This year, we imagined our Human Practices as a grand hall, each chamber tells a different story of PRESS. Essential Human Practices gave PRESS its roots, shaped by the real voices of patients, doctors, and researchers.
The journey then led us to the Integrated Human Practices chamber, where expert insights acted like lighthouses, guiding us through challenges, transforming feedback into meaningful improvements.
The Sustainability chamber opened the door to the future, aligning our work with the SDGs and ensuring PRESS would remain responsible forever.
Further along, the Education space came alive with posters, campaigns, and conversations, echoing with voices of awareness about asthma and inspiring healthier choices within communities.
Finally, Entrepreneurship stood as our bridge to the real world, where innovation meets industry and a prototype becomes a promise. Together, these five interconnected chambers form a living journey, showing how PRESS grew not just as a treatment, but as a vision for healthier lives and a sustainable future.
Through this page, we mentioned the basic steps we went through while achieving our human practice journey. We began by recruiting new members to strengthen our team, then moved into a brainstorming stage driven by a powerful social story that sparked our inspiration.
From there, we identified a specific challenge which is severe asthma management. Next we started developing a solution, where we actively engaged with stakeholders. Additionally, we considered their feedback and integrated it into our project design. These collaborations helped us continuously refine our approach and ensure its alignment with real world needs.
In addition, we went with a definite focus to close the loop between PRESS design and asthmatic patient desire. Finally, we have connected and communicated our project with different stakeholders, industrial managers, doctors, patients and high risk occupation workers.
At this stage, we addressed the essential questions that guided our journey. We highlighted the things that inspired our work, ensuring that our vision carried a meaningful impact. In parallel, we focused more on the problem weighing every possible approach that could make a true difference. After we found the problem (severe asthma burden) we examined existing solutions and their limitations.
We explored the prevalence and epidemiology of asthma. Additionally, we deeply searched for asthma triggers and main pathological pathways. After that, we identified patient journey and daily life struggles. The answers to these questions highlighted the urgent need for developing a new solution!
Like a football team, every member has a specific role to play, this collaboration of different responsibilities drives our project forward.
To create our team, we set out in early January to bring in new members who could contribute to different aspects of our work. With guidance from our team leaders and advisors, we started interviewing candidates from various academic backgrounds including biology, media and web design.
We focused on people who have special abilities and interest in innovation, scientific research and synthetic biology. Once selected, we made sure to place them in roles that matched their unique skills. Therefore, ensuring that everyone could possess a great impact on our project.
Our choice for this year was a long process, yet it was important for us to fully meet the criteria we had in mind. Therefore, we chose to address a condition that could affect anyone and create a solution that includes both prevention and treatment.
During our brainstorming sessions Muhanad, one of our team members, shared the heartbreaking struggles of his friend who couldn’t find an adequate treatment for his severe symptoms. Moved by this story our team set out Asthma as the central focus for this year’s project.
We took the chance to identify the challenges of chronic asthma patients by conducting extensive patient meetings and visits. In addition, we aim to explore the broader impact the severity of asthma can have on both individual patients and society. Further details are discussed in Integrated Human Practices; called “The Inspiration”.
By listening to the stories of patients, our team highlighted the urgent need for a novel treatment that addresses the root causes of severe asthma.
Severe asthma comes with persistent symptoms and frequent exacerbations. Moreover, it requires high dosage of oral corticosteroids since they are often corticosteroid resistant. The severe asthmatic patient is usually left with limited therapeutic options and a repeated cycle of exacerbations causing a constant threat to their quality of life.
A particularly challenging type of asthma is neutrophilic asthma which is found in the majority of severe asthmatics. Studies indicate that up to 50% of severe asthmatics may exhibit a non-eosinophilic inflammatory profile, showing a rise in patients with neutrophilic inflammation. We identified that even after high doses of the primary anti-inflammatory inhalers used, they still fail to control the disease.
Although mild cases may be controllable, severe cases are not easily relieved. These cases usually face frequent exacerbations leading to significant reduction in their lung functions. Severe patients are often very physically limited due to their constant breathing difficulties. This may decrease a patient's ability to participate in sports and eventually have a sedentary lifestyle.
