its growth. The huge tragedy behind this situation is that the National Medical Products Administration of the People's Republic of China has not yet included XP in the official list of rare diseases. Due to the very few lack of awareness, there are not enough expertise research on this particular disease to make it considered an important area of focus. Since there are only around 6,000 diagnosed patients in China, the potential market is too limited for any large pharmaceutical company to even consider putting effort into developing medications for XP.

Luckily, gene therapy can be a potential cure for XP. Inspired by the gene therapy for Epidermolysis Bullosa (EB) in the United States that has recently been approved by the FDA, we wanted to design a gene therapy specifically aimed to alleviate the symptoms of XPC, which can also be altered slightly to aim at other subtypes of XP. By inserting XPC gene directly into the epidermal stem cells through microneedles, XPCures allows XP patients to finally dance under the sun. Though our method may not radically eliminate the illness embedded in the genes of XP patients, it provides an alternative solution to the longstanding issues that they encounter.

The simplified timeline below illustrates the general journey an XP patient must undergo throughout the course of development of the disease. With the innovative gene therapy, XPCures, iGEM SJTU-BioX Shanghai also aims to call attention to the often neglected disease, and by doing so eliminate the obstacles a patient would encounter during diagnosis and therapy to our greatest extent.

[1]: XP is classified into 8 categories according to current researches: XPA, XPB, XPC, XPD, XPE, XPF, XPG, and XP-variant.

In order to validate the practicability of our project, our HP team interviewed several stakeholders, including individuals and organizations, to investigate the perception of our project amongst the society. After interacting with various stakeholders relevant to our field of research, we classified them into six distinct categories, shown and briefly described in the following section. The interactive stakeholder identification map below specifically indicates the correlations among different stakeholders by illustrating the flow of influence.

Acadamia consists of organizations of research expertise on XP and genetic diseases in general, such as renowned university research institutes.

Healthcare consists of hospitals and hospital workers. We interviewed dermatologists and geneticists from various hospitals across few cities in China.

Public Organizations consists of authorized organizations concerned with public health and well-being.

Government consists of the government itself as well as relevant organizations and advising bodies.

Industry consists of pharmaceutical companies that direct researches along the path of XP medications.

Patients consists of patients diagnosed with various subtypes of xeroderma pigmentosum (XP) and parents or guardians of those patients. We interviewed one patient diagnosed with XPA, one patient diagnosed with XPC, and the parent of two underaged patients diagnosed with XPC.

Local Community consists of local organizations and the general public and society.

Figure 3 below shows a power-interest matrix^[2] for all the stakeholders, arranging them according to their interest in XPCures and their impact on the design. The matrix effectively helps us identify the most relevant stakeholders. That is, the most interested and most powerful/impactful ones. We developed distinct strategies upon interacting with stakeholders in each of the four quadrants.

The stakeholders in this quadrant are the ones most relevant to XPCures, and thus deserve the most attention when building up our product. We have interacted with all of the stakeholders here which we have the access to, asked for suggestions about our project, and improved upon our design after close conversations with them. As mentioned previously, it is crucial to meet the expectations of these stakeholders in order to make XPCures a product well-suited for the general society.

The stakeholders in this quadrant are the primary consumers of XPCures, and they are the major reason XPCures exists. Thus, it is important to satisfy the needs of these stakeholders despite their limited power. We went into thorough conversations with members of these stakeholders and encouraged them to keep in contact with us by following our official account to ensure that they will be informed upon any updates in our progress.

The stakeholders in this quadrant are generally the ones that are harder to gain access to. These global health organizations are crucial for the promotion of XPCures and raising awareness for rare diseases and orphan drugs. However, since they would have little interest in XPCures, the connection with them is relatively low and mainly single-sided. We aim to simply satisfy certain laws passed by these organizations.

The stakeholders in this quadrant are the least relevant to XPCures, so there will be limited focus on them. We do, in occasions, reach out to them for needs of expertise advice.

[2]: Also known as the Mendelow's Matrix

In our pursuit of addressing the needs of those affected by Xeroderma pigmentosum (XP), we emphasize the importance of integrating societal input into the engineering design process. We believe that for our proposed gene therapy to be accepted and effective, it is crucial to actively listen to, assess, and incorporate the perspectives and contexts of both the patients and the broader society. This approach aligns with the principles of consumer-driven product design, which has been shown to more effectively meet user needsⁱ.

To achieve this, we have adopted the value-sensitive design (VSD) methodology for our project. This method has been successfully utilized in previous iGEM projects and it allows us to proactively consider the human values of all stakeholders throughout the engineering design process^ii,iii.

For each stakeholder involved in or impacted by our XP treatment, we have identified and prioritized their values, which we then translated into corresponding norms and design requirements. The VSD approach provides a systematic framework to gather, compare, and integrate the values of all parties into our new technology. Furthermore, it has enabled us to identify potential value conflicts and prioritize the values that should be embedded in our therapeutic strategy. The most relevant values for the design of our gene therapy system, distilled from our stakeholder analysis, are summarized in the subsequent sections.

The previously identified values per stakeholder (see Fig.2), are condensed to the most relevant values for the design of XPcures in Fig.4.

The values we have identified will guide the design and development of our gene therapy system by translating them into specific norms and design requirements. Each of these values is represented through a value framework, which helps ensure that our approach aligns with stakeholder needs and ethical considerations. For a detailed exploration of how each value influences our design and its application, please refer to the value framework provided. This approach will help us to systematically integrate stakeholder values into our technology, ensuring that it not only addresses the technical challenges of XP but also aligns with the broader societal and ethical expectations.

