Overview
To make a great impact in our society, we wanted to target a disease that truly threatens the lives of people. Therefore, our platform’s idea was issued from our people, developed into a complete therapeutic approach, and finally returned to the people as an end to the suffering of all RA patients. This is why we made sure to establish good communication with all the people relevant to our project, which are our stakeholders”. We wanted to make our project good and responsible for the world. Hence, we developed our project upon the values and needs of the stakeholders. We also respected all the laws, regulations, and policies of the market. Furthermore, we tried to make our project responsive to our Human Practices work by integrating various perspectives and building upon different feedback. Finally, we did our best to ensure the safety and personal privacy of all members participating in our project. This is applied and implemented through all the upcoming sections of our Human Practices. Starting from the Education and its five steps. Then, the Human Practices page where you can find our Essential Human Practices with all the hospital visits, events, and also our project’s questionnaire. After that comes our Integrated Human Practices with its five stages. Finally, we reach the Entrepreneurship where we show how our project can make the leap from lab experimentation to commercialization.
Introduction
In the Integrated Human Practices of this year, we aimed to engage as many relevant stakeholders as possible. This is why we contacted experts and professors in many different fields related to our project. Then, we reflected upon every feedback and every criticism issued from these stakeholders, as we wanted to optimize our device SUPER in order to become the most feasible, effective and successful solution for Rheumatoid Arthritis (RA).
At the same time, we were aware that the development of any new technology is never all about researchers and engineers. We must have constant contact with the people who are influenced the most by this invention. Hence, these people could improve and reshape our design based on their needs and values. This value-sensitive approach could consequently help us make a great impact on the lives of those who are suffering.
Thanks to all our visits, interviews and meetings throughout the year, we created a large database for our project where we grouped all the different perspectives of the stakeholders. Next, all these reflections were implemented and integrated to pave the path for the development of our device SUPER. This integration is represented throughout our Interactive Timeline where we tell the story of our design with all our setbacks and our victories, arriving at our final complete approach.
We wanted to tell this long story in the simplest way possible. Therefore, we divided our Integrated Human Practices into five consecutive stages represented by our Interactive Timeline. The first stage is the Motivation where we reveal our main source of passion and dedication which kept us going all along the journey. Next comes the Research and Thesis stage where we gathered tons of information about the epidemiology, the pathophysiology and the regular management of RA. Then, it was time to check the feasibility and the laws regulating different types of cell-based therapy in the Ethical Background stage. After that, we explain all the milestones of our design with all the integrated modifications suggested by our stakeholders. This stage is called the Development. Finally, we show how our project started to take small steps into the real world as a true feasible drug in the Lab To Market stage. This final stage is considered a starting point for our Entrepreneurship work.
Stage I: Motivation
Our Story
Parallel to our objective this year in finding a cure for one of the prevalent autoimmune diseases in our country, we found that Rheumatoid Arthritis (RA) risk is doubled in electricians and tripled in building craftsmen. In the last few years, our country has taken tremendous steps towards the development of infrastructure and building new cities as industrial expansions. A clear example of that is the employment of about two million people just in the New Administrative Capital. Although these workers follow all the safety precautions and occupational medicine’s preventive measures, they are still at risk for various health hazards.
Here comes our role as medical students and researchers to help and protect these workers. Therefore, in cooperation with the Ministry of Health, we launched a campaign to screen the construction laborers working in the new capital city for RA using mobile clinics. We also provided them with techniques to protect themselves based on ergonomics. Hence came the idea of our project this year: developing a therapeutic approach against Rheumatoid Arthritis using synthetic biology. To ensure that we have chosen the right path, we decided to head to construction sites, hand out questionnaires, and conduct in-depth interviews with workers.
After discussing their difficult working conditions, we found that repeated motions and lifting heavy weights incorrectly lead to muscle injuries and joint pain. Before they even recognize it, this pain turns out to be Rheumatoid in origin. Unfortunately, only a small number of these workers were aware that they were suffering from RA; the majority of them were simply taking potent painkillers and over-the-counter (OTC) analgesics to get through the day.
