Overview

Throughout the process of our project, human practice plays an essential role as a source of guidance and innovation, attending to both the societal and scholarly dimensions of our subject matter. We have interacted with the world by conducting interviews, surveys, educational activities, and fostering collaborations, all aimed at exploring various aspects of our topic. To recognize the broader implications, impacts, and perspectives beyond the technical aspects of our project, we visited and invited many experts to evaluate the products of our project and gave advice to them. Throughout these procedures, we hope to improve all aspects of our project from the point of view of the stakeholders. Furthermore, conducting post-interview discussions holds significance in gathering supplementary information for various aspects of our project, spanning from hardware and software considerations to educational initiatives and biosafety precautions. In the subsequent section, we will dive into the methodologies and key insights acquired through our integrated human practice efforts.  

Public Survey

Before delving into our project, we conducted two public surveys, one to students and one to the community to gain insights into people's familiarity with sarcopenia and to ensure that our product has market potential. Due to time constraints and budget, we used convenience samples to collect the data.  

Student survey

We distributed questionnaires to 85 students in the school. The questionnaire aimed to assess the students' awareness and understanding of sarcopenia 67.5% of the students we investigated had no prior knowledge of sarcopenia. It is evident that awareness of sarcopenia among youngsters is insufficient. It is crucial for people to enhance their understanding of this condition, as it will prepare them for potential challenges in their middle or old age.

Community survey 

To gain a deeper understanding of the prevalence of sarcopenia patients within the population, we conducted a survey among 91 individuals of varying age groups. In the survey, the community has a better understanding of sarcopenia than students do, compared to the previous survey. According to the exercise guidelines established by the U.S. Department of Health and Human Services (HHS) in 2018 for adults, it recommends that adults engage in at least 2.5 to 5 hours of medium-intensity exercise per week, or 1.25 to 2.5 hours of high-intensity exercise per week, or an equivalent combination of both. The evidence presented below indicates that individuals do not engage in sufficient physical activity, as 7.7% of the people rarely exercise; 13.2 %of the people exercise once or twice a month; and 17.3 %of the people exercise less than once or twice a month. Additionally, 79.2% of the people exercise for only an hour or less than an hour at a time. Also, through the survey, we made sure that the community was interested in the project and thought it promising, as 71.4% of people agreed with the potentiality of developing the probiotic that is used for sarcopenia.

Stakeholders

Stakeholders played a crucial role in making our project both viable and beneficial to the community. We actively sought their advice and made enhancements to our product based on their input. We engaged numerous stakeholders in our project, who offered valuable insights and support. They provided the initial project ideas, offered suggestions for product improvement, shared market insights, and provided guidance on legal matters, among other contributions. In total, we identified seven key stakeholders: researchers, healthcare professionals, regulatory authorities, pharmaceutical companies, caregivers, nonprofits, and sarcopenia patients, and we incorporated their feedback to enhance our project.

In integrated human practice, we focus on our interaction with researchers, healthcare professionals, regulatory authorities, and pharmaceutical and supplement companies. In education and communication, we have intellectual conversations with caregivers and nonprofits. However, due to inaccessibility, we have not reached sarcopenia patients in the clinical field.

Interviews with Stakeholders

[Healthcare Professionals ]

Dr.Tsai
- Chief physiatrist in the Puli Branch of Taichung Veterans General Hospital 
- Chief Physiatrist at Catholic Fu An Hospital 
- Co-originator of Taiwan Association of Prolotherapy and Regenerative Medicine

Purpose of the Interview 

We wanted to know first-hand information about the sarcopenia drug market, including health insurance, patients’ awareness, and current development of the drugs, from its users, so we interviewed Dr. Tsai, an experienced physiatrist, to improve our product and gain some stimulus to the human practice activities and education and communication.

Takeaway and Reflection

In the interview, Dr. Tsai highlights that Sarcopenia hasn't gained official disease recognition in Taiwan. Consequently, sarcopenia drugs aren't covered by health insurance. Also, a significant portion of the population is unaware of sarcopenia. This led us to elevate the awareness of sarcopenia through education and communication; we put much effort into spreading knowledge about sarcopenia to the community through presentations, games, and social media. Furthermore, many individuals grappling with sarcopenia-related pain often avoid seeking treatment due to the discomfort associated with current therapies and nutritional supplements' limiting effects on sarcopenia. Hence, our approach of using a drug to treat sarcopenia is validated because taking medicine does not cause much pain to the patients. Additionally, the clinical community faces a considerable challenge due to the absence of accurate and precise diagnostic tools for sarcopenia, and nutritional supplement has limiting effects.