Asthmatic patients are not only affected physically but socially, mentally and economically. After talking to severe asthmatic patients, we recognized that their constant fear of an asthma attack is psychologically draining. Thus, it often leads them to give up on social gatherings like school or work. Here is the patient journey!
Despite severe asthma patients making up only a fraction of the total asthma population, they still account for over 50% of total asthma-related healthcare expenditures. The amount of money a person with severe asthma can spend annually may become financially challenging. The Journal of Managed Care & Specialty Pharmacy reported that the total cost for patients with severe asthma were estimated to be $18,554 per year and may reach over $20,000 yearly. These costs represent medications, doctor's visits, emergency room visits, and hospital admissions.
In conclusion, asthma is one of the most prevalent chronic respiratory diseases worldwide. Therefore, our team identified that an effective asthma management should not only focus on symptomatic control but also offer a long-term solution for those who have long endured these relentless challenges. Finally, after we had selected our problem, we went with a definite focus to develop a solution!
Here is the patient journey!
During this stage, we focused on integrating insights from different stakeholders into each step of our project development. We engaged with asthmatic patients, doctors, organizations, ethical committees, lab experts, the public community, and industrial companies to ensure a comprehensive approach.
Through this journey we take in consideration to ensure our project safety and responsibility to our world. Additionally, we ensured ethical acceptance. Our team has documented our project progress to ensure that each step is in its right time. Finally, our aim was definitely focused which is closing the loop between PRESS objectives and patients satisfactions!
In our journey of integrated human practice, we met with several stakeholders from different categories. Every meeting has its own story, composing a step in PRESS’s road toward the real world. This helped us evolve and refine our apprach aiming to stick to the latest rules and guidelines.
Through our meetings, we integrated the stakeholders' feedback and re-evaluated our development process. We show this integration in our meeting documentation in a few ways. We used a storytelling style for documenting what happened in the meetings. Also, our notes for each meeting have four main parts:
1. Profile: Where we give a brief introduction about the stakeholder.
2. Purpose: Where we list our aims for that meeting or visit.
3. Discussion: This includes the specific details about the meeting or visit.
4. Potential Impact: Where we list how this meeting or visit reshaped our plan.
Additionally, we tried to be specific in listing how these interactions helped us adjust our milestones as we worked towards our final product.
Stakeholders play an essential role in the journey of turning your idea from a concept to a real project! To ensure our project responsibility towards our world, it was essential for us to engage stakeholders who have a long term practical expert. We needed partners who would provide us with meaningful contributions in return.
As a result, we selected our stakeholders with great care and precision, ensuring that their involvement would strengthen the project. However, not all stakeholders serve the same purpose or play identical roles. Our integrated human practice journey was divided into 8 stages (Explained further on our Integrated Human Practice page). We carefully matched each stakeholder to the phase where their expertise and input would have the greatest impact.
In the timeline of each stage in integrated human practice, a colored bookmark is used to indicate the category each stakeholder belongs to. As a final step, we organized all stakeholders into six distinct categories based on their specific roles:
As we develop PRESS, our focus remains on a human-centered approach that prioritizes the needs and values of all stakeholders. This analysis highlights the fundamental values that guide our project. It ensures that PRESS effectively addresses the challenges faced by asthmatic patients while aligning with ethical and practical considerations.
Safety remains the paramount value for any stakeholder, especially concerning medical products. As PRESS targets all asthmatic patients, focusing on the severe form, the team has ensured a multi-layered safety approach. Additionally, the concept of using dried bacteria in a treatment product was considered a point of concern for various stakeholders. Our main goal was to maximize patients' beneficence and minimize side effects for asthmatic patients.
Consequently, from the early stages of development, the team insisted on adherence to the WHO's 2024 international guidelines for safety and cell-based therapy. We reviewed the latest international recommendations of the WHO Programme for International Drug Monitoring (WHO PIDM).
We also included the FDA's guidance documents regarding the phases of drug development. We depended on their data to plan our steps, from the design stage through manufacturing and distribution.
Additionally, the Pulmo- event, world asthma day, and pharmaconex provided an opportunity to meet with representatives from different organizations and authorities who further clarified for us the journey of new drug development. These visits are detailed mentioned in stage 1,5 and 8 respectively.