This appears to be a turning point in the professional lives of many people because RA is a deteriorating disease. Little by little, this disease stops these workers from doing their everyday jobs and might consequently lead to their unemployment.
We explained to them the early symptoms upon which they had to head to a rheumatology clinic and seek medical advice. These important signs and symptoms include; Morning stiffness of the hand and wrist, gradual appearance of skin nodules around the elbow and changes in the normal appearance of their fingers, causing deformity. We know that there are many treatment modalities for this deteriorating disease, sometimes even leading to joint replacement surgeries. However, all these options are limited to relieving the inflammatory symptoms and easing the pain. Therefore, we aim to come up with a complete cure for this serious condition, a therapeutic tool that would target the auto-inflammatory cells to stop the propagation of the disease and -at the same time- promote the healing of injured tissues.
An extra step: Upon handing out the questionnaires we found that, unfortunately, a lot of the workers can’t read due to low economic and social status so we tried to simply explain the questionnaires. Then, we decided to take the extra step and reach out to a well-established literacy association called ”El Resala” to help these workers learn how to write and read.
Stage II: Research & Thesis
After returning from our field visit, we decided it was time to launch our ultimate search in order to gather more information about our target disease: Rheumatoid Arthritis (RA).
Thus, we divided our team into two research groups: the first was responsible for the local research about the prevalence of RA in Egypt and the currently used drugs by different patients around the country, and the second group was assigned to look up new emerging treatment modalities for the different autoimmune inflammatory diseases that have similar pathophysiology as our target disease.
Driven by our consistent desire to make an impact in our society and our passion for genetic engineering, we launched our enthusiastic research with no delay in time. All along our journey, we had one goal in mind and that is to return to our fellow construction workers with a promising cure to their suffering in the least time possible.
Our first research group tried to contact many public health professors in our college to learn more about the prevalence of auto-inflammatory diseases in our country in general. Therefore, we discovered that RA has quite a high prevalence all over Africa, not just in Egypt. According to a 2020 review, the prevalence of RA in the Middle East and Africa ranged from 0.06 to 3.4%. while the global prevalence of RA was 0.5 to 1% in developed countries.
The group also managed to meet with Dr. Tamer A Gheita, a member of the International Osteoporosis Foundation (IOF), Nyon, Switzerland.
Dr. Gheita is one of the authors of the Rheumatoid arthritis study of the Egyptian College of Rheumatology (ECR): nationwide presentation and worldwide stance. This study provided us with solid information about the epidemiology and treatment patterns of RA across Egypt. Thanks to Dr. Gheita, we learned that the age of onset of RA in Egypt was lower than that in other countries and nations, which raises the burden of RA as one of the most common diseases threatening laborers in the working-age population. Takeaway: Thanks to the first research group, we made sure that RA is one of the most common diseases in Egypt that has no effective or useful therapy up to now. So, a radical therapeutic approach acting as a complete cure for RA is needed, and that is why we directed our efforts towards using synthetic biology.
On the other hand, the second group started looking for novel treatment modalities against different autoimmune diseases. After talking to many experts in the fields of Rheumatology and Immunology, we came across a variety of new treatment approaches. Interestingly, we discovered a flourishing research field of therapy that consists of modifying a patient’s cells or cells from a donor to fight disease and improve medical conditions. This works by boosting the patient's immune function while suppressing the autoreactive cells of the immune system. This field is known as Cell-based Therapy. This emerging therapeutic field has various applications against many autoimmune inflammatory diseases based on the immune modulatory functions of various cells like B-cells and T-cells. Therefore, we started thinking about the possibility of using such cells to suppress and even eliminate the auto-reactive cells responsible for the pathophysiology of RA. Adopting this new cell-based therapeutic approach was still challenging, so we thought about using SynBio to make this hope of finding a real effective treatment for RA possible. Therefore, we accepted the challenge, as it is the only hope for creating a definitive cure for RA and putting an end to the suffering of all the RA patients in our country. Before working on the treatment modality itself, we needed to check its ethical background and ensure the legalization of our project.
Stage III: Ethical background
Mr. Amr Kirshah
Mr. Amr Kirshah: Lawyer & patent attorney at Kirshah IP. Member of the Egyptian association for the protection of industrial property (EAPPI).
