Figure 1 The Overview of Integrated Human Practices

Inflammatory Bowel Disease (IBD) is a chronic and currently incurable condition that affects millions of people worldwide. In China, the number of cases has surged from approximately 344,000 in 1990 to nearly 1.24 million by 2019 (Wang et al., 2023). Globally, the incidence has risen from 3.7 million to nearly 6.8 million during the same period (Wang et al., 2023). Despite the availability of various treatments, they are often prohibitively expensive, placing a significant financial burden on patients. Additionally, many IBD treatments come with serious side effects. For example, while anti-TNF biologics are essential, they are frequently linked to severe complications such as heightened risks of infections and malignancies, and patients often develop resistance to these drugs over time. To address these challenges, our team has developed an innovative solution: a cost-effective and portable EcN probiotic capsule that provides an alternative to current therapies.

To ensure our product addresses the needs of those affected by IBD, we have made integrated human practices a key element of our approach. Our goal is to maintain open, continuous communication to gather insights and feedback from a broad range of stakeholders, including the public, IBD patients, experts, doctors, and PhD researchers. Through interviews, seminars, and public surveys, we actively engage with these groups to refine and enhance our product. This iterative process of listening, reflecting, and improving is central to our mission of developing a solution that genuinely meets the needs of the IBD community.

At the start of our project, we conducted this survey with the dual purpose of identifying the most effective strategies to promote our product and assessing public awareness and understanding of Inflammatory Bowel Disease (IBD). A total of 300 participants completed the survey, offering valuable quantitative data. To ensure the integrity of our analysis, we excluded responses that appeared insincere or irrelevant, ensuring that our findings remained reliable.

Figure 2 Geographical Distribution of Respondents

Figure 3 The Age Distribution of Respondents

Figure 4 The Educational Background of Respondents

Figure 5 Respondents’ Level of Understanding of IBD

As illustrated in Figure 3-5, individuals under the age of 18 represent the largest group. Most respondents have a middle school or high school education, indicating that the majority are likely middle school students. Their knowledge of IBD is very limited, often at a basic level. Consequently, our future activities should primarily target teenagers under 18.

Figure 6 Respondents’ Preference to Learn about IBD

The data shows that nearly half of the respondents are interested in learning more about IBD, regardless of the medium. However, 35.71% of participants expressed a preference for online learning. Consequently, we are prioritizing online promotional efforts more than offline initiatives.

Figure 7 Respondents’ Preference to Offline Activity Formats

Figure 8 Respondents’ Preference to Online Activity Formats

Regarding our promotional strategies, the survey revealed that community activities were the most preferred offline method, followed by voluntary services. In response to this interest, we have organized several community events for children and prepared lectures specifically for teenagers. Among online platforms, Red Booklet, TikTok, and WeChat were identified as the most popular. Consequently, we have established accounts on each of these platforms. This survey has provided valuable insights that we hope will effectively support the promotion of our EcN product.

To ensure our project is responsible and beneficial for the world, our team visited the SynBio Suzhou China Synthetic Biology expo. This event gathered pharmaceutical companies and industry experts from both domestic and international backgrounds, providing emerging companies like ours with valuable opportunities to engage with industry leaders, gain insights, and refine our strategies. The expo covered over 300 specialized topics, with four primary themes: biopharmaceuticals and synthetic biology, pharmaceutical CMC & innovation & CXO, MAH & CXO & DDS, and the pharmaceutical supply chain. The focus on synthetic biology and biopharmaceuticals is particularly relevant to the ENC probiotic drugs we are developing. Attending sessions on these subjects allowed us to deepen our understanding of current market trends and assess the strengths and weaknesses of our products.

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We attended a presentation on synthetic biology by an international company that, while not a traditional pharmaceutical firm, leverages probiotics to optimize infant formula. Their approach, drawing inspiration from natural evolution, views breast milk as the optimal means of protecting intestinal flora. Accordingly, they developed a nutritional intervention—infant formula—designed to help infants with gastrointestinal issues restore their intestinal microecological balance. The company's methodology, which integrates natural inspiration with the rational application of scientific principles, is a model we can emulate in our own product development.

They emphasized that using related bacteria poses minimal risk to human health, which aligns with our use of E. coli—a bacterium commonly found in the human gut—thereby reinforcing our product’s strong safety profile. However, they also noted that while E. coli is favored for its ease of cultivation, recent advancements in biotechnology indicate that alternative strains might offer superior efficacy. This is an area our team should closely monitor.