Public Health +

The mission of our team with the XP gene therapy project is to enhance the quality of life for Xeroderma pigmentosum (XP) patients and thereby contribute to public health. The value of Public Health, as defined by the World Health Organization (WHO), emphasizes the importance of complete physical, mental, and social well-being^iv, beyond the mere absence of disease or infirmity. The design requirements associated with this value are shaped by the expectations of stakeholders such as public health organizations, the National Medical Products Administration(NMPA), China Rare Disease Alliance(CRDA), the Xeroderma Pigmentosum Society, and healthcare providers. These requirements are crucial for ensuring that our therapy aligns with broader public health goals and meets the needs of XP patients. You can learn more about these stakeholders in Fig.2.

Through our Human Practices efforts, we have identified a significant conflict between Public Health and the value of Accessibility. While our stakeholders, including the NMPA and the CRDA, and healthcare organizations, recognize the potential of new gene therapies to greatly benefit patients, they also highlight the challenges posed by accessibility. Ensuring that cutting-edge therapies reach those in need requires substantial investments and societal support. However, if the therapy is not made sufficiently accessible or lacks the necessary financial backing, it may never reach the patients who could benefit from it the most.

Quality +

Three critical aspects of the gene therapy for Xeroderma Pigmentosum (XP) are quality, effectiveness, and precision. Quality is central to ensuring that the therapy meets the highest standards of safety, consistency, and regulatory compliance, aligning with rigorous guidelines established by healthcare authorities. Effectiveness refers to the extent to which the gene therapy successfully restores DNA repair mechanisms in XP patients under typical clinical conditions, while precision ensures the therapy consistently delivers the desired outcomes across diverse patient populations with minimal variability. The design requirements associated with these values have been informed by insights from leading healthcare institutions, including the XP , National Medical Products Administration (NMPA), and collaborative research efforts with organizations such as the China National Cancer Center (CNKC), Shanghai Children's Medical Center (SCMC), West China Hospital (WCH), and Changchun GeneSci Pharmaceuticals.

Safety +

Safety considerations in our project are multifaceted, addressing the well-being of the patient, the environment, and society as a whole. We define safety as the state in which risks and potential harms—whether physical, genetic, or environmental—are minimized or eliminated to protect the health and well-being of individuals and communities, as described by the World Health Organization (WHO)^v. Measures to ensure patient safety are supported by institutions such as the China National Cancer Center (CNKC), Shanghai Children's Medical Center(SCMC) and West China Hospital(WCH). The Xeroderma Pigmentosum Society and patient advocacy groups have emphasized the critical importance of minimizing risks in gene therapy for XP patients. Additionally, organizations like the National Health Commission(NHC), Xeroderma Pigmentosum Non-profit Organization provided valuable insights into minimizing environmental impact. Besides, we investigated several XP patients and their family to find out most concerned safety problem. Lastly, we consulted with bioethicists, ethics experts, and National Medical Products Administration(NMPA), including the potential dual-use of our gene therapy approach.

Innovation +

Medical innovation, as defined by the World Health Organization (WHO), involves advancing knowledge and refining existing medical approaches to better address evolving health challenges and patient needs.^vi the context of our project, innovation is essential, as our gene therapy for Xeroderma Pigmentosum (XP) must either target a novel aspect of the disease or utilize groundbreaking technology to ensure its effectiveness. Protecting this innovative approach is crucial for its long-term success. When we consulted with Dr. Na Li, the member of Ethics Committee of West China Hospital, she strongly recommended us to protect our intellectual property as soon as possible. Furthermore, leading medical institutions such as China National Cancer Center (CNKC), Shanghai Children's Medical Center(SCMC), West China Hospital(WCH), Children's Hospital of Fudan University and the XP Society provided invaluable guidance in identifying the most impactful application of our gene therapy.

Efficiency +

Efficiency in healthcare is a measure of how well resources are utilized to achieve the best possible outcomes, ensuring that all research fee spent delivers maximum value. In our project, efficiency is critical not only for the testing process of our gene therapy for Xeroderma Pigmentosum (XP) but also for the overall operations of our iGEM team. Insights from Changchun GeneSci Pharmaceuticals emphasized the importance of efficiency during the production of our gene therapy, including the need for streamlined and cost-effective manufacturing processes. However, the design requirements related to Efficiency often conflict with those derived from our focus on Quality. Meeting all quality standards can increase the complexity of the gene therapy, which in turn may complicate and lengthen the process.

Integrity +

Just like the broader iGEM community, we place a high value on integrity, honesty, and trustworthiness in all aspects of our project. Integrity, which we define as adhering to strong moral principles and practicing honesty, has been a cornerstone of our work. To reinforce this value, we collaborated closely with the Ethics Committee at our university to ensure that our research and project development adhered to the highest ethical standards. Additionally, we have committed to following the ethical and legal guidelines established by the biotechnology and pharmaceutical industries, particularly concerning the transparent reporting and responsible marketing of new therapies. These guidelines are crucial for the safe and ethical implementation of our gene therapy for Xeroderma Pigmentosum(XP), ensuring that it meets both scientific and societal expectations.

Communication +

We have learned that effective communication is essential in the field of genetic therapy, especially when dealing with complex conditions like Xeroderma Pigmentosum (XP). Through our collaboration with various stakeholders, including patient advocacy groups, healthcare professionals, and regulatory bodies, we discovered that the general public's understanding of XP and genetic therapy is often limited. For more details on our outreach efforts, please refer to our Integrated Human Practices page. With the assistance of organizations such as National Medical Products Administration(NMPA), healthcare institutions, and communication experts, we explored how to effectively convey information to diverse audiences, ensuring that it is both accessible and comprehensible.

