We used the AREA Framework created by Professor Richard Owen, optimized and implemented by iGEM Team Exeter 2019, TU Eindhoven 2022, and TU Eindhoven 2023. In our project we used the optimized version which is introduced by the captain of ZQT-Nanjing 2024. We divided each human practices activity into a tripartite structure of "Purpose, Contribution, Result". Through this framework, we are able to present the feedback from different stakeholders in a more comprehensive way, ensuring that every aspect of our project is fully considered. This not only enhances the scientific and practical nature of our projects, but also helps us to deeply understand the needs of our stakeholders and integrate them into the design and development of our projects, making our solutions more socially adaptable and sustainable.
In addition to the AREA framework, we utilized DBTL Cycle to evaluate and prioritize feedback from various stakeholders. Incorporating the DBTL (Design, Build, Test, Learn) cycle into our iGEM project has significantly shaped our approach to stakeholder engagement and project development. The cyclical nature of DBTL allowed us to integrate stakeholder feedback methodically at each stage, enhancing the overall project outcomes and ensuring alignment with real-world needs and expectations.
Finally, the reflections gathered from each cycle were documented and analyzed to inform subsequent phases. This ongoing process not only improved our project iteratively but also deepened our understanding of the stakeholder landscape, ensuring that each iteration was more informed and effective than the last.
Name: Learning from past iGEM competitions
Theme: Analyze outstanding projects of the past few years’ competitions and learn from them
Purpose: The Purpose of this study is to explore the success factors of previous iGEM competition award-winning projects, understand how they design experiments in combination with practical problems and social needs, how to use creative expressions, such as storytelling, integration of cultural elements, to improve the attractiveness of projects, and how to solve them through interdisciplinary cooperation. By drawing on these successful experiences, we can optimize our experimental design process and improve both of the social influence technical realization and level of the project.
Contribution: Through in-depth research on the 2023 HainanU-China team, 2024 ZQT-Nanjing team and 2024 HainanU-China team projects, we have learned a series of methodologies from problem discovery to solutions. These projects not only show how to turn complex scientific concepts into easy-to-understand stories or cases, but also provide research ideas on interdisciplinary cooperation, technological integration, innovation, and social demand-oriented, which greatly enriches our knowledge system and provides a reference framework for our future research.
Result: We’ve realized that a successful project should not only have a solid technical foundation, but also have an attractive presentation in order to better convey its value and significance. For example, combining synthetic biology technology with popular cultural elements can enhance the fun and memory of the project. In addition, interdisciplinary cooperation is crucial to solving complex practical problems. It not only promotes the cross-application of knowledge and technology, but also provides multi-angle support for the successful implementation of the project. These observations will guide us to pay more attention to overall planning and social impact in future projects.
No photos when learning.
Name: Dr. Yuhan Bao (iGEM liaison officer and human practice (HP) project leader)
Theme: Dr. Yuhan Bao’s thoughts of the iGEM Human Practices
Purpose: Learn the basic norms and precautions of the experiment, learn the design and measurement standards of the experiment, learn the real pursuit of HP, and carry out standardized learning for the subsequent experimental design and experimental process, so as to better achieve the standards of HP.
Contribution: We participated in Dr. Bao Yuhan's online course. From the safety of experiments to ethics to the application of AI technology, we have broadened the ideas of our experimental design and strengthened the norms of our experimental design. In the introduction of HP, we understand that the significance of HP lies in the mutual influence of experiments and the world, so that our thinking is no longer limited. After that, the requirements of the maturity model also brought our understanding of the experiment to a higher level.
Result: Through this meeting, we deeply understand the far-reaching significance of iGEM Human Practices. It not only focuses on experimental safety and ethics, but also emphasizes the impact of the project on society and the future. The "Human Practices Cycle" explained by Mr. Bao makes us understand that this is a process of continuous evolution, which requires closed-loop reflection from the problem to the solution. In particular, the opportunities and risks brought about by the integration of AI and biotechnology make us realize that innovation must be as important as responsibility. As iGEM participants, we should not only complete the experiment, but also think about how to make research truly benefit society. This meeting has brought me a lot of gains. In the future, I will carry out the HP concept throughout the project, embody social responsibility in innovation, and contribute humanistic care to the development of synthetic biology.
Name: stakeholder map
Theme: Rational allocation of resources through stakeholder maps
Purpose: Identifying stakeholders is to fully understand all individuals, groups and organizations related to our iGEM project to ensure that their needs, expectations and influence are fully taken into account, so as to support the success and sustainability of our project, optimize resource allocation, enhance communication and participation, and improve the success rate of the project.
