Team:AFCM-Egypt/Entrepreneurship
Entrepreneurship
Bioentrepreneurship to Custommune
Problem Definition
Every day in Egypt, hundreds of cancer patients are newly diagnosed, most of them are diagnosed in advanced late stages and hundred other souls are lost daily to cancer. According to the National Cancer Institute, breast cancer solely forms 29% of all cancers in Egypt. Globally, breast cancer is the second most common cancer affecting humanity and it is the most frequently diagnosed cancer among women in 140 out of 184 countries including both developed and underdeveloped countries.
It is estimated that more than 600,000 breast cancer deaths among women and men occurred in 2018 worldwide. With 29% mortality among Egyptian breast cancer patients, it is apparent that there is some kind of shortage on the preventive and therapeutic side.
By analysing the treatment modalities offered for cancer patients locally, we tried to outline the core reasons for this therapeutic deficit and here is what we concluded. Firstly, lack of advanced immunotherapies for cancer patients and lack of the companies’ flexibility to meet the demands of the researchers due to their fixed platforms. Also focusing their work to fulfill the demand of common strains of diseases regardless of the needs of other patients.
Secondly, the unaffordability of advanced immunotherapy both in developed and developing countries.
Finally, there are many strains of the same disease, yet companies focus their platforms to work on the most common globally. This means that patients infected with the other strains don't receive the appropriate care and treatment due to the inflexibility
Stakeholder analysis
A stakeholder analysis is a mandatory step that guides small startups to direct their efforts of customizing customer needs according to the stakeholders opinions. The more important and influential a stakeholder is, the further their opinions should be taken into consideration. We sorted out the stakeholders that could be relevant to our case and we agreed that out stakeholders would consist of Biotech funding agencies (accelerators, incubators, and seed investments) ,cancer patient communities (BCFE and Baheya's Foundation) and support groups, academic funding agencies (STDF and ASRT) ,and clinical investigators oncology research labs. Our team members validated the extent of influence and importance given to each stakeholder as shown in the figure.
Market analysis
In an effort to discover customer needs and demands, our team had to carefully study and analyze all the segments and aspects of the breast cancer market. Before introducing Custommune, the market analysis process was a fundamental step in building a sound business strategy through gathering more information regarding the environment, regulatory, and competitive systems of the field.
Geographically, breast cancer is widely distributed among remote countries across the world thereby contributing to an increased economic loss and a general financial burden shared by different governments and private institutes. Despite the millions of dollars funnelled into research, the global burden of breast cancer is increasing. Although Egypt is not considered one of the top 25 countries suffering from breast cancer in terms of age standardised rates (1) (F, 2018), yet we are aware that unfortunately these statistics may not be accurate due to factors such as diagnosed but unrecorded cases and undiagnosed cases in the first place,as a result, the prevalence of breast cancer in Egypt may be larger than we expect. Nevertheless, in 2017 it was estimated that 34% of Egyptian women suffer from breast cancer significantly impacting the Egyptian healthcare budget. For this reason, Custommune was designed as a novel therapeutic modality that would help not only egyptians, but also patients and healthcare facilities from all over the world who are incompetent to afford the full course of standard treatment by providing a more effective patient personalized approach that is made available with lower costs.
When we come to analyze the total per patient costs related to a certain disease it is important that we consider all the factors contributing to the expanding economic burden caused by breast cancer. These factors include, the costs of per day hospitalization of inpatients, the costs of outpatient, costs of medication, cost variations based on different cancer stages, and finally the opportunity costs that arise due to loss of productivity from both patients and other health care providers. In a trial to combine all these costs together in order to calculate the per-breast cancer patient treatment costs we used a tool enhanced by Google named as Costhelper Health, which is a tool the operates by collecting information from a community consisting of thousands of users around the globe, we estimated that patients not covered by health insurance breast cancer average treatment typically costs $100,000 or in advanced cases $300,000 or more (2) (chemo 072, 2007), plus the additional costs required for breast reconstruction which may reach up to $50,000 for "flap" techniques and this wide range is dependent on the individual case as the costs of treatment are inversely related to the stage of presentation. In Egypt, a return-on-investment (ROI) analysis of a breast cancer screening program concluded that the average per-person treatment cost for screened and unscreened patients was estimated to be $28,632 and $58,170 respectively (3) (Skrundevskiy AN, 2018
World's response and Investments concerning Breast cancer
On the 8th of march 2021, the international women's day, WHO launched the novel Global Breast Cancer Initiative to diminish the global breast cancer mortality by 2.5% per year, thereby evading around 2.5 million deaths worldwide by the year 2040 among women under age of 70, thus reducing the overall breast cancer management costs. According to the national cancer institute (NCI), the financial burden caused by the global medical expenditure of breast cancer has surpassed all other types of cancer projecting to 16.2 billion USD of which 11.5 billion USD are the value for the targeted therapy, 3.3 billion USD for hormone drugs and 1.4 billion USD for chemotherapy drug sector in 2018 meaning that with the current CAGR of about 9.5% reaching to around 30.6 billion dollars by the year 2025 (4) (Ugalmugle, 2019). Unfortunately, we faced a great difficulty to sort out how much exactly was the budget allocated for each sector namely the diagnostic, preventive, treatment, and R&D (research and development). However, we acknowledged that the current fiscal year (2021) budget consecrated to the NCI is 6.56 billion USD which is a 119 million dollar increase over the year 2020 as well as countless announced grants by different organisations which reflect an increased willingness by prominent stakeholders to invest more in breast cancer development.
In Egypt, it is estimated that between the years 1990 – 2017 there was a drastic increase in the relative incidence rates by 200 - 400% which was only exceeded by the Kingdom of Saudi Arabia (5) (Li N, 2019) and apparently the Egyptian government is aware of the situation as it started initiating several moves and protocols to fight breast cancer and reduce its economic burden over the years. For instance, In july 2019, the Egyptian president Abdelfattah El Sisi launched the women's health initiative to improve early detection of breast cancer and other diseases. Moreover, Egypt's latest approach was the collaboration between GE Healthcare and Gustave Roussy, a pioneer in the "one step diagnosis", under the patronage of the Egyptian ministry of health aims to accelerate early detection and treatment planning for breast cancer (6) (Cairo, Egypt and Villejuif & Buc, France, 2021). According to data from the world bank R&D in Egypt adds up to no more than 0.8% of the total GDP (7) (UNESCO Institute for statistics, 2018) Unfortunately, it is not clear how much is the Egyptian government allocating as a budget for all those breast cancer fighting approaches and no clear records for the percentage from R&D allotment to breast cancer but we can see that there is an economic rationale behind all the mass screening, prevention, and treatment approached taking place and we may at some point be able to introduce our product.
Competitors
Higher accuracy and lower treatment costs are the general current needs of potential customers, for this reason customised medicine offers a very promising potential for the future of therapy.
The present day treatment modalities in the local market host a number of therapeutic shortages or gaps as they offer rigid, predefined, and non-customized targets. Moreover, commercially available designing platforms offered by local clients and importers for international biotech companies are usually unaffordable. This is an illustration of a few biotech companies providing similar products.
Competitor Analysis
Regulations
Having an effective and enforceable legal structure for the pharmaceutical sector is an essential element in achieving the country's goals of accessibility, quality, and rational use of therapeutics in general. Unfortunately, there are no currently set Egyptian rules for the manufacturing of biopharmaceuticals but for pharmaceuticals in general all companies should follow these regulations.
There are 3 main regulatory authorities affiliated to the Egyptian MOH that are mainly responsible for the pharmaceutical sector namely Central Administration for pharmaceutical affairs (CAPA), the National Organization for Drug Control and Research (“NODCAR”), and National Organization for Research and Control of Biologicals (“NORCB”) which is responsible for the monitoring, inspection and release of all biological products like vaccines and serum. Its main function is to ensure the quality, safety and efficiency of all imported, exported and domestic biological products whether for human being use or for veterinary consumption and according to the properties of our product, NORCB is where we need to get the authorization from. At this point we are halting at a crossroad, weather to use local manufacturing factories which according to law should be licensed by the MOH and the Industrial Development Authority (IDA) or the other option is to rely on contract development and manufacturing companies (CDMO) abroad and Current Good Manufacturing Practice (CGMP) facilities which may prove to be more efficient as they enjoy remarkable expertise and more readily present equipment and facilities, yet in this case we will need to follow the regulations for pharmaceutical importation. Either way we will have to turn back to the NORCB for validation if the product is going to be used inside Egypt.
Another step which is crucial for our product to come into reality is the registration which consists briefly of the following (8) (Riad, 2017):
- The Request , an appointment request sent by email to the MOH regulatory facility concerned with the product.
- Pricing Committee
- Technical Committee, which looks into safety and security guidelines.
- Stability Committee
- Naming Committee
- Inspection Committee
- National Organisation for Drug Control and Research (NODCAR)
- Bioequivalence Committee
- Further stability studies
- Final approval
Our calculations for the expected time for the registration approval may exceed the 5 years time period which is quite a long time but this is what it takes to launch a product to the therapeutics market in Egypt yet here we are paving the road for ourselves and for others following us
OUR SOLUTION
We consider Custommune as an additional extra weapon introduced to our battle against cancers as this product is mainly focused to provide a higher quality immunotherapy for cancer patients who can't afford other customised treatment methods.
Immunotherapy is achieved via circuits developed to operate logical decisions upon recognizing intracellular targets. Using DNA launching of replicons as a potent delivery system, the platform regulates the expression of the subgenomic immunotherapeutic message based on sensing intracellular mRNAs or proteins via novel protein fusion constructs. This regulation depends on a set of riboswitches to control downstream expression. To provide a safety switch for clinical applications, the system can be stopped through a small molecule inhibition. This design is also environment-responsive, as it depends on a set of toehold-like switches to sense a cell-specific set of RNAs leading to feedback regulation of the delivered cargo. The platform was adapted to deliver intratumoral oncolytic and immunotherapeutic signals. It is aided by a set of deep learning models and a computational directed evolution algorithm for developing functional proteins.
Cost analysis
Performing a cost analysis is mainly based upon estimations. While estimating is one of the greatest challenges anyone faces due to lots of uncertainties specially with novel technologies such as immunotherapy, we tried our best using several combined cost analysing techniques. First of all we started by a basic estimating method where we divided the different steps of the procedure according to their order of magnitude, hence, starting with the big chunks allowed us to get a sense of how big the cost might be. Hence, we singled out the three main procedures namely, vaccine design, recombinant alpha viral vector construction, and vaccine validation then we anticipated the costs of the project protocol to be as follows.
Secondly, we utilised a technique where we depended on tenders, bids ,and contracts with Contract Development and Manufacturing Companies (CDMOs) which are basically facilities that have the professional expertise and the equipment and are capable of producing vaccines such as ours’. Unfortunately, to this point our team was unsuccessful to make a solid contract with any of the CDMOs nearby therefore we do not have an appropriate cost estimate of relying on other companies to produce our product. In our last approach, we resorted to past projects or “reference classes” by looking up readily established companies that produce immunotherapeutics. We relied on a study that aimed to quantify the cost of establishing vaccine manufacturing facilities and producing vaccines in developing countries through averaging estimates of twelve vaccines produced by eight developing country vaccine manufacturers (DCVMs). Estimates of the capital and operating costs were tested under three hypothetical scenarios and results revealed that it costs about US $2.18 per dose and typically these costs decrease at large scale manufacturing. Noticeably, when the costs were 47% lower compared to the prices (9) which again clarifies the fact that in developing countries there is a producer surplus and potential profits may be attainable if we achieved sustainable productions. Another African feasible business model for new vaccine production was conducted and according to the approximate calculations, it would cost around US $1.5 to develop a vaccine in Africa with a similar production protocol (10).
Based on these values, we could roughly estimate that our product could allow a 10 fold decrease in price of a vector based vaccine.
Customers
As we were brainstorming who our potential customers in the region could be, initially we started by trying to e-reach lab PIs in Egyptian universities, research labs, cancer institutes,and oncology hospitals as well as spreading out surveys to patients to get their opinion regarding the use of immunotherapy (vaccines) for their treatment. We tried to briefly introduce our services and get a yes or no answer for an interest in developing targeted immunotherapies using our platform.
Finally, we settled on two major customers namely, the Egypt Oncology Research Labs and the Infectious Diseases Research Labs. Further studies of the market revealed the presence of around 30 running medical field research labs in Egypt, 2 major companies running clinical trials, and approximately 10 oncology centers in Egypt. We've sent them surveys along with introductions to Custommune in order to find out more about their willingness to develop targeted immunotherapies using our platform. From those who replied back, we found 80% interest from the analyzed replies
Business plan
Click here to check the business plan
Funding
From where we stand now with Custommune and as we are on the verge of starting our clinical trials we must look forward to the next step ahead and we have to choose between two pathways. The first one is to move on with the production inside Egypt and the other one is to try and reach out for contract development and manufacturing organisations (CDMOs) which is a more likely choice. In both cases we have to consider future funding.
Lately, we have been lurking for a funding opportunity provided by academic grants and seed investments. From our stalking, we found out about three main institutions that would be likely to fund our product namely Science and Technology Development Funding (STDF), Academy for Scientific Research and Technology (ASRT) ,and Information Technology Industry Development Agency (ITIDA). We sent them our product proposal according to each template requirement. Finally, and thanks to our integrated human practices, we were introduced to a “call for proposals” announced by Mounir Armanios Research Center (MARC) for biotechnology innovation which specifically matches our product. Funding will be provided by EVA Pharma without exceeding 3 million pounds and for a duration of no longer than two years and we sent them our proposal and are still waiting for a reply.
References
- F, B. (2018). Global Cancer Statistics . International Agency for Research on Cancer (IARC).
- chemo 072. (2007). Community. Retrieved from breastcancer.org: https://community.breastcancer.org/forum/69/topics/694803Community. (n.d.). Retrieved from Breastcancer.org: https://community.breastcancer.org/forum/69/topics/694803
- Skrundevskiy AN, O. O. (2018). Return on investment analysis of breast cancer screening and downstaging in Egypt: implications for developing countries. Value Heal Reg Issues., 16:22–7
- Ugalmugle, S. (2019). Breast Cancer Therapeutics Market Size By Product (Hormone Drugs, Chemotherapy Drugs, Targeted Drug Therapy), By Distribution Channel (Hospitals, Ambulatory Surgical Centres, Clinics, e-commerce, Retail Pharmacies), Regional Outlook, Application Potential. Global Market Insights, 150.
- Li N, D. Y. (2019). Global burden of breast cancer and attributable risk factors in 195 countries and territories, from 1990 to 2017 : results from the Global Burden of Disease Study 2017. J Hematol Oncol., 12(1).
- Cairo, Egypt and Villejuif & Buc, France. (2021). Speeding up Breast Cancer Diagnosis in Egypt: GE Healthcare, Gustave Roussy and the Egypt Ministry of Health Partner to Create Rapid Breast Cancer Diagnosis Clinics. Chicago, Illinois: GE Healthcare.
- UNESCO Institue for statistics. (2018). Retrieved from The World Bank: https://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS?locations=EG
- Riad. (2017). LEGAL FRAMEWORK OF THE PHARMACEUTICAL SECTOR IN EGYPT. Articles.
- Munira SL, Hendriks JT, Atmosukarto II, Friede MH, Carter LM, Butler JRG, Clements ACA. A cost analysis of producing vaccines in developing countries. Vaccine. 2019 Feb 21;37(9):1245-1251. doi: 10.1016/j.vaccine.2018.11.050. Epub 2019 Jan 14. PMID: 30651198.
- Makenga, Geofrey, et al. "Vaccine production in Africa: a feasible business model for capacity building and sustainable new vaccine introduction." Frontiers in public health 7 (2019): 56.