Additionally, we identified significant challenges in the current communication strategies surrounding genetic therapies, including XP treatment. Key issues include the need for a clearer, universally accepted definition of genetic therapy, as multiple interpretations can lead to confusion and misinformation. Furthermore, there is a pressing need for better frameworks on how genetic therapy developments are disclosed and shared with the public. Lastly, increasing investment in public education about genetic therapies is crucial to bridge the knowledge gap.

The design requirements for our communication strategy align closely with our commitment to transparency and ethical standards. Information must be communicated clearly and accurately to the intended audiences, ensuring that it is both honest and objective. This approach not only fosters trust but also ensures that stakeholders are well-informed about the implications and benefits of our genetic therapy for XP.

Privacy +

Privacy is an integral part of conducting ethical, responsible, and honest research. Data Privacy can be defined as the measures taken to protect personal information from unauthorized access, misuse, or loss. Given the increasing digitalization, privacy has become a prominent topic in the news and media, and it is a complex legal issue. As a participant in iGEM, our team prioritizes the safety and interests of our partners. In collaboration with a data steward from our university, we have established the necessary requirements to ensure the privacy of all individuals involved in our XPC treatment project. We adhere to the General Data Protection Regulation (GDPR) guidelines to protect personal and medical data. Of particular importance, the need for informed consent is particularly acute in the conduct of clinical research and treatment program. XP patients, due to their social status, have extremely sensitive personal information and medical data, which is not only a legal requirement, but also a fundamental principle of medical ethics. It reflects respect for patient autonomy and ensures that patients are able to make choices according to their own wishes at all times. Our privacy requirements are aligned with our commitment to integrity in all aspects of our research.

We discovered that creating a project that is both ethical and effective requires careful consideration of diverse stakeholder perspectives. During our stakeholder analysis for the XP treatment project, it became clear that different stakeholders—ranging from patients and healthcare providers to regulatory bodies—hold varying values, which lead to distinct and sometimes conflicting design requirements. The challenge lies in balancing these requirements so that the overall benefits outweigh the costs for all parties involved.

Our experience taught us that it is impossible to completely satisfy every stakeholder's needs and interests. Therefore, prioritization is key. By using tools like a power-interest grid, we identified which stakeholders, values, and design requirements should take precedence. Our goal was to fulfill the most critical needs in a way that still leaves other stakeholders content. This balancing act is essential not only for our project but for any team in the iGEM community.

We encourage future iGEM teams to adopt a similar approach. Rather than attempting to meet all design requirements, they should focus on prioritizing the most impactful ones, ensuring that the most influential and relevant stakeholders are satisfied first. This strategic prioritization will lead to more successful and responsible project outcomes.

We started off the construction of XPCures with the goal to make actual changes to the world, beginning with XP patients and hoping to spread the impact towards a larger population. To do so, we interviewed as many stakeholders as there are willing to be interviewed, learning from their experience and words how to perfect the concept and implementation of XPCures. The stakeholders we interviewed come from diverse backgrounds. There were doctors from renowned hospitals, medical school students, parents of XP patients, and even patients themselves. These beneficial interviews, alongside researches and analyses we have previously conducted, contributed to the progress of XPCures significantly, making sure that our product is not only applicable, but also meaningful in a way that may introduce changes to the medical world. Here, we summarize the potentials and challenges of XPCures in the following six sectors:

XPCures has received approval and acknowledgement from all sectors of the stakeholders. While there are challenges and weaknesses of the design, all interviewees believe that we will be able to overcome the struggles and finalize a project that is good and responsible for the world as well as local communities. Specific ideas provided by each interviewed stakeholder is presented on the Integrated Human Practice page. Working in cooperation with the stakeholders, taking their advice and gaining confidence from their acclaims, iGEM SJTU-BioX Shanghai has created a safe, ethical, and technologically advanced product that will sure benefit populations of high interest in our work. To develop further, XPCures has a feasible business potential and practical real-world implementation. In conclusion, XPCures is considered an effective design which serves as a viable and responsible solution to address issues in our society.

1. Scheller L, Strittmatter T, Fuchs D, Bojar D, Fussenegger M. Generalized extracellular molecule sensor platform for programming cellular behavior article. Nat Chem Biol. 2018;14(7):723-729. doi:10.1038/s41589-018-0046-z
2. 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
3. Tough DF, Sprent J. Life span of naive and memory t cells. Stem Cells. 1995;13(3):242-249. doi:10.1002/STEM.5530130305
4. Kojima R, Aubel D, Fussenegger M. Building sophisticated sensors of extracellular cues that enable mammalian cells to work as “doctors” in the body. Cellular and Molecular Life Sciences. 2020;77(18):3567-3581. doi:10.1007/s00018-020-03486-y
5. World Health Organization. Patient Safety
6. Hruskova Z, Rihova Z, Mareckova H, et al. Intracellular Cytokine Production in ANCA-associated Vasculitis: Low Levels of Interleukin-10 in Remission Are Associated with a Higher Relapse Rate in the Long-term Follow-up. Arch Med Res. 2009;40(4):276-284. doi:10.1016/j.arcmed.2009.04.001

Our project cannot remain solely a theoretical concept. To effectively bridge the gap between our design and societal needs, we must continuously gather feedback from various stakeholders, optimizing XPCures into a more effective, feasible, and implementable initiative. We categorize those who can influence our project into six groups: Academics, Healthcare, Patients, Government, Industry, and Ethics. Engaging with these groups allows us to gain a deeper understanding of patient needs and the entire process of developing gene therapies: from research and development to securing intellectual property, conducting preclinical and clinical testing, managing production, navigating regulation, and achieving market entry.