Contribution: Making a stakeholder map allows us to sort out all the stakeholders related to our project, which helps us to rationally allocate resources and identify the core stakeholders of the project, and helps us make a more in-depth analysis of the feasibility of the project.
Result: After the production of the stakeholder map, we are deeply aware of its importance. Our stakeholders have 24 individuals, companies or organizations. We divide them into 9 categories, mark the 9 categories on the coordinate axis, and mark 24 individuals on the concentric circle. Patients and their families, life science research institutions, medical institutions and patient rights and interests organizations are the objects of our focus, close communication, and priority allocation of resources.
Name: Peipei Lei (tumor clinical drug researcher)
Theme: Clinical feasibility study on the treatment of colorectal cancer by
Purpose: We aimed to understand the feasibility of the mechanism of action of the drug; understand the acceptance of such therapies by clinical patients; understand the existing shortcomings of the project and clarify the direction of improvement.
Contribution: We interviewed tumor clinical drug researchers, from the feasibility of the drug to the acceptability of clinical patients to the mental journey of cancer researchers. In this interview, we realized that the project still needs to be improved ethically and technically. We also know that the recent efficacy is more important when evaluating the efficacy of drugs, which has improved our evaluation system.
Result: Through this interview, we know that we should pay more attention to the clinical value of drugs when discussing feasibility. We also realize that the development of cancer drugs has a long way to go. We will continue to improve the project and contribute to human health.
Name: oncologist Jinzhong Chen (Chief Physician of the Department of Oncology and Radiology at Yancheng Third People’s Hospital)
Theme: Dr. Chen’s summary and reflection
Purpose: Dr. Jinzhong Chen is the chief physician of the Department of Oncology and Radiology at Yancheng Third People’s Hospital. After contacting, it was decided to interview Dr. Chen, who worked in the hospital and was strongly related to the professional department, to further clarify the urgent needs of the hospital and the patients. At the same time, it provides possible ideas for the next step of research and the direction of drug research and development.
Contribution: Through this interview, we realize that the development cycle of the project is still not perfect. At the same time, due to the limitations of funding and technical problems, the efficacy and stability of drugs are very limited, which forces us to make breakthrough innovations in other aspects, such as the path of treatment or the underlying logic. At the same time, synthetic biological treatments naturally have the advantages of human affinity over chemotherapy and radiotherapy, which to some extent means fewer side effects such as exclusion reactions and inflammation.
Result: This makes us realize that solving the systemic inflammation that may be caused by immunotherapy such as canine uridine treatment may be a feasible research and development direction of the project. At the end of the interview, Dr. Chen proposed a plan for collaborative treatment with the same
Name: Jingning Zhu (Academician of the Academy of Life Sciences of Nanjing University)
Theme: Summary of Prof. Zhu's interview about molecular biology experiments.
Purpose: Ask about the room for improvement of molecular biology in this experiment, understand the transformation strategy of
Contribution: We interviewed Prof. Zhu on experimental-related issues. We have received professional guidance from the optimization of experimental design,
Result: Through this interview, we have a clear understanding of the optimization direction of the experimental design, such as the expression conditions and the specific methods of protein engineering transformation; clarifying the engineering transformation ideas of
Name: Xue Cao (Chief of Chunhe Elderly Care)
Theme: Through conducting an interview with a nursing home, we can understand the impact of rectal cancer patients on the interests of nursing homes.
Purpose: Understand the impact of rectal cancer patients on the operation of nursing homes, including the specific performance of economy, nursing difficulties, staffing, etc., and then understand the possible impact of our project on them.
Contribution:
Economic impact: Although accepting cancer patients will increase the difficulty and cost of nursing, nursing homes are more inclined to accept elderly people with high nursing levels, because this can significantly increase income.
The impact of new drugs: If the new drugs can extend the survival rate of patients, nursing homes have a positive attitude towards it. Because the improvement of patient survival rate means the extension of the nursing cycle, thus bringing more stable revenue to the nursing home.
Nursing cost: Increasing the accommodation rate of cancer patients will not increase the nursing cost of nursing homes.
Result: This project is of great economic and social significance to the institution of the nursing home. This interview helped us improve the plan, so that our research results can further help nursing homes ensure the quality of life of patients and improve the economic efficiency of nursing homes.
Name: Jianyong Chen (Vice-president of Ascentage Pharma)
Theme: Knowledge sharing on cancer and anti-cancer drugs
Purpose: Our current iGEM activity is related to colorectal cancer. Interviewing experts in cancer can provide constructive suggestions for our subsequent experimental design, while also allowing us to learn more about common knowledge of cancer and prevention methods.
