Team:AUC-EGYPT/Entrepreneurship









Executive Summary

We are adopting a B2B business model targeting physicians in military hospitals and directly distributing to them. Our target market strategy: concentrated marketing. Our unique value proposition: Our therapy is specifically designed & tailored for the treatment of COVID-19; It is not a repurposed drug similar to indirect competitors available in the market.

Team

We are adopting a B2B business model targeting physicians in military hospitals and directly distributing to them. Our target market strategy: concentrated marketing. Our unique value proposition: Our therapy is specifically designed & tailored for the treatment of COVID-19; It is not a repurposed drug similar to indirect competitors available in the market.







Market

Environmental Analysis

Macroeconomic:



Political & Legal:

Recently, the relevant Egyptian Health authorities backed by the government pushed for a clinical research management bill that legalizes and controls the implementation of clinical trials in the country (Gomaa, 2020). This shows an increasing interest on the government’s end in supporting the research and development of novel therapeutics created within the country. The country’s interest in COVID-19 therapeutics is also evident in the promptness of action in securing a production license of Remdesivir in June just weeks after the drug received its Emergency Usage Authorization from the FDA (Al Tawy, 2020). However, support for genetic engineering endeavors is not yet available as a bill for the regulation of GE research remains in parliament debate (Badr, 2015).

Economic:

With the COVID-19 pandemic, we have seen a growing investment in therapeutic and diagnostic R&D by Egyptian funding bodies (ex: Academy of Scientific Research and Technology- ASRT Call 2020). Recently, we witnessed the launch of the largest research project in Egyptian history aiming to fully sequence the Egyptian genome with a whopping budget of 1 billion Egyptian pounds led by the Egyptian center for Research and Regenerative Medicine and guided by the ASRT (ياسين, 2020). This we believe will strongly support our cause as the first Egyptian developer and manufacturer of a SynBio-based therapy for such a heavy health burden.

Technological:

There is not an already existing infrastructure for a product like ours. Research facilities are mostly purely academic, while production facilities mainly focus on producing drugs and compounds under license without R&D. There is a strong focus related to teaching biotechnology and related techniques in universities, but with little real-world implementation. An unseized opportunity exists in connecting the dots by calling for collaborations between academia and industry. Further, as a startup, we do not have an already supported and fully functioning infrastructure (biological factory, bioreactor machine etc.).

Socio-cultural:

The expectation is that the social environment in Egypt will not be receptive to GMO products upon release. We may face some resistance. In 2013 for instance, protests were held in front of the Ministry of Agriculture to oppose the use of GMO crops as there was a perception that they cause cancer (Sadek, 2014). There is clearly a certain associated stigma with the public’s perception regarding GMOs resulting from a lack of awareness about what the term actually means and negative connotations associated with DNA manipulation.

Microeconomic:



Consumers:

Our consumers are B2B markets, specifically Egyptian hospitals. We plan to expand to international markets in the future.

Marketing Intermediaries:

No marketing intermediaries as we will be directly distributing to the hospitals.

Competitors:

There is no evidence of any direct competition in the Egyptian market, which is an advantage. This is viewed as an opportunity for our business as this environment perfectly sets the scene for the release of our product.

Problem Identification

The lack of a specific and efficient treatment option for SARS-CoV-2. Over 37 M cases have been diagnosed worldwide and over 1 M deaths have occured as of October 12th 2020. Generally, the current treatment protocol is conservative and non-specific and even using non-specific treatments, there are no effective therapies currently in the market approved by the FDA. Further, there is no evidence that scientific R&D for a COVID therapeutic is even taking place in the African region.