By fostering collaborations and open dialogue, we aim to create a comprehensive ecosystem that not only addresses the unique challenges faced by patients with Xeroderma Pigmentosum but also aligns with regulatory frameworks and industry standards. This holistic approach would enhance our project's viability and ensure that it meets the expectations of all stakeholders involved. Through iterative feedback and refinement, we aspire to transform our vision into a tangible solution that truly makes a difference in patients' lives.

The AREA framework is a methodology used for Responsible Research and Innovation (RRI), created by Professor Richard Owen. It has been optimized and employed by iGEM Team Exeter in 2019 and iGEM Team TU-Eindhoven in 2022. Similar to iGEM Team TU-Eindhoven 2022, we use the AREA framework to analyze and digest feedback from each interview, organizing our findings into four sections: Purpose, Contribution, Implementation, and Outlook. This structured approach helps us better understand stakeholder perspectives and refine our project accordingly.

The interactive timeline showcases our project's engagement with the outside world, integrating all our efforts in human practice. It highlights how XPCures has been optimized through external feedback, making it beneficial and responsible. Communication with stakeholders has been integral throughout the development of our project. Academics provide valuable insights and research, while Healthcare professionals offer practical perspectives on feasibility. Patients contribute personal experiences that guide our design choices, and Government bodies help navigate regulatory pathways. Industry partners provided us with valuable advice on implementation, and Ethics committees ensure that our practices align with moral standards. By actively engaging with these stakeholders, we ensure that XPCures remains responsive, effective, and aligned with the needs of those it aims to serve.

From the very beginning of the XPCures project, we have been exploring how to translate our therapy into a lucrative real-world application. To achieve this, we identified our primary customer base and engaged with them to understand their values, needs, and challenges. Collaborating with pharmaceutical industry experts, we conducted multiple analyses regarding our customers, the product, the product's market positioning, our commercialization strategy, financial planning, and our team. By integrating insights from experts and the outcomes of our analyses, we crafted a business plan to commercialize XPCures.

To validate our business plan, we participated in the 11th China Conference of iGEMer Community (CCiC), where we presented our project to major companies such as Yunzhou Bio, Xiaoxiongmao Bio, SynMetaBio and Jinsey Pharmaceutical, as well as other stakeholders. We are honored to have received the Best Project Award, Best Project Presentation Award, and Best Poster Award, which underscores the potential of our project's presentation and product concept.

On these pages, we share information and analyses about our customers, products, and team. For more details, arguments, and assumptions that support the presented analyses, we encourage you to read our full business plan.

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

Nowadays, there are well over 6,000 known genetic disorders, ¹ and new genetic disorders are constantly being described in medical literature.² Around 1 in 50 people are affected by a known single-gene disorder, and around 65% of people have some kind of health problem as a result of congenital genetic mutations.³ One of the most impactful genetic disorders is Xeroderma Pigmentosum (XP) in which there is a decreased ability to repair DNA damage such as that caused by ultraviolet (UV) light. For patients with it, sunlight, source of life's simplest and the most natural pleasure, becomes a dangerous threat. XP affects all races with a worldwide incidence of 1 in 250,000 live births.^4,5 The incidence of XP is estimated to be 1, 2.3, 17.5 and 45 per million live births in the United States, Western Europe, Middle East and Japan, respectively,^6,7,8,9,10 increased in areas where consanguinity is common.¹¹ Among all the subtypes of XP, XPC is the most prevalent one, especially in the United States, Europe and Africa. Symptoms of XP typically appear around the age of 1, including a severe sunburn after only a few minutes in the sun, freckling in sun-exposed areas, dry skin and changes in skin pigmentation. Due to accumulation of UVR-induced photoproducts and unrepaired DNA damage, XP patients have a 1000 times higher risk of developing skin cancer compared to the general population. Progressive neurodegeneration occurs in approximately 25% of patients with XP.¹² The median age of death is 32 years,¹³ and approximately 60% of XP patients die before the age of 20.¹⁴ Metastatic skin cancer is the leading cause of death, followed by neurodegeneration and internal cancer.

Currently, there is no cure for XP. Treatments mainly focus on strict and consistent sun avoidance and protection and early detection and management of premalignant and malignant skin lesions. No matter how uncomfortable it is, if exposure to sunlight is inevitable, patients need to be covered with layers of UV protection equipment: long-sleeved clothing, wide-brimmed hats, UV-resistant face masks long enough to envelop the neck, UV-protective gloves, UV absorbing/blocking sunglasses with side shields and UV-resistant films on windows in cars and buildings.¹⁵ However, it's difficult for patients to avoid any UV light, developing malignant melanoma is only the matter of time. Treatments of skin cancer include photodynamic therapy, aggressive cryosurgery, surgical excision, curettage with electrodessication an oral vismodegib, pembrolizumab, nivolumab and cemiplimab. Regular follow-up is necessary to prevent the condition exasperating. Frequent tumor treatments cause patients to endure long-term physical and mental suffering, and caregivers also endure significant hardship.

The healthcare burden for the family increases year by year. Fibroid cell carcinoma becomes more frequent as the patients get older, severe condition may develop into malignant melanoma. In China, some parents even sell their house to pay for the annually increased medical expenses. However, this is a vicious cycle, poor families find it harder to afford comprehensive UV protection, leading to higher medical costs.