Moving forward, we contacted Dr Wagida from our college's ethics committee, Dr Yehia Badway, a representative from the Egyptian Drug Authority , and Mr. Rajeesh from the FDA. These sessions offered the opportunity to learn about our local political rules and paperwork needed, especially in safety and efficacy. This meeting is detailed in stage 5 of the integrated human practice.
Moreover, we are also very aware of the risks of operating with modified bacteria. Bacterial contamination must be prevented.
Measures to prevent bacterial contamination are vital. We aimed and planned for various meetings with biotechnology, drug production, and healthcare specialists to identify possible measures and barriers related to protocols for using bacteria. Such as our meeting with Dr. Hazman and Dr.Raghda in stage 3 of the Integrated Human Practices
Furthermore, discussions with medical doctors and asthma specialists have been very important in enabling us to enhance our safety protocols so that we can create a dependable inhaler. We have met with Dr.Sameh from Al- Abbasya, Dr Anani from Zagazig university hospital in both stage 1 and 6 in the Integrated Human Practices
Beneficence, the ethical duty to act in the best interests of patients, drives our mission. With PRESS, we aim to deliver si-RNA targeting TSLP in the asthma inflammation pathway using a dried, modified Lactobacillus plantarum. We arranged meetings with experts in biotechnology and genetic editing specialists such as Dr. Raghda, Dr. Ahmed Atef, and Dr. Mohamed Hazman. ( details of all meetings are all discussed in the integrated HP page). They helped us validate our approaches, clarifying software tools to test and document our data. They also guided us to test the stability of our loading system and ensure the accurate delivery of our therapeutic agent.
Additionally, we contacted drug manufacturing specialists at EPICO factory to take a closer look at the inhaler manufacturing process. Besides, we have the chance to meet representatives from pharmaceutical companies such as Astrazence, Eva pharma, Europeans, and lefancaps.This allowed us to properly design the inhaler , selecting the ideal techniques of manufacturing and selecting the most suitable capsule type that would ensure drug delivery regardless of patient technique or environmental factors. Most of these meetings are mentioned in the real world implementation stage in the integrated HP page.
Moreover, this targeted treatment ensures enhanced patient control over severe and neutrophilic asthma. Additionally, it focuses on eliminating the adherence problem by requiring only one to two puffs per year. PRESS also aims to eliminate the use of corticosteroids from asthma treatment protocols. This will reflect positively on patients by providing an effective treatment journey without the local and systemic side effects of corticosteroids. Our goal is to provide a faster, more effective solution that controls severe asthma conditions and reduces the frequency of asthma inhaler doses, in addition to eliminating their side effects.
We recognize the importance of sustainability in healthcare. A sustainable product needs to be updated in line with market requirements, have a clear future plan, and be able to cope with environmental changes. Therefore, PRESS is designed based on the requirements and needs of the local and international asthma markets. Additionally, PRESS addresses various sustainable development goals (SDGs) at different milestones throughout its development journey. These goals are further explained on the SDGs page, where we show the specific goals we target and how we addressed them through each stage. We target different goals from various aspects, such as SDG 3,4,5,7,11,13,15 and 17. These goals helped us reshape our broad development timeline and key milestones according to the unmet needs of the local and international community.
Public health is the science and practice of protecting and improving the health of populations through disease prevention, health promotion, and policy interventions. Our commitment to public health principles is a cornerstone of PRESS. We aimed to address asthma as a significant public health issue by promoting education and awareness. We targeted different populations with diverse age groups and educational levels to raise their awareness regarding the identification and management of asthma. Our educational journey focused on all age groups and high risk populations. You can see the detailed journey in the educational page.
In addition, PRESS, as a targeted approach, helps replace the use of inhaled corticosteroids in asthma management protocols. This will have a positive long-term effect on patients' quality of life. PRESS will save patients from oral thrush, hoarseness of voice, recurrent infections, and other side effects due to the use of corticosteroids. This leads to protecting the mental and psychological health of patients by shielding them from complications that hinder their daily lives. Overall, this aligns with the public health directive of "doing no harm" to patients. Additionally, PRESS ultimately reduces the overall burden of asthma on patients and the entire community.
