This year’s iGEM journey has ensured the engagement of six main groups of stakeholders identified during our stakeholder analysis.
These groups are: burn survivors and their caregivers, healthcare providers, public health and ethics professionals, pharmaceutical companies, law experts, and finally general communities.
We ensured to get regular feedback from these relevant stakeholders during different stages of our project’s journey. This human-centric approach included a number of meetings, interviews and visits represented in the interactive timeline of our project’s journey.
On the Integrated Human Practices page, detailed information about all the stakeholder conversations are seen in a five-stage development process. Additionally, three main tools are used to represent this information in a more organized and accessible way.
This is the preliminary tool that any team should depend on to connect an iGEM project to the world. Starting by a clear identification of the targeted problem and its associated sectors. Then, understand all the aspects of the problem and trying to communicate with relevant sectors to understand their values and needs. After that comes the integration of this feedback into the project’s design. Finally, the implementation of this project into the real-world hoping to make a change in the life of those in need.
Therefore, we advise all iGEM teams to start their project’s journey with a similar tool to organize the development of their idea until its implementation in the real-world.
Thanks to this cycle, we managed to divide our Integrated HP journey into five main stages, where we have grouped all the feedback and the reflections that reshaped the developmental process of SONG-H.
Feedback is the basis of integration of an iGEM project with the world. To make sure that every feedback is taken into consideration, we have developed a Feedback Template that is inspired by frameworks used by previous iGEM teams. This template consists of:
Purpose: This is where we state the relevance and the motivation behind our meeting with the stakeholder in question
Contribution: This is where we highlight the main points of the engagement with the stakeholder, which can be reflected on the project’s development.
Core: In this part, we give further details about the discussion and the integration of the feedback into the project’s design.
Plan of action: In this final part, we describe the future steps that could further improve our design, in the same course of our discussion with the stakeholder in question
To categorize all experts that we contacted along our journey, we used identification cards for every stakeholder group. Each card is associated with the specific icon and color corresponding to the stakeholder to help with the feedback collection process. More information about the stakeholder categorization can be found in the Essential Human Practices page in the stakeholder analysis part.
As end users of our platform, burn survivors are considered essential stakeholders in our project. The integration of their insights along with the concerns of their caregivers will allow us to gain deeper understanding of the problem, prioritize their needs, and meet their expectations with our therapeutic approach.
This category includes plastic surgeons, experts in regenerative medicine, and molecular biology. These stakeholders are either working with burn patients or on similar medical technologies. They can greatly contribute to the development of our design from a theoretical and also clinical perspective.
Professionals related to this category will help us draw the social and ethical framework for the design of our platform. These experts will provide us with essential ethical regulations and social considerations regarding the development of our therapeutic platform.
Stakeholders of this group are collected based on their great market experience. Hence, they will help us develop our final product from an entrepreneurial point of view and set a convenient plan for the implementation of our platform in the real-world.
Experts from this sector are specialized in the protection of intellectual property of similar novel regenerative technologies. They will also give us important insights about the process of filing patent for the application of our new drug.
This category includes all stakeholders who does not belong to any of the previous groups. This will include the whole community which will be impacted by our solution in many indirect ways. Thus, we need to reflect upon their feedback and take their values into consideration.
Finally, all these tools are grouped together to build the core of our Project’s Journey, which is represented in the following five staged-interactive timeline:
This stage started in mid-January after we settled on the 2024 AFCM iGEM team. We launched our brainstorming and topic selection sessions as mentioned in our Essential Human Practices. In this stage, we relied mainly on our PIs and our instructors to help us chose the targeted problem of our 2024 iGEM project.
After broad literature research, multiple focused brainstorming sessions, and many meetings with our PIs and professors from the AFCM, we have finally settled on a topic that represents a mix of originality, innovation, and feasibility. This choice was not only based on materialistic information from our academic environment, as we insisted to reach out for the community and listen to the needs of its fellow members. This real-world connection approved our initial problem selection and gave us the inspiration necessary to find realistic solutions needed worldwide.
Dean of the AFCM and our primary PI
Phd of Biotechnology and our secondary PI
After the recruitment of new members, our 2024 AFCM iGEM team was ready to hold our first meeting with the PIs. With a long experience in the medical field and great knowledge of the most recent biotechnology applications, our PIs should help us in choosing a specific iGEM track for this year’s project. Hence, we can start our brainstorming sessions and literature search to select the targeted problem in iGEM competition.
Thanks to this meeting, we decided to choose the Therapeutics Track in this year’s iGEM competition, based on recommendations from our PIs and instructors. We also received a brief walk-through some recent trends in the synthetic biology field including new treatment options to various diseases. This orientation would be our ultimate guide throughout the upcoming brainstorming sessions. Our PIs also advised us to widen the scope of our literature research while taking in consideration problems with heavy medical burden faced by our community. Bearing in mind the potential of synthetic biology in creating feasible solutions for the selected problem.
During this first meeting, we started to learn more about synthetic biology applications in different fields. Our PIs were also keen on giving us the main insights about the iGEM competition and the journey awaiting us, which is going to change our life as we are contributing to change the life of people around the world with our project.
Our PIs advised us to choose one of the Healthcare Tracks, especially the Therapeutics Track, where we could benefit from our academic background as medical cadets. Hence, we directed our efforts for the first brainstorming sessions to find real-world medical issues that could be solved by a new synthetic biology application. At the same time, the team members were interested in the emerging stem cell-based technologies. Therefore, under the supervision of our instructors, we were guided to start a deep literature research to learn more about stem cell therapeutic applications that could fit in a SynBio-based design for iGEM competition.
Our plan is to launch brainstorming sessions regarding the main medical issues encountered worldwide, start a detailed broad literature research about stem cell-therapeutic potentials, and also review previous iGEM team which depended on cell-based therapies in their therapeutic approaches. Hence, we divided our team into subgroups of two, distributed the tasks, and started a time-bound mission to find and select an impactful topic for the 2024 iGEM project.
After a deep literature research, every subgroup of our team came out with an idea for the iGEM competition. We needed to go back to our PIs in order to help choose between the proposed ideas. The goal of this meeting was to measure the impact and then feasibility of each idea according to the feedback of our PIs and instructors. We also wanted to get information about the applicability of such ideas in iGEM competition and the way we could integrate SynBio in every approach.
Thanks to this second meeting with our PIs, we could narrow the scope of our literature research on two main ideas which are burn management and regenerative therapy. These ideas were given special interest by our professors and were considered the most suitable for iGEM competition. With a long history of research in cell-based therapies, Dr. Danira advised us to focus our attention on the most recent trends in burn management bearing in mind stem cells regenerative potentials. In addition, our instructors could foresee these approaches as future therapeutic products that could change the life of people in need, as the topics in question have a huge impact globally.
In this meeting, we started by explaining to our PIs the main ideas that resulted from our early brainstorming sessions. We thought about optimizing a platform for the gene therapy of congenital cystic fibrosis, or degenerative cognitive diseases like Alzheimer disease. On the other hand, burn management was another interesting idea that crossed our minds due to its heavy burden not only on healthcare systems, but also its global effect on the international economy and the global environment. Regenerative therapy was also a fascinating topic with all the potential applications in the restoration of various organs depending on the regenerative functions of stem cells.
With a total of five main ideas generated from the interests and research of all team members, it was time to refer to our PIs and instructors for guidance to select the best topic for this year’s project. We discussed the reliability of each idea and the potential to integrate it into a SynBio-based platform. Our instructors also highlighted the expected impact of every one of the topics in question on the world as a whole, and also on our community in particular.
Despite the great potential of all ideas, we selected two specific topics for further research and development which were: burn management and regenerative therapy.
After taking our PIs advise, we needed to do more brainstorming on both of the selected ideas, contact professors in our university for more insights on regenerative therapy, and try to reach people who could be most affected by these approaches in the future, as our objective is to come up with an iGEM project that could be good and responsible for the world.
Dean of the AFCM and our primary PI
Phd of Biotechnology and our secondary PI
Assistant Lecturer of Biotechnology and Pharmacotherapeutics, German University in Cairo (GUC)
After a deep literature research, every subgroup of our team came out with an idea for the iGEM competition. We needed to go back to our PIs in order to help choose between the proposed ideas. The goal of this meeting was to measure the impact and then feasibility of each idea according to the feedback of our PIs and instructors. We also wanted to get information about the applicability of such ideas in iGEM competition and the way we could integrate SynBio in every approach.
Thanks to this second meeting with our PIs, we could narrow the scope of our literature research on two main ideas which are burn management and regenerative therapy. These ideas were given special interest by our professors and were considered the most suitable for iGEM competition. With a long history of research in cell-based therapies, Dr. Danira advised us to focus our attention on the most recent trends in burn management bearing in mind stem cells regenerative potentials. In addition, our instructors could foresee these approaches as future therapeutic products that could change the life of people in need, as the topics in question have a huge impact globally.
In this meeting, we started by explaining to our PIs the main ideas that resulted from our early brainstorming sessions. We thought about optimizing a platform for the gene therapy of congenital cystic fibrosis, or degenerative cognitive diseases like Alzheimer disease. On the other hand, burn management was another interesting idea that crossed our minds due to its heavy burden not only on healthcare systems, but also its global effect on the international economy and the global environment. Regenerative therapy was also a fascinating topic with all the potential applications in the restoration of various organs depending on the regenerative functions of stem cells.
With a total of five main ideas generated from the interests and research of all team members, it was time to refer to our PIs and instructors for guidance to select the best topic for this year’s project. We discussed the reliability of each idea and the potential to integrate it into a SynBio-based platform. Our instructors also highlighted the expected impact of every one of the topics in question on the world as a whole, and also on our community in particular.
Despite the great potential of all ideas, we selected two specific topics for further research and development which were: burn management and regenerative therapy.
After taking our PIs advise, we needed to do more brainstorming on both of the selected ideas, contact professors in our university for more insights on regenerative therapy, and try to reach people who could be most affected by these approaches in the future, as our objective is to come up with an iGEM project that could be good and responsible for the world.
“I was just cooking dinner like any other normal day”
“My newborn does not recognize me anymore”
“It seems like yesterday, I still get nightmares about the horrifying scenes of that day”
“My scars? I kinda like them. I mean they look cool. Make me feel stronger and braver”
In the beginning of February and parallel to our literature research, we came across hundreds of tragic stories of burn survivors. We decided to mention some parts of the stories which affected us the most and for that we considered them an essential source of motivation for us in this year’s project. These stories did not just direct our attention towards the management of burns, but also we were inspired to start mass awareness campaigns on burn prevention and first aid measures essential in emergency burn management, this part forms the core of the Educational program of our iGEM project.
