Integrated-Human-Practice
Human Practices plays a crucial role in bridging the gap between scientific innovation and its real-world applications, ensuring that our work is not only technically feasible but also responsible and good for society. Guided by this vision, our team regards Human Practices as the bridge that integrates scientific exploration with human needs, values, and responsibilities. With epilepsy as our project focus, our goal is to develop an innovative, safer, and more accessible therapeutic approach for patients who face both medical and social challenges.
To pursue this goal, we carried out extensive integrated Human Practices activities, including in-depth interviews with clinicians and ethicists, investigations into pharmaceutical enterprises and markets, engagement with patients and the public, and continuous reflection on safety and ethical issues. These efforts allowed us to refine our design iteratively, ensuring that our project evolved in response to real-world insights. Ultimately, through continuous dialogue and reflection with diverse stakeholders, we have built a complete closed loop between our project and society. This process not only demonstrates our dedication to pursuing the Best Integrated Human Practices, but also lays the foundation for a sustainable and impactful future in improving the lives of epilepsy patients responsibly.
In order to ground our project in real-world needs, we began by asking a fundamental question: what issues does the public truly care about? Through early surveys and interviews conducted across the hometowns of our team members, we discovered a strong and consistent concern for health, particularly for vulnerable groups who often lack sufficient medical support. These conversations revealed how deeply the public values equitable access to healthcare, and they provided us with an initial direction to explore conditions where unmet medical and social needs intersect.
This public dialogue soon became personal. During our brainstorming session, several team members shared experiences of relatives, neighbors, or acquaintances living with epilepsy. At the same time, we were also struck by the way epilepsy has appeared in world culture and science—from Vincent van Gogh’s struggles recorded in his letters and portrayed in the film Lust for Life, to Hippocrates’ early description of the condition as the “sacred disease,” to John Hughlings Jackson and Hans Berger, pioneers whose work laid the foundation for modern epileptology and EEG technology. These lived realities and historical inspirations resonated with the societal concerns we had identified, strengthening our determination to take epilepsy as the focus of our project.
To transform these insights into concrete understanding, we turned to authoritative sources. According to the World Health Organization (2024), more than 50 million people worldwide are living with epilepsy, with mortality rates nearly three times higher than those of the general population. We also studied publications from the Chinese Anti-Epilepsy Association’s Drug Therapy Committee and Sichuan University, which outlined the current standards of care and limitations of existing treatments. Furthermore, our market research revealed the dominant share of a few established drugs, the challenges of high costs and limited accessibility, and the gaps where novel therapeutic approaches are urgently needed.
Taken together, these layers of investigation—public consultation, personal reflection, literature review, and market analysis—formed a clear picture of both the medical urgency and the social responsibility surrounding epilepsy. We chose epilepsy not merely as a research topic, but as a mission to address a pressing health challenge with innovation and compassion.
At the very beginning of our project, we sought to understand epilepsy not only as a biomedical problem but as a lived condition shaped by clinical, psychological, and social realities. To do this, we conducted field interviews with medical experts, beginning with Dr. Li Zhaokai, Director of the Department of Neurology at Puyang People’s Hospital in Henan Province. Dr. Li introduced us to the current clinical landscape of epilepsy, outlining standard treatments, their limitations, and the major pain points in practice. He emphasized three critical areas often overlooked in research: comorbidities that complicate treatment, the psychological well-being of patients, and the urgent need for public education on first aid during seizures. These insights not only grounded our project in real medical needs but also inspired elements of our later Education and Inclusivity initiatives.
Acting on Dr. Li’s advice, we collaborated with Prof. Zeng Meiqing, a certified emergency rescue trainer of the Red Cross Society of Hainan Province and a lecturer in Emergency Medicine at Hainan University, with over 13 years of teaching experience and more than 100 public training sessions. Together, we organized an innovative public science event that combined lectures, scenario simulations, and interactive demonstrations. This activity strengthened campus awareness of health and safety, fostered inclusivity, and contributed to building a supportive and informed community.
In addition, Dr. Li introduced us to the therapeutic potential of ketogenic diets and β-hydroxybutyrate (BHB), pointing to possible new pathways for treatment beyond conventional drugs. These ideas laid an early conceptual foundation for our project, guiding our exploration toward innovative strategies that integrate metabolic therapy into synthetic biology design. By listening carefully to experts and translating their insights into concrete actions, we ensured that the initial direction of our project was deeply rooted in both clinical reality and social responsibility.
Building upon our initial concept of engineering gut microbes to produce β-hydroxybutyrate (BHB) as an alternative to ketogenic therapy, we actively sought feedback from experts and stakeholders to refine our design and ensure both feasibility and responsibility.
Expert ConsultationsOn June 2nd, we consulted Dr. Wei Yongjun, Associate Professor at Zhengzhou University School of Pharmacy and a recipient of the Henan Outstanding Young Scholar Award. Dr. Wei raised critical concerns about the practicality and safety of oral or injectable BHB. He explained that such delivery methods could cause unstable blood concentrations, posing risks of ketoacidosis while offering low efficiency in reaching the brain. In contrast, he emphasized that gut-colonizing engineered bacteria could achieve more stable, localized release of BHB, mediated. He further suggested exploring hydrogel-based delivery systems to enhance stability and considering genetic integration strategies to minimize biosafety risks. His constructive feedback reshaped our technical direction, aligning our design more closely with clinical viability and public safety.
Patient and Community Engagement
On July 30th, our team shadowed Dr. Li Qifu at the First Affiliated Hospital of Hainan Medical University to observe epilepsy patient's medical visit and interact with patients’ families. Throughout this process, we strictly adhered to ethical guidelines by obtaining informed consent from all participating patients and their families, ensuring their rights and privacy were fully protected. We heard first-hand accounts of the struggles patients face, particularly high treatment costs, limited efficacy of current drugs, and difficulties in recording seizure episodes. These insights prompted us to reconsider economic accessibility and user-friendly monitoring tools as essential elements of our project. In response, we began exploring ways to lower production costs and developed ideas for integrating seizure-recording devices, such as improved EEG systems, into our therapeutic design. This hospital visit reinforced our commitment to addressing not only the biomedical challenge but also the social and financial burdens of epilepsy, while consistently upholding the standards of safety and ethics in all our stakeholder engagements.
Peer Collaboration
From August 8–10, our team participated in the 12th Conference of iGEMer China Community (CCiC) & Synbiopunk 2025. Engaging with teams from across the country, we exchanged perspectives on biosecurity, ethics, and practical challenges in project design. In particular, discussions on biosafety regulations and real-world implementation highlighted areas where we could further strengthen risk mitigation in our design. The feedback we received from peer teams, as well as the collaborative spirit of the conference, expanded our vision and inspired us to approach our project as part of a broader movement to advance synthetic biology responsibly.
Iterative Refinement
In an in-depth consultation on August 16th, Dr. Li Changyu, a neurosurgeon at Hainan Cancer Hospital, reminded us that epilepsy is not only a medical condition but also a profound psychological and social challenge. He emphasized that therapies should protect patient dignity, minimize stigma, and support overall well-being. His insights encouraged us to prioritize discreet, patient-friendly solutions, from oral bacterial therapy that avoids the social visibility of ketogenic diets to the adoption of privacy-preserving EEG devices, while also acknowledging complementary practices such as moderate exercise.
Fig 9. Communicating with Dr. Li Changyu
Building on Dr. Li’s advice, we recorded a video demonstration of Tai Chi Baduanjin exercises adapted for epilepsy patients and shared it on our team’s social media platforms. The response was encouraging—one commenter noted that he had forwarded the video to a friend living with epilepsy, calling it genuinely helpful. This simple outreach illustrated how even small, culturally rooted practices can reduce anxiety, promote inclusion, and extend the impact of our project beyond the laboratory, reinforcing our belief that responsible innovation must also empower everyday lives.
Shortly afterward on August 19th, we held a detailed exchange with Mr. Meng from the Harbin Pharmaceutical Group, whose advice provided both technical guidance and a broader framework for thinking about drug development. He began by outlining the essential traj ectory from discovery to market—moving from conceptualization and early validation, through process development, preclinical testing, and clinical trials, before finally entering the regulatory and commercial stages. From a clinical perspective, Mr. Meng reminded us that neurological diseases remain particularly challenging, not least because of the blood–brain barrier, which hinders the delivery of most conventional drugs to their intended site of action. He pointed out that this technical bottlen eck is one of the main reasons many companies hesitate to pursue neurotherapeutics. In contrast, he recognized the novelty of our strategy: our engineered bacteria produce BHB locally in the i ntestine, which then crosses the BBB naturally via monocarboxylate transporters. This approach not only bypasses a major hurdle but also introduces a potentially safer, more physiologically integrated form of therapy.