Justice focuses on equitable access to our inhaler for all patients. We are committed to ensuring that PRESS is accessible to diverse populations, particularly those disproportionately affected by asthma.
We explored the high prevalence of asthma among children and those in low socioeconomic states; this highlighted for us the importance of taking steps to ensure PRESS accessibility for these vulnerable groups. As we are aware of the high cost of synthetic biology approaches, we started to explore potential collaborations with various insurance and pharmaceutical companies.
We began at the World-Asthma Day identifying many insurance companies and understanding the necessary steps to include a new product in health insurance programs for asthma patients. The World Asthma Day is clarified with details in stage 4 of our Integrated human practice page.
Upholding patient privacy is paramount. We are dedicated to keeping patient confidentiality and information obtained in our research and development procedures. We met with Dr. Wagida from our college ethics committee and reviewed IRB policy on data management and ethics (You can see our meeting details at stage 5 Integrated human practice page ). We also ensured we had the complete consent of all the subjects of our project data collection
Innovation is at the heart of PRESS. By utilizing modified bacteria to produce CO-BERA scaffold containing targeted si-RNA, we are pioneering a novel treatment approach that distinguishes us from existing therapies (Further explanation of our design and the mechanism of action in the Project description page and Design 1 page Design 2 page ).
Additionally, the treatment protocol for PRESS is estimated to require only one to two puffs per year. This unique feature, besides PRESS's ability to control corticosteroid-resistant asthma (neutrophilic asthma), offers more interest for stakeholders. Furthermore, PRESS will provide an efficient suitable replacement for the current market competitor, saving patients from their long term trouble side effects.These features ensure PRESS will attract the interest of all relevant stakeholders. You can see detailed representation of the GAP in the market and our unique selling points in the Entrepreneurship Page.
Tracking the progress of our project, we have documented both the basic scientific aspects and safety evolution of PRESS. Moreover, we paid attention to social and ethical considerations as they play a critical role in shaping real world applicability and patient acceptance
To ensure a well organized documentation, we adopted a step by step process using basic tools and templates, to overcome missing any part and to guide us through each phase. These tools allowed us to refine each stage of the project and determine the next steps. Therefore, we could go further and seek relevant scientists or stakeholders’ guidance
For instance,
- Creating the HP cycle helped us to connect our project to the world.
- Ensuring that every feedback is taken into consideration.
- Stakeholder cards were to categorize all experts along our journey.
Moving next, here are the critical ideas we kept in mind while documenting our progress:
- Keeping a timeline that documents the beginning and ending of each stakeholder engagement stage, therefore monitoring progress and modifications over time.
- Performing stakeholder analysis to ensure that we were reaching out to a wide variety of doctors and covering all aspects of PRESS.
- Avoiding leading questions and employing a random sample while developing surveys and constructing interviews. Consequently, we could minimize bias as possible.
- Fulfilling our educational, entrepreneurship and sustainability goals in parallel with our scientific progress.
- Ensuring that we were aligned with patient needs, healthcare requirements, and ethical considerations.
Through our human practice journey, we went with a definite focus to close the loop between PRESS design and asthmatic patient’s desire. This through establishing various meetings and visits with relevant stakeholders, additionally listening to asthmatic patients’ opinions through live conversations or through patients’ surveys analysis. We aimed to go with patient satisfactions and avoid patients’ displeasures, therefore making PRESS fit as many as possible asthmatic patients.
We have collaborated with a diverse range of stakeholders, including healthcare providers, policymakers and industry partners. After that, we have integrated all stakeholders’ insights to fulfill patient requirements and reach the most beneficial impact.
Furthermore, we were tracked up with stakeholders after their feedback had been integrated to ensure that we were reflecting on their concerns and suggestions precisely in our project.
For project implementation and marketing, we aimed to close the loop between the knowledge we received from our competitors’ stakeholders and PRESS as a product. For example, we have refined our design to avoid the commonest problem of our competitors, which is patient drug negligence due to frequent doses.
Consequently, we modified PRESS design to ensure patient compliance with our treatment and reduce patient-related misusing. Additionally, we have developed an implementation plan discussing long term impact and the first steps for PRESS market introduction.
Finally, combining the closing the loop procedure with our deep literature research was key in reshaping PRESS development. Moreover, it allowed us to effectively address asthmatic patients’ challenges, additionally ensuring PRESS safety and sustainability.