The problem described leads to the opportunity that iGEM SJTU-BioX Shanghai discovered. Our project creatively proposes a design strategy aimed at developing a new therapy based on optogenetics and gene therapy. By targeting the mechanism of XPC patients' disease, we create a UV-B regulated gene expression system that allows for controlled expression of the XPC gene in the patient's body. This converts UV from a harmful factor into a therapeutic tool. The highlight is using UV as a controllable switch to regulate XPC levels via rare codons. By providing XPC protein at an appropriate level, XPCures may largely reduce the risk of developing skin cancer. Moreover, when the risk of skin cancer decreases, the workload for hospital and healthcare costs decrease. The UV-responsive gene switch not only provides a solution for XP but also holds potential as a treatment for other hereditary skin diseases.

Since our company will only be in direct contact with our primary customers, large pharmaceutical companies, we will only be considering our relationship with this customer segment in this section.

As iGEM SJTU-BioX-Shanghai aims to form a long-term partnership with one or more pharmaceutical companies, we must keep in contact with the liaison of the collaborating company. Thus, a small group of employees in our company will be in charge of contact with other companies. We hope, through dedicated stable connection, to form a tight bond with our business partner as well as our primary customer, and by doing so expand the potential of XPCures in market.

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.

iGEM SJTU-BioX Shanghai has designed the UV-responsive gene therapy XPCures for genetic disorders and Xeroderma Pigmentosum(XP) in specific. As explained in the problem statement, we focus on a subtype of XP named XPC, but in this report we will refer to the disease in its general way as XP. In this part the characteristics of XPCures will be described in detail.

Many genetic disorders are characterized by the deficiency or malfunction of specific proteins essential for cellular repair and defense. In the case of XPC, the lack of functional XPC protein impairs the DNA repair process, making patients highly sensitive to ultraviolet (UV) radiation. Our innovative UV-switch controlled gene therapy addresses this by introducing a system that activates the expression of the XPC gene in response to UV light, as outlined in Figure 4. Upon UV exposure, the UVR8 protein in our system dissociates from its dimer form and translocates into the nucleus, where it interacts with the COP1 protein, triggering the expression of the XPC gene. This mechanism ensures that the production of XPC protein occurs only when UV light is present, providing localized and temporally controlled therapy. Moreover, our design includes the RUP2 gene with rare human codons, which produces the RUP2 protein to interrupt the interaction between UVR8 and COP1, thereby regulating the concentration of XPC protein to an optimal level.

This innovative therapy is delivered through an adeno-associated virus (AAV) vector combined with hydrogel, allowing the therapeutic system to be injected directly into the patient's epidermal stem cells via microneedles. This localized treatment ensures precise targeting of the affected areas without systemic side effects.

The value of our UV-switch controlled gene therapy can be viewed from several perspectives. Our goal is to develop a proof of concept for a gene therapy platform that can be extended to treat other genetic skin diseases beyond Xeroderma Pigmentosum (XP), thereby creating significant value for the healthcare sector. While XP is a rare condition, genetic skin diseases collectively affect millions of people worldwide. Enhancing individual health by restoring essential DNA repair mechanisms, reducing disease-related symptoms, and improving quality of life will lead to less stress, greater independence, increased energy, and a happier life for patients and their families, friends, and caregivers. This improvement in individual well-being positively impacts society, as healthier individuals contribute to a stronger economy through a more sustainable and productive workforce.

In addition, our gene therapy has a significant impact on healthcare professionals. By reducing the frequency and severity of symptoms, as well as the need for intensive treatments, we decrease the workload for healthcare workers. XP patients often require continuous medical attention, including frequent dermatological examinations, treatments for skin lesions, and protective measures against UV exposure. Our therapy, which activates DNA repair mechanisms upon UV exposure, reduces the need for constant medical supervision and hospital visits. This allows healthcare workers, including doctors and nurses, to allocate their time and resources more effectively, improving overall patient care.

The reduction in medical interventions correlates with decreased healthcare costs. Managing XP and other genetic skin diseases can be expensive due to the need for ongoing care, surgical procedures, and preventive strategies. By minimizing the number of treatments, hospitalizations, and the duration of care required, our gene therapy significantly lowers healthcare expenses for hospitals and insurance companies. Furthermore, indirect costs associated with these conditions—such as loss of productivity, absenteeism, and the need for long-term care—are also reduced, resulting in substantial economic benefits.

Lastly, the ethical implications of our UV-switch gene therapy have a broader social impact. While debates about the use of genetic engineering and synthetic biology in medicine persist, the successful implementation of a safe and effective gene therapy can demonstrate the positive potential of these technologies. By responsibly advancing gene therapy solutions, we help alleviate public concerns and foster acceptance of innovative medical treatments. Our therapy is classified as an advanced therapy medicinal product (ATMP), representing a new frontier in medical science focused on innovative treatments for complex conditions. By pioneering in this field, we inspire further research and development, ultimately benefiting a wider range of patients with various genetic disorders.

To reach the end consumer in China and potentially across Asia, the value chain of the pharmaceutical and clinical research industry must be thoroughly understood and strategically navigated. It is essential to determine the position of XPCures within this value chain. As a startup, we must identify which assets we possess and which are controlled by other stakeholders to ensure the right commercialization strategy is implemented. All stakeholders must be identified, and for each step in the value chain, we must assess whether collaboration with a third party is necessary. The structure of complementary assets will determine their availability, whether they are freely accessible or concentrated within certain entities.

Firstly, we need to outline the necessary steps to reach the end consumer. In the pharmaceutical industry, we consider five key operations: drug discovery, drug development, production/manufacturing, distribution, and marketing & sales. These operations run concurrently with the drug development process. At present, XPCures is positioned in the "drug development phase."

The second step involves identifying all third parties within the value chain. A summary overview of all relevant third parties at each stage of the value chain, along with corresponding examples, is essential. The structure of the complementary assets is detailed, and assets that are readily available internally are allocated.