Contribution: This interview is an in-depth dialogue between Dr. Chen Jianyong, Deputy General Manager of Ascentage Pharma, and the iGEM team, focusing on breakthrough applications of synthetic biology in the field of cancer diagnosis and treatment. By systematically reviewing the drug resistance bottlenecks and clinical translation difficulties currently faced in anticancer drug development, we innovatively proposed a combination drug regimen based on synthetic biology technology. The interview particularly emphasized the precise alignment between basic research and clinical needs, a concept that directly guided our team’s technical route design for engineered bacteria treatment of colorectal cancer. The cutting-edge insights shared by Dr. Chen provided important theoretical support for the project’s key aspects such as biomarker screening and in vivo microenvironment regulation, significantly enhancing the clinical translation value of the research. This exchange not only deepened industry-academia collaboration but also laid a solid scientific foundation for subsequent technological development.
Results：This study, through interviewing Dr. Jianyong Chen of Ascentage Pharma, clarified that student research projects must adhere to a clinical-need-oriented research direction, and systematically identified key clinical pain points in colorectal cancer diagnosis and treatment, such as insufficient sensitivity of biomarkers and drug resistance in targeted therapies. A translational medicine research framework incorporating medical device approval requirements and drug regulatory policies was constructed. Innovatively, it proposed incorporating microenvironmental factors such as gut microbiota into the validation system for engineered bacteria treatment regimens. Leveraging the technical advantages of Dr. Chen’s team in synthetic biology, an industry-academia collaborative innovation mechanism was established, providing professional support for subsequent experimental plan optimization and preclinical research. These outcomes significantly enhanced the scientific rigor and translational feasibility of this project.
Name: Dejing Wang (70-year-old Esophageal cancer patient)
Theme: Comprehend patients' real experiences with current treatments and their perspectives on convenient therapies
Purpose: Through in-depth interviews with esophageal cancer patients, we explored their daily treatment routines, frequency of hospital visits, dietary challenges, and current quality of life, further investigating their acceptance of and core needs for novel therapies (such as bacterial therapy) to better guide the human-centered goal-setting of our project.
Contribution: The interview revealed that the patient has transitioned to a "no hospital visits unless necessary" status, currently relying mainly on Tibetan medicine and injections, with severe dependence on nutritional fluids and nasogastric tube support, accompanied by significant weight loss and poor treatment experiences. Although the patient had never heard of synthetic biology therapies before, upon hearing the description "as simple as getting a vaccine," they clearly expressed, "That would definitely be desirable." What mattered most to them was not how advanced the therapy is, but rather "whether it can reduce hospital visits" and "whether it can be administered at home." This feedback holds substantial practical value, providing us with two key design recommendations: reducing dosing frequency and promoting the development of home-administered treatment mechanisms.
Result: This interview highlighted the practical difficulties faced by elderly cancer patients—the compounding effects of physical exhaustion, complex medication regimens, nutritional depletion, and mental burdens. We came to realize that "convenience" is not merely an added benefit in treatment options but a call for dignity by frail patients. Therefore, our team has placed greater emphasis on developing one-time deliverable engineered bacterial therapies and designing accompanying home-based assessment/monitoring modules to address the genuine demand of “whether we can avoid frequent hospital visits?"
No photos were taken for privacy reasons.
Name: Ruping Wang (Researcher, Nanjing R&D Department, Geneseeq)
Theme: Summary of Interview with Ruping Wang on Biotechnology Applications in Cancer Therapy
Purpose: We aimed to comprehend the application principles, key technologies, and related methods of protein engineering and enzyme engineering in cancer treatment, learn the application logic of biotechnology in this field, in order to provide theoretical reference for knowledge accumulation and subsequent potential research or practice
Contribution: Through the interview with expert Ruping Wang, I learned about the specific application approaches of protein engineering and enzyme engineering in cancer treatment. Examples include modifying anticancer proteins through protein engineering to enhance stability and achieve targeted effects, and engineering enzymes to destroy cancer cells or improve catalytic efficiency. This broadened my understanding of biotechnology applications in cancer treatment and provided references for related research or practice.