At this stage, we show how we built a good connection with our community and experts during our education, sustainability and human practice journeys. This was through touring places, conducting many visits to various occupations and exchanging perspectives with different stakeholders.
These interactions not only enriched our understanding but also allowed us to design a solution that achieve real-world needs.
iGEM is about more than just the scientific approach; it's about developing products that are both good for people and responsible for the world. From the early stage, we made our responsibility to the community a top priority. This is the principle that guided us throughout the planning process.
This commitment was there from our beginning brainstorming, where we were set to solve a problem that afflicts our society and humanity as a whole. We focused on the plight of severe asthma patients and went into their entire ordeal from their initial symptoms to beginning their long-term therapy.
To better understand the problem, we started our journey with visits to the Al-Abassya hospital and Pulmo Event. These visits allowed us to look at the problem from the perspective of both patients and healthcare professionals. We interviewed both, and examining the findings allowed us to determine the exact needs and difficulties patients face when undergoing their treatment. Furthermore, speaking with chest specialists brought to light the gaps in existing treatment protocols and the significant long-term side effects of current therapies. (Read more about these visits on our Integrated Human Practices page.)
Based on what we learned from these visits, we established a set of core values to guide the development of our project, PRESS. These criteria ensured that community responsibility was built into our process from the ground up. During each stage, we kept re-evaluating and refining our project in an effort to serve the needs of patients better and fulfill these core values.
Our Integrated Human Practices approach guided us through the entire project in five broad phases: Identify, Understand, Integrate, Communicate, and Implement. These phases are represented in our integrated human page through eight steps: Problem identification, hypothesis formation, Product design,ethical considerations, social acceptance, responsibility to our world, and real world implementation.
Each stage involved specific visits and meetings designed to shape our development path and ensure our project was both reliable and responsible.(For a detailed breakdown, please visit our Integrated HP page).
During our project, we engaged with a representative cross-section of stakeholders who were central to educating us about our concept. They helped us identify specific unmet needs, identify the market gap, and confirm the technical potential and probable efficacy of our product. We consulted with experts at different levels of our development, including ethicists and regulators, healthcare professionals, lab experts, geneticists and bioinformatics specialists, entrepreneurs, and company and authority representatives. (You can see our stakeholder analysis )
In addition, our PRESS project is aligned with several of the UN Sustainable Development Goals (SDGs). As through our sustainability journey we have ensured that PRESS is responsible to our world.
Throughout, we focused strongly on education and outreach to the community. We tried to teach individuals the asthma risk factors, management skills, and how to recognize when they should seek advice from a physician. We created an educational plan across different age groups with a specific focus on high-risk groups. Our outreach was as varied as creating an original song and educational graphics to doing hands-on workshops. We also created a child book ,game , story ,podcast, and a parents guidebook.
Through our HP program we were focused on being engaged in various meaningful interactions such as touring many places, attending conferences, consulting doctors with diverse specialties and meeting workers in various occupations. This to ensure that our project was raised by diverse perspectives and established in relevance to our world.
Our main goal through these visits and meetings was to refine our idea, develop a well market plan, educate humans, learn more and raise our knowledge.
- Presenting the importance of asthma and proper asthma management.
- Explaining basic synthetic biology definitions and the role of synthetic biology.
- Correcting misconceptions.
- Introducing the concept of SDGs and its role in achieving a better future.
- Discussing the process of integrating SDGs in scientific approaches.
- Accessing the problem size and the patients’ opinions from patient interviews or through surveys.
- Earning special insights from doctors in hospitals
- Organizing meetings with experts.
- Gaining knowledge about our competitors from the presenters of companies we meet at the conferences we attend or from meeting them online.
- Attending important conferences (World Asthma Day & Pulmo_event)
- Listening to workers opinions’ at high risk occupations.
Finally, visits, doctors’ meetings, conferences, public people conservations and occupational asthma workers are documented on all HP pages.
Our Human Practices journey shaped PRESS into a responsible and patient centered approach, as it was refined by expert insights and guided by patient needs.
By closing the loop between science and society, PRESS represents not just a novel treatment, but a promise for healthier lives and a sustainable future.
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