Human Practices is an indispensable part of any project aiming to have an impact on the society. For the society to grasp the most benefit out of any project, it must also have an active role in the development and the optimization of the main milestones of this project. Consequently, we insisted on involving our community throughout every step of our journey. This is mainly reflected in our five stages Integrated Human Practices, where we explain how we interacted with our society along the course of our project.
This early social integration of the community was based on a solid identification of this year’s target problem, a clear analysis of all stakeholders involved, and ,above all, a detailed list of essential values upon which we built our project. These preliminary steps are discussed in detail along our Essential Human Practices.
Moreover, the continuous feedback received from our community helped reshape the project’s journey along 2024, ending with the potential implementation of our proof of concept to the existing market through our entrepreneurship model. Hence, we could achieve our core mission for this year; to create a new therapeutic platform that could make a great impact and enhance the quality of life of as many people as possible.
In this page, we explain the preliminary steps that we went through in the beginning of this year’s project. We start by the brainstorming sessions in which different topics were issued from all team members. We proceeded to our topic selection phase, in which we started prioritizing our ideas based on the expected impact of each one of them. Afterwards, we made a clear problem identification and started a detailed stakeholder analysis, trying to involve all relevant stakeholders with the selected topic. Then, we set a list of essential values for the project, according to the main needs and concerns of different stakeholder's groups.
Our team believes that all our work should be directed towards the greater good of humanity. To achieve that, we decided to start our brainstorming sessions in early January, where we insisted on targeting global problems that has a great impact on the world in general and also on our society. We also looked up for issues that could be solved by simple innovative solutions combined with the magic of synthetic biology.
Multiple ideas were present on our board after all the fruitful collective sessions. In fact, topic selection was such a hard and time-consuming process, as we were looking for certain medical problems that affect every household in our country, every family, and every citizen, whatever the age or the socioeconomic status. A lot of devastating diseases came to our minds such as untreatable end stage cancers, autoimmune diseases and metabolic diseases. However, the idea that could totally fulfill our selection criteria was never considered under any of the previous categories of disease. In other words, we chose to target an incident that could affect any human being which its treatment and prevention of utmost importance. For our 2024 iGEM project, we decided to create a regenerative paltfrom for irreversible tissue injuries taking wound healing of skin burns as our proof of concept.
Our topic selection was not only guided by our team’s discussions; it was also affected by our community, represented in the patients we meet every day as medical cadets in different hospitals and burn care centers through our clerkship programs. We were inspired by their survival stories, which encouraged us to learn more about the impact of burns on patients and the community. This is discussed in detail in the first stage of our Integrated Human Practices; called “The Inspiration”.
After settling on this year’s topic, we needed to make sure that our team understands all the aspects of the existing problem in order to come out with innovative solutions that could bridge the gap between scientific research and the real-world. More information about our problem understanding efforts is found in the second stage of our Integrated HP.
To do so, we launched a deep and intensive research about burn injuries. We learnt that burns are one of the most common forms of trauma. According to the WHO, an estimated 180,000 deaths yearly are caused by fire-related burn injuries. Even burn accidents survivors suffer from burn-related disabilities and disfigurements leading to many psychological, social, and economic problems. Additionally, the burden of burn injury falls heavily on low and middle income countries, where 95% of fire-related burn deaths occur.
Furthermore, we discovered that severe deep second-degree and third-degree burns take long time to heal, which increases the risk of scarring and skin contractures. This issue could be controlled by the induction of faster healing of burn wounds in order to prevent different disfiguring complications. On the other hand, first-degree and superficial second-degree can be treated conservatively without leaving any scars.
Hence, existing wound management options directed to deep tissue burn injuries are mainly sterilized wound dressings, surgical debridement, and skin grafting. All of which may lead to many disfiguring complications as scars and contractures often aggravated by wound infections which even prolongs the healing process establishing more functional and aesthetic impairments.