For XPCures, the value chain analysis is crucial for understanding our path to market and the resources required at each stage. We will collaborate with contract research organizations (CROs) for clinical trials, manufacturing partners for production scale-up, distributors for market penetration, and marketing agencies to create awareness and drive sales. Each of these partnerships will be strategically chosen to complement our internal capabilities and accelerate our journey to providing a transformative therapy to patients with XPC.

The XPCures project is dedicated to treating Xeroderma Pigmentosum (XP), particularly the XPC subtype, which is one of the most common types of this rare genetic disorder. Globally, there are approximately 20,000 to 30,000 patients with XP, and in China, fewer than 50 individuals are currently registered with relevant organizations. Our goal is to provide an effective treatment plan for these patients through innovative gene therapy technology. Our therapeutic strategy involves using a synthetic genetic switch that is sensitive to ultraviolet (UV) light to control the expression of the XPC gene, thereby repairing DNA damage caused by UV exposure.

Currently, there are two primary treatments for patients with XP-C: T4N5 repair lotion and tumor excision surgery for skin cancer caused by DNA damage:

• T4N5 Repair Lotion:

  The T4N5 repair lotion is widely used as a treatment that relies on the enzyme T4 endonuclease V, derived from a bacteriophage, to help repair UV-induced DNA damage. While this topical treatment can mitigate acute UV damage and reduce the risk of skin cancer, it does not address the underlying genetic defect in XP patients. As a result, long-term DNA damage continues to accumulate, leading to a higher risk of skin cancer over time.

• Tumor Excision Surgery:

  When XP patients develop skin cancer due to prolonged UV exposure, tumor excision surgery is often the primary treatment option. While surgery can remove cancerous tissue and temporarily control the progression of the disease, the genetic defect persists, and patients remain at high risk for further skin cancers. Repeated surgeries increase patient suffering and the healthcare burden.

Our project, XPCures, employs an innovative approach to treating Xeroderma Pigmentosum Complementation Group C (XPC), which is one of the most prevalent types of Xeroderma Pigmentosum (XP). This treatment is based on a patent-pending technology that involves the use of a synthetic genetic switch responsive to ultraviolet (UV) light, designed to control the expression of the XPC gene. The patent application will be currently under review in China, ensuring our freedom to operate within the Asian market where our business is primarily located.

With a focus on protectability, our team will file a detailed patent application in China. The patent specification, claims, abstract, and any necessary drawings are needed. The application should outline the innovative aspects of our technology, such as the UV-responsive switch that can maintain the expression of XPC at an appropriate level.

Through the China National Intellectual Property Administration (CNIPA), XPCures will apply for an invention patent, which generally expires 20 years after the application filing date. This will provide our company with 20 years of protectability in China to develop and sell the XPCures license. If everything goes smoothly, we will obtain the patent in two years after the submission. After the successful completion of phaseⅢclinical studies, we will be granted a license for the technology of XPCures.

This strategic approach to intellectual property protection will ensure that our innovative treatment for XPC patients remains safeguarded and exclusively accessible through our company, paving the way for a new era in gene therapy for genetic skin diseases.

Our team, XPCures, will initiate the research and development phase for a novel gene therapy tailored for a rare genetic disease, XP, following the acquisition of our initial license. Post the generation of preliminary results for this novel disease, we will proceed with the patent application process. Orphan drug designation is crucial for rare diseases, which is a global concern.

In China, diseases included in the rare disease catalog can benefit from special policies when applying for clinical trials and production licenses. Unfortunately, XP is not yet on this list. But the good news is China is currently actively promoting the legislation of a rare disease act. Besides, in the future, we will also actively work on the inclusion of XP in the rare disease catalog in China.

As shown in Figure 8, the drug development timeline for breakthrough therapy is the shortest. Considering that there is no cure for XP, XPCures stands as a promising candidate for breakthrough therapy designation. This designation could accelerate its development and regulatory approval process, enabling faster access to potentially life-saving treatments for XP patients. By targeting the underlying genetic defects in XP, XPCures has the potential to not only manage the symptoms but also address the root cause of the disease, making it a strong contender for this designation.

Following the analysis of the value chain, it can be concluded that XPCures has access to the necessary assets during the drug discovery phase. However, for all other phases, not all assets are readily available in-house, indicating the need for significant investment or collaboration with third parties to acquire them. Consequently, XPCures will focus on the initial stage and part of the second stage of the value chain, concentrating on drug discovery and development up to phase IIa clinical trials. A successful phase IIa clinical trial is considered a golden standard for proof of concept in clinical research. This strategy aligns with the current trend in the pharmaceutical industry, which has seen a dramatic increase in outsourcing R&D activities since 2004, due to the high risks and costs associated with this stage. Traditional large pharmaceutical companies are now focusing on specific later stages of the drug development process to reduce overall costs, encouraging strategic partnerships and outsourcing of services.

To commercialize the technology, XPCures will legally protect its intellectual property to license it in the technology market, including to large pharmaceutical companies in China and Asia. As explained in the "Protectability" section, the proof of concept and the technology underlying the engineered cell can be well protected. However, the complementary assets needed to bring the cell therapy to market are not freely available and are primarily controlled by large pharmaceutical companies. Based on the commercialization environments described by Gans and Stern's model, this situates us in the "Ideas Factories" scenario. In this scenario, collaboration with external parties is necessary because they hold the complementary assets. However, since there is high bargaining power due to the well-protected technology, it is possible to make contract agreements. The incumbents have high bargaining power because of the complementary assets they own, and XPCures has high bargaining power because of the strongly protected technology. The goal is to identify incumbents that are most in need of the technology, optimizing XPCures' bargaining power to secure attractive licensing deals with these external parties.