Dr.Chen
- Attending Orthopedic Surgeon at Show Chwan Memorial Hospital. 
- Attending Orthopedic Surgeon at Pingtung Christian Hospital and Chief of Orthopedics at Bai Chuan Hospital. 
- Specialize in spinal surgery, general orthopedics, minimally invasive spinal surgery, radiofrequency ablation, spinal slippage, herniated disc treatment, and sciatica management. 

Purpose of the Interview

We wanted to know first-hand information about the sarcopenia drug market, including health insurance, patients’ awareness, and current development of the drugs, from its users, so we interviewed Dr. Chen, an experienced Orthopedist, to improve our product and gain some stimulus to the human practice activities and education and communication.

Takeaway and Reflection

In the interview, Dr. Chen underscores the significance of prioritizing prevention over treatment when it comes to sarcopenia. Maintaining a regular exercise regimen and making lifestyle adjustments are crucial aspects. Hence, we believe it is important to encourage healthier exercise habits among individuals. Furthermore, he underscores the absence of formally approved medications for addressing sarcopenia. Additionally, Dr. Chen places importance on the concept that enhancing muscle endurance, rather than sheer strength, is essential. Moreover, he draws attention to the connection between sarcopenia and osteoporosis. Interestingly, he also mentions that not only skinny people get sarcopenia. In fact, obese people have a higher chance of getting sarcopenia because the accumulation of fat can trigger systemic inflammation, ultimately inhibiting muscle synthesis. because fat accumulation leads to systemic inflammation, which depresses muscle synthesis. Therefore, we have chosen to include fat reduction as one of the objectives of Sarcotreat.

Dr.Lian
- Chief physiatrist at Show Chwan Memorial Hospital. 
- Occupational therapist 

Purpose of the Interview

We wanted to know first-hand information about the sarcopenia drug market, including health insurance, patients’ awareness, and current development of the drugs, from its users, so we interviewed Dr. Lian, an experienced physiatrist, to improve our product and gain some stimulus to the human practice activities and education and communication.

Takeaway and Reflection

During our discussion, Dr. Lian mentioned that sarcopenia is a multicausal disease, so we decided to incorporate the concept of "cocktail therapy" into our project, utilizing a combination of various chemicals to address the diverse factors contributing to sarcopenia. Dr. Lian also mentioned that doctors often visit day-care centers to supervise muscle rehabilitation and cognitive training for senior individuals, frequently incorporating engaging games to capture their interest. This gave us the idea that we could host a sarcopenia and synthetic biology quiz game in our school to boost people's interest in understanding sarcopenia and synthetic biology. Notably, a significant majority of participants in rehabilitation centers are women. Also, the Long-Term Care program initiated by the Ministry of Health and Welfare did not offer practical help to sarcopenia patients and their families because of the budget. Moreover, some day-care centers have operating hours from 8:00 AM to 5:00 PM, which can be inconvenient as they open later than many people's work schedules and close earlier than their off-work hours. We recognized the current daycare system had some problems, so we decided to visit a daycare center to propose some changes to the system to the CEO, ED, and volunteers there.

Dr.Lian
- Thе Chiеf of Nеurology at Show Chwan Mеmorial Hospital. 
- The Director of the Dementia Care Cеntеr 
- Spеcialize in Parkinson's disease, еpilеpsy, еncеphalitis, and other nеurological diseases.  

Purpose of the Interview

Sarcopenia shares a significant connection with the field of neurology; an important cause of sarcopenia is the loss of motor units. Many neurologists have experience in treating elderly sarcopenia patients. In the interview, we presented our project to Dr. Chiou and sought to gain some feedback from a clinician to make our product more practical and feasible. During our discussion, Dr. Chiou presented sarcopenia to us from a clinical perspective, mentioning the progress and difficulties of the field.

Takeaway and Reflection

Dr. Chiou offered valuable recommendations concerning the product we are currently developing. Firstly, he doubted the effectiveness of the five chemicals we chose to treat sarcopenia, and we had to admit that our product might not be able to cure sarcopenia on its own since no current drugs or treatments can do that. However, Sarcotreat could supplant the supportive therapies that had strong side effects and could facilitate and complement exercise and physical therapies. Also, he questioned that is the microorganisms chosen to deliver drugs in the human gut can reach their destination after consumption. To address this problem, we deliberately choose Bacillus subtilis and Clostridium butyricum., microorganisms of the gut normal flora, and Kluyveromyces marxianus, a potential probiotic that shows high survivability in the gut, as vectors of drug delivery. As a result, we can elevate the survival rate of the drug vectors and successfully deliver drugs to humans.