In addition, to gain a deeper understanding of burns as our targeted problem, we decided to come up with a burn patients’ survey. This survey was translated to Arabic, our mother tongue, in order to be distributed in different occasions throughout our journey, including multiple visits, meetings, and social engagement with burn survivors. Moreover, we made a detailed analysis for all the answers collected from the wide variety of burn patients that we met along the course of our project. This step helped us get real-world insights about the burden of burn injuries on patients, healthcare systems, and the whole community. Both documents; The Burn Patients’ Survey and The Survey Analysis are represented in the following files:
It is also important to mention that all participants in the previous survey had to read and sign an informed consent document before answering the survey’s questions. A copy of the informed consent can be found here.
Therefore, we need to come up with a new therapeutic approach that could boost the wound healing process, achieving minimal scarring and better cosmetic outcomes.
After an in-depth identification of this year’s targeted problem, we had to start gathering and analyzing all stakeholders relevant to our project. To do so, we searched the literature looking for an accurate definition of the term “stakeholder” in the simplest yet the most formal way possible. Thanks to the Project Management Institute, we learnt that a stakeholder is any individual or organization who are actively involved in the project, or whose interests may be positively or negatively affected as a result of project execution or successful project completion.
Then, we launched brainstorming sessions to identify the stakeholders who are relevant to different steps of our journey, as these stakeholders are not equally involved in all phases of our journey. We divided our project into five main phases that are going to be discussed in detail in our Integrated Human Practices page.
Then, we prioritized stakeholders needed in every phase according to the following diagram:
Finally, we categorized all the stakeholders into six main groups, and gave each group a specific icon that will be used as tags to all the meetingsin the Integrated Human Practices section:
These icons will be explained in more detail in the introduction of the Integrated HP section.
After taking into account the relevant stakeholders that would help us build a human-centric approach, we had to make sure that the interests of these stakeholders are satisfied along different stages of our journey. Hence, we needed to identify the core values essential to our stakeholders which will guide us to an optimized development of our product’s design.
We started a value-sensitive analysis to prioritize and fulfill the needs of our stakeholders while also focusing on the technological and scientific development of our platform. These values later became the foundation and the reference we depended on through every step in our journey. It is also important to note that different values vary in importance according to each stakeholder.
In the following, we try to take you through all essential values that helped us reshape our design:
Safety is by far the most important value identified among all stakeholders. Our human-centric approach requires multiple layers of safety along different steps of its design to satisfy the needs of its end-users. As our product will be used by patients, we must minimize all unwanted side effects; and at the same time maximize safety and efficacy starting from the production process up and until the treatment of the patient.
This is why, we made sure we are strictly following the international guidelines of biological and cell-based therapy. We started by revising the latest recommendations of the WHO Program for International Drug Monitoring (WHO PIDM), putting medicines and vaccine safety at the heart of global healthcare.
We also insisted on implementing the policies and regulations of the FDA guidance documents discussing all the drug development phases starting from the design to the manufacturing and testing phases.
The African Health ExCon was the perfect place for us to look for answers, as it helped us connect with former clinical reviewers in the FDA who gave us a detailed explanation about the necessary steps of safe drug development.
Locally, we contacted representatives of the Egyptian Drug Authority (EDA) who gave us a walk through the 2023 Egyptian Guidelines for conducting bioequivalence studies for marketing authorization of generic pharmaceutical products Thanks to these guidelines, we gained a wider scope of the national policies and the process required in order to file a new drug in the market while ensuring its safety and efficacy.
Moreover, we were keen on meeting many professionals in the fields of drug development and cell-based therapies, and also experts in relevant medical fields. Thanks to these professionals, we could transform our therapeutic approach into a unique form of personalized medicine for each patient; as we engineered our stem cells to respond according to the degree of severity and the condition of the injured site. Hence, we could prevent unwanted side effect or overshooting of our therapeutic device. More information about different safety systems included in our design could be found on the Implementation page. Additionally, detailed meetings with all the safety experts who helped reshape our design could be found on the Integrated Human Practices page.
Beneficence is the ethical duty of physicians to act in the patient's best interest. It is one of the main values of our stakeholders as it estimates the benefits our end-users should gain using our new therapy compared to other existing treatment options. This is why wanted to maximize the benefits of SONG-H on burn patients providing a faster wound closure and a more efficient healing process of the injured site. In other words, the greatest benefit of using SONG-H relies in the restoration of skin integrity and function while preventing disfiguring complications including scars and contractures. This new approach is also non-invasive as it depends on the application of a hydrogel scaffold containing our engineered MSCs on the wound site. Therefore, SONG-H significantly reduces the cosmetic, social and psychological complications of burn management on patients.