Fig 10. Communicating with Mr. Meng
Following our discussion with the Harbin Pharmaceutical Group, we also developed a pharmacokinetic model to predict the proportion of BHB produced in the gut that would successfully reach the brain. Mr. Meng also illuminated the regulatory and market pathways for live biotherapeutics, reminding us that social need often outweighs commercial profit in the development of “serious medicines” such as epilepsy treatments.
Synthesizing this diverse feedback, we arrived at a final therapeutic design centered on engineered E. coli Nissle 1917 encapsulated in a three-layer hydrogel system. This platform not only stabilizes gut colonization and enables controlled BHB release but also integrates quorum-sensing regulation and biosafety switches to ensure effective, safe, and responsible use. In this way, our design is more than a technical solution—it is a direct embodiment of the values we learned from stakeholders, a project shaped iteratively to be scientifically robust, socially responsive, and truly aligned with the vision of science in service of humanity.
Through these iterative engagements—expert consultations, patient-centered observations, and peer dialogues—we continuously refined our project to respond to real-world needs and constraints. This process exemplifies the feedback loop at the heart of integrated Human Practices: by listening, reflecting, and redesigning, we move closer to building a the rapeutic solution that is both innovative and aligned with the values of responsibility , inclusivity, and human benefit.
Our project was shaped not only by clinical and industrial experts but also by the voices of the broader community.
The Public＆InclusivityDuring the summer, we conducted interviews across different regions to understand how the public perceives epilepsy. Many respondents emphasized ealth as a central concern, particularly for vulnerable groups, but also reve aled widespread misconceptions and stigma associated with epilepsy. To furthe r explore these themes, we distributed questionnaires and conducted intervie ws with university students during the freshman orientation on September 3rd . Their feedback offered valuable insights: while awareness of epilepsy rema ined limited, students expressed strong interest in learning more and in sup porting inclusive approaches. One participant even mentioned a folk remedy f or epilepsy, which underscored the need for accurate scientific education. In response, we integrated this feedback into our Education and Inclusivity in itiatives, using public engagement not only to raise awareness but also to dispel myths and reduce stigma.
Fig 11. Interviewing College Students
In practice, this commitment was reflected in our activities. On June 28th, World Epilepsy Day, we organized a symbolic “Tear off the Labels” campaign to confront stigma directly. Comm on misconceptions such as “epilepsy is contagious” or “patients cannot exercise” were writte n on labels covering a table, and participants were invited to tear them away to reveal the scientific truths beneath: “epilepsy is not contagious”, “patients are encouraged to exercise safely under guidance.” The act of tearing off these labels carried both ritual and power, r epresenting a collective effort to dismantle prejudice and promote inclusivity.
Fig 12. “Tear off the Labels” Campaign
In parallel, we published a series of educational articles on our WeChat official account, explaining the science behind epilepsy, clarifying misunderstandings, and introducing synthe ic biology in accessible language. These continuous efforts not only raised public awarenes s but also fostered a spirit of empathy and acceptance, reinforcing our project’s core miss ion of caring for people with epilepsy.
We designed a questionnaire. With the help of Dr. Li Qifu, w hom we had contacted earlier, the questionnaire was distributed t o some epilepsy patients at the First Affiliated Hospital of Hainan Medical University, and a total of 13 valid responses were collected.
From the data, we can see that most patients’ concerns about medications remain focused on side effects and high costs. Regarding the ketogenic diet therapy, the biggest troubles for most patients are the inconvenience of preparing special fo ods and the social impact caused by being unable to eat together with family and friends.
Most patients stated that they look forward to a new medication that is more convenient, effective, and affordable, and expressed their support for us. However, the safety of medications remains the top concern for everyone and an issue that deserves our co ntinuous consideration.
