Overview

The drug market is constantly evolving with discoveries being made every day. However, despite the progress of science and technology, many diseases still do not have any treatment options available. Autoimmune diseases are a prime example of this problem. This year, the AFCM-Egypt team has decided to launch our innovative new drug, SUPER, which we have developed its proof of concept and verified it in the lab. To bring SUPER to market, we have developed a strong business plan that covers all opportunities to penetrate the market. Our first step was to identify a major problem affecting a large segment of people worldwide, which is the debilitating effects of rheumatoid arthritis disease. Our solution is to offer our drug, SUPER, which can provide patients with relief from their symptoms for life. SUPER is the first drug for RA that uses modified mesenchymal stem cells. We understand that bringing a drug to market is a lengthy and expensive process. As a result, we have chosen large pharmaceutical companies as our primary customers. These companies have all the necessary facilities and funds to conduct pre-clinical and clinical trials, as well as the FDA approval needed for our drug. We have also engaged with healthcare workers who are our relevant stakeholders. They will play a crucial role in shaping our product,prescribing it to patients,and emphasizing its importance. More details about these meetings with healthcare workers will be discussed in the human practices sector sector. Furthermore, we have analyzed the market and our competitors' landscape to identify how we can gain a competitive advantage over leading companies. We have also provided a detailed overview of our products and services and conducted an in-depth market and costing analysis. Additionally, we have conducted a SWOT analysis to determine our strengths, opportunities, weaknesses, and threats. All of these factors have been discussed in detail in our entrepreneurship model.

Customer

Problem Statement

Rheumatoid arthritis is assumed to be a multifactorial autoimmune illness, although its exact cause is uncertain. Indeed,the immune system of the body unintentionally attacks its tissues. Causing Joint pain, stiffness, edema, and tenderness as major symptoms. Additionally, the hands, wrists, knees, and feet are the most frequently affected joints. (1) Although the primary area of the body affected by rheumatoid arthritis is the joints, it can also affect other organs and systems, leading to disability and early death. (2) RA does not currently have a cure;however, there are therapies that can help manage the symptoms and avoid joint damage. Immunosuppressants, physical therapy, and lifestyle modifications are frequently used as part of the treatment process. (3)

Meanwhile, one in every 10 people around the world is affected by autoimmune diseases and the number is rising. (4) According to the World Health Organization (WHO), it is estimated that 18 million people worldwide are living with rheumatoid arthritis (RA) (5). This represents about 1% of the global population. RA is more common in women than men, with a female-to-male ratio of 3 to 1. (5) Employing RA medication with in wider range,Rheumatoid arthritis (RA) can be treated with a wide range of drugs. Methotrexate, sulfasalazine, and hydroxychloroquine are examples of DMARDs (disease-modifying antirheumatic medications), which are regarded as the first line of therapy modalities because they work by lowering inflammation and suppressing the immune system(6). They are also regarded as long-term medications because they may take weeks or months to begin acting.

Another line of treatment is steroids and painkillers which are considered short-term solutions as they calm the inflammation and the pain for a short time but don’t prevent further damage to the joints. (7) All the treatments available now only help by calming the inflammation and reducing the joint damage but neither of them treats the cause itself. Moreover, those treatments are taken for a lifetime and cause a lot of side effects that could be life-threatening to the patient ranging from nausea, vomiting, diarrhea, liver damage, and blood cell abnormalities ( as in DMARDs) (8) to weight gain, bone loss, and high blood pressure in steroids use. (9)

Opportunity

The need for RA treatments is high and expanding globally. In 2021, the market was valued at $60 billion, and by 2030, it is anticipated to reach $70.1 billion(10)registering a CAGR of 1.75% during the forecast period (2022- 2030). This expansion is being driven by the rising incidence of RA, the rising cost of healthcare, and the development of new and more expensive treatments as biologicals. (11)

Additionally, there is a significant unmet demand for a medication that can effectively and permanently cure RA. RA is currently incurable, and therapies are limited to symptom management. The lives of those who suffer from the disease would be greatly impacted by a medicine that may solve all their problems.