Result: Through this interview, we gained in-depth knowledge of numerous application details of protein engineering and enzyme engineering in cancer treatment. It was clarified that protein engineering can enhance the stability of anticancer proteins through chemical modifications, nano-encapsulation, etc., and achieve precise targeting by adding targeting tags; enzyme engineering can modify enzymes specific to cancer cell biomarkers and improve catalytic efficiency by optimizing active centers, etc. Simultaneously, we recognized that these technologies must balance safety and effectiveness in application. In the future, we will integrate these insights to more deeply understand the value and challenges of biotechnology in cancer therapy.
Name: Tingting Liu (AIA Health Insurance Company)
Theme: Feasibility of medical insurance coverage for engineered bacteria regulating tumor metabolism in colorectal cancer treatment
Purpose: We aimed to explore the possibility of applying a novel therapy utilizing
Contribution: Through an interview with Ms. Tingting Liu from AIA Health, we gained in-depth insights into the prospects and challenges of medical insurance coverage for engineered bacteria-based cancer therapies. The interview revealed that including new therapies in insurance schemes requires comprehensive consideration of R&D costs, the economic status of target populations, and cost-effectiveness of medications. Additionally, it clarified the importance of establishing a multi-stakeholder negotiation mechanism to promote high-cost innovative therapies, including enhanced collaboration among patient organizations, insurance institutions, and pharmaceutical companies to jointly advance rational allocation of medical resources and maximize social benefits of technological progress.
Result: This interview not only broadened our understanding of medical insurance policies and drug inclusion criteria but also helped us incorporate critical factors such as cost control, long-term medication risks, and patient affordability during the initial experimental design phase. This alignment makes our research more responsive to practical needs and societal interests. Simultaneously, we learned that despite the significant potential of novel therapies, numerous challenges remain regarding pricing negotiations, indication restrictions, and long-term sustainability of medical insurance funds. This interview provided valuable insights and guidance for our subsequent research direction.
Name: Wei Lu (Director of Oncology Department, Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Theme: evaluation of clinical feasibility and challenges for kynureninase-based tumor therapy strategy using engineered bacteria
Purpose: We aimed to comprehend frontline clinical doctors' perspectives on tumor treatment using engineered
Contribution: Dr. Lu pointed out that the strategy's greatest advantages lie in tumor-localized targeting, high metabolic stability, and controllable toxicity/side effects, potentially significantly improving patients' quality of life and progression-free survival. Simultaneously, he clearly identified three major risks of this therapy: uncontrolled live bacterial infections, immune hyperactivation responses, and horizontal transfer of foreign genes. Furthermore, he emphasized that transitioning from basic research to clinical practice must overcome multiple obstacles including comprehensive safety data validation, standardization of administration methods and dosages, as well as ethical and public acceptance issues.
Result: This interview helped us validate the practical significance of our design from a clinical perspective, while prompting the team to further refine safety control modules, consider standardization of delivery routes, and prioritize incorporating risk management mechanisms and public science communication in future designs. While expressing "cautious optimism" about therapeutic prospects, the doctor stressed the importance of real-world validation and phased clinical trials, establishing a scientific foundation and directional guidance for our project's future clinical translation.
Name: workers in Jiangdong Senior Wellness Center, Ma’anshan
Theme: commercial feasibility study on
Purpose: This interview explored the acceptance of engineered bacterial therapy for colorectal cancer among elderly patients and the willingness of senior care institutions to collaborate. The discussion aimed to assess the implementation feasibility of this innovative therapy in geriatric care settings, particularly from perspectives of safety, management convenience, and ethical compliance, to provide data support and improvement suggestions for subsequent clinical application and social promotion.
Contribution: Through in-depth communication with Ma'anshan Jiangdong Senior Wellness Center, we gained crucial insights into elderly patients' acceptance of novel cancer treatments and the cooperation potential of senior care institutions. Nursing home staff emphasized the extremely high demand among elderly patients for low-side-effect and high-safety treatment methods, while noting that care facilities prioritize management viability and legal compliance when introducing new therapies. Results indicated that nursing institutions are willing to support such therapies—especially those significantly improving quality of life—provided sufficient clinical evidence and professional medical guidance are ensured.
Results: This interview helped us recognize the critical importance of addressing safety concerns, management feasibility, and legal/ethical issues when promoting
Name: Chen Renhai (partner at Ennovation Ventures)
Theme: Early-stage investment strategy and future outlook of innovation therapy in life sciences and healthcare sector
Purpose: We aimed to learn about the core logic of investment of pharmaceutical companies, knowing the standard and challenge in early projects, and exploring the commercial potential and risk in innovation therapy (like cancer immunotherapy and bacterial therapy) to provide reference for technology transfer and investment decision in the future.
Contribution: Through communication with doctor Chen, we had gained deep insights into investment philosophy and practice in life science and healthcare sector. Doctor Chen explained the key focus AREA in investment of pharmaceutical companies, including contents from early-stage incubation to innovative therapy selection, especially risk and prospect assessment of emerging biotechnologies (like genetic therapies and bacterial therapies), and provided valuable experience for our team.
Result: This interview helped us realize that the success of a new drug not only depends on scientific innovation but also faces a lot of challenges from clinical tests to the market. Doctor Chen’s philosophy of “early-stage investment with a focus on original innovation” and his positive attitude to emerging biotechnologies (like gut microbiota editing) promoted us to think about the balance between technological commercialization and business value. In the future, we will focus more on interdisciplinary ground-breaking technologies, meanwhile strengthen the consciousness of risk to promote more socially valuable innovations in medicine and biology.
Name: Wu Xiaofeng（Chairman of Damei Medical Equipment (Yancheng) Co., Ltd）
Theme: Study on the commercial feasibility of
Purpose: Learning the commercial feasibility of the project, and knowing the patients’ demand on new drugs, new market of new drugs and some ethical problems.
Contribution: Through our interview with Wu Xiaofeng, we realized that our project needs the injection of some outstanding improvement. For example, it is beneficial to make improvement in living standard of patients during their treatment. We also learned that the quantity demanding of cancer drugs is still large, and many patients are willing to attempt pre-commercialized cancer therapies). As a result, we are sure that our project has significant commercial feasibility.
Results: Through this interview, we learned that patients focus on the improvement in living standards during treatment and many of them have positive attitudes to the attempt of new drugs, so we will continuously improve our project and complies it with ethical guidelines when satisfying the patients’ demand.
No photos were taken for privacy reasons.
Name: Jirong Wang (Director of the Department of Oncology, the Second Affiliated Hospital of Nanjing Medical University)
Theme: The Clinical Application Potential of Microbial Engineering in Tumor Immunotherapy
Purpose: This interview aims to explore from the perspective of clinicians the feasibility, safety and potential for translational application of the synthetic biology strategy of "expressing canine insinase using
Contribution: The doctor provided clinical feedback and suggestions on the key scientific hypothesis in our project (the role of the kynurenine pathway in tumor immune tolerance)：
Recognition and reminder of the target mechanism: Doctors point out that the mechanism of action of kynurininase has been preliminarily studied, and they believe that its potential role in tumor immune tolerance has application value. However, it has not yet become a routine detection index, and the mechanism still needs to be verified in preclinical Settings.
Comparative evaluation of the strategy: The doctor believes that our direct degradation of KYN by canine insinase has a more direct mechanism compared to traditional IDO inhibitors. However, attention still needs to be paid to functional differences and biological impacts.
Clinical recommendations for the vector system: If it is taken orally, attention should be paid to the imbalance of the microbiota and the risk of diarrhea. If it is an intravenous injection, the risk of bacteremia needs to be evaluated. If it is a local injection, attention should be paid to local inflammation and immune response.
Regarding the applicable population and treatment timing: Doctors suggest that this therapy can be prioritized for patients with primary or secondary resistance to immunotherapy, and screening should be based on the expression of IDO.
Individualized application suggestions: It is recommended to combine future therapies with the molecular typing of patients to achieve personalized treatment and enhance therapeutic effects.
Mechanism clarity: Is the effect of a single molecule sufficient? Is there a collaborative mechanism?
Safety issues: including immunogenicity, delivery efficiency, large-scale preparation stability, etc
Industrial development bottleneck: Currently, microbial engineering is still in the exploration stage in tumor treatment, especially facing challenges such as the safety, stability, and horizontal gene transfer of engineered bacteria.
Result: Through this interview, we have further clarified the key challenges and optimization directions that the project needs to face in the process from basic research to clinical transformation:
Strengthen the research on the mechanism of the kynurenine pathway, especially its specific role in the tumor microenvironment;
Improve the expression system of Escherichia coli to enhance targeting and reduce immunogenicity;
Attempt to develop clinical detection methods to screen the patient population with positive IDO expression;
Strengthen the exploration of delivery systems, such as encapsulation technology and targeted delivery, etc.
In the design of the treatment plan, the safety and feasibility of the treatment methods (oral/intravenous/local injection, etc.) should be fully considered.
No photos were taken for privacy reasons.
Name: Kai Wang (a 55-year-old liver cancer patient)
Theme: Starting from real cases, explore the mechanisms behind the failure of immunotherapy
Purpose: To understand the reasons for the failure of current immunotherapy in colorectal cancer through real cases, explore the metabolic targets behind the immunosuppressive mechanism, and provide a theoretical basis for the project direction.