The idea of burn management was emphasized and now we have a new goal in mind which is to heal burn wounds with minimal scarring. This could minimize burn physical and psychological complications and reduce the social stigmatization of burn survivors. To do that, we thought about the integration of cell-based regenerative therapy with active burn care. An integration that will need further detailed studies, deeper literature research, and consultation of more relevant experts.
We believe that burn survivors are active members of the community who deserve to be treated equally and respectfully under different circumstances. Therefore, we have taken the responsibility to change the life of burn patients around the world and promote their wellbeing.
At this point of our journey, we needed no further guidance in terms of topic selection after all the dramatic stories that we read along our research. We have chosen burn management as our main therapeutic approach for the 2024 iGEM competition. Now, we are ready to start the second stage of our project which consist of a clearer understanding of the targeted problem.
In this stage, we follow the second step of the Integrated HP cycle that was previously mentioned in our Recommended Tools section. In this step, we need to achieve a deeper understanding of our targeted problem for this year’s project. Therefore, we decided to get in touch with more healthcare providers in the fields of plastic surgery, dermatology, and emergency as the most concerned domains with burn management. Hence, we could gain a clearer picture of burns’ pathophysiology, current burn care techniques, and also the heavy burden of burn management on healthcare systems worldwide.
We also needed to collect detailed information about the prevalence, incidence, and common causes of burn injuries globally. This is why, we needed to meet with public health experts and epidemiologists to collect accurate numbers about the current burn injuries status and its public health burden. Additionally, we want to make our own stats for the local prevalence of burns in different public hospitals in our city. Therefore, we will create a simple survey for patients and public communities affected by burn injuries. This survey will be distributed during our visits to different burn care facilities and during every interaction we are going to have with the general public throughout our project.
Parallel to our Human Practices in this stage headed towards deep understanding of burn injuries, our scientific efforts were directed towards reviewing the most recent papers about regenerative therapy of damaged organs. We focused on stem cells’ regenerative potentials and its mechanism of action in different existent therapeutic applications. Hence, we needed to contact researchers concerned with these papers who would have more experience in cell-based therapies.
After deep literature research and medical textbooks review, we needed to contact an expert in plastic surgery in order to deeper understand the pathophysiology of burn wounds. We knew that plastic surgeons are the most experienced and -at the same time- the most involved healthcare professionals in different wound healing management technique, especially burn wounds. Therefore, we wanted to get detailed information about the burn patient journey starting from the necessary first aid measures to the chronic burn treatment options.
Dr. Mousa gave us a walk through the different aspects of burn etiology and management from a clinical point of view. First, he highlighted the most common causes of burn injuries that he encountered during his long years of practice, as burnt male patients often present due to workplace flame burn injuries, while children and female patients are usually burned in domestic kitchens. After that, he stated that most burn patients present with deep second stage or third stage burns, so the majority of treatment options are focused on these specific stages. Dr. Mousa also explained that burn wound healing process goes through 3 main successive stages: inflammation, proliferation, and remodeling. This third stage is responsible for scar formation in severe burns that take more than three weeks to heal causing fibrosis of the injured site. This is why, current wound treatment options, either surgical as grafts and flaps or medical like silicone agents, often lead to disfiguring complications. Therefore, there is a gap in burn wounds management which needs to be bridged by a new therapeutic platform that could prevent the scarring and contractures caused by available treatments.
This meeting was an essential step in gaining a deeper understanding of burn injuries including their causes, pathophysiology, healing mechanisms, and also complications. Hence, we could be more aware of the different aspects of burn as our targeted problem for this year’s project. We also needed to identify the dynamics of burn injuries on a wide scale to explore needs and concerns of our community. As a result, we can optimize our platform according to people’s needs in order to finally meet their expectations and make a change in their life.
Through this deep understanding, we identified the populations at risk to which we are going to direct our educative and burn prevention programs. We recognized the gap present in burn wounds management which often leads to serious complications as scarring, disfigurement, loss of function, and contractures. These complications cannot be overcome by surgical treatment options like skin grafts and flaps, nor by medical ointments and gels which are more used in chronic burn wounds management. We also discovered that burn injuries require complementary therapy that consist of topical and systemic antibiotic therapy, physiotherapy, and psychological therapy.
After this fruitful meeting, we want to put everything we learnt into practice by visiting an actual burn care centers to contact more doctors deeply involved with the topic in question, and also meet patients and burn survivors to learn about their journey and their recovery process.
Plastic and Reconstructive Surgery Resident at AFCM
After deep literature research and medical textbooks review, we needed to contact an expert in plastic surgery in order to deeper understand the pathophysiology of burn wounds. We knew that plastic surgeons are the most experienced and -at the same time- the most involved healthcare professionals in different wound healing management technique, especially burn wounds. Therefore, we wanted to get detailed information about the burn patient journey starting from the necessary first aid measures to the chronic burn treatment options.
Dr. Mousa gave us a walk through the different aspects of burn etiology and management from a clinical point of view. First, he highlighted the most common causes of burn injuries that he encountered during his 20 years of practice, as burnt male patients often present due to workplace flame burn injuries, while children and female patients are usually burned in domestic kitchens. After that, he stated that most burn patients present with deep second stage or third stage burns, so the majority of treatment options are focused on these specific stages. Dr. Mousa also explained that burn wound healing process goes through 3 main successive stages: inflammation, proliferation, and remodeling. This third stage is responsible for scar formation in severe burns that take more than three weeks to heal causing fibrosis of the injured site. This is why, current wound treatment options, either surgical as grafts and flaps or medical like silicone agents, often lead to disfiguring complications. Therefore, there is a gap in burn wounds management which needs to be bridged by a new therapeutic platform that could prevent the scarring and contractures caused by available treatments.
This meeting was an essential step in gaining a deeper understanding of burn injuries including their causes, pathophysiology, healing mechanisms, and also complications. Hence, we could be more aware of the different aspects of burn as our targeted problem for this year’s project. We also needed to identify the dynamics of burn injuries on a wide scale to explore needs and concerns of our community. As a result, we can optimize our platform according to people’s needs in order to finally meet their expectations and make a change in their life.
Through this deep understanding, we identified the populations at risk to which we are going to direct our educative and burn prevention programs. We recognized the gap present in burn wounds management which often leads to serious complications as scarring, disfigurement, loss of function, and contractures. These complications cannot be overcome by surgical treatment options like skin grafts and flaps, nor by medical ointments and gels which are more used in chronic burn wounds management. We also discovered that burn injuries require complementary therapy that consist of topical and systemic antibiotic therapy, physiotherapy, and psychological therapy.
After this fruitful meeting, we want to put everything we learnt into practice by visiting an actual burn care centers to contact more doctors deeply involved with the topic in question, and also meet patients and burn survivors to learn about their journey and their recovery process.
Assistant lecturer of public health and community medicine, AFCM
During our literature research, we read about different new trends in burn wounds management. Papers and researchers adopted a wide variety of scientific concepts to invent an optimized therapeutic approach aiming to enhance wound healing and minimize complications. Therefore, we needed to contact a researcher with a long experience in cell-based therapy applications in order to guide us through the initial steps of our scientific concept.
Prof. Savarino explained the mechanism of action of some new therapeutic agents which depend on the induction of wound healing through the proliferation of growth factors, anticoagulants, and antioxidants. Apart from these cellular components, Prof. Savarino stated that collagen-based formulations have been widely used in regenerative medicine to create hydrogel scaffolds inducing wound healing. Additionally, he insisted on the importance of the proliferation of natural anti-microbial agents and the application of external antibiotics to optimize the wound healing process and prevent different types of injured-site infection.
Our meeting with Prof. Savarino was a foundational step in the understanding of new wound treatment platforms depending on different scientific concepts. The recognition of these concepts provided important insights that could be implemented in our design early in the scientific development of our project. We also identified the limitations of existing treatment options, including therapeutic approaches that have not been yet approved in the management of wound healing. Thus, we could overcome these limitations during the development of our platform.
Thanks to our meeting with Dr. Savarino, we identified the main characters that must be considered in the creation of a burn treatment platform. First, the proliferation of different cellular and bioactive molecules as growth factors must be enhanced in order to boost the process of wound healing and prevent disfiguring complications. Secondly, an infection-free environment must be provided at the burnt site to ensure proper closure of the wound. This is could be done by the administration of antibiotic agents within a hydrogel scaffold at the burnt area. Thirdly, the mechanism of delivery of such a complex therapeutic system should differ according to the site, extent, and severity of the burn injury. Hence, we need to refer to an expert plastic surgeon to learn more about this topic. Finally, the integration of SynBio into our genetic circuit design would still be a question to discuss with a molecular biology professional in a future meeting.
After our meeting with Dr. Savarino, we managed to establish the main frame of our design integrating recent burn management techniques with cell-based regenerative therapy. Thus, we need to contact more experts in the molecular biology, modeling, and synthetic biology fields in order to make further progress in the development of our platform. We also need to meet with experienced plastic surgeons who are more oriented with the new treatment alternatives of burn wounds, their clinical limitations, and their feasibility as real-world therapeutic applications.
Virologist and Immunologist at Istituto Superiore di Sanità, Rome, Italy
During our literature research, we read about different new trends in burn wounds management. Papers and researchers adopted a wide variety of scientific concepts to invent an optimized therapeutic approach aiming to enhance wound healing and minimize complications. Therefore, we needed to contact a researcher with a long experience in cell-based therapy applications in order to guide us through the initial steps of our scientific concept.
Prof. Savarino explained the mechanism of action of some new therapeutic agents which depend on the induction of wound healing through the proliferation of growth factors, anticoagulants, and antioxidants. Apart from these cellular components, Prof. Savarino stated that collagen-based formulations have been widely used in regenerative medicine to create hydrogel scaffolds inducing wound healing. Additionally, he insisted on the importance of the proliferation of natural anti-microbial agents and the application of external antibiotics to optimize the wound healing process and prevent different types of injured-site infection.
Our meeting with Prof. Savarino was a foundational step in the understanding of new wound treatment platforms depending on different scientific concepts. The recognition of these concepts provided important insights that could be implemented in our design early in the scientific development of our project. We also identified the limitations of existing treatment options, including therapeutic approaches that have not been yet approved in the management of wound healing. Thus, we could overcome these limitations during the development of our platform.