Take away
We understand the importance of working with a lawyer who has experience in the pharmaceutical industry and is familiar with the detailed patent laws and regulations involved in the process. A patent attorney can offer critical guidance and support in protecting our intellectual property for our drug. After we met with the professor, he provided a clear explanation that cell based therapy is a form of medical treatment involving the use of living cells to repair or replace damaged tissue in the body or regulate the immune system. While it holds tremendous potential for transforming disease treatment, there are important ethical considerations to address. These include concerns surrounding the source of cells, their safety and effectiveness, and equitable access to the therapy.
We believe that it is essential to work with a patent attorney who is experienced in the pharmaceutical sector and at the same time an expert in patent laws and regulations. This is why we decided to contact Mr. Kirshah. After discussing our project briefly with Mr. Kirshah and the nature of the iGEM competition we are participating in. He informed us that the first step is to discuss the innovation and do a patent search to determine its patentability. Mr. Kirshah even offered to help us in the development of a patent strategy and the submission of a patent application, which contains a full description of the invention as well as claims defining its scope. He also offered assistance in responding to any office actions and making any necessary changes. Our ultimate objective is securing a patent that gives the innovation the exclusive right to be created, used, and sold. We also made it clear to him that in order to bring our medicine to the market, we will still need to discuss our findings with wet lab professionals in the upcoming months. He explained to us the significance of maintaining non-disclosure communication to ensure the protection of all our rights.
Furthermore, he weighs the significance of guiding the use of cell therapy with ethical principles such as informed consent, respect for individual autonomy, and the principle of doing good (beneficence). This ensures that patients are protected and that the therapy is employed responsibly and ethically. It is crucial to prioritize the well-being of patients and uphold ethical standards as cell therapy becomes more prevalent. The professor also cautioned against the potential commercialization of cell therapy, where profit-driven motives may overshadow the primary goal of benefiting patients. It is essential to safeguard against this risk and ensure that cell therapy is used ethically, with high consideration of the welfare of patients.
At the end of the meeting, we thanked Mr. Kirshah for his precious time and had an agreement with him to have another meeting as soon as we are done with our Wet Lab work so that we can talk more about the patency of our drug in more details.
Dr. Wagida Anwar & Dr. Mona Fouad
Dr. Wagida Anwar: The head of the Institutional Ethical Board in the Armed Forces College of Medicine.
Take away
When developing and applying cell therapy, several ethical issues must be taken into account. It is crucial to make sure that the therapy is administered in a morally and safely manner, and that patients are fully informed about any possible side effects or therapeutic limitations.
After our discussion with the professors, Dr. Mona gave us an explanation about the idea of cell therapy. Cell therapy is a type of medical treatment that aims to introduce new, healthy cells into a patient's body, to replace the diseased or missing ones or boost the immune system. Although it has a great deal of promise to change how diseases are treated, there are significant ethical issues that need to be taken into account. These include doubts about the origin of the cells, their efficacy and safety, and equality in access to the treatment.
On the other hand, Dr. Wagida showed us how important it is to make use of ethical standards like informed consent, respect for personal autonomy, and beneficence to guide the use of cell therapy. This guarantees that patients are protected and that therapy is applied responsibly and morally. As cell treatment becomes more and more common, it is crucial to put patients' needs first and acknowledge ethical standards.
Then, Dr. Mona expressed her concern about the possible commercialization of cell therapy, where profit-making interests would take precedence over the main objective of helping patients. It is important to take precautions against this risk and make sure that cell therapy is applied morally and with the greatest consideration for patients' well-being.
Finally, we took advantage of our meeting with Dr. Wagida by showing her our questionnaire in order to be revised and validated by the ethical committee and the IRB board of our college.
Dr. Hany El Saadany
Take away
We are now aware of the importance of bringing a new drug to the market, as existing drugs have numerous side effects and cause serious health concerns. Furthermore, all of these medications only reduce inflammation and do not treat the condition. As a result, getting our medicine to the market is a matter of need.