Contribution: In the interview, we learned that elderly patients prefer treatment methods with lower side effects and greater safety. However, the treatment with engineered bacteria may cause patients to worry that it not only kills tumors but also poses a threat to their lives and quality of life.
Result: This interview made us realize that we need a method to control the release of KYNase more precisely. Therefore, in order to enable the KYNase produced intracellular to be released after reaching an effective concentration, we designed a cell lysis module based on the lysis protein PhiX174E. This lysis module can more precisely control the release and automatically lyse upon treatment completion, avoiding long-term retention in the body. It ensures that the bacteria can be eliminated in a single treatment without the need for additional surgery or drug intervention.
No photos were taken for privacy reasons.
Name: Lisa Liu (Associate Researcher, School of Pharmacy, China Pharmaceutical University)
Theme: Summary and Reflections of the Interview with Associate Researcher Liu Lisha on Colorectal Cancer
Purpose: Gain a thorough understanding of the screening criteria and implementation paths for colorectal cancer, master the treatment principles and effects for different stages of cancer, explore the mechanism of action, clinical application bottlenecks (such as drug resistance and side effects), and future development trends of targeted therapy, provide scientific basis for the design of related projects and the adjustment of research directions, and also accumulate professional knowledge for subsequent practice in the field of cancer prevention and treatment.
Contribution: We conducted an in-depth interview with Associate Researcher Liu Lisha on core issues such as screening, treatment, and targeted therapy for colorectal cancer. She not only systematically answered the applicable population and specific methods of colorectal cancer screening, but also elaborated in detail on the treatment plans for different stages of cancer. Moreover, she provided professional interpretations on the advantages of targeted therapy, the causes of drug resistance, types of side effects and countermeasures. These contents not only help us clarify the overall framework for the prevention and treatment of colorectal cancer, but also provide support for me to understand the underlying logic of precision medicine, and at the same time offer a clear direction for related research (such as the optimization of screening technology and the improvement of treatment plans).
Result: Through this interview, we gained a lot. In terms of screening, it has been clearly stipulated that the general population over 45 years old should undergo regular screening. High-risk groups with a family history, etc., should start screening earlier. Colonoscopy can be used as the first-line screening method, and fecal occult blood tests can be used as supplementary methods. Moreover, screening is crucial for the early detection of lesions and the improvement of cure rates. In terms of treatment, it is known that for early-stage colorectal cancer, surgical resection is the main approach, with a cure rate of up to 90%. For middle and advanced stages, a comprehensive treatment plan combining surgery, radiotherapy, chemotherapy, targeted therapy, etc. is required. Even for advanced stages, there is still a 30% to 50% possibility of clinical cure through conversion therapy and other methods. In terms of targeted therapy, it is known that it has entered the precise stage of multi-target combination. Drugs targeting molecular targets such as EGFR and BRAF V600E can significantly improve the prognosis of patients in the middle and advanced stages. However, approximately 50% of patients will develop drug resistance (related to RAS mutations, MET amplification, etc.) after 6 to 12 months of medication. Moreover, it may be accompanied by side effects such as skin rashes, hypertension, and proteinuria. New therapies such as combined immunotherapy, dynamic genetic testing, and CAR-T provide ideas for solving these problems.
Name: Ding Ruifeng (Doctor, Department of Oncology, Aikang Hospital of Traditional Chinese Medicine)
Theme: The Traditional Chinese Medicine Perspective on Cancer and the Inspiration of Ecological Regulation Concepts for Modern Therapies
Purpose: By interviewing traditional Chinese medicine oncologists, this paper explores how traditional Chinese medicine understands the causes of cancer, its treatment philosophy, and the way it manages side effects, and uncovers the wisdom in traditional medicine regarding "ecological balance", "psychological intervention", "nutritional adjustment", etc., in order to provide a more systematic view of the human body and a more comprehensive support strategy for modern synthetic biological therapy.
Contribution: Doctor Ding emphasized that the essence of cancer is "long-term abuse of the internal environment and imbalance of the external environment", and the core treatment should be to restore the balance of the ecosystem rather than "fighting cancer" itself. He pointed out that approximately 70% of the side effects of treatment stem from patients' psychological fears rather than the drugs themselves, emphasizing that emotional stability is crucial for recovery. At the same time, specific suggestions are provided, such as supplementing nutritional protein and consuming fruits that have "endured the four seasons and frost sedimentation", like apples, to combat the physical weakness and toxic side effects caused by radiotherapy and chemotherapy. In terms of the view on "bacteria treating cancer", he does not deny its potential, but believes that if it is only used as product promotion, its value is limited and still needs scientific verification and clinical feedback.