Thanks to our meeting with Dr. Savarino, we identified the main characters that must be considered in the creation of a burn treatment platform. First, the proliferation of different cellular and bioactive molecules as growth factors must be enhanced in order to boost the process of wound healing and prevent disfiguring complications. Secondly, an infection-free environment must be provided at the burnt site to ensure proper closure of the wound. This is could be done by the administration of antibiotic agents within a hydrogel scaffold at the burnt area. Thirdly, the mechanism of delivery of such a complex therapeutic system should differ according to the site, extent, and severity of the burn injury. Hence, we need to refer to an expert plastic surgeon to learn more about this topic. Finally, the integration of SynBio into our genetic circuit design would still be a question to discuss with a molecular biology professional in a future meeting.
After our meeting with Dr. Savarino, we managed to establish the main frame of our design integrating recent burn management techniques with cell-based regenerative therapy. Thus, we need to contact more experts in the molecular biology, modeling, and synthetic biology fields in order to make further progress in the development of our platform. We also need to meet with experienced plastic surgeons who are more oriented with the new treatment alternatives of burn wounds, their clinical limitations, and their feasibility as real-world therapeutic applications.
Resident of Plastic and Reconstructive Surgery at Helmia Military Hospital
We wanted to meet with a plastic surgeon who -apart from his clinical expertise as a physician- is interested in innovative research and cutting-edge studies in the field of wound healing. Thus, we can learn about recent developments in advanced wound care technologies and their feasibility among local healthcare systems.
As a passionate researcher, Dr. Hany gave us important insights about new trends in plastic surgery and reconstructive medicine, which could help us identify the essential criteria for the development of a new treatment for wound healing. He stated that recent technological advances in the management of wounds include nanotherapeutics, stem cells therapy, bioengineered skin grafts, and 3D bioprinting-based. Dr. Hany also highlighted that the best new wound management techniques are characterized mainly by inducing rapid wound closure and minimizing scar formation through minimally invasive procedures. These features should be taken in consideration as major goals of our design.
Dr. Hany gave us a brief about new technologies of wound management and their different mechanisms of action enhancing the process of wound healing. Despite their effectiveness in achieving minimal scarring, most of these treatment options might lead to serious complications due to overshooting, increased risk of infection, and allergic reactions. Therefore, tight safety measure must be taken along the course of development of a new therapeutic approach for wound healing.
In addition, we talked with Dr. Hany about burn wounds potential to give the same response to treatment like any other traumatic wound. He stated that burn management is done through different levels by a multidisciplinary team at the hospital. In other words, burns are a major cause of trauma as its treatment starts from the early first aid measures that should be done directly after the injury before reaching the hospital, arriving to the different resuscitative procedures and surgical interventions performed in the emergency department, and finally reaching all the complementary treatment options that include antibiotic therapy, physiotherapy, and psychological support.
To see this patient journey in real life and meet with other experts in reconstructive medicine, Dr. Hany invited us to visit Helmia Military Hospital where we can come around one of the biggest burn care center in Egypt.
After this meeting, we decided to plan our first visit to Helmia Military Hospital. This visit would represent an important step in the understanding of the problem that we are facing. Hence, our PIs started contacting the head of Helmia Hospital who was very hospitable especially after he heard that we are working on a new burn wound treatment in our therapeutic platform.
After exploring the different recent advancements in wound healing, we need to choose one of these new technologies as the main mechanism of action for our therapeutic platform. We want our design to take the advantages of optimized wound healing treatments while preventing their disfiguring and malfunctioning complications. This is why we contacted an expert in the field of plastic surgery like Prof. Dr. Tarek El Menoufi during our visit to Helmia Military Hospital.
After explaining the main goal of our project which is the induction of wound healing in burns, Dr. El Menoufi recommended the implementation of stem cell-based therapy in our approach. Stem cells have the most promising results in most of the drug prototypes targeting wound healing. Additionally, Dr. El Menoufi explained that stem cells would have a remarkable effect on burn wounds specifically, as they accelerate wound healing via a complex series of pathways promoting neo-angiogenesis, collagen deposition and granulation tissue formation. Stem cells are also characterized by their potential to decrease the severity of the inflammatory cascade, which could help reduce the risk of infection at the wound site. Therefore, we decided to use stem cells in the delivery of our genetic circuit for our burn wound treatment.
During our visit to Helmia Military Hospital, we managed to meet Prof. Dr. Tarek El Menoufi who is one of the best plastic surgeons in our country with more than 25 years of experience in the field. We wanted to take his feedback on our project’s idea and the theoretical points that we intend to implement in our design. We also wanted his help to choose between different new technologies in regenerative medicine, according to the safest and the most feasible technique for wound healing.
Dr. El Menoufi advised us to prioritize minimal scar formation in our design, as this complication lead to severe mental, physical, and social problems that affect patients’ quality of life. Then, he clarified that scars are life-long side effects of most burn treatment options, causing irreparable damage to the patient’s skin and also intolerable social exclusion leading to stigmatization of burn survivors in the community. Thus, a new burn treatment that could reduce scarring would represent a major contribution in the future of all people at risk for burn injuries.
After choosing stem cells as the core of our theoretical concept, we are now on track for the scientific development of our design. We need to contact an expert in cell-based regenerative medicine to identify important details in our genetic circuit including the growth factors and the receptors to be used.
Medical Director of Helmia Military Hospital
After exploring the different recent advancements in wound healing, we need to choose one of these new technologies as the main mechanism of action for our therapeutic platform. We want our design to take the advantages of optimized wound healing treatments while preventing their disfiguring and malfunctioning complications. This is why we contacted an expert in the field of plastic surgery like Prof. Dr. Tarek El Menoufi during our visit to Helmia Military Hospital.
After explaining the main goal of our project which is the induction of wound healing in burns, Dr. El Menoufi recommended the implementation of stem cell-based therapy in our approach. Stem cells have the most promising results in most of the drug prototypes targeting wound healing. Additionally, Dr. El Menoufi explained that stem cells would have a remarkable effect on burn wounds specifically, as they accelerate wound healing via a complex series of pathways promoting neo-angiogenesis, collagen deposition and granulation tissue formation. Stem cells are also characterized by their potential to decrease the severity of the inflammatory cascade, which could help reduce the risk of infection at the wound site. Therefore, we decided to use stem cells in the delivery of our genetic circuit for our burn wound treatment.
During our visit to Helmia Military Hospital, we managed to meet Prof. Dr. Tarek El Menoufi who is one of the best plastic surgeons in our country with more than 25 years of experience in the field. We wanted to take his feedback on our project’s idea and the theoretical points that we intend to implement in our design. We also wanted his help to choose between different new technologies in regenerative medicine, according to the safest and the most feasible technique for wound healing.
Dr. El Menoufi advised us to prioritize minimal scar formation in our design, as this complication lead to severe mental, physical, and social problems that affect patients’ quality of life. Then, he clarified that scars are life-long side effects of most burn treatment options, causing irreparable damage to the patient’s skin and also intolerable social exclusion leading to stigmatization of burn survivors in the community. Thus, a new burn treatment that could reduce scarring would represent a major contribution in the future of all people at risk for burn injuries.
After choosing stem cells as the core of our theoretical concept, we are now on track for the scientific development of our design. We need to contact an expert in cell-based regenerative medicine to identify important details in our genetic circuit including the growth factors and the receptors to be used.
By the end of March, we have successfully covered different aspects of burn injuries including common causes, stages, pathophysiology, and natural healing process. This was a result of our deep literature research, all our meetings with various stakeholders and the regular integration of their feedback in our project. In addition, we have gathered a lot of information about current burn wounds treatment options and their limitations. We have learned about the most recent trends in regenerative therapy, hence we have chosen to implement stem cells in our design to benefit from their great potential in the induction of wound healing.
Moreover, we have clearly understood the burden burn injuries have on healthcare systems globally, especially the prolonged treatment of disfigurements and contractures caused by chronic wounds. We have also noticed the physical, social and psychological problems facing burn survivors during their recovery due to life-long burn complications. Hence, we decided to direct our efforts towards enhancement of burn wound healing and minimization of scar formation in order to improve the health and wellbeing of patients and also populations at risk for burns.
After this foundational understanding stage, we are ready to communicate everything we learned with our stakeholders, either by collecting their feedback along the development of our therapeutic platform, or by contributing to their education through giving away burn prevention tips and first aid measures necessary to face burn hazards. As a result, we could effectively reduce the heavy burden of burn injuries in our country.
In the third stage of our Integrated HP, we move forward in the Integrated HP Cycle to the Communication phase of our project with relevant stakeholders. This stage involve many researchers in regenerative medicine, ethics professionals, biotechnology experts, and also -like previous stages- burn survivors. Therefore, we can ensure the engagement of different aspects of our project with the real-world.
Throughout this stage, we will start consulting ethics professionals in order to approve our therapeutic research in regenerative medicine. We also want to learn about the process necessary for a new biological drug approval. Thus, this step marks the beginning of the transformation of our theoretical concept into a true product in the market.
In addition, we need to refer several stem cell experts to start optimizing scientific details in our design. We want to keep regular feedback loops of relevant scientists and researchers to ensure the feasibility of every new modification we integrate along our platform development.
Finally, we will keep contact with burn survivors to ensure the fulfillment of their needs and the respect of their values along this stage. We also want to spread the knowledge about burn prevention tips and first aid essential measures, as we dived deep into both of these two topics in previous stages of our journey. This is why, we want to put our previously learnt information into action by participating in massive awareness campaigns, reaching out more populations at risk, and planning visits to burn care centers. More information about our awareness efforts can be found in the Education section .
Head of Pharmacology and Toxicology Department Member of the IRB of AFCM
We wanted to discuss the clinical potentials of our therapeutic approach to replace current treatment options for acute burn injuries. We also needed to outline the corresponding dosage, timing, and route of administration of our future product on the burnt area. We needed to make sure that our platform would surpass other burn wound care techniques, while also reducing the financial burden associated with long-term burn disfiguring complications.
Dr. Moiemen explained that burn management goes through several procedures and varies according to the severity of the injury. He advised us to target deep second degree and third degree burns to ensure regeneration of the remaining skin and prevent scar formation often caused by these specific burn degrees. Since our product should enhance wound healing at the burnt area, the first dose should be directly applied on the injured site topically after escharectomy that removes dead burnt skin. This dose must be combined with antimicrobial agents followed by a closed dressing. If a second dose is needed, it should not be applied before 10 days of the first one, to prevent overshooting. The amount of product used would mainly depend on the surface area and the depth of the wound. Dr. Moeimen also highlighted the potential of our platform to improve wound healing in acute burn injuries and also chronic wounds, thanks to its non-invasiveness and easy administration.
We started the meeting by presenting the scientific concept of our project to Dr. Moeimen who expressed interest in our new technology. He supported the use of stem cells to benefit from its innate regenerative functions in enhancement of wound healing and reduction of burn injury complications like massive scars and physical disabilities. Dr. Moeimen noted that most burn management techniques tend to focus on the treatment for acute burn wounds regardless the long-term disfiguring complications of burns. Therefore, our approach should exceed other treatment options by bridging the gap between optimal wound healing and minimal scar formation.
After that, Dr. Moeimen discussed traditional burn management techniques that start by first aid and resuscitative therapy aiming to stabilize the patient at the emergency department, and reach different burn care procedures like surgical skin grafts and laser therapy. Then, he listed the main limitations of surgical skin grafts and flaps in the management of burn injuries, such as donor site morbidity, limited availability of grafts, contracture formation, and risk of infection. He also stated that laser therapy is not suitable for all scar types and is also considered an expensive treatment for scars as multiple sessions may be required. Thereby, this emphasizes the imperative need for developing a cost-effective treatment that aligns with market-driven appeal.
With Dr. Moeimen's support for our strategy of restoring skin integrity by inducing burn wound healing, we are able to move forward with more confidence in the development of our scientific concept. We also need to plan a visit to Ahl Masr Foundation which is considered the pioneer of research, prevention, and treatment of trauma and burn injuries in Egypt.
President of the International Association of Burn Injuries (ISBI), past President of European Burn Association (EBA) and the British Burn Association (BBA).
We wanted to discuss the clinical potentials of our therapeutic approach to replace current treatment options for acute burn injuries. We also needed to outline the corresponding dosage, timing, and route of administration of our future product on the burnt area. We needed to make sure that our platform would surpass other burn wound care techniques, while also reducing the financial burden associated with long-term burn disfiguring complications.
Dr. Moiemen explained that burn management goes through several procedures and varies according to the severity of the injury. He advised us to target deep second degree and third degree burns to ensure regeneration of the remaining skin and prevent scar formation often caused by these specific burn degrees. Since our product should enhance wound healing at the burnt area, the first dose should be directly applied on the injured site topically after escharectomy that removes dead burnt skin. This dose must be combined with antimicrobial agents followed by a closed dressing. If a second dose is needed, it should not be applied before 10 days of the first one, to prevent overshooting. The amount of product used would mainly depend on the surface area and the depth of the wound. Dr. Moeimen also highlighted the potential of our platform to improve wound healing in acute burn injuries and also chronic wounds, thanks to its non-invasiveness and easy administration.
We started the meeting by presenting the scientific concept of our project to Dr. Moeimen who expressed interest in our new technology. He supported the use of stem cells to benefit from its innate regenerative functions in enhancement of wound healing and reduction of burn injury complications like massive scars and physical disabilities. Dr. Moeimen noted that most burn management techniques tend to focus on the treatment for acute burn wounds regardless the long-term disfiguring complications of burns. Therefore, our approach should exceed other treatment options by bridging the gap between optimal wound healing and minimal scar formation.
After that, Dr. Moeimen discussed traditional burn management techniques that start by first aid and resuscitative therapy aiming to stabilize the patient at the emergency department, and reach different burn care procedures like surgical skin grafts and laser therapy. Then, he listed the main limitations of surgical skin grafts and flaps in the management of burn injuries, such as donor site morbidity, limited availability of grafts, contracture formation, and risk of infection. He also stated that laser therapy is not suitable for all scar types and is also considered an expensive treatment for scars as multiple sessions may be required. Thereby, this emphasizes the imperative need for developing a cost-effective treatment that aligns with market-driven appeal.
With Dr. Moeimen's support for our strategy of restoring skin integrity by inducing burn wound healing, we are able to move forward with more confidence in the development of our scientific concept. We also need to plan a visit to Ahl Masr Foundation which is considered the pioneer of research, prevention, and treatment of trauma and burn injuries in Egypt.
Chief Medical Officer at Ahl Masr Hospital
As burn survivors are considered our primary stakeholders, we had a constant objective throughout our journey, which is to gain broader insights about their life and all the struggles they encounter. So we met with a psychiatrist, Dr. Tohamy, who has a great experience in dealing with different Post-Traumatic Disorders (PTSD) patients, especially post-burn patients.
Dr. Tohamy highlighted the various psychological issues that burn survivors deal with along their recovery journey. These issues are caused mainly by mental stress following the tragic accident itself or the consequent scars or deformities leaving permanent damage on the patient’s mentality. We learnt that depression is one of the main issues faced by burn victims due to social stigmatization, isolation, and negative body image due to scarring. Hence, Dr. Tohamy advised us to focus our platform on the minimization of scar formation while treating burn wounds, this way we could reduce the psychological complications caused by burn injuries.
We started our meeting with Dr. Tohamy by explaining the main idea of our project while highlighting that our ultimate priority is to help burn survivors lead a normal life in the future. Then, we explained the importance of integrating all the aspects that affect our stakeholders in our project, as these aspects help us build our core values along our journey and also guide us towards the optimization of our platform. This is why we wanted to learn about the psychological effects of burns and the management of burn victims from a psychological point of view. We also explained the impact of Human Practices as a fundamental part of our project making our approach better and even more responsible for the world.
Dr. Tohamy was fascinated by our therapeutic approach and even more fascinated by our dedication to make a change in the life of burn victims. So he started explaining different psychological insights caused by unfortunate stressful events such as burns, accidents, etc. Adding to the physical and physiological effects of these events on patients’ life, these patients also deal with unbearable distress that could lead to many mental illnesses on the long-term. PTSDs, anxiety, depression and even substance abuse all are common psychological disorders caused by major traumas like burns. However, different management techniques are used to deal with this kind of traumas preventing their regression to serious disorders like the ones mentioned above. The management of such traumas is individualized according to environmental and genetic predisposition of each patient. In general, essential management plans would often include Cognitive Behavioral Therapy (CBT), Cognitive Processing Therapy (CPT) and specific psychological medications according to the patient’s symptoms.
Dr. Tohamy also mentioned that severe burns like third degree burn could affect the brain causing acute brain damage leaving no place for medical care to intervene or to stop the destructive course of such a dramatic injury. Unfortunately, the life expectancy of these patients is very low and even our novel approach would be of little benefit due to the vulnerability and destruction caused by the burn.
After this meeting, we plan to communicate our knowledge with more burn survivors to ensure that we acquired the social and ethical backgrounds necessary for our project, which is the main goal of this stage of our Integrated HP.
Head of Psychiatry Department at AFCM
As burn survivors are considered our primary stakeholders, we had a constant objective throughout our journey, which is to gain broader insights about their life and all the struggles they encounter. So we met with a psychiatrist, Dr. Tohamy, who has a great experience in dealing with different Post-Traumatic Disorders (PTSD) patients, especially post-burn patients.
Dr. Tohamy highlighted the various psychological issues that burn survivors deal with along their recovery journey. These issues are caused mainly by mental stress following the tragic accident itself or the consequent scars or deformities leaving permanent damage on the patient’s mentality. We learnt that depression is one of the main issues faced by burn victims due to social stigmatization, isolation, and negative body image due to scarring. Hence, Dr. Tohamy advised us to focus our platform on the minimization of scar formation while treating burn wounds, this way we could reduce the psychological complications caused by burn injuries.
We started our meeting with Dr. Tohamy by explaining the main idea of our project while highlighting that our ultimate priority is to help burn survivors lead a normal life in the future. Then, we explained the importance of integrating all the aspects that affect our stakeholders in our project, as these aspects help us build our core values along our journey and also guide us towards the optimization of our platform. This is why we wanted to learn about the psychological effects of burns and the management of burn victims from a psychological point of view. We also explained the impact of Human Practices as a fundamental part of our project making our approach better and even more responsible for the world.
Dr. Tohamy was fascinated by our therapeutic approach and even more fascinated by our dedication to make a change in the life of burn victims. So he started explaining different psychological insights caused by unfortunate stressful events such as burns, accidents, etc. Adding to the physical and physiological effects of these events on patients’ life, these patients also deal with unbearable distress that could lead to many mental illnesses on the long-term. PTSDs, anxiety, depression and even substance abuse all are common psychological disorders caused by major traumas like burns. However, different management techniques are used to deal with this kind of traumas preventing their regression to serious disorders like the ones mentioned above. The management of such traumas is individualized according to environmental and genetic predisposition of each patient. In general, essential management plans would often include Cognitive Behavioral Therapy (CBT), Cognitive Processing Therapy (CPT) and specific psychological medications according to the patient’s symptoms.
Dr. Tohamy also mentioned that severe burns like third degree burn could affect the brain causing acute brain damage leaving no place for medical care to intervene or to stop the destructive course of such a dramatic injury. Unfortunately, the life expectancy of these patients is very low and even our novel approach would be of little benefit due to the vulnerability and destruction caused by the burn.
After this meeting, we plan to communicate our knowledge with more burn survivors to ensure that we acquired the social and ethical backgrounds necessary for our project, which is the main goal of this stage of our Integrated HP.
Date: 30/4/2024
Second visit to Helmia Military Hospital
On our second visit to Helmia Military Hospital, we decided to head to the inward and outpatient clinics to meet the burn survivors. We wanted to communicate different aspects of our project with such an important stakeholder as burn victims. This visit is considered the peak of our social engagement activities and an application of all ethical considerations upon which we developed our project through the third stage of our Integrated HP.
Like our first visit, we made sure we had a detailed agenda including all the activities and missions we are willing to achieve throughout this visit to Helmia Military Hospital. We also stated an estimated time for each activity and split the team in order to gain the maximum benefit out of this visit.
Here is a copy of our second Helmia Hospital visit Agenda.| Activity | Estimated Time | Team Members |
|---|---|---|
| Interview with Dr. Ahmed Harfoush | 30 mins |
|
| Touring hospital wards and teach burn prevention tips | 60 mins | All team members (divided into groups of two) |
| Burn patients’ survey | 90 mins |
|
Burn Guidebook | 30 mins | All team members |
We planned this second visit with four main goals in mind:
1- Meeting with one of the most famous plastic surgeons around the city: Dr. Ahmed Harfoush
2- Teach all patients about the first aid measures followed at the time of burn injuries and give them essential tips about burn prevention in different settings. (home, school, work,…)
3- Fill out our burn patients’ survey
4- Take patients on a brief journey through our Burn Guidebook
During our second visit to Helmia Hospital, we had the chance to meet with one of the most skillful Plastic Surgeons around the country, Dr. Ahmed Harfoush.
After this meeting, our team headed to the inward section to meet the burn survivors. We had the opportunity to talk to patients from different age groups, with different social backgrounds and various depth of injuries. Within a very short period of time, we found ourselves noting a list of inspiring stories that could be assembled in a novel full of lessons about compassion, adaptation and bravery. It was very hard for us to stay professional with all these emotional tails, but at the end of the day we managed to turn these feeling into motivation to keep us on track in our journey against burn injuries.
After hearing their stories, we wanted to raise the awareness of all hospital visitors about the first aid measures followed in case of burn injuries. Hence, we divided ourselves into several groups of two and started to hold poster presentations in every ward. This was followed by the distribution of our flyers that contained a list of all the “DOs & DON’Ts” tips concerning burn prevention.
Then, we headed to the outpatient clinics where we distributed our translated Survey to more than fifty patients. After signing the Informed Consent Document, we helped the patients fill the survey in order to obtain critical insights about their recovery journey. This collected data was analyzed in details along other surveys collected along the course of our HP activities in the survey analysis section .
At the end of our second visit to Helmia Hospital, we decided to give patients an idea about our Burn Guidebook with all the interesting and helpful information it contains. Hence, we left some copies of this guidebook in the reception of the Burn Care Building in order to reach a wider population of patients that would visit the outpatient clinics of Helmia Hospital in the future.
Our second visit to Helmia Military Hospital was an important milestone in our Human Practice as we engaged with a vast population of patients, we listened to their needs and learned about their hopes and beliefs for the future. Thanks to this visit, we started taking responsibility for the realization of these patients’ hopes through the application of our therapeutic approach. Now, we have enough information to retail and refine our platform in order to optimize it to our patients’ needs and inquiries.
Dr. Harfoush is an expert in the therapeutic applications of stem cells in regenerative therapy. So we contacted him to give us more insights about the optimization of stem cell implementation in our design preventing possible side effects of burn wounds treatment.
Dr. Harfoush talked us through several clinical applications of stem cells in the restoration of skin integrity. Then, he listed different adverse effects encountered in previous clinical trials of stem cell-based therapies which should be avoided along the development of our design to ensure its safety. Thus, overshooting of stem cell-based therapies often leads to local complications like hyperkeratosis and psoriasis-like effects. In addition, stem cells could rarely cause major health problems as thrombosis, fibrosis, and tumor formation. Therefore, we must engineer our stem cells to tightly control their activity according to the severity of the burn injury.
Our meeting with Dr. Harfoush was an important step to guarantee a fundamental value for our project which is safety. As an expert in regenerative medicine, Dr. Harfoush was quiet interested in our platform especially the way we depend on stem cells innate regenerative functions in boosting the wound healing process. He also added that choosing burns as a proof of concept for this therapeutic approach is such a smart idea, as burn wounds occur in skin which features assistant factors for healing like collagen tissue repair, adequate blood supply, and active cells migration.
However, multiple safety measures should be adopted into our design in order to prevent the side effects of stem cells locally and systemically. These measures include the control of engineered stem cells expression in case of burn injury according to the depth and extent of the wound. Therefore, we could ensure adequate wound closure, minimal scarring, and least side effects compared to other burn wounds treatment options.
We must direct our literature research and our upcoming scientific work towards the development of a controlled expression of our engineered stem cells to ensure safety and optimal delivery of our platform according to the degree and the severity of burn injury.
Consultant of Plastic and Hand Surgery ,Head of the Plastic and Reconstructive Surgery Department at AFCM
Dr. Harfoush is an expert in the therapeutic applications of stem cells in regenerative therapy. So we contacted him to give us more insights about the optimization of stem cell implementation in our design preventing possible side effects of burn wounds treatment.
Dr. Harfoush talked us through several clinical applications of stem cells in the restoration of skin integrity. Then, he listed different adverse effects encountered in previous clinical trials of stem cell-based therapies which should be avoided along the development of our design to ensure its safety. Thus, overshooting of stem cell-based therapies often leads to local complications like hyperkeratosis and psoriasis-like effects. In addition, stem cells could rarely cause major health problems as thrombosis, fibrosis, and tumor formation. Therefore, we must engineer our stem cells to tightly control their activity according to the severity of the burn injury.
Our meeting with Dr. Harfoush was an important step to guarantee a fundamental value for our project which is safety. As an expert in regenerative medicine, Dr. Harfoush was quiet interested in our platform especially the way we depend on stem cells innate regenerative functions in boosting the wound healing process. He also added that choosing burns as a proof of concept for this therapeutic approach is such a smart idea, as burn wounds occur in skin which features assistant factors for healing like collagen tissue repair, adequate blood supply, and active cells migration.
However, multiple safety measures should be adopted into our design in order to prevent the side effects of stem cells locally and systemically. These measures include the control of engineered stem cells expression in case of burn injury according to the depth and extent of the wound. Therefore, we could ensure adequate wound closure, minimal scarring, and least side effects compared to other burn wounds treatment options.
We must direct our literature research and our upcoming scientific work towards the development of a controlled expression of our engineered stem cells to ensure safety and optimal delivery of our platform according to the degree and the severity of burn injury.
By the beginning of May, we have successfully engaged relevant sectors and collected feedback to guide the development of several essential aspects of our project. We started by ensuring the ethical validation of our approach taking in consideration future ethical regulations required to transfer our platform from lab to market. After expert consultation, we managed to determine the clinical framework for the application of our platform. Thus, our product would target deep second degree and third degree burns, and it will be administered topically at the wound site combined with corresponding antimicrobials followed by a closed dressing. The dosage should vary according to the surface area and the depth of the wound, with a maximum of 3 doses separated by a ten-day interval.
To ensure a true communication of our project with the real-world, we visited the largest two foundations in our country specialized in burn research and management which are Ahl-Masr Hospital and Helmia Military Hospital. Both of these visits provided us with essential feedback from relevant experts and also important insights from burn survivors. This has resulted in multiple modifications in our design to satisfy the needs and values of different stakeholders.
Thanks to our active real-world engagement, we decided to focus our therapeutic approach towards the minimization of scar formation preventing the life-long physical, social, and psychological problems encountered by burn patients during their recovery process. We also need to implement a controlled expression system to reduce all possible adverse effects of our engineered stem cell-based therapy. This way we could ensure the effectiveness and safety of the wound healing process with minimal complications.
Since the beginning of our journey, we tried to reach out for the high risk populations of burns, especially low-socioeconomic households for whom we aspire to make our product available and accessible. This is why, we focused on the induction of wound healing to reduce hospital length of stay, decrease DALYs, and also empower early social reintegration. Therefore, we could relieve the burden of burns not just on patients and their families, but also on the society as a whole.
In this stage of our project, we start the integration of the theoretical concepts -resulting from our literature research and expert reviews- into a real product that could serve in the management of acute burn injuries.
Following the recommendations of experts and under the supervision of our PIs, we seek to validate every modification in our design. This validation is guided by the instructions of relevant published literature, and parallel to that, the evaluation of different alterations through laboratory experimentation.
Our goal through this stage is to develop a novel modular dynamic system which would be able to enhance the performance of our cell-based therapeutic platform in achieving optimum tissue healing, while preserving the safety boundaries of regenerative gene therapy. By the end of this stage, we aim to modulate the design of our platform creating a stem cell-based occlusive nutritive gel of healing. Thus, we would like to call this platform SONG-H, to make sure our approach leaves an unforgettable impression on all relevant stakeholders.
Researcher in molecular biology, regenerative medicine and mesenchymal stromal cells and tissue engineering for skin wound healing
We needed to select a specific type of stem cells to be adopted as a dynamic vector carrying out our therapeutic platform. By looking up the literature, we managed to set a criteria for the main features required in our stem cell line. This criteria includes the ability to differentiate to multiple cell lines, the ease of extraction, the affordability, and also low incidence of immune rejection. To help us make this cell selection, we met with Dr. Zomer.
Dr. Zomer recommended using Mesenchymal Stem Cells (MSCs) in our therapeutic approach as these cells meet our selection criteria in terms of accessibility, ease of extraction from different available tissues, and great ability of cell differentiation. Additionally, Dr. Zomer added that we could benefit from other unique innate features of MSCs in tissue repair, such as their immune-regulatory functions, exosome-based intercellular communication, and also targeted delivery to specific organs. These features can significantly ensure effective delivery of our therapeutic agents.
Our meeting with Dr. Zomer was a fundamental step in the beginning of the validation process of our concept. We needed to make an important choice regarding the type of stem cells to be implemented in our design. We also could not set an accurate framework for the stromal characteristics required for proper induction of wound healing through our platform.
Dr. Zomer helped us understand important insights about different stem cell types and their special features. As an experienced researcher in regenerative medicine, she highlighted the great contribution of MSCs in recent technological advancements of regenerative medicine. MSCs were actually validated experimentally and clinically in previous regenerative approaches. Therefore, we decided to adopt MSCs as a core element in our design.
Dr. Zomer also explained that MSCs implementation provide us with two different options for transgene delivery, either through the whole MSCs or through exosomes alone. We learnt that each option would modulate the delivery of our therapeutic platform in a different dynamic way. As a result, we decided to combine both methods by using the whole functional cell along with its extracellular vesicles in order to achieve optimal transgene delivery of our regenerative agents.
After choosing MSCs for the effective delivery of our platform, we need to reinforce the regenerative functions of MSCs at the injured site, as we aim to achieve the best regenerative outcomes of wound healing.
We wanted to find a therapeutic agent that could enhance tissue regeneration, as implementing MSCs alone would not be enough to achieve effective and controlled wound healing. Thus, we needed to learn more about the cellular and molecular features that could be modulated to improve the wound healing process.
Dr. Abou-el-Enein gave us a brief about different effector proteins and regulatory genes that could contribute to the enhancement of wound healing mechanisms. He highlighted that different therapeutic agents modulate the internal pathway responsible for stem cell proliferation, differentiation, and regeneration. Hence, while looking up some very recent studies, we came along a protein called Yes-Associated Protein (YAP), which is a transcription activator regulating stem cells regenerative functions. After discussing the potential regenerative abilities of YAP with Dr. Abou-el-Enein, we concluded that this protein would fit ideally in our design.
As our approach aims to achieve optimal tissue repair, we wanted to enhance the regenerative abilities of our previously implemented MSCs. According to Dr. Abou-el-Enein, this could not be done without adding an effector protein or a regulatory gene directed to the promotion of MSCs regenerative functions. Dr. Abou-el-Enein advised us to search for therapeutic agents that modulate the internal pathway responsible for stem cell proliferation, differentiation, and regeneration. Through this modulation, these agents could achieve better healing outcomes in different non-regenerative tissues like cardiac, neural, hepatic, and also skin tissues.
After reviewing several papers addressing the previous topic, we found a recently discovered protein called YAP that works as a transcription activator for stem cell functions. Then, we discussed with Dr. Abou-el-Enein the possibility of modulation of YAP functions to match our design’s targets. Finally, we concluded that YAP could help us control stem cell proliferation at the injured site to promote proper tissue regeneration.
After modulating SONG-H to achieve proper tissue repair, we need to find a suitable mode of delivery for our new technology to reach its target cells in the disturbed microenvironment of the burn wound.
Associate Professor, Medicine (Oncology), Pediatrics, Stem Cell Biology and Regenerative Medicine, Keck School of Medicine of USC; ,Executive Director, USC/CHLA Cell Therapy Program; Member, USC Norris Comprehensive Cancer Center
We wanted to find a therapeutic agent that could enhance tissue regeneration, as implementing MSCs alone would not be enough to achieve effective and controlled wound healing. Thus, we needed to learn more about the cellular and molecular features that could be modulated to improve the wound healing process.
As our approach aims to achieve optimal tissue repair, we wanted to enhance the regenerative abilities of our previously implemented MSCs. According to Dr. Abou-el-Enein, this could not be done without adding an effector protein or a regulatory gene directed to the promotion of MSCs regenerative functions. Dr. Abou-el-Enein advised us to search for therapeutic agents that modulate the internal pathway responsible for stem cell proliferation, differentiation, and regeneration. Through this modulation, these agents could achieve better healing outcomes in different non-regenerative tissues like cardiac, neural, hepatic, and also skin tissues.
After reviewing several papers addressing the previous topic, we found a recently discovered protein called YAP that works as a transcription activator for stem cell functions. Then, we discussed with Dr. Abou-el-Enein the possibility of modulation of YAP functions to match our design’s targets. Finally, we concluded that YAP could help us control stem cell proliferation at the injured site to promote proper tissue regeneration.
After modulating SONG-H to achieve proper tissue repair, we need to find a suitable mode of delivery for our new technology to reach its target cells in the disturbed microenvironment of the burn wound.
Assistant lecturer of Biomedical Research at AFCM
As we are targeting skin burn injuries, we considered multiple modes of delivery for the topical application of our engineered MSCs on the skin. Through literature research, we came across different types of scaffolds that support the delivery and release of drugs to the skin, such as natural collagen scaffolds, synthetic polymers scaffolds, and 3D-printed scaffolds. To choose a convenient scaffold for our platform delivery, we contacted Dr. Galal who is a specialist in drug design and development.
Dr. Galal highlighted the vulnerability of MSCs when applied topically at the wound site, due to several microenvironment stressors which could lead to phenomenon of cellular aging and decline in stromal regenerative abilities known as Senescence. Therefore, Dr. Galal recommended introducing our engineered MSCs through a protective scaffold to provide stem cells’ resilience in the wound microenvironment. After exploring many options, we chose Hydrogel scaffold as the mode of delivery of our novel healing technology.
Through this meeting, we needed to find an effective mode of delivery for our engineered MSCs to overcome different injured-site hazards which could lead to a Senescence state of stem cells. This phenomenon is characterized by cellular aging combined with a decline in cellular regenerative abilities. Thus, Dr. Galal advised us to look up the literature for different types of protective scaffolds in order to find a suitable type for the delivery of our MSCs.
In addition, Dr. Galal recommended that the implemented scaffold should provide a structural nutritive support to enhance stem cells’ resilience in wound microenvironment. Among the various options that we came across in the literature, we selected Hydrogel scaffold as it offers protection of MSCs from microenvironment stressors, ensures waste removal, and also promotes specific cell behavior required for tissue repair.
After the selection of the Hydrogel scaffold as our mode of delivery, we want to ensure proper implantation of the engineered MSCs to enhance the therapeutic efficiency of our platform.
By the end of May, our theoretical approach has reached its peak thanks to deep research efforts done by the team and also constant feedback collected from different experts. We have successfully highlighted a clear framework which includes our engineered MSCs as vectors, YAP as effector therapeutic agents, and Hydrogel scaffold as our mode of delivery. We also implemented Hyaluronic Acid (HA) as an essential component of our Hydrogel to benefit from its significant role in angiogenesis and normal tissue remodeling.
owever, this concept still cannot be transformed into a real product or achieve its therapeutic targets, as it lacks different types of experimental validation. In other words, we need to consider the major risks which may interfere with our enhanced healing process like infections and hyper inflammatory states. As a result, we plan to add multiple therapeutic substances like antimicrobials, anti-inflammatory, and anti-oxidants to our platform in the future.
For now, we need to get back to our PIs with the latest form of our concept design in order to get ahead with the experimental assessment of different components of our platform. This upcoming phase would depend mainly on the laboratory characterization through Dry lab, Wet lab, and Mathematical Modelling.
By the end of May, our theoretical approach has reached its peak thanks to deep research efforts done by the team and also constant feedback collected from different experts. We have successfully highlighted a clear framework which includes our engineered MSCs as vectors, YAP as effector therapeutic agents, and Hydrogel scaffold as our mode of delivery. We also implemented Hyaluronic Acid (HA) as an essential component of our Hydrogel to benefit from its significant role in angiogenesis and normal tissue remodeling.
owever, this concept still cannot be transformed into a real product or achieve its therapeutic targets, as it lacks different types of experimental validation. In other words, we need to consider the major risks which may interfere with our enhanced healing process like infections and hyper inflammatory states. As a result, we plan to add multiple therapeutic substances like antimicrobials, anti-inflammatory, and anti-oxidants to our platform in the future.
For now, we need to get back to our PIs with the latest form of our concept design in order to get ahead with the experimental assessment of different components of our platform. This upcoming phase would depend mainly on the laboratory characterization through Dry lab, Wet lab, and Mathematical Modelling.
Assistant Lecturer of Biotechnology and Pharmacotherapeutics, German University in Cairo (GUC)
Starting from June, our scientific team started the integration of multiple synthetic biology technologies to build the final design of our therapeutic platform. Throughout the months of June and July, we added several modifications in our dynamic system to guide its scientific development into an effective wound healing mediator while bearing in mind fundamental safety boundaries.
Under the supervision of our PIs, we directed all our efforts towards the scientific validation of every alteration we add on our modular system. This validation took place through 3 different processes: Dry lab, Wet lab, and Mathematical Modelling. More information on each of the previous processes could be found on the pages of Dry lab, Results, and Modelling.
It is also important to mention that our team has encountered a lot of difficulties to get different biological products and laboratory materials necessary for the scientific validation of our platform. Moreover, due to the lack of most of the required materials in our local markets, we had to order them from different international manufacturers, which cost us a lot of time and lead to a delay in certain laboratory experimentations. However, we tried to overcome these time-consuming Wet lab constraints by validating many system modifications based on experimental characterization from related studies, software validation and visualization tools, and finally mathematical modelling performance simulations.
This marks the end of the fourth stage of our Integrated HP journey where we showed the way SONG-H was optimized and modified according to stakeholders’ feedback along with literature research; to be finally integrated into the lab for scientific validation. Now, SONG-H is ready to get ahead to the next stage of this journey where it is transferred from the lab into the market as an original product.
Since the beginning of August, we are ready to learn about the necessary steps to transfer our therapeutic platform from lab to market. To do that, we need to meet experts in various fields, such as ethics, regulations, and the drug industry. Stakeholders from each group should guide us throughout the implementation of SONG-H into the real-world. Thus, we intend to start by gathering essential ethical considerations regarding the social engagement of patients in our project through surveys, meetings, and visits. We want to stick to our Human Practices’ values while providing justice, privacy, beneficence, and above all safety for every person taking part in our project. Besides, we should learn about necessary approvals required for the pre-clinical and clinical trials of SONG-H. After that, we will focus on drawing a detailed timeline for the implementation plan of our project. Hence, we should refer to national and international guidelines and specialized organizations to learn about the regulatory framework, which is going to pave the way for the upcoming validation phases of our drug. Then, we want to ensure a solid protection for the novel technology adopted in SONG-H. This is why we should reach out to law experts to talk us through the requirements of filing a patent to provide the protection for our Intellectual Property through various phases of clinical validation. At the end of this stage, we want to contact some well-established pharmaceutical companies in order to build the necessary partnerships that will shape our entrepreneurship model. Thanks to these large drug manufacturers, we will be able to highlight the unique value that SONG-H provides among existing burn treatment options in the market.
Public Health Consultant and Advisor for the World Health Organization, Egyptian Environmental Affairs Agency
Taking a drug to the market involves a complex process with multiple phases which require time and resources. So we wanted to have better knowledge about drug licensing steps locally and the requirements to comply with regulatory guidelines. Additionally, we wanted to inquire about the verified clinical trial facilities and understand the overall time and cost involved in the drug licensing process.
Meeting with representatives of the Egyptian Drug Authority helped us gain a better understanding of regulatory guidelines and the phases of the EDA for drug licenses which helped in drawing our timeline and the implementation plan of the drug.
Taking a drug to the market involves a complex process with many phases. It starts from the discovery and preclinical research, goes through clinical trials, and ends with a new drug application (NDA). We need to understand the regulatory steps required for licensing our drug locally and the requirements to comply with regulatory guidelines. We knew in advance that the EDA was participating in the African Health Excon conference, so we met with their representatives to introduce ourselves and our project. They informed us that our project involves biologicals and falls under a special department for drugs that use stem cell therapy. We then inquired about the drug approval process, and they explained that the key phases of EDA include the submission of a drug application with all required documentation such as the drug formula, clinical trial data, and labeling and packaging information. This is followed by the evaluation phase which involves a technical assessment of safety, efficacy, and quality, as well as an assessment of the clinical data. After the interpretation, a decision is made whether to approve or reject the marketing of the drug. If approved it will be followed by post-market surveillance. Finally, we inquired about the clinical trial facilities verified by the FDA and started negotiating with them regarding the overall cost and estimated duration for the phases of drug approval. They provided us with all the necessary responses to consider for future drug licensing.
Since we knew the regulations and requirements of local drug licensing and the overall cost and time needed. We made a timeline that included the average time for each phase and presented it, along with the overall cost, to our PI. Then, we needed to reach out to an FDA representative to get a better understanding of the global drug licensing requirements.
Egyptian Drug Authority
Taking a drug to the market involves a complex process with multiple phases which require time and resources. So we wanted to have better knowledge about drug licensing steps locally and the requirements to comply with regulatory guidelines. Additionally, we wanted to inquire about the verified clinical trial facilities and understand the overall time and cost involved in the drug licensing process.
Meeting with representatives of the Egyptian Drug Authority helped us gain a better understanding of regulatory guidelines and the phases of the EDA for drug licenses which helped in drawing our timeline and the implementation plan of the drug.
Taking a drug to the market involves a complex process with many phases. It starts from the discovery and preclinical research, goes through clinical trials, and ends with a new drug application (NDA). We need to understand the regulatory steps required for licensing our drug locally and the requirements to comply with regulatory guidelines. We knew in advance that the EDA was participating in the African Health Excon conference, so we met with their representatives to introduce ourselves and our project. They informed us that our project involves biologicals and falls under a special department for drugs that use stem cell therapy. We then inquired about the drug approval process, and they explained that the key phases of EDA include the submission of a drug application with all required documentation such as the drug formula, clinical trial data, and labeling and packaging information. This is followed by the evaluation phase which involves a technical assessment of safety, efficacy, and quality, as well as an assessment of the clinical data. After the interpretation, a decision is made whether to approve or reject the marketing of the drug. If approved it will be followed by post-market surveillance. Finally, we inquired about the clinical trial facilities verified by the FDA and started negotiating with them regarding the overall cost and estimated duration for the phases of drug approval. They provided us with all the necessary responses to consider for future drug licensing.
Since we knew the regulations and requirements of local drug licensing and the overall cost and time needed. We made a timeline that included the average time for each phase and presented it, along with the overall cost, to our PI. Then, we needed to reach out to an FDA representative to get a better understanding of the global drug licensing requirements.
Medical Officer (Pharmacovigilance and Drug Risk Mitigation) EMMES - USA ,Former fellow of the NIH and the FDA
We met with Dr.Elfeky, one of the most recognized individuals in his field, to gain more insights about FDA regulations and specific preclinical studies we should prioritize for developing our drug, which is based on engineered MSCs. Additionally, we sought his guidance throughout the drug validation process.
The meeting with Dr. Elfeky increased our awareness of the potential limitations we may face during preclinical studies, particularly in the use of stem cells. He also provided detailed information about the phases of drug approval, which helped us formulate our timeline for the upcoming years.
Dr. Ashraf Elfeky's extensive expertise in the FDA and the DEA has established him as one of the most recognized individuals in his field. We met with him to gain more insights about FDA regulations and specific preclinical studies we should prioritize for developing our drug, which is based on engineered MSCs. Dr. Elfeky emphasized that FDA regulations are detailed on their website and that it's challenging for any drug to pass the approval phases. Therefore, a constant fund should be guaranteed as the phases are quite expensive and can take years of testing and experiments.
During our discussion, we shared our progress with our lab work and our timeline going forward. Dr. Elfeky advised us to focus on preclinical studies for now, as this phase is where drugs are usually rejected. He stressed that several specific preclinical studies are essential to prioritize when utilizing mesenchymal stem cells. These include the characterization of the MSCs through phenotypic analysis and genetic stability assessment to confirm the identity and genetic integrity of the engineered MSCs over multiple passages. Additionally, in vitro efficacy studies to evaluate the therapeutic potential of the engineered MSCs through relevant in vitro assays, and safety studies by cytotoxicity assays to assess the toxicity of the engineered MSCs to ensure they do not induce adverse effects in target cells. Dr. Elfeky emphasized that these steps are crucial to validate our drug in vitro, followed by in vivo studies, pharmacokinetics, and pharmacodynamics studies.
He concluded by advising us to continue our work, as biologicals are a promising field in drug manufacturing. We expressed our gratitude to Dr. Elfeky for his time and effort and scheduled another meeting with him after progressing further with our drug development.
Since we are aware of the regulations of the EDA and FDA, we need to protect our work by filing a patent with the Egyptian Patent Office. This will ensure that our intellectual property is protected and its details are not disclosed to anyone.
Mr. Kirsha's extensive experience in this field has made him one of the most reliable attorneys to depend on. We met with Mr. Kirsha to gain better insights into how to protect our intellectual property and to determine whether our project is patentable. Additionally, we wanted to ensure that all our work is protected at every step we take with our project.
The meeting with Mr. Kirsha was very valuable. He emphasized the importance of signing a non-disclosure agreement with every stakeholder involved in our project and lab protocols to protect our intellectual property. Additionally, he offered to assist us with filing patent applications at the Egyptian Patent Office and suggested working with a global attorney to file patent applications at the European Patent Office.
To ensure that our intellectual property is protected in all ways possible through the project we get in contact with Mr.Kirsha an expert in the field of intellectual property protection. Mr. Kirsha's long experience in this field made him one of the most reliable attornies to depend on also he has a background in the drug discovery field. We had a meeting with him on a date and discussed with him all the aspects of our project and our main pillars to see whether our project is patentable or not. He responded positively that drugs that involve engineering mesenchymal stem cells are patentable providing they achieve the criteria of being novel, meeting the ethical and regulatory considerations, and having specific utility. He added that further search is needed to make sure of the novelty of our drug and that no other drug is licensed with the same protocol and function. We asked him about when we should start applying for the patency, and he responded that in the future after the end of the pre-clinical trials and the start of the clinical trials, a patent file should be applied in the Egyptian patent office(EGYPO) consequently with the clinical trials phases. He added that until the pre-clinical trials end a non-disclosure agreement(NDA) should be signed by anyone who gets access to the project's lab protocols to ensure confidentiality.
After meeting with Mr. Kirsha, we now know how to file a patent application locally and protect the confidentiality of our idea. Our next step is to find a global attorney specializing in patent applications at the European Patent Office, so we can file a patent application and protect our idea across European countries.
Mr. Kirsha's extensive experience in this field has made him one of the most reliable attorneys to depend on. We met with Mr. Kirsha to gain better insights into how to protect our intellectual property and to determine whether our project is patentable. Additionally, we wanted to ensure that all our work is protected at every step we take with our project.
The meeting with Mr. Kirsha was very valuable. He emphasized the importance of signing a non-disclosure agreement with every stakeholder involved in our project and lab protocols to protect our intellectual property. Additionally, he offered to assist us with filing patent applications at the Egyptian Patent Office and suggested working with a global attorney to file patent applications at the European Patent Office.
To ensure that our intellectual property is protected in all ways possible through the project we get in contact with Mr.Kirsha an expert in the field of intellectual property protection. Mr. Kirsha's long experience in this field made him one of the most reliable attornies to depend on also he has a background in the drug discovery field. We had a meeting with him on a date and discussed with him all the aspects of our project and our main pillars to see whether our project is patentable or not. He responded positively that drugs that involve engineering mesenchymal stem cells are patentable providing they achieve the criteria of being novel, meeting the ethical and regulatory considerations, and having specific utility. He added that further search is needed to make sure of the novelty of our drug and that no other drug is licensed with the same protocol and function. We asked him about when we should start applying for the patency, and he responded that in the future after the end of the pre-clinical trials and the start of the clinical trials, a patent file should be applied in the Egyptian patent office(EGYPO) consequently with the clinical trials phases. He added that until the pre-clinical trials end a non-disclosure agreement(NDA) should be signed by anyone who gets access to the project's lab protocols to ensure confidentiality.
After meeting with Mr. Kirsha, we now know how to file a patent application locally and protect the confidentiality of our idea. Our next step is to find a global attorney specializing in patent applications at the European Patent Office, so we can file a patent application and protect our idea across European countries.
European Patent Attorney at GJE intellectual property
Mr. Cummings is an expert European patent attorney. We contacted him based on Mr. Kirsha's request to find a global attorney to file a patent application in the European Union. We also wanted to understand the details, including the phases, costs, and timeline, in order to present this information to our PI and to incorporate it into our project's implementation plan for our drug.
The meeting with Mr. Cummings allowed us to have better knowledge about how to protect our intellectual property worldwide especially if we are targeting the European and the US societies. He informed us about the timeline frame, the requirements, and the costs estimated for all the phases of the patent file application.
To expand our patent globally, we contacted Mr. Ross Cummings, a European patent attorney at GJE Intellectual Property. He advised us on the essential steps required to file for patents in European countries. He recommended applying for a patent application in the European Patent Office (EPO) once the local patent application is completed. Mr. Cummings explained that the EPO regulations are complex and it can take two to five years for the application to be granted. We thoroughly discussed each step of the regulations and reached an agreement with him after the approval of our PI. According to Mr. Cummings, the first step is to prepare the application which he is going to send a sample from it to us, then the application is filed in the EPO. Following the submission, the patent office conducts a formal examination to ensure compliance with formal requirements, which could take around three months. Substantive examination follows and could take between one to three years. Once the examination is completed, it may take a few months to receive the grant, after which the patent needs to be validated in different patent offices worldwide. We also discussed the costs involved, and Mr. Cummings informed us that the process is quite expensive. He provided a breakdown of the costs for each step individually.
After meeting with Mr. Cummings, we now have a clear vision of how we are going to protect our intellectual property globally, which will help us in preparing our entrepreneurship model.
We reached out to Mr. Youssef, who represents LUNA Cosmetics at the African Health Conference, to discuss the possibility of having our drug manufactured at their facilities. We are aware that LUNA has the necessary facilities and experts for this. Collaborating with this company would give us access to their extensive network of researchers, doctors, and regulatory experts. This collaboration would allow us to benefit from their experience and knowledge, while also speeding up the development and commercialization of our medicine.
After meeting with Mr. Youssef, we identified LUNA as our primary customer due to their excellent facilities, well-trained staff, and experts who can help bring our drug to the market. Additionally, Mr. Youssef clarified the steps for LUNA to become the external manufacturer of our drug. He also provided insights about our indirect competitors, such as the anti-scarring agents, and the available opportunities.
After conducting thorough research and discussions, we found that building facilities for large-scale productions from scratch would be impractical and time-consuming, in addition to its high cost and lack of expertise.
Therefore, we have identified LUNA Cosmetics as the ideal partner, as they possess the financial resources and necessary knowledge to distribute our medicine and make it accessible to those in need. During the African Health Excon, we met with Mr. Sherif Youssef, the project development manager at LUNA Cosmetics, and presented our project and unique selling point compared to our competitors. Mr. Youssef welcomed the idea and highlighted the shift towards regenerative medicine over invasive surgeries in current research. He also mentioned the significant investments being made in anti-scarring agents, with new competitors continually introducing innovative features.
In our discussions, we explored opportunities for collaboration with established firms such as LUNA. Mr. Youssef emphasized that bringing drugs to the market is a challenging journey with numerous obstacles, requiring time and resources. However, once we reach further with our drug beyond the pre-clinical and clinical phases and obtain patency. Then we should begin negotiations with the company for the manufacture of the drug on a large scale. We thanked him for his efforts and time and he invited us to visit one of their facilities to have a better experience.
Working with this corporation will provide us access to their extensive network of researchers, doctors, and regulatory experts. This allows us to learn from their experience and knowledge while also accelerating the development and commercialization of our medicine.
After that meeting, we found the opportunity to scale the production of our drug in partnership with LUNA. The next step is securing an effective marketing plan after the approval of our drug to guarantee its high reach and demand.
International Marketing Project Manager Assistant for LUNA
We reached out to Mr. Youssef, who represents LUNA Cosmetics at the African Health Conference, to discuss the possibility of having our drug manufactured at their facilities. We are aware that LUNA has the necessary facilities and experts for this. Collaborating with this company would give us access to their extensive network of researchers, doctors, and regulatory experts. This collaboration would allow us to benefit from their experience and knowledge, while also speeding up the development and commercialization of our medicine.
After meeting with Mr. Youssef, we identified LUNA as our primary customer due to their excellent facilities, well-trained staff, and experts who can help bring our drug to the market. Additionally, Mr. Youssef clarified the steps for LUNA to become the external manufacturer of our drug. He also provided insights about our indirect competitors, such as the anti-scarring agents, and the available opportunities.
After conducting thorough research and discussions, we found that building facilities for large-scale productions from scratch would be impractical and time-consuming, in addition to its high cost and lack of expertise.
Therefore, we have identified LUNA Cosmetics as the ideal partner, as they possess the financial resources and necessary knowledge to distribute our medicine and make it accessible to those in need. During the African Health Excon, we met with Mr. Sherif Youssef, the project development manager at LUNA Cosmetics, and presented our project and unique selling point compared to our competitors. Mr. Youssef welcomed the idea and highlighted the shift towards regenerative medicine over invasive surgeries in current research. He also mentioned the significant investments being made in anti-scarring agents, with new competitors continually introducing innovative features.
In our discussions, we explored opportunities for collaboration with established firms such as LUNA. Mr. Youssef emphasized that bringing drugs to the market is a challenging journey with numerous obstacles, requiring time and resources. However, once we reach further with our drug beyond the pre-clinical and clinical phases and obtain patency. Then we should begin negotiations with the company for the manufacture of the drug on a large scale. We thanked him for his efforts and time and he invited us to visit one of their facilities to have a better experience.
Working with this corporation will provide us access to their extensive network of researchers, doctors, and regulatory experts. This allows us to learn from their experience and knowledge while also accelerating the development and commercialization of our medicine.
After that meeting, we found the opportunity to scale the production of our drug in partnership with LUNA. The next step is securing an effective marketing plan after the approval of our drug to guarantee its high reach and demand.
Health insurance Company
Mr. Ahmed Azzam ,CEO of Triple-A advertising agency
While developing the SONG-H entrepreneurship model, we aim to seek expert validation for our work, particularly when working on the commercialization plan. To achieve this, we met with Mr. Ahmed Azzam to discuss our marketing strategy and provide him with a brief explanation of our drug. We also explored potential options that could aid in the commercialization of our drug and increase its demand among consumers.
The meeting with Mr. Azzam aided in the development of our commercialization plan in the entrepreneurship model in addition to the marketing campaign post drug approval.
When we started developing our marketing strategy, we knew we would face numerous obstacles in introducing our new drug. Switching from the established treatment modality for burn treatment to a non-invasive one would be particularly challenging. So a good market strategy is drawn starting from regulatory approvals and patents, all the way to reaching the end users who are the patients. To ensure wide distribution and reach our potential customers, we met with Mr. Ahmed Azzam, CEO of Triple-A advertising agency. After giving a brief idea to him about our drug and our commercialization plan, he praised the idea and emphasized that marketing is all about creating a connection with the target audience.
He advised us to wait for FDA approval before launching a marketing campaign for the drug. When we inquired about the best distribution channels for our product, he emphasized the need to earn the trust of our main audience, which consists of surgeons and burn victims. This would involve conducting awareness campaigns about stem cell therapy and the emergence of regenerative medicine as a new treatment modality alongside reconstructive surgeries. Once surgeons trust the product, they will start prescribing it to patients, making them our primary gateway to reaching a larger patient base. Mr. Azzam also highlighted the significant role of health insurance companies in facilitating the drug's wider adoption through financial coverage. We expressed our gratitude for his insights and requested his supervision of our marketing strategy and assistance in future drug marketing across different channels, to which he agreed and wished us luck in completing the clinical phases of drug approval.
After meeting with Mr. Azzam, we are now aware of the marketing plan to reach our target audience. We had to meet with Mr. Azzam, a health insurance company representative, to explore the opportunities for SONG-H coverage through insurance.
Health insurance companies are significant stakeholders in the journey of bringing a drug to market. If a drug is covered by insurance, it can greatly influence the decisions made by surgeons and patients. We have reached out to Mrs. Minar to determine if our drug is covered by health insurance and to understand the steps required for our drug to be financed by the firm he represents.
The meeting with Mrs. Minar provided us with insights into the financial analysis of our product and how financing by health insurance companies could contribute to the sales and commercialization of our drug. This led us to target health insurance companies as one of our primary customers and helped us formulate our commercialization plan within the entrepreneurship model.
One of our major stakeholders is health insurance companies, which play a vital role in determining the commercial success and patient access to a drug. We reached out to Mrs. Minar to know if our drug modality could be added side by side to reconstructive surgeries as a treatment modality for burn patients. We began the meeting by introducing ourselves and providing an overview of our drug. She welcomed us and we asked about the requirements for our drug to be covered by health insurance companies. Mrs. Minar also explained that several assessments must be completed before the drug is approved for coverage. First, the drug must pass all regulatory approvals and establish a positive reputation and demand in the market as a treatment option. Subsequently, negotiations will occur regarding pricing and what will be covered by health insurance companies versus out-of-pocket expenses for patients. She even emphasized that the fewer patients have to pay out of pocket, the more likely they are to choose the treatment option, leading to higher sales. Additionally, coverage by major insurers can significantly increase the drug's adoption among healthcare providers and patients. We concluded the meeting by highlighting that a strong marketing strategy is crucial for the drug to be included in the formulary list of drugs covered by insurance.
We have received validation from all the experts we need to effectively bring SONG-H from the lab to the market. Our future market plan will be based on the detailed information provided during the previous meetings and will be discussed in detail on the our entrepreneurship page.
Head of Sales Department at Allianz Insurance Company
Health insurance companies are significant stakeholders in the journey of bringing a drug to market. If a drug is covered by insurance, it can greatly influence the decisions made by surgeons and patients. We have reached out to Mrs. Minar to determine if our drug is covered by health insurance and to understand the steps required for our drug to be financed by the firm he represents.
The meeting with Mrs. Minar provided us with insights into the financial analysis of our product and how financing by health insurance companies could contribute to the sales and commercialization of our drug. This led us to target health insurance companies as one of our primary customers and helped us formulate our commercialization plan within the entrepreneurship model.
One of our major stakeholders is health insurance companies, which play a vital role in determining the commercial success and patient access to a drug. We reached out to Mrs. Minar to know if our drug modality could be added side by side to reconstructive surgeries as a treatment modality for burn patients. We began the meeting by introducing ourselves and providing an overview of our drug. She welcomed us and we asked about the requirements for our drug to be covered by health insurance companies. Mrs. Minar also explained that several assessments must be completed before the drug is approved for coverage. First, the drug must pass all regulatory approvals and establish a positive reputation and demand in the market as a treatment option. Subsequently, negotiations will occur regarding pricing and what will be covered by health insurance companies versus out-of-pocket expenses for patients. She even emphasized that the fewer patients have to pay out of pocket, the more likely they are to choose the treatment option, leading to higher sales. Additionally, coverage by major insurers can significantly increase the drug's adoption among healthcare providers and patients. We concluded the meeting by highlighting that a strong marketing strategy is crucial for the drug to be included in the formulary list of drugs covered by insurance.
We have received validation from all the experts we need to effectively bring SONG-H from the lab to the market. Our future market plan will be based on the detailed information provided during the previous meetings and will be discussed in detail on the our entrepreneurship page.
At the end of our long integrated HP journey, we wanted to close the loop between what we learnt from relevant stakeholders and the true impact of our project on the world. This is why we engaged with a variety of stakeholders in different fields including not only healthcare providers, but also important policymakers, industry partners, and community members. In total, we reached more than 100 individuals with our work through meetings, collaborations, visits, and public engagement. This extensive outreach helped us prioritize the essential values and needs of a wide variety of stakeholders.
In addition, we were keen on getting back to the stakeholder in question after integrating their feedback, to ensure the application of their opinion in the best and the most convenient way within our project. This vital engagement of relevant sectors along with our deep literature research helped reshape the development of our platform to break through the barriers of sustainability, innovation, and also safety. Finally, we tried to close the loop between our project and the world by coming up with the plan of implementation of SONG-H. This plan includes the following; the optimized design of SONG-H required to reach its full therapeutic potential, the long-term impact of our project on relevant stakeholders, and finally the future steps that could be taken to introduce our product into the market.
ARMED FORCES COLLEGE OF MEDECINE
AFCM EGYPT iGEM 2024