To be more oriented about the disease and to get a better scope of its effects on the patients both physiologically and psychologically, we took the opportunity to meet Dr. Hany Elsaadany, one of the most experienced Rheumatologists in the Middle East. We prepared some questions, primarily about the kinds of medications used to treat different types of patients and how to monitor patients' progress. We were amazed by the encyclopedic answers of Dr. Elsaadany as he clarified that not all the Rheumatoid Arthritis patients are seropositive but sometimes taking a detailed history and revising the patient’s daily routine got the lion’s share in diagnosing the disease. In addition, he added that the medications given to rheumatoid arthritis patients must be customized to their case as most of the drugs given have serious side effects that could harm the patient and compromise his immunity. Adding to that, medications given only calms the inflammation but doesn’t solve the problem itself. Furthermore, he stated that sticking to medications is only half of the battle because patient education is critical to ensuring the patient's progress; this was the turning point that prompted us to create the patient's guidebook. At last, he added that patient education begins with customizing the diet plan to be gluten, lactose, and caffeine-free and that the patient must be stress-free by engaging in relaxation techniques such as exercise and yoga.
Dr. Manal Mostafa
Take away
Thanks to Dr. Manal Mostafa, we are now aware of the risks related to stem cell production including the regulations, the time challenge, applicability, and the high cost of stem cell production. We will try to challenge the time and choose the most applicable and efficient protocol that will accomplish our mission of developing our targeted drug with our specifications.
To ensure that we are taking the correct path, we got in contact with Dr. Manal Mostafa, asking her about the availability of different cell centers in our country. In addition to the nature of experiments that could be done in these centers in the field of cell-based therapy. She clarified that due to the high cost of cell lines used in the labs and due to the variation between each cell line and the other, the materials are not always available. Most of the materials used in the lab are exported from abroad and unfortunately take a dozen of regulatory procedures and a lot of time to be delivered. However, the good news is that there are a few stem cell centers in Egypt that are specialized in the production of certain types of stem cells which coulb be suitable for our future design. Then, we got into more details with her regarding our initial approach that depended back then only on Macrophages with phenotypic switches. We also discussed the expected time needed for this approach to be tested and applied in the lab, which presented a big obstacle that we needed to overcome as the deadline was in November. Hence, Dr. Manal gave us an estimated duration for our lab work of about three months in order to obtain sufficient results to verify the efficiency of our approach. She also advised us to revise our theoretical work well before getting into the lab phase. To do that, she advised us to meet with doctors in the upcoming Michigan State University visit to our college in order to guide us through the following steps of our project.
Stage IV: Development
Overview
>After settling on Rheumatoid Arthritis RA as our target disease this year, then reviewing the ethical background behind the use of Cell Therapy, and finally gaining the approval of our mentors, we started working on our cell-mediated therapeutic approach to RA. Our scientific development has been through many stages that we prefer to call “Milestones”. Every milestone has its own story, upstanding limitations and creative solutions to finally reach our ultimate design.
Milestone I: Phenotypic switch of Macrophages
According to many papers, Macrophages are one of the most involved cells in the pathogenesis of Rheumatoid Arthritis. This is why we decided to change the M1 pro-inflammatory phenotype that induces host defense and inflammatory response to the M2 phenotype responsible for the resolution of inflammation and wound repair.
Drawback
Unfortunately, we found that this approach would only relieve some of the inflammatory symptoms of RA like all other existing Rheumatoid therapies. Whilst our main objective was to find a complete cure for this disease, this mismatch left us with a great concern about finding a new therapeutic design, using a new kind of cells that would have a significant effect on controlling autoimmune disease.
Interview 1: MSCs and ACPA targeting
Take away
Thanks to our meeting with MSU doctors, we decided to integrate a mesenchymal stem cells-based therapeutic approach. To do that, we must start detailed research about the immunomodulatory functions of MSCs and the way they could affect autoinflammatory cells of RA.
In the search for a new treatment modality for RA, and following Dr. Manal’s advice in Stage III, we managed to grasp a meeting with Dr. Neubig and Dr. DiRita on the Michigan State University (MSU) visit to our college. We were eager to learn from the great experience of both doctors in the fields of Molecular engineering and Synthetic Biology.
First, we explained that RA management, like many other autoimmune diseases, is about relieving symptoms more than treating the cause. As a result, there is not a complete treatment for this disease up until now.
Hence, the doctors highlighted that there is a new field of therapy coming out recently that is targeting inflammatory diseases which is “stem cell-based therapy”. As shown in many recent papers, MSCs possess a unique immunomodulatory function which makes them a potential novel modality of treatment for autoimmune diseases in general and RA in particular. But to use these MSCs, the doctors advised us to find a way to gain the maximum benefit out of these MSCs with the least side effects.
Milestone II: Mesenchymal Stem Cells (MSCs) and ACPA targeting
After our enlightening meeting with MSU experts, we started our journey with stem cell-based therapy. Given the self-renewal, multi-differentiation, immunoregulatory, and tissue maintenance properties, mesenchymal stem cells (MSCs) are considered an attractive treatment option for autoimmune diseases in general and RA in particular. We also focused on increasing the expression of long non-coding RNAs (lncRNAs) responsible for modulating MSCs homeostasis and differentiation. This increased IncRNAs can also control the activity of Fibroblasts-like synoviocytes essential in inducing joint inflammation. On the other hand, we discovered that anti-citrullinated peptide antibodies (ACPAs) play a significant role in the pathogenesis of RA. As a result, we decided to add an extracellular synthetic receptor called SynNotch in order to make our MSCs able to detect the auto-reactive B cells producing ACPAs.
Drawback
Despite their great immune-modulatory effect, MSCs’ activity against RA remains uncontrolled which means they might proliferate causing fibrosis of the joints or be even oncogenic.
Milestone III: MSCs to NK
After a lot of research in MSCs, going through many articles, and consulting different papers, we got a very enthusiastic idea of turning our MSCs into Natural Killer (NK) acting-like cells. Thus, we went on modifying the cytolytic enzymes (Perforin/Granzyme) inside the Exosomes to target the auto-reactive B cells.
Drawback
Going back to our instructors, we concluded that these cytolytic enzymes would have a very low specificity to our target cells and hence might represent a real threat to all other normal cells inside the body.
Interview 2: Settling on the first approach
As an expert in stem cells, Dr. Aldhamen highlighted the great immunosuppressive effect of MSCs on autoinflammatory cells and their effective contribution to tissue healing. Therefore, he suggested that we focus on increasing the expression of these innate features of MSCs and try to make them more selective against the cells responsible for the pathogenesis of RA. As a result, we can control the propagation of such a severe disease as RA while minimizing the unwanted immunosuppressive effects on other normal cells.
In addition, Dr. Aldhamen was firmly against the idea of transforming MSCs into NK-acting-like cells. He then explained that the cytolytic enzymes present inside the exosomes would be very difficult to direct toward the autoreactive cells. Hence, these killer enzymes could attack any normal cells in the body causing severe damage and multiple side effects.
Take away
We decided to focus on engineering the MSCs to increase their selectivity to the target cells and also to maximize their immunomodulatory effects.
Milestone IV: Our first approach
In this step, we decided to settle on MSCs as our main approach. Therefore, to gain the maximum benefit out of them, we targeted the JAK-STAT 3 pathway by increasing the expression of P13K to trigger the immunomodulatory functions of MSCs. We also added our previously designed receptor on MSCs targeting ACPA auto-reactive B cells, to minimize the specificity limitation of MSCs in our project.
Drawback
We still haven’t overcome the limited response of the cells to MSCs. Moreover, we were still worried about the short-term hindering effect of MSCs on auto-reactive B cells.
Interview 3 Exosomes derived from MSCs
While we were busy trying to enhance the effects and selectivity of MSCs on auto-reactive B cells, we contacted Dr. Siciliano who suggested a slightly different design. Dr. Siciliano shed light on the important role of Exosomes in near and long-distance intercellular communication. Thus, these Exosomes can be used to deliver an apoptotic signal to the auto-reactive B cells. Moreover, this new approach could overcome the limited response of autoimmune cells to MSCs potentiating the immunomodulatory effect and making a longer impact on the target B cells. This could also prevent the oncogenic effect of the proliferating MSCs.
Take away
After this meeting, we started developing a new design depending on Exosomes derived from MSCs, making them as specific and effective as possible.
Milestone V: Exosomes as a vector
Thanks to our meeting with Dr. VELIA SICILIANO, we started working on Exosomes as a vector synthesized by MSCs. Then, we tried inserting the BH3 interacting-domain death agonist (BID) apoptotic signal inside the Exosomes and also adding a targeting receptor on the Exosomes to ensure that the cargo reaches and suppresses only the autoreactive B cells.
Drawback
Exosomes have more than 200 normal peptides targeting various cells. As a result, the apoptotic signal is very liable to off-targeting and thus might unintentionally target other normal B cells or even the MSC itself.
Milestone VI: Our second approach
In this step, we decided to work on an Exosome-based approach without the use of MSCs. Therefore, we tried to isolate the modified Exosomes carrying the BID apoptotic signal to suppress the autoreactive B cells.
Drawback
We found that Exosomes alone have a very short half-life, so they will require multiple doses to be effective. In addition, off-targeting of the BID signal was still an unsolved issue, which made this design less effective than expected.
Interview 4: Choosing a suitable approach
Take away
We need to start writing our design’s protocol including a list of all the needed parts and equipment to test this design in the Wetlab.
As we reached a crossroads in our project, we needed the help of an expert to decide between both of our approaches. Hence, we contacted Dr. Said Omar, who is one of the most experienced professors in the Wetlab work. We also stated that our choice must be based on the feasibility and the safety of the design, not just its lab validation. Dr. Said preferred the first approach since it is more effective and also would be more time-bound in terms of lab work. Moreover, he advised us to use the SDS Website to get information about the validation of the receptors. On the other hand, Dr. Said stated that the big size of the PID Protein and the limited capacity of the Lentiviral vector are considered two major limitations of the second approach of our project. Finally, Dr. Said advised us to begin validating our designs in the lab as soon as possible as the lab results would help us settle on a final design.
Milestone VII: Our final integrated approach
Our meeting with Dr. Said left us eager to start the Wetlab tests so we could compare both of our approaches. We expected that the lab results would decide which design would be more feasible and effective. But instead of that, our very early lab tests gave us the novel idea of merging both of our designs. As a result, a third integrated design was born. We also replaced the BID apoptotic signal of Exosomes with a Cas9 system that knocks down the B cell-activating-factor-receptor (BAFF-R) gene necessary for B cell survival. Hence, we designed MSCs carrying this CRISPR Cas system making them selective to the B-cells only.
Interview 5: Safety
Take away
We went on looking for a safety switch suitable for our circuit so that we could achieve the highest levels of safety in our project.
As safety and well-being are always the priority for our team, we contacted Dr. Marwa Ali to come up with a safety design for our project. We had one purpose through this meeting, to make sure that our project is responsible and good for the world. At the beginning, Dr. Marwa Ali highlighted the importance of following all the safety and security precautions during our lab tests. Then, she noted that we must validate all the aspects of our design in the lab to find the adverse effects and try to minimize them. She also gave us some information about the application of safety switches that can control complex circuits such as the one we have in our project.
Milestone VIII: The safety switch
As safety has always been one of the ultimate priorities of our team, we were keen on developing a safety switch to control the Cas12K\g\BAFF-R system. This way we could spare normal B cells from the silencing effect of the CRISPR Cas system. As a result, we inserted a new tissue-specific switch in our circuit called DART VADAR (Detection and Amplification of RNA Triggers via ADAR). This switch will guarantee a conditioned translation for our system, based on the availability of ACPA’s mRNA in the auto-reactive B cells. Accordingly, our design has peaked in selectivity and specificity to the target inflammatory cells, with minimal off-targeting effects and maximum safety levels. Finally, it was time to validate all our theoretical work and test the applicability of our most recent approach in the lab. Unfortunately, upon starting this new project phase, we found ourselves in front of an inevitable problem, for which we had to find an efficient resolution as quickly as possible. To learn more about our Wet Lab work, please visit our experiments page.
Stage V: From lab to market
To bring our drug successfully into the market, we worked hard to contact every stakeholder available which we listed as major and minor contributors.
Dr. Mohamed Mansour Saad Farag
Take away
We are now completely aware of the drawbacks that we are going to face to implement our drug in real life including safety, efficacy, ethical issues, and most importantly public acceptance. So we need to take some initiatives for our drug idea to turn into a real usable product.
We got in contact with Dr. Farag after we finalized our drug and verified it in the lab. First, we explained the project to him, clarified the scientific details of our therapeutic approach, and also the possible side effects that could affect the patient. We highlighted that our integrated design is based on MSCs that carry a CRISPR Cas system making them selective only to the autoreactive B cells. In addition, we tried to make this design as safe as possible by implementing a tissue-specific safety switch. Dr. Farag welcomed the idea very well and added that stem cells and synthetic biology have aroused a lot of interest from many experts in the scientific and medical fields thanks to their marked potential to revolutionize medicine production. However, he raised some concerns related to these technologies as well. Those concerns include the need for thorough safety and efficacy assessments along with ethical issues with the stem cell's origin. To guarantee consistent and dependable products, standardization and quality control are essential. In addition to that, the way the public perceives and understands stem cells and synthetic biology can impact how readily they are accepted and adopted. It's necessary to preserve transparency, participate in effective communication, and carry out public education activities to promote acceptance and empowered decision-making. These initiatives are essential for clearing up misunderstandings, promoting trust, and ensuring that people have the information they need to make wise decisions.
Mr. Max Mundt
Take away
We were enlightened on how important it is to find a co-founder who will secure the way for us until our product is out on the market. Meanwhile all we need to do is to acquire grants and funding to enable our project to finish the laboratory phases until our method is fully verified.
We contacted Mr. Max to gain a deeper understanding of the market and carry out a more detailed market analysis. We gave him an overview of our project concept and suggested working together to get better insights about the market, in addition to providing him with an overview of our business model and sharing our progress so far. Mr. Max was enthusiastic about the concept regarding its long-term viability and importance in solving a problem that has no solution yet. He suggested starting by convincing people of the advantages of our approach and the safety of our treatment technique. Also, he suggested engaging with patients at clinics and health conferences as one strategy, which prompted us to think about going to the African Conference of Health. By adopting this platform, we can raise awareness of the difficulties faced by rheumatoid arthritis patients and emphasize the importance of finding a long-term cure for the disease. Additionally, we intended to educate the audience on the safety of stem cells and synthetic biology in the manufacture of pharmaceuticals under the appropriate security measures. On the other hand, to get the medicine on the market, Mr. Max underlined the importance of following FDA laws and completing trials, while also noting that these processes can be time-consuming, taking years to complete, and costing millions of dollars. He claimed that finding a co-founder to help with pre-clinical and clinical research would be a pretty straightforward approach in the process. In the end, he stressed that until our proof of concept is fully validated in the laboratory, grants and financing should be secured to complete this step of our path.
Dr. Yasser Ahmed Farghaly
Take away
We are now more aware of the Egyptian market and the environment in which our new drug will be issued. Therefore, transferring our work from the lab to the market will need great effort and also undisputed will to keep going against all the obstacles. So, for our design to come to life, we need to start a market analysis, implement a business plan, and settle on a source of financial support.
At the end of this stage of our Integrated Human Practices, we decided it was time to head to one of the largest pharmaceutical manufacturers in Egypt -Kahira Pharmaceuticals- to discuss the application of our innovative drug in the Egyptian market. Hence, we met with Dr. Yasser Farghaly with whom we discussed different aspects of our project and some concerns regarding the implementation of such a revolutionary drug in our local market. Dr. Farghaly also gave us a brief history about Kahira Pharmaceuticals and highlighted that this company works towards one goal: to provide highly effective and safe pharmaceutical products to patients at an affordable price. Then, he added “ With such an extraordinary mission to change the world, we need extraordinary people to achieve it.” pointing at the extraordinary progress we made along the journey of our battle against RA. Dr. Fraghaly also reminded us that the validation of our therapeutic approach would take years and would acquire high costs before the final drug product can come to light. So if we need a large company like Kahira Pharmaceuticals to adapt such a project, it will not be easy but surely it will be worth trying.
These points among others build up the core of our Entrepreneurship model of this year