Segmentation

i. Market Segmentation:

Following a brief analysis of the surrounding environment and the identification of a problem, we wanted to develop a solution that would address the issue. We wanted to develop a therapeutic that could help solve the problem of the COVID-19 pandemic, but we first needed to conduct a market segmentation to identify the needs of the various segments and accordingly identify our target market. Our product follows a B2B model, so we started by segmenting the market into governmental and non-governmental entities as a first step (diagram below).



ii. Segmentation of hospitals in Egypt:

We chose to distribute to hospitals since we value equity and fairness and we hope that our product will eventually become available and accessible to everyone regardless of socioeconomic class. So, now we knew that we wanted to target Egyptian hospitals, but we had to narrow this down to a more specific segment. Based on this, we segmented Egyptian hospitals in order to narrow down to the most suitable target market for our product.





iii. Target Market:

Based on an analysis of these hospitals’ firmographics, behaviors, and needs during segmentation, we have come to identify that we primarily want to target military hospitals during the first rollout phase of our drug. Our decision to select this particular segment to begin with was based on a host of reasons.

First, Military hospitals have the lowest capacity out of all hospitals, which although may appear at first glance to be a disadvantage since the market size we will be targeting will be relatively small compared to if we were to target other types of hospitals like higher education hospitals, this is not the case. The low capacity is actually a benefit to us as a new startup since our production capacity will be limited during the product’s introduction phase, and we will also not have the technological capacity at this point to benefit from economies of scale. Another important reason we decided to go after this segment in particular, and this is arguably the most critical factor in our decision, is that we realize the level of power that Military hospitals have on influencing the decisions of other types of hospitals. This means that although the segment is small, there is higher potential for segment growth. Finally, military hospitals market themselves as quality sensitive, and since our end goal is to be the most efficient treatment on the market, this is the most relevant segment for us to go after. Once we have captured the Military hospitals as a segment, we will follow this by other rollout phases during the growth and maturation phases of our product targeting MHE and then MOH hospitals as per market segmentation.

As discussed, we will only be targeting the segment of military hospitals during the first rollout phase of our drug following a concentrated target market strategy. Since our product is a therapy, it is to a large extent standardized and will not necessarily be tailored differently to meet the needs of various segments during later rollout phases. Thus, it will likely follow an undifferentiated target market strategy distributing to hospitals all around Egypt once we gain our primary segment’s trust and loyalty and become more established in the market. We will utilize connections with Health authorities to market our product directly to hospitals and penetrate our market segments accordingly.

Stakeholder mapping

Onion model:

i. Product: SynBio-based therapy for COVID-19

ii. System: Patients

iii. Containing system: Hospitals and physicians

iv. Wider Environment: Ministries and governing bodies



Stakeholder importance & Influence:

In mapping out our stakeholders, we managed to identify which ones are most worthy of our attention and which garner the least importance and influence. According to our analysis, the most relevant stakeholders for us to focus on (both high importance and high influence) are universities and research centers as those may help us in getting approvals during our clinical trial phases and authoritative bodies like the Egyptian drug authority that will either approve or deny our request to bring our product to the market. Government hospitals, specifically military hospitals, and the physicians working in those hospitals also top the list as highly relevant stakeholders. They are highly influential since they are the ones who will be prescribing our therapy to patients and also extremely important as they are our primary distribution channel.

The most important stakeholders for us who have a low influence in the market are our patients as well as NGOs and private hospitals. Patients are our most important stakeholders as they are the ones who will be receiving treatment and NGOs and private hospitals can help us distribute our therapeutic. However, despite their high level of importance, both have a low influence in the market. In other words, patients will not be directly purchasing the therapy from us; we are targeting physicians in a hospital setting, and NGOs and private hospitals are not the most influential organizations in our market- the most influential are the military hospitals as discussed.

The most influential stakeholders with low importance are the public along with media and news. They are influential because both affect public opinion regarding our therapeutic and in Egypt generally, there is not much public approval for genetic modification. However, those stakeholders are considered of low importance for two reasons: we are not aiming to satisfy their needs (they are not our patients) and they are also not our distributors. So, they are highly influential stakeholders, but with low importance when it comes to making product related decisions.

Of course, our least relevant stakeholders are the health insurance companies as they have both low importance since these are not the ones we aim to tailor the product for as well as low influence since they are not influential like the publics or other media outlets.





Competitor analysis

We divided our competitors into direct and indirect. We did not find any SynBio based therapies for COVID 19 currently in the market, thus the lack of indirect competition. However, there are many indirect competitors that despite not having official endorsement are currently involved in treatment protocols. Since there are currently no drugs or other therapeutics presently approved by the U.S. Food and Drug Administration (FDA) to prevent or treat COVID-19 (Commissioner, 2020), our solution will solve a huge unmet need that exists both locally and globally. We predict that our solution will strongly aid in the control of the ongoing COVID-19 pandemic.



Direct Indirect
No direct competitors since there are no SynBio-based therapeutics for COVID-19 currently in the market Antivirals currently under EUA include Remdesivir (evidence from a single trial shows that patients using remdesivir showed lesser times to recovery, however, further evidence is still needed).

The COVID-19 Treatment Guidelines Panel (NIH) recommends against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19 in hospitalized patients (AI).

Major players in the COVID-19 current therapy market are Moderna Therapeutics, Novavax, Bravovax, Ascletis Pharma, Altimmune, Clover Biopharmaceuticals, Inovio Pharmaceuticals, Inc., Biocryst Pharma, Gilead Sciences, and Regeneron Pharmaceuticals.

*Refer to appendix for a more detailed list of competitors

Unique Value Proposition

Our therapy consists of a Virus-like particle (VLP), Circuit, and short-interfering RNA (siRNA). The VLP allows our therapeutic solution to specifically bind to and enter cells that are susceptible to SARS-CoV-2 infection. Our circuit (including the toehold switch) senses whether a cell is already infected by the virus, if that is the case the circuit produces the siRNA. The siRNA specifically targets SARS-CoV-2 replication machinery thus preventing the virus from creating any more copies within the cell. These components put together enable our solution to be highly specific, efficient and targeted. Unique value proposition: Our therapy is specifically designed & tailored for the treatment of COVID-19. It is not a repurposed drug similar to indirect competitors available in the market.





Possibility & scalability

In order to estimate the possibility and scalability of our proposed solution, we generated our anticipated cost structure and milestones. We designed our business model with collaborations and partnerships in mind that would allow us to maximize production and minimize time to market. We identified potential stakeholders and partners for each of our milestones to help strengthen our efforts in an attempt to create our minimum viable product. Based on our analyses presented below in our cost structure section and the fact that the global SARS-CoV-2 therapeutic market is expected to stabilize and reach $27.27 billion in 2023 at a CAGR of 18.2%, we deem our project to be highly implementable and scalable.





Cost Structure

In vitro proof of concept → 25,000 USD (9,500 USD received in support from the university - Currently Applying for continuation)

Animal testing → 250,000 USD (Applied for an international research grant)

Clinical trial testing → 7 M USD

The average cost of phase 1, 2, and 3 clinical trials in the US across therapeutic areas is around $4, 13, and 20 million respectively. The field of clinical trials is still novel in our country as the first fully approved clinical trial for a vaccine in Egypt began two months ago. The cost of clinical trials in Egypt is expected to be significantly less as is the case with countries of similar nature such as india. We also anticipate that we will receive support from relevant stakeholders like the Ministry of Health for example as they have already shown tremendous support for COVID-19 therapeutic and prophylactic approaches.

Cost of manufacturing VLPs:

First of all, we plan to have a partnership with Rhein-minapharm and VACSERA to deal with some of our project’s technicalities.

Then, the preliminary cost structure based on 500-L fermentor:

Investment($) = 18708511.5

Unit production cost,(UPC)($kg−1) = 187658

Production rate(kgyr−1) = 54

Operating cost ($yr−1) = 10099913.5

Operating cost component ($yr−1)

Raw materials = 2749381.5 (27%)

Equipment dependent = 3248734 (32%)

Labor = 2803797 (28%)

Consumables = 558456.5 (6%)

Quality control(QC) and assurance (QA) = 420569.5 (4%)

Utilities = 5423.5 (<1%)

Waste treatment and disposal -= 313552 (3%)

Operating cost by section ($yr−1)

Fermentation = 3559534 (35%)

Primary recovery = 2014025.5 (20%)

Chromatography = 3121443.5(31%)

Assembly = 404061.5 (4%)

Aggregate removal = 763235.5 (8%)

Formulation = 237614 (2%)





Funding

i. Success metrics

Our therapy must pass all relevant clinical trial phases and obtain appropriate and relevant approvals needed for our product to be released (ETA). Another success criterion is our ability to penetrate our first market segment (Military Hospitals) by 25% during the first year upon release as this will serve as a springboard for market entry. This percentage is reasonable and realistic since we currently have no direct competition in the market.

ii. Funding milestones Receive a research grant for proof of concept by mid-2021 Secure either an international grant for animal trials or a second research grant by the end of 2021 Receive seed funding for clinical trials by 2022



Alternative revenue stream:

Diagnostic Kit. We can utilize our genetic circuit as a diagnostic assay to aid physicians in diagnosing potential patients. This could be done through a cell-free expression system and a lateral-flow assay format allowing us to produce a cheap and accurate paper-based biosensor. This biosensor would circumvent many of the current challenges facing SARS-CoV-2 diagnostics as it would be suitable for point-of-care diagnosis in resource-limited settings since it does not require advanced equipment or skilled labor. We predict that this biosensor will meet the WHO ASSURED criteria:

A = Affordable

S = Sensitive

S = Specific

U = User‐friendly (simple to perform in a few steps with minimal training)

R = Robust and rapid (can be stored at room temperature and results available in <30 min)

E = Equipment‐free or minimal equipment that can be solar‐powered

D = Deliverable to those who need them





Impact

Positive:

Alleviating disease burden by providing an efficient therapeutic solution. Providing a window of opportunity for growth of SynBio-based ventures in the region. Providing employment opportunities during the pandemic, creating a strong network of collaborators in the field of SynBio further bolstering advancements in the region. Furthermore, our circuit design and delivery method are highly modular allowing them to be utilized in diagnostics and therapeutics of many other diseases. This would serve as a potential future expansion for our bio-venture or as an alternative revenue stream in case of market stagnation.

Negative:

Potential inequitable distribution of the therapeutic solution: Therapies have the potential of becoming a rare commodity and entering illegitimate distribution channels very easily especially in times of global crisis. We attempted to navigate this challenge by choosing a B2B model and targeting public healthcare facilities first. This risk, however, is still imminent.

Potential disruptive technology for otherwise well established industry sectors: Currently, there are various production platforms for licensed drugs and therapies in the region. By boosting the SynBio market, these production facilities may suffer from losses of some valuable revenue streams. This risk is one we tried to mitigate by leveraging existing resources and partnerships within the market rather than working independently. This would ensure an alleviation of the disruptive effects of our platform on already-existing technology platforms in the region.





References

Torgersen H. (2009). Synthetic biology in society: learning from past experience?. Systems and synthetic biology, 3(1-4), 9–17. https://doi.org/10.1007/s11693-009-9030-y

Gomaa, A. (2020, September 03). How this law can help Egypt in clinical trials amid COVID-19 crisis. Retrieved October 20, 2020, from https://www.al-monitor.com/pulse/originals/2020/09/egypt-clinical-trials-law-coronavirus-vaccine-medical.html

Al Tawy, A. (2020). Egypt's Eva Pharma granted licence to manufacture, distribute Gilead's COVID-19 drug remdesivir in 127 countries - Politics - Egypt. Retrieved October 20, 2020, from http://english.ahram.org.eg/NewsContent/1/64/372125/Egypt/Politics-/Egypts-Eva-Pharma-granted-licence-to-manufacture,-.aspx

Sadek, G. (2014, March 01). Restrictions on Genetically Modified Organisms: Egypt. Retrieved October 20, 2020, from https://www.loc.gov/law/help/restrictions-on-gmos/egypt.php

Commissioner, O. (2020). There are no FDA-approved drugs or vaccines to treat COVID-19. Retrieved October 20, 2020, from https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments

Badr, H. (2015). بحوث الهندسة الوراثية بمصر.. لا تشريع ولا تطبيق. Retrieved October 20, 2020, from https://www.scidev.net/mena/gm/feature/Genetic-engineering-research-Egypt-legislation.html

ياسين, م. (2020, October 07). إطلاق برنامج "الجينوم المصرى" بتكلفة مليار جنيه. Retrieved October 20, 2020, from https://www.almasryalyoum.com/news/details/2057262





Appendix

Antibody therapies:

Company names: AbCellera and Lilly

Location: Vancouver, BC

Method: Looking for functional antibodies to neutralize the virus

Development status: Phase 2



Company name: CytoDyn

Location: Vancouver, Washington

Method: “Developing leronlimab (PRO 140), a CCR5 antagonist”

Development status: Phase 2



Company name: Emergent Biosolutions

Location: Gaithersburg, Maryland

Method: “hyperimmune specialty plasma” (human/equine-derived)

Development status: Phase 2



Company name: Kamada

Location: Rehovot, Israel

Method: “Anti-corona [immunoglobulin] (IgG) from plasma derived from donors recovered from the virus”

Development status: Not identified



Company name: La Jolla Institute

Location: La Jolla, California

Method: Screening existing drugs (specifically those with a “dose-response” relationship) for repurposing

Development status: N/A



Company name: Regeneron

Location: Tarrytown, New York

Method: “multi-antibody cocktail” to neutralize virus

Development status: “Potential to enter human clinical trials by early summer”



Company name: Takeda

Location: Japan

Method: “Polyclonal hyperimmune globulin (H-IG)”

Development status: Not identified



Rapid antibody discovery

Company names: Berkeley lights

Location: Emeryville, United States

Method: Accelerating the use of cell-based products by providing access to find the best cells in a fraction of the time and at a fraction of the cost of traditional methods.

Development status: Completed



Company names: Distributed Bio

Location: South San Francisco, United States

Method: Engineering a panel of anti-SARS antibodies to make them block the novel coronavirus

Development status: Phase 1, 18/05/2020



Company names: Immunoprecise

Location: North Dakota, United States

Method: Developing innovative treatments against the new coronavirus, SARS-CoV-2.

Development status: Phase 2, 12/03/2020



Company names: Macromoltek

Location: Texas, United States

Method: Designing custom antibodies using computational modeling

Development status: Completed, 12/04/2020



Company names: Abcellera

Location: Vancouver Canada

Method: Creating antibody therapeutics for treatment and prevention of COVID-19.

Development status: Phase 2, 12/03/2020



Company names: Swiftcovid

Location: South San Francisco, United States

Method: Accelerating the normal timelines for translation of antibody treatments.

Development status: Phase 1



Other therapeutics

Company names: Alnylam

Location: Cambridge, United States

Method: Advancing RNAi Therapeutics for the Treatment of Coronavirus Infection

Development status: Phase 2, 04/03/2020



Company names: Ir Direct

Location: New York , United States

Method: Developing an immunotherapy to treat the COVID-19 coronavirus using its patented LEAPS peptide technology

Development status: Phase 1, 09/04/2020



Company names: Biorxiv

Location: New York , United States

Method: Developing peptide binder to the SARS-CoV-2 spike protein

Development status: Phase 2, 20/03/2020



Company names: Voigtlab

Location: Massachusetts, United States

Method: Facilitating large genetic engineering projects.

Development status: Not identified