Additionally, the company customizes its formulas for different age groups, such as infants, teenagers, and the elderly. We could apply a similar strategy to our product by developing specialized versions targeting specific segments of the gastroenteritis patient population, including teenagers, middle-aged adults, and the elderly.

Furthermore, the company’s significant investment in clinical research, including both animal and human studies, serves as a compelling example of the effective application of synthetic biology. We should consider allocating more resources to clinical research to enhance our chances of passing drug trials. Their approach of incrementally increasing R&D investment as the product reaches key milestones is also a strategy we can adopt, especially after achieving break-even. They also offered valuable advice on promotion, stressing the importance of basing our marketing efforts on factual accuracy to avoid negative consequences and maintain public trust.

Figure 11

During our visit to other companies, we also learned about the innovative application of nanotechnology, particularly the extraction of nano antibodies from alpacas. This diverse sourcing strategy is something we can explore in our R&D efforts.

Figure 12

Furthermore, a discussion with a marketing manager at a pharmaceutical company provided us with practical guidance on the cold chain transportation of biologics. She advised that dry ice could be used as a cooling agent in domestic transportation, which offers a cost-effective solution to a logistical challenge we had been facing. Additionally, insights gained from this discussion will inform our financial planning, particularly in projecting research costs and sales forecasts.

Figure 13

The expo provided a wealth of knowledge and networking opportunities, allowing us to engage with industry leaders and refine our ENC probiotic drug development strategies. The insights gained, particularly in synthetic biology and biopharmaceuticals, have deepened our understanding of market trends and identified areas for product improvement. We learned valuable lessons from companies that successfully integrated nature-inspired innovation with rigorous clinical research. Additionally, practical advice on logistics and promotion will help us navigate future challenges more effectively. We will apply these insights to enhance our product’s efficacy, safety, and market success, positioning us for growth in the competitive biopharmaceutical landscape.

1. Interview with Patient Mr. Li

1.1 Interview Process

Our team interviewed an IBD patient, Mr. Li, who experienced his first symptoms of the disease on April 1, 2024. The purpose of this interview was to gather feedback on current IBD treatment methods and to gauge patient acceptance of an innovative therapeutic approach. We began by discussing Mr. Li’s symptoms, and he described the painful experience of living with IBD. Despite trying various biological injections, he noted, “these injections are expensive, and the stimulants cause blains to form on my body”. Specifically, Mr. Li pointed out that some treatments not only failed to help but also seemed to exacerbate his condition. One such treatment was vedolizumab, which research has shown can cause multiple side effects, including body aches and fever (Mayo Clinic, 2024).

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Furthermore, Mr. Li mentioned that he is currently using Infliximab, a biologic injection costing around 6,000-8,000 CNY per dose. This high expense is unaffordable for many working-class families, highlighting the need for a safer, more effective, and less costly IBD treatment. Additionally, Mr. Li pointed out the difficulties with current probiotics, which are often in powder form and can be hard to consume without causing coughing. This indicates that our pill-form product could have a market advantage.

Our conversation with Mr. Li reaffirmed our commitment to developing a safer IBD treatment and confirmed the potential for broad acceptance among IBD patients. However, he raised a concern that EcN probiotics would need to be taken continuously, as their effects diminish within 1-3 weeks after discontinuation, according to BioNAZE (Grace, 2024). In response, we discussed with our lab team the critical importance of ensuring our product’s long-term efficacy. We are now focused on demonstrating that our treatment can offer a radical cure, minimizing the need for lifelong use.

In summary, our interview with Mr. Li has confirmed the value of our product and strengthened our confidence that it could make a significant contribution to medical science by addressing the rising incidence of IBD.

1.2 Reflection

2. Interview with Expert Dr. Mo

2.1 Interview Process

At 7 P.M. on August 14, we interviewed Dr. Mo, an expert in digestive diseases and traditional Chinese medicine. The purpose of this interview was to gain a medical perspective on our EcN oral capsule probiotic therapy, specifically its potential application for treating inflammatory bowel disease (IBD). By consulting Dr. Mo, we aimed to critically assess our product’s positioning, advantages, and challenges from a clinical standpoint. The insights gathered were intended to help us refine our product development, understand the market landscape, and align our strategies with the needs and expectations of healthcare professionals and patients.

From Dr. Mo’s analysis of product positioning and advantages, it was noted that our EcN oral capsule probiotic therapy—based on the synthetic biological modification of Escherichia coli—aims to improve intestinal microecological balance, inhibit inflammation, and enhance the immune system. This therapy has potential for long-term use and may serve as a valuable adjunctive treatment for patients with inflammatory

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During the interview, Dr. Mo highlighted the challenges and market analysis, noting that many probiotic products currently available are highly homogenized, primarily consisting of bifidobacteria and yeast. By focusing on Escherichia coli as the foundation for our probiotic research, we may offer new options for patients. However, this also implies that we must invest significantly in marketing and education to enhance awareness and acceptance of E. coli probiotics among both the public and healthcare professionals.

Figure 19

In terms of clinical application and efficacy evaluation, Dr. Mo pointed out that in terms of clinical application, the effect of probiotics in the treatment of IBD is generally considered positive, but there are individual differences. This suggests that we need to focus on the specific needs of different patient populations during product development, which may require personalized strain selection and dose adjustment.

Dr. Mo also provided valuable suggestions for improving our products. First, he recommended strengthening research to assess the efficacy of specific strains in various subpopulations of IBD patients. Developing multiple strain combinations may be necessary to address the diverse needs of different patients. Additionally, he emphasized the importance of continuously monitoring the safety and tolerability of the product to ensure it remains safe for long-term use.

Dr. Mo also noted that our probiotic products may be more effectively combined with traditional Chinese medicine rather than Western medicine. He suggested exploring synergies with other treatment methods, such as traditional Chinese medicine and dietary adjustments, to potentially enhance the overall treatment outcomes.

Dr. Mo also provided insights into the marketing strategy for our products. He suggested enhancing education for both healthcare professionals and patients to raise awareness about probiotic therapies. Additionally, conducting more clinical studies to gather data on product safety and efficacy was recommended. After completing the experiments, establishing a patient feedback mechanism to collect input on user experience and treatment outcomes will be crucial for continuous product improvement.

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Additionally, we should consider forming partnerships with medical institutions, pharmacies, and online health platforms to broaden our product’s market reach. Given that a significant number of IBD patients are in North America, expanding into international markets could be a valuable strategy.

Dr. Mo also analyzed the impact of policies and regulations on our products. He highlighted the importance of ensuring that our product passes all necessary drug testing processes to secure the appropriate drug approval number. Additionally, exploring the possibility of including our product in the Medicare catalog could help reduce the financial burden on patients. We should also stay vigilant about changes in both domestic and international regulations concerning probiotic therapies to ensure ongoing compliance with the latest regulatory standards.

In conclusion, this interview provided us with invaluable insights that will guide the further development and optimization of our EcN oral capsule probiotic therapy. We understand that a successful product launch involves not only validating the scientific efficacy of the product but also comprehending market needs, patient preferences, and medical policies. By focusing on continuous product improvement, strengthening our marketing efforts, and maintaining effective communication with healthcare professionals and patients, we believe that EcN oral capsule probiotic therapy has the potential to become a significant addition to the IBD treatment landscape.

2.2 Reflection

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3. Interview with Professor Li

Our third interviewee was Li Yanan, Associate Professor and Master’s Supervisor at Nanjing Normal University. Professor Li specializes in the genetic modification of engineered bacteria, particularly EcN probiotics 1917, for treating digestive tract inflammation and other related symptoms. Her research also includes developing encapsulation and delivery systems to ensure the activity and efficacy of oral probiotics within the human body.

As we advance in our wet laboratory research, we are exploring how to integrate novel technologies for probiotic therapy to address IBD. This interview provided us with valuable insights into promoting our product, including its market advantages and challenges. Professor Li discussed the role of EcN probiotics, the two main types of IBD, and the critical importance of maintaining probiotic effectiveness and adhesion in the intestine.

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In the meeting, we discussed our EcN probiotics combined with nanotechnology with Professor Li. She highlighted the importance of ensuring the effectiveness of our product, emphasizing the significant potential of EcN probiotics. Professor Li also provided insights into how probiotics work in the gut to block inflammation, while noting the challenge of maintaining the stability of EcN probiotics within the gastrointestinal environment. To address this, she recommended protecting the probiotics from the acidic conditions of the gastrointestinal tract to ensure effective colonization. These key insights will guide our upcoming experiments and are essential considerations for our product development.

Figure 23

Regarding the product’s potential, Professor Li highlighted that current market trends are increasingly favoring synthetic biology as a mainstream approach, supported by favorable policies in China. She noted that the market has few alternatives, and if we can ensure the safety and efficacy of our EcN probiotic capsules, they have the potential to become a mainstream treatment for IBD. Given that research and development on EcN probiotics only commenced this year, Professor Li is confident that our product will maintain a competitive edge in the market for the foreseeable future.