Although the market for RA treatment is highly competitive, there is still room for new players, especially since Our team can offer a drug that is more effective or has fewer side effects than the existing treatments. (12) Knowing that the regulatory requirements for bringing a new drug to market are complex and expensive. However, the rewards can be significant as they can impact the lives of people with RA and could also generate a significant financial return.

Our drug SUPER will be a personalized medication, tailored to the patient's condition as it will only regulate the production of APCA B-cells that are responsible for attacking the joints and the tissues without affecting the immunity as a whole. This will make our SUPER platform personalized for every patient as it will be tuned by the activity of the SYN notch receptor that is mediated by the number of autoreactive B-cells in the environment. Also, the response and the levels of our therapeutic agent will be variable in each patient according to the condition and severity of the disease. Thus, diminishing the possibility of complications from the disease and multiple organ damage due to improper management of the patient's condition. In addition to controlling the cycles of relapse and progression phases that are poorly managed by the current modalities of treatment.

Primary Customers

Well-known businesses in the drug development industry like Pfizer and Johnson & Johnson will be our main customers.

Such companies are believed to have the financial resources and knowledge necessary to sell our medicine and make it accessible to those who need it. (13) Moreover, working with these corporations 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.

Additionally, they should be in possession of all necessary licenses for conducting clinical trials, and their facilities should be compliant with all GMO(Genetically Modified Organism) regulations and laws.

Relevant Stakeholders

Our team worked very hard to navigate every individual or organization that might have an impact on our drug, either favorably or unfavorably. We started by talking to the major pharmaceutical corporations, who were our main stakeholders.

Rheumatologists thus hold the advantage in the success of our drug since they will prescribe it to patients, oversee the course of treatment, and offer important insights into the requirements of RA patients and the efficiency of our drug. We tried to get closer insights into their response to our new treatment modality during our visit to Maadi hospital. Insurance companies will play a significant role in determining whether or not to fund the treatment cost for their members after patients have verified their own knowledge of the drug's safety and efficacy. They will assess the price, effectiveness, and accessibility of other treatment choices.

Product Users

Patients with rheumatoid arthritis are going to be SUPER product users under the supervision of healthcare providers. SUPER isn’t a simple drug that could be taken from home; rather, it’s like a cell therapy technique that should be administered by experts according to the patient's condition. To ensure that SUPER is available for all the people in need we will do our best to make it covered by health insurance companies and governments. Although health insurance companies only partially cover the expenditures, the RA patient journey is difficult, expensive, and lengthy. Although the price of SUPER is considerable, it will save a lot of money and time when compared to current treatment approaches. As a last treatment for rheumatoid arthritis, SUPER is also intended to address the primary patient need. This need was determined by conducting patient interviews, which were then discussed in the human practices sector in context with the patient's journey and the course of the disease.

Product

Description

Differentiating with our value proposition:

Thanks to our extensive research in the field of RA, we believe that “SUPER” will represent a unique treatment for our targeted disease compared to other used management modalities. Our “SUPER” platform provides the following benefits as part of our value proposition:

1-Safe and specific: “SUPER” is focused on targeting the autoimmune cells with the least side effects on other healthy organs, unlike other known medications that cause general immune suppression on long-term use.

2-Full treatment not only management: our system is directed not only to work against the spread of the disease in different parts of the body but also to the remodeling of the already damaged tissues leading to a complete cure of the disease. While other treatment options aim to only manage the pain and relief of the symptoms caused by RA.

3-Long-term treatment: we understand the fact that we are targeting a chronic lifetime disease. Therefore, SUPER is characterized by a very long half-life compared to other used drugs, so it provides efficient long-term protection against such chronic diseases.

4-Few administrative doses: normally, treating a disease like RA requires multiple and large doses of different drugs. However, our drug is designed to provide the maximum benefit with the minimum dosage.

Market Analysis

Rheumatoid arthritis is considered one of the most prevalent autoimmune diseases following diabetes type l.