Result: This interview broadened the team's understanding of cancer treatment and prompted us to think about the questions of "how to coordinate the regulation of psychological states" and "how to combine nutritional and ecological adjustment strategies" in synthetic biological therapy. The most inspiring aspect is the combined approach of "antioxidant fruits + mood regulation". We realized that we could explore the integration of the expression system of engineered bacteria with the synergistic activation mechanism of natural substances to create a more humanistic synthetic biological treatment path. In the future, we also plan to add emotional support content and adaptive popular science modules in addition to the design of engineered bacteria, in response to the concept proposed by traditional Chinese medicine that "treating diseases starts with treating the mind".
Name: Yang Yu (Deputy Director of the Verification Center of Jiangsu Provincial Drug Administration)
Theme: Regulatory difficulties of Synthetic Biology Products and Suggestions for biosafety Measures
Purpose: To understand the regulatory challenges faced by synthetic biology products in their translational applications, identify the potential biosafety risks caused by engineered bacteria in medical use, and guide the safety design of the project.
Contribution: Through interviews, we have recognized that the state attaches great importance to the control issues after the release of engineered bacteria in terms of supervision, especially the deficiencies in the adjustment of drug dosages and the mechanism for removing bacteria. Meanwhile, experts from the Jiangsu Drug Administration pointed out the practical predicament that the treatment mechanisms for children and adults cannot be simply applied, guiding us to design a more rigorous safety module for the fixed-point release + suicide system.
Result: The interview helped us build a complete biosafety closed-loop system, including the "population density-responsive lysis + blue light-induced suicide" combination module. Through this exchange, we have also come to understand that safety is not merely a technical issue, but rather a boundary between ethics and regulation, which has enhanced our reflection and sense of responsibility regarding the social impact of the project.
Name: Qing Hu (Senior Securities Analyst, Orient Securities)
Theme: Views and Tendencies in the investment Field regarding the future prospects of Escherichia coli in treating colorectal cancer by consuming kyrie acid.
Purpose: This interview aims to deeply analyze the core concerns of the investment community regarding the engineered Escherichia coli (targeting the kuretic acid consumption pathway) technology for treating colorectal cancer, including the feasibility of the clinical pathway for technology implementation (such as milestone design within a 5-7 year transformation cycle), and the logic for building a differentiated competitive advantage (breakthroughs in efficacy or safety compared to PD-1 inhibitors/chemotherapy). And the quantitative balance strategy of risk and return (balancing the bottlenecks of industrial production, the difficulties in regulatory approval and the dividends of a market size of 39 billion). By obtaining feedback from a professional investment perspective, it provides key decision-making basis for the team to clarify the direction of technical optimization and business transformation strategies.
Contribution: Through communication with Mr. Hu Qing, we have gained a deep understanding of the investment community's views on the future prospects of the engineered Escherichia coli (consuming kynurenine to treat rectal cancer) technology. The main points are as follows:
- 1. Clinical application is the top priority: What investors value most is a clear path that can achieve clinical transformation within 5 to 7 years. This requires strong preclinical data support, as well as clear phase I/II/III clinical trial results with high success rates.
- 2. Emphasize differentiated competitive advantages: This technology must prove that it is significantly superior to existing therapies (such as PD-1 inhibitors or chemotherapy) in terms of efficacy (such as survival rate) or safety in order to gain market recognition.
- 3. Focus on the balance between risk and return: Investors closely monitor the challenges in the industrialization process (such as whether the standardization of bacterial preparations and regulatory approval obstacles can be resolved). At the same time, it is necessary to balance the continuous investment in research and development costs with the development opportunities of the rectal cancer drug market (which is expected to reach a scale of 39 billion yuan by 2028).
Result: Based on the interviews, we have identified the following improvement directions:
- 1. Supplement combined treatment data: Focus on supplementing the effect data of the combination of engineered bacteria and other therapies (such as immune checkpoint inhibitors).
- 2. Differentiated positioning: Consider positioning the technology as a second - or third-line treatment option to avoid direct competition with the dominant first-line chemotherapy.
- 3. Strengthen data presentation
I. Improve short-term efficacy indicators: For instance, more prominently display short-term benefit data such as tumor response rate (ORR).