As detailed in the "Analysis of the Value Chain" section, not all assets are available, or their acquisition may involve significant investment barriers. Therefore, partnerships are essential for a successful commercialization strategy. The commercialization strategy for the next five years is outlined in Business plan.

On this page, our team and its skills and characteristics are reviewed. 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.

The iGEM SJTU-BioX-Shanghai 2024 team is a dedicated group of students from Shanghai Jiao Tong University, united by a passion for synthetic biology and innovation. Our team comprises interdisciplinary members from diverse fields such as biology, engineering, and medicine, creating a rich collaborative environment that encourages the exchange of ideas and expertise. This diverse background enables us to approach complex biological problems from multiple perspectives, enhancing our creativity and problem-solving capabilities. We actively engage in research, hands-on experimentation, and discussions, leveraging each member's strengths to develop effective and sustainable solutions. Our commitment to teamwork and interdisciplinary collaboration drives us to push the boundaries of scientific inquiry and create impactful projects that contribute to both academic advancement and societal benefit. The team members and their roles in the iGEM SJTU-BioX-Shanghai 2024 team are shown in Figure 9.

A SWOT analysis is is a strategic management technique used to help our new venture identify Strengths, Weaknesses, Opportunities, and Threats related to business competition.

Innovative Approach: The use of optogenetics and a UV-responsive gene switch for precise control of XPC gene expression is a novel and cutting-edge strategy. This makes XPCures stand out in the field of gene therapy.

Targeted Therapy: XPCures directly addresses the root cause of XP-C by introducing a functional XPC gene and providing real-time UV-triggered DNA repair, offering a more effective solution than existing treatments like T4N5 repair lotion.

Development Stage: As a novel therapy, XPCures is still in the experimental stage, with potential challenges in transitioning from laboratory research to clinical application.

Regulatory Hurdles: Gene therapies face stringent regulatory approvals, especially with the introduction of novel mechanisms like UV-responsive gene switches. This may delay clinical use.

Untapped Market: Currently, there are no direct competitors offering a gene therapy solution for XP-C. XPCures could be the first to market a long-term treatment for this condition.

Collaborations with Pharmaceutical Companies: Partnering with pharmaceutical companies could accelerate development, access to resources, and eventual market introduction.

Competitors in Gene Therapy: Although there are currently no direct competitors for XP-C, the rapidly evolving gene therapy space means that other players could develop similar or superior treatments.

Market Accessibility: High production and treatment costs might limit widespread access, especially in countries with less developed healthcare systems or limited insurance coverage.

For whole SWOT analysis can be read in Business plan.

In order to increase sales in the health market, we must first analyze the growth potential of XPCures. In this section, the growth potential of XPCures is detailed, along with the exit strategy.

Figure 10 above displays the famous Ansoff Matrix, which vividly explains the growth potential based on market and pruduct potential. Hence, the more market penetration, market development, product development, and diversification, the less risk a business experiences, especially when developing an innovative strategy like XPCures.

The foremost growth potential of iGEM SJTU-BioX-Shanghai lies in the existing market development and product development. Our direct potential customers will be pharmaceutical companies. Since our team is grouped from students of Shanghai Jiaotong University, a university with high reputation in Asia, and since we are already participating in iGEM, a competition recognized worldwide, we have accumulated some reputation to increase the customer potential. Furthermore, as XP is a rare disease and few institutions have been investigating it, especially in Asia, our innovative gene therapy strategy may play out well in the Japanese market, thus increasing the market potential.

Entrepreneurial exit refers to the process by which an entrepreneur or founder of a company either sells their shares or leaves the company entirely. This can be due to various reasons, such as personal financial goals, desire for new challenges, or lack of alignment with the company’s vision. In the case of iGEM SJTU-BioX-Shanghai, the founders of XPCures will be exiting after the company runs for around 5 years. None of the team members have the experience of marketing, and we are not going to dedicate a few decades of our lives to operating and financing a pharmaceutical company. Thus, it would be best to sell the share of XPCures to reliable pharmaceutical companies. As mentioned previously, we have decided to sell the license for marketing XPCures to a Japanese pharmaceutical company initially, but the number of companies holding shares for iGEM SJTU-BioX-Shanghai will be expanding.

More information about the growth and exit strategies can be found in the Business plan.

1. Cost of revenue analysis

   Creating a sophisticated financial plan is a necessary step towards successfully executing the business plan of any firm. In order to structure a well-developed financial plan, we should first make some essential assumptions regarding the expected cost structure and revenue streams.

1.1 Fixed costs

For starters, all possible fixed costs should be taken into consideration. For our pharmaceutical company, inevitable fixed costs include human resources expenditures, training expenses, infrastructure and operational costs, and marketing charges. In addition, costs for production license and legal protection (patents, etc.) are also accounted, as iGEM SJTU-BioX-Shanghai is developing a new medical technology and will thus need to undergo specific legal procedures. Since the license fee may vary according to various unknown situations, the cost assumption will be based on the expected, or average, license fee pharmaceutical companies normally pay in order to sustain the development and marketing of their products.

If the preview does not work, you can find detailed information in the Business plan.

A business model is an easy tool to visualize all fundamental business building blocks and to quickly define and communicate our business idea. In short, a business model is a conceptual framework that describes how a company creates, delivers, and captures value. This section explains the business model of XPCures and summarizes all the aspects of the model.

1. Proposition

   XPCures is an innovative UV-switch controlled gene therapy designed for genetic disorders, especially xeroderma pigmentosum. We are focusing on a specific subtype of xeroderma pigmentosum, XPC.