[Researchers and Scientists]

Dr. Samuel 
- Former team manager of iGEM team NCKU Tainan, the undergrad grand prize receiver in 2019 
- Volunteer as an iGEM Ambassador for Asia and Oceania last year 
- Volunteer as an iGEM project head for a science communication-related project   

Purpose of Interview

As inexperienced iGEMers, our team seeks external assistance that guides us to learn more about iGEM. Dr. Samuel introduced iGEM and synthetic biology to us, so we visited Dr. Samuel, an experienced iGEMer. We asked her to assess the feasibility of the project, Sarcotreat, engineered sarcopenia live biotherapeutic product, to introduce iGEM and synthetic biology to us, and to make plans for the iGEM project with us.

Takeaway and Reflection

After her introduction, we gained more insight into iGEM and synthetic biology and were able to make the initial plan for our iGEM project. We proposed our project, using a live biotherapeutic product to treat sarcopenia, to her. She noted that our project is too massive and we may not be able to finish it within one season of iGEM. Also, our initial design of the project was too simple and did not show many characteristics of synthetic biology. Hence, we decided that will make the project a two-year project and will participate in iGEM for two straight years so that we will have enough time to get familiar with iGEM and to complete the iGEM project. Also, to focus more on synthetic biology, make the project more diverse and safer, and contribute to the iGEM community, we planned to make two kill switches for live biotherapeutic products.

Dr. Chang 
- Associate Professor in the Graduate Institute of Integrated Medicine of China Medical University  
- Patentee and inventor of the PGASO, a synthetic biology tool for engineering yeast. 
- Specialize in microbiology, biopharmaceuticals, synthetic biology, and molecular biology

Purpose of the interview

We did not have a lab in school, so we asked Dr. Chang if we could use his lab to do the iGEM project. Also, in the interview, we discussed what to do in this year’s iGEM competition and made a plan and schedule for the whole project.

Takeaway and Reflection

Dr. Chang kindly allowed us to use his lab and sponsored many experiment consumables. Also, because we did not have any lab experience prior to iGEM, Dr. Chang provided us with training and safety training before we really started to do our project. With his experience in the field of synthetic biology, he proposed three topics to us: engineered live biotherapeutic products that treat sarcopenia, biosynthesis of essential chemicals in outer space, and microorganisms that clean plastic scraps in the environment. Ultimately, we chose “engineered sarcopenia live biotherapeutic product” because we had strong interests in the medical field and recognized the immense need for this product in the market.

[Pharmaceutical and Supplement Companies]

Dr. HO
- Chief Operating Officer (COO) of TWBIO biotech company 
- Patentee and inventor of the PGASO, a synthetic biology tool for engineering yeast. 
- Ph.D. of Life Sciences in National Chung Hsing University 

Purpose of the Interview

In the interview, Dr. Lain discusses how the prevalence of sarcopenia is on the rise as Taiwanese society turns into a super-aged society. During the interview, we focused on the market of sarcopenia. Also, we had an intense discussion over the design of the kill switch as we tried to make it economically desirable and feasible.

Takeaway and Reflection

We realized that sarcopenia drugs have a large market globally. We were sure that there was a need for improvement in the current treatment of sarcopenia. Dr. Ho discusses how the prevalence of sarcopenia is on the rise as Taiwanese society turns into a super-aged society, so the sarcopenia drug market is expanding at an unprecedented rate. Moreover, there are currently no specific drugs designed to treat sarcopenia, so we need to pour our effort into the field. Also. Dr., Ho gave some advice regarding our kill switch design. The initial design of our kill switch system is a two-gear system, indicating that manufacturers had to use a massive amount of Na2S in culturing our product. Consequently, the cost of making Sarcotreat may be too high which makes the product not lucrative, and the chemical residues may make the product less desirable. Therefore, we changed the design of our kill switches into a three-gear system, so that manufacturers do not have to add Na2S while culturing Sarcotreat.

[Regulatory Authorities]

Dr. Chen
- TFDA adviser of numerous biotech companies 
- Former director of R&D inADIMMUNE Corporation 

Session Summary

In the interview with Dr.Chen, we sought to clarify the position of our product in the medical market and gained a deeper understanding of the regulation of live biotherapeutic products in Taiwan.

Takeaway and Reflection

Unlike genetically modified food (GMF), Sarcotreat is designed to treat certain diseases. Unlike pure nutritional supplements, Sarcotreat was genetically modified. Dr. Chen explained that Sarcotreat is classified as a live biotherapeutic product in Taiwan, subject to specific regulations separate from GMF, nutraceuticals, and drugs, as those provided below. However, he also emphasized the need to conduct experiments to assess the toxicity, biosafety, and efficacy of Sarcotreat to establish its rightful place in the medical field in the future.