II. Strengthen long-term benefit evidence: Fully demonstrate long-term efficacy indicators such as progression-free survival (PFS) and overall survival (OS) to meet clinical needs and investor expectations.
- 4. Focus on market access
Accelerate patent layout and team building: Rapidly advance patent protection, build a competitive core team, and construct technological barriers.
II Grasp the trend of innovation in China: Fully leverage the opportunity of China's rising influence in the global field of drug innovation.
Name: Yan Wang (family member of an Esophageal Cancer Patient)
Theme: Family Perspectives under the Burden of Cancer Treatment and Expectations for Emerging Therapies
Purpose: Through in-depth interviews with the families of cancer patients, to understand the difficulties, economic and emotional pressures they face in treatment decisions, as well as their attitudes and acceptance thresholds towards new treatment methods such as synthetic biology bacterial therapy, and further explore the trade-off ranking among efficacy, safety, operational difficulty and cost for the families of cancer patients.
Contribution: The interviewee shared his 74-year-old father's experience of radiotherapy and chemotherapy after being diagnosed with esophageal cancer, the treatment response, and the direct and hidden expenses (annual expenditure exceeding 100,000 yuan) borne by the family. He emphasized the priority of "efficacy first" and frankly admitted that he was completely unfamiliar with synthetic biological therapy but held a cautiously hopeful attitude. She pointed out that the certainty of therapeutic effect, safety verification, national recognition and implementation by authoritative institutions are the prerequisites for her willingness to try new therapies. She also called on the research team to reduce treatment steps, lower the burden on family caregivers and accelerate the pace of transformation.
Result: This interview deepened the team's understanding of the "audience acceptance threshold for innovative therapies", which is "not to reject, not to blindly believe, but to see if it is safe and effective". Although the patient's family is confronted with high costs and treatment difficulties, once the new therapy can provide clear data and official endorsement, they will have a high willingness to try it. This inspires us that in the future, when designing bacterial therapies, we should emphasize the efficacy verification mechanism, the safety closed loop, and the humanized and simplified design of the usage process, promoting the application of technology from the perspective of patients' families.
No photos were taken for privacy reasons.
Name: Zhang Hao (Specialist in oncology)
Theme: The Occurrence and Development of Colorectal Cancer
Purpose: Our iGEM project focuses on treating colorectal cancer (CRC) by inhibiting the kynurenine pathway. To build a strong foundational understanding of our target disease, we attended an online lecture titled "The Occurrence and Development of Colorectal Cancer" presented by Dr. Zhang Hao. Our primary purpose was to gain a comprehensive and expert overview of the molecular pathways, risk factors, and multi-stage progression of colorectal cancer, from initial polyp formation to metastasis. This knowledge is critical for ensuring our project design is biologically relevant and effectively targets the key mechanisms of CRC.
Contribution:
Deepened Biological Context: It gave us a detailed understanding of the "adenoma-carcinoma sequence," the classic model of CRC development. This helps us contextualize where and how our intervention in the kynurenine pathway could be most effective in halting or reversing cancer progression.
Identification of Key Mechanisms: Dr. Zhang's explanation of critical signaling pathways (e.g., Wnt/β-catenin, KRAS, TP53) allowed us to better understand the complex tumor microenvironment we are targeting. This informs our hypothesis on how modulating tryptophan metabolism via the kynurenine pathway interacts with these established mechanisms.
Strengthened Project Rationale: The epidemiological data and clear explanation of the disease burden strengthened the rationale for our project, highlighting the significant need for novel therapeutic strategies in CRC.
Informed Experimental Design: Understanding the genetic and cellular hallmarks of CRC development helps us design more relevant in vitro and in vivo experiments, ensuring our models accurately represent the disease.
Result: As a direct result of this activity, we synthesized the acquired knowledge into actionable insights for our project. We did not merely consume the information; we provided feedback and integrated the learning:
Internal Knowledge Transfer: Our wet-lab and dry-lab teams held a discussion session to summarize and translate the lecture's key points into specific project considerations.
Refined Project Design: We used this knowledge to refine our molecular strategy, specifically considering the stage of cancer our therapy would target most effectively.
Public Engagement: To acknowledge Dr. Zhang's contribution and to educate our community, we created a social media post summarizing the key learnings about CRC for a public audience, thereby fulfilling part of our education and communication goals for Human Practices. We credited Dr. Zhang and the lecture as our source.
Informed HP Dialogue: This expert input directly informed the questions we ask in subsequent stakeholder interviews (e.g., with oncologists and patients) to ensure they are technically sound and relevant.