A sustainable project should be able to meet new requirements, make future maintenance easier, and cope with the changing environment. Therefore, the foundation of SONG-H is based on the main social, environmental, economic, and cultural principles of sustainability
In other words, sustainability is one of the few values that combines many stakeholder’s needs together under one umbrella. SONG-H satisfies these needs upon various occasions along the project. This is explained in detail on the SDGs page where we show the way our project targets and achieves international goals of sustainability such as the eradication of poverty, the promotion of health and well-being, and also the empowerment of women and gender equality. In broad terms, these SDGs helped build the main framework of our design aiming to fulfill various unmet needs and important values to the whole community.
Public Health is the science of protecting and improving the health of people and their communities.
As we moved forward with our project, we remained committed to upholding the principles of public health. As our therapeutic platform targets burn wounds as a proof of concept, we prioritized the prevention of burns and the promotion of first aid measures all along our project’s journey. These public health activities represent the main core of our Educational Program for this year’s project.
We also learnt the importance of massive awareness campaigns as an indispensable method to promote health and prevent disease. This is why, we partnered with established burn care centers like Ahl Masr Hospital in their burn prevention campaigns directed towards the high risk populations; as children, women, and low-socioeconomic status households. This is considered a demonstration of our infinite desire to prevent and ,at the same time, cure burn wounds.
Additionally, our personalized approach aims to minimize all unwanted side effects of burn wound management, which goes with the public health morals of doing no harm to patients. SONG-H also achieves faster wound healing and skin restoration, which reduces the burden of burn injuries on the patients and their families, hospitals and burn care centers, and finally on the community from an economic point of view.
Justice is the fair distribution of healthcare resources equitably. It is one of the main morals that any therapeutic project should take into consideration to ensure its accessibility to all patients. Our team has taken this value into account since the beginning of the year; as we are targeting a problem that endangers the lives of vulnerable groups. Burns are mostly prevalent among low socioeconomic status populations, where elderly and children are at higher risk for burn injuries. This is why, we have to ensure our burn prevention efforts ,as well as our therapeutic device, are accessible for all groups of patients.
We are totally aware of the high costs of cell-based therapies, so we reached out for health insurance companies in different occasions along our journey like the African Health ExCon. We wanted to understand the process required in order to make our platform affordable as a part of health insurance of every patient. We also contacted representatives and policy makers of the Ministry of Health in order to include SONG-H in local hospitals as one of the emergency drugs in case of acute burns.
Privacy is one of the main aspects that must be highlighted while conducting a research, especially while developing new therapeutic devices. As a result, we consulted the Ethical Review Committee of our university before doing any data collection activity. We also revised our burn patients’ survey and our online survey with the IRB. We also made sure we had the Informed Consent of all participants in our projects data collection. We prioritized data security and safe data storage, more information about this part could be found on the Safety page.
“Healthcare innovation is accelerating at unprecedented scale,” says the WHO. SONG-H shows its own innovative values in its great ability to fasten the process of wound healing preventing fibrosis that leads to disfiguring scars. This makes stakeholders more interested in our design as it offers a unique feature that cannot be compared to any existing treatment alternative.
In addition, the combination of technologies which are used in the design of our promising platform was not applied in any therapeutic concept before, which adds more innovation and novelty to our project.
Essential Human Practices represents the ultimate guide for any iGEM team willing to make a great impact on the world. This preliminary phase is based on a clean and accurate identification of every essential part of the project; starting from the moment the main idea is born and paving the way for the growth and development of this idea on different levels. However, this development should be always controlled by the essential values established in this section, which will ensure the satisfaction of relevant stakeholders while making the project beneficial to the world in general.
Detailed information about our background research concerning our targeted problem, our personal reflections represented in Our Efforts, and also our engamenent with different communities can be found through our Interactive Timeline in the Intergated Human Practices.
ARMED FORCES COLLEGE OF MEDECINE
AFCM EGYPT iGEM 2024