On August 8th, several of our team members visited the China Association Against Epilepsy (CAAE) in Beijing, where they explored exhibitions and engaged with staff to better understand the national framework for epilepsy prevention and care. Throug h the CAAE’s livestream studio, we learned how digital platforms are being used to s pread accurate information, support patients, and connect physicians across regions. We were also introduced to the tiered epilepsy center network, a system that links co mmunity clinics, regional hospitals, and national centers of excellence, ensuring pat ients receive timely referrals and specialized treatment. This experience broadened o ur vision by showing how coordinated national efforts can reduce disparities in care and accelerate knowledge exchange. For our team, it reinforced the idea that our proj ect must not only advance technology in the lab but also integrate into global and na tional health ecosystems to achieve meaningful and lasting impact.
Fig 13. Visit the China Association Against Epilepsy (CAAE)
From the perspective of commercialization and drug distribution, we engaged with stakeholders in the pharmaceutical industry. On August 18th, we visited Yanxitang Pharmacy in Shandong, where we learned about the current selection of epilepsy medi cations available to patients, the role of probiotics in consumer health, and the p urchasing habits of local residents. This exchange helped us better understand how new drugs enter the market, the importance of physician and pharmacist recommendati ons, and the regulatory hurdles involved in drug promotion.
Fig 14. Visiting Yanxitang Pharmacy
Our exploration of the pharmaceutical landscape also underscored the pivotal role of laws and regulations on epilepsy treatments. Current Chinese health policies, in cluding national reimbursement lists, bulk procurement programs, and accelerated ap proval channels for rare-disease and biotherapeutic drugs, are reshaping both acces sibility and market competition. For example, while inclusion in the national insura nce catalogue has dramatically reduced the cost of innovative antiepileptic drugs, it has also compressed profit margins for developers, slowing investment cycles. Sim ilarly, consistency evaluations for generics have improved quality but raised barrier s for smaller companies. For our project, these lessons highlighted that any future t ranslation must not only demonstrate clinical value but also align with evolving regu latory frameworks that demand both affordability and quality assurance. By embedding t his awareness early, we position our design within the realistic boundaries of health are systems, ensuring that innovation remains both sustainable and socially responsible.
Throughout our project, we treated ethics and safety not as constraints but as the foundation of responsible scientific practice. From the outset, we recognized that developing a live biotherapeutic product requires rigorous safeguards to protect both patients and the environment.
On September 11th, we engaged in a critical dialogue with Professor Cheng Guobin, a distinguished bioethicist and Director of the Medical Humanities Department at Sou theast University, whose expertise spans life ethics and clinical review processes. Professor Cheng urged us to strengthen the ethical justification for our innovativ e approach, emphasizing that given the existence of conventional epilepsy treatment s, we must clearly demonstrate our project’s clinical added value, such as enhanced safety, reduced side effects, or improved accessibility. In response, we have cons idered the project's safety from multiple aspects, including chassis organisms, co mponents, and laboratories, and strengthened the demonstration of project safety i n the wiki.
Fig 15. Communicating with Professor Cheng Guobin
On September 13th, we consulted Professor Bao Jiaolin, a pharmaceutical scientist at Hainan University specializing in drug development for neurological disorders. She promp ted us to consider key translational questions, such as the precise quantification of BH B delivery from the gut to the brain, the feasibility of hydrogel oral delivery, and th e pharmacokinetic profile of sustained BHB release. Drawing from drug development princi ples, Professor Bao advised us to align our dosing strategy with clinical standards—sugg esting, for example, that engineered BHB production should match the ketone yield of a tra ditional ketogenic meal. Her insights directly influenced the refinement of our pharmaco kinetic model and dosing regimen.
Fig 16. Communicating with Professor Bao Jiaolin
These expert exchanges underscored that responsible innovation must integrate ethical rigor with translational science. In response, we not only improved tech nical elements—such as the quorum-sensing regulation system and layered hydrogel encapsulation—but also established clear protocols for data privacy protection an d community engagement based on informed consent.