Professor Li also shared insights on the promotion of EcN probiotics. In China, clinical trials are necessary to prove the safety and efficacy of the medication before it can be submitted to the government for approval. She mentioned that if the results are positive, the government will help promote our product. Additionally, we can collaborate with doctors and department heads to recommend our product.

From the perspective of adhesion, probiotics have a short stay at the site of inflammation. Due to the periodicity of human fecal emptying, it limits the medication. So oral medications are usually taken once or twice a day. The professor suggested embedding probiotics in multiple layers outside, with the first layer preventing them from being digested through the gastrointestinal tract, such as inulin, and the second layer promoting their adhesion to the colon or targeted recognition, such as hyaluronic acid.

From a development perspective, probiotics offer a cost advantage and have the potential to lower the prices of existing market drugs. The advancement in high-activity, high-density fermentation technology plays a crucial role in accelerating probiotic development. Building on our previous discussion with Dr. Mo, we explored the benefits of selecting strains from probiotics that are naturally prevalent in the gut microbiota. Professor Li concurs that this approach is advantageous, as these strains are more likely to proliferate and persist in the gut over time. Even after genetic modification, strains with natural gut presence generally have a better chance of colonizing and multiplying in the gut compared to others. While the Nissle 1917 strain is a well-established model organism and relatively easy to engineer, it may not be as effective as strains directly isolated from the gut microbiota. Given the current lack of effective treatments, our product holds broad feasibility and significant potential.

Overall, Professor Li provided us with valuable insights, prompting us to reconsider the effectiveness and gut adhesion of our product. We've also integrated the feedback from our previous interview with Dr. Mo. Moving forward, we will focus on incorporating both of their perspectives and ideas in our upcoming experiments.

3.1 Reflection

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4. Conclusion

Through our engagement with doctors, patients, and other medical professionals, we have gained deeper insights into the challenges of treating IBD and the pivotal role our EcN probiotics can play. As Dr. Mo highlighted, the probiotic strain we are utilizing differs from conventional treatments by promoting intestinal diversity, a key factor in suppressing inflammation.

Our team has come to recognize that integrating human practices has been essential at every stage of advancing and refining our EcN-based treatment. This approach will remain invaluable as we continue our research and development efforts, striving to provide the "keys" to unlocking solutions for IBD, as our team name, Inteskey, suggests.

Who are your proposed end users?

The proposed end users are individuals suffering from Inflammatory Bowel Disease (IBD). This includes patients who have found existing treatments to be expensive or ineffective, and those seeking alternatives with fewer side effects. The document specifically highlights IBD patients like Mr. Li, who require more affordable and safer treatments compared to current biologic injections.

How do you envision others using your project?

The project envisions its EcN probiotic capsule as an innovative and cost-effective alternative to current therapies for IBD. It aims to serve as both an adjunctive and potentially primary treatment that improves intestinal microecological balance, inhibits inflammation, and boosts immune function. It is designed for long-term use and may be more convenient to consume compared to existing probiotic treatments​. Additionally, the capsule is targeted to be developed for different age groups and could be combined with traditional Chinese medicine to enhance effectiveness.

How would you implement your project in the real world?

To implement the project in the real world, the team is focusing on several steps: Clinical Trials: The product would undergo clinical trials to validate its safety and efficacy, as suggested by experts like Dr. Mo and Professor Li​. Regulatory Approvals: The team would ensure the probiotic capsule meets all regulatory requirements to obtain a drug approval number. The product may also be included in government health programs, reducing the financial burden on patients. Market Promotion: The team plans to educate both healthcare professionals and patients to raise awareness of the benefits of their probiotic therapy. They also intend to collaborate with medical institutions, pharmacies, and online health platforms to distribute the product.

[1] Wang, R., Li, Z., Liu, S., & Zhang, D. (2023). Global, regional and national burden of inflammatory bowel disease in 204 countries and territories from 1990 to 2019: A systematic analysis based on the global burden of disease study 2019. BMJ Open, 13(3). https://doi.org/10.1136/bmjopen-2022-065186

[2] Mayo Clinic. (2024, May 1). Vedolizumab (intravenous route, subcutaneous route) side effects. https://www.mayoclinic.org/drugs-supplements/vedolizumab-intravenous-route-subcutaneous-route/side-effects/drg-20110147

[3] Grace, C. (2024, June 3). How long do probiotics stay in your system? - ask the experts. Bionaze. https://bionaze.com/how-long-probiotics-stay-your-system/