2. Business partners

   Our primary business partners, which are, at the same time, our potential customers, are large pharmaceutical companies who have the ability to sell XPCures to the market. They will be the ones helping iGEM SJTU-BioX-Shanghai generate majority of the income. The pharmaceutical companies will then be selling our product to hospitals that treat genetic diseases like XP. The hospitals, lastly, will be providing our product/therapy to its patients diagnosed with the disease. The value of XPCures is mostly for the last section of consumers, the patients, as they will be the ones benefiting non-financially from the product.

3. Key activities

   There are a few types of key activities that must be conducted for XPCures. The most time- and capital- consuming activity is research and development of the therapy. iGEM SJTU-BioX-Shanghai plans to finished clinical trial phase III before licensing XPCures out to large pharmaceutical companies. Therefore, biological experiments is a crucial factor of the operation of our business. The R&D process includes cell experiments (in vitro experiments), animal experiments, and clinical experiments. The wet lab members of iGEM SJTU-BioX-Shanghai will be working with the help from mentors and advisors from Shanghai Jiaotong University to accomplish the R&D stage of XPCures.

If the preview does not work, you can find detailed information in the Business plan.

A business plan is a comprehensive document that outlines the objectives, operations, industry position, commercialization strategy, marketing goals, risk analysis, and financial projections of our venture, XPCures. The business plan serves as a roadmap for our project, detailing the entrepreneurial efforts of the SJTU BioX Shanghai 2024 team, in developing a gene therapy for Xeroderma Pigmentosum Complementation Group C (XPC).

Please find the preview of our business plan below, or download the PDF version for a detailed overview of our strategic approach and financial planning.

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We focused on the promotion of sun protection knowledge and the concern of XP, and organized both on-line and off-line science popularization and education activities, and selected the regions with high UV indexes for the youth and residents of Qinghai and Jiangxi Provinces in China respectively, reaching over 200 people.

On 28th July 2024, our team cooperated with Shanghai Jiaotong University's "Microscopic Knowledge" social practice group to carry out a synthetic biology science lecture and interactive investigation, bringing a variety of educational lectures to high school students in Huangchuan Middle School in Qinghai Province.

Team member Li Enran firstly introduced synthetic biology, explained the concept of synthetic biology with videos, and shared its applications in medicine and pharmaceuticals, environmental protection, agricultural production and other aspects. She vividly explained the principles and applications of CRISPR technology in simple and easy-to-understand language, and introduced the team's previous iGEM competition projects, such as "Melanin Sunscreen Clothes for Space Bacteria" and "Gene Therapy for Pigmented Dry Skin Disease", etc., which led students to get closer to the world of gene editing step by step. She led the students to get closer to the world of gene editing.

Afterwards, Yao Jiayi shared his knowledge about sun protection with his team's research project. From the question of "why do we get sunburned", he explained the causes of sunburn, basic knowledge of sunscreen, common sunscreen measures and possible misunderstandings, which gave the students a deeper understanding of sunburn prevention and skin health protection.

In order to deepen their understanding and activate the learning atmosphere, the class also set up an emoticon guessing session, in which students gave full play to their reserves of idioms and ended the educational activity with a lot of guesses and laughter.

On 8 August 2024, our team cooperated with Shanghai Jiaotong University's "Tracing Red History, Empowering Healthy Villages" social practice group to carry out a popularization talk and interactive exchange activities at Ruijin People's Hospital, covering more than 100 young people.

Team member Yao Jiayi gave an in-depth popularization talk on the topic of sun protection tips. He talked in detail about the basic knowledge of sun protection in daily life and the skills of selecting sun protection products.

The students on the stage listened attentively, nodded their heads from time to time, and responded positively to the questions in the interactive session, showing their strong interest and desire for knowledge. The lectures of the two students not only enriched the medical knowledge of the students, but also inspired them to pursue a healthy life.

• Regional Outreach:

The activities spanned high UV index areas, reaching over 200 people through a combination of online and offline methods.

• Collaborative Efforts:

In cooperation with the "Microscopic Knowledge" social practice group from Shanghai Jiaotong University, we conducted science lectures and interactive surveys, providing a wealth of educational resources to high school students.

• Synthetic Biology Education:

Team member introduced the concept of synthetic biology through videos and simple language, explaining its applications in medicine, environmental protection, and agricultural production. The vivid explanation of CRISPR technology and the team's previous iGEM competition projects, such as "Melanin Sunscreen Clothes for Space Bacteria" and "Gene Therapy for Pigmented Dry Skin Disease," allowed students to gradually approach the world of gene editing.

• iGEM Project Showcase:

TThe presentation of the team's previous iGEM competition projects showcased the practical applications of synthetic biology and sparked students' interest.

• Sun Protection Knowledge Education:

Team member shared knowledge about sun protection through the team's research project, explaining the causes of sunburn, basic knowledge of sunscreen, common sun protection measures, and possible misconceptions, deepening students' understanding of sunburn prevention and skin health protection.

• Interactive Learning Experience:

An emoji guessing session was set up to stimulate students' enthusiasm for learning, ending the educational activity on a light and joyful note.

• Promotion of Healthy Living:

In a popularization talk and interactive exchange activities, team member gave an in-depth talk on the topic of sun protection tips, detailing the basic knowledge of daily sun protection and the skills of selecting sun protection products.

• Positive Learning Feedback:

Students listened attentively during the lectures, nodded in agreement from time to time, and responded positively to questions in the interactive sessions, demonstrating their strong interest and desire for knowledge.

Interested in organizing a similar event? In the pdf file you can find a complete analyses of our event but also some advice when you would like to organize your own event. Besides, we wrote down our struggles so you can learn from it!.