Specifically, we developed comprehensive informed consent procedures for all engagemen ts involving vulnerable populations, including epilepsy patients and minors. We created tw o distinct informed consent forms—one for non-interventional clinical observation and anot her for structured patient interviews—both ensuring voluntary participation, transparent c ommunication, and robust privacy protection. These documents clearly outlined the purpose and scope of engagement, emphasized the non-interventional nature of our activities, guara nteed anonymization of all collected data, and explicitly stated participants' right to wi thdraw at any time without affecting their medical care. By implementing these measures, w e demonstrated our commitment to establishing a genuine two-way dialogue with the communit y, respecting patient autonomy and dignity, and ensuring our project remains responsible a nd good for the world. This approach not only aligned with iGEM's emphasis on ethical enga gement but also set a standard for how synthetic biology projects can responsibly incorpor ate stakeholder perspectives while maintaining the highest ethical standards.
Together, these steps reflect our commitment to developing a therapeutic solution that is bo th scientifically sound and ethically grounded. By embedding ethical reflection into every stage of design, we ensured that our project advances not only scientific innovation but also the values of accountability and trustworthiness. This e thical backbone—our “golden thread”—guarantees that our proposed therapy is developed in a way th at is both effective and responsible
Beyond scientific feasibility, we sought to evaluate the commercial potential and long-term sustainability of our project. Guided by the s tructure of business plans and informed by market analyses, we assesse d the competitive landscape of epilepsy therapies and the positioning of our probiotic-based intervention. Reports show that the global epile psy drug market exceeded 8 billion USD in 2023 and continues to expand, with China undergoing especially rapid transformation under strong pol icy drivers. While traditional drugs dominate through generics and volu me procurement, there is increasing demand for innovative therapies tha t improve patient compliance, reduce stigma, and provide lasting therap eutic value.
Stakeholder recognition further validated this direction. Based on 153 effective survey responses, a large majority of participants expressed accep tance of microbiome-based therapies and portable EEG monitoring, with over 80% supporting the idea of exploring alternatives to ketogenic diets. Impor tantly, respondents highlighted the potential of our project to reduce soc ial isolation for patients, while also pointing out concerns about safety, technical maturity, and regulatory barriers. These results confirmed that our design resonates with public expectations while also identifying cri tical areas for improvement.
Fig 17. Questionnaire on the Public's Views on the Project
Looking ahead, the entrepreneurial pathway for our therapy will involve balancing medical necessity with regulatory navigation. The government-defined pricing of “ser ious medicines” means that profit margins are modest, yet the social impact is subs tantial. Our approach offers clear added value: by improving adherence, reducing dai ly treatment burdens, and addressing stigma, it goes beyond pharmacological efficacy to deliver meaningful quality-of-life benefits. Future efforts will include refinin g our business plan, engaging with regulatory agencies, and establishing partnershi ps with pharmaceutical companies to guide translation from the laboratory to the cl inic.
Ultimately, by integrating stakeholder validation, market realities, and ethical responsibili ty, our project lays the groundwork for a therapy that is not only scientifically innovative bu t also commercially viable, socially impactful, and sustainable.
Looking back, our integrated Human Practices journey revealed both the progress w e achieved and the challenges that remain. We successfully built a project deeply inf ormed by patients, clinicians, and industry experts, but time and resource constra ints limited the extent of our validation experiments and market analyses. In futur e work, we hope to expand preclinical testing, engage more directly with regulatory agencies, and explore large-scale implementation strategies.
The impact of our efforts is already visible. On the positive side, our d esign advances a novel therapeutic platform for epilepsy, our outreach activities reduced public stigma, and our stakeholder engagements created a model for patien t-centered innovation. At the same time, we remain conscious of potential negativ e impacts, such as unequal access if high treatment costs limit affordability. To address this, we envision open licensing or patent-sharing models that would enabl e generic production, ensuring broader accessibility and equity. By acknowledging both achievements and limitations, we commit to a path of continuous improvement.
Our Human Practices journey was not a parallel activity but the very framework that shaped our science. From public interviews to expert consultations, from ethical reflection to industrial dialogue, each engagement informed the next sta ge of our work, creating a closed loop between the lab and society. This iterati ve process can be visualized as a cycle of Inspiration → Intercommunication → In vestigation → Implementation → Impact.
Through this loop, our project grew from an idea into a human-centered design that is scientifically promising, ethically responsible, and socially relevant. In doing so, we not only embodied our vision that “the real and legitimate goal of the sciences is the endowment of human life with new inventions and riches ” (Francis Bacon) but also demonstrated our commitment to pursuing the Best In tegrated Human Practices award—building science that truly serves humanity.