The AFCM iGEM team is targeting around 18 million(19) patients from 400 million (20) suffering from autoimmune diseases around the world. Assuming that the annual contract of the treatment of rheumatoid arthritis in the USA ranges between 12,509-36,053 (21) depending on the patient severity and early detection this addresses a potential addressable market (PAM) of 216-648 billion dollars.

As a result of their stated regulations, the AFCM iGEM team will initially focus on the USA and Europe. Additionally, a large portion of the patient's medical expenses are covered by the insurance companies there. There are 3.6 million people affected by RA in both societies as a whole(22) (23), with a total addressable market (TAM) that ranges from 43.2 to 129.6 billion dollars.

Additionally, SUPER is designed for seropositive patients (positive for RF and CCP) excluding seronegative patients who do not express RF or ACPA in the serum despite meeting clinical classification criteria for RA.

SUPER targets APCA B cells which are specific for rheumatoid arthritis patients. Seropositive patients represent around 80% (7) of total patients.This means the serviceable addressable market (SAM) will count 2.88 million patients of about 36-104 billion dollars.

We concentrated on gathering every factor that can help in market penetration in order to compute the market share. According to our analysis of the market competition, DMARD and bio-DMARD producers will be the main competitors. In comparison to the expense of a year's worth of treatment with DMARDs, which the patient must take for years, the price of SUPER will take the lead because it will only cost roughly 20,000 dollars. Additionally, cell therapy is a cutting-edge treatment that is less expensive and more efficient than current options. Within 10 years, all of these elements will finally result in a market share of 14 to 40 billion dollars.

Products and Services

For several years, researchers have been working to find a complete cure for rheumatoid arthritis. As a result, the development of new treatment methods has sped up. Because stem cells offer unique treatments with few side effects and have been employed in many therapeutic strategies, such as the therapy of malignant tumors and other conditions, scientists and doctors have grown more involved in using them, despite the high expense.

The work done by the team during the past few months can be divided into four categories:

1-Discovering New Cells

The AFCM IGEM team intended to use mesenchymal stem cells therapeutically to treat rheumatoid arthritis. Because the anti-inflammatory characteristics of MSCs have been investigated in several animal models of inflammation and demonstrated to diminish inflammation and alleviate tissue damage, our team started designing MSCs to act specifically on auto-reactive B-cells.

2-Dry Lab

The AFCM IGEM team developed a technique for assessing the specificity and sensitivity of three arrays of biomarkers using machine learning. The first biomarker assesses the specificity and sensitivity of binding between our MSCs and auto-reactive B-cells; the second considers the sensitivity of engineered exosome secretion following activation of our syn-notch receptor; and the third considers the activation of our engineered exosomes specifically for auto-reactive B-cells. The overall performance of the biomarkers shows high specificity and sensitivity.

3-Wet Lab

The AFCM IGEM team will begin by setting up a cell culture using HEK-293T in D-MEM media, then we'll amplify fragments and get them ready for digestion and ligation so they can be inserted within the backbone vector PC-DNA3.1(-), after which we'll transfect cells using the poly transfection technique based on lipofectamine, measure the transfection using flow cytometry and cell sorters, and finally validate each component of our project.

4-Software Tool

This year, we are providing a conjugation between clinical and bioinformatics software tools. Firstly, we have provided the bioinformatics tool with a database for T-cell receptor beta chain (CDR3) and many variable rheumatoid epitopes. The tool’s input is the CDR3 of a certain patient and the tool’s output is the ranking of the affinities between the CDR3 and the rheumatoid epitope specific for this patient. As our aim is a complete cure for rheumatoid arthritis, we can use this specific CDR3 as the external domain of our SYN-notch receptor to target the disease accurately. Moreover, the clinical software tool is a tool in which the patient applies a hand X-ray and is informed whether this X-ray is rheumatoid,non-rheumatoid, or normal. It will not only be a prognostic tool that will ensure the efficacy of our treatment but also will confirm the clearance of erosions, periarticular osteopenia, and hand deformities.

Competition

Industry and Market Analysis

The gold standard for rheumatoid arthritis treatment is DMARDs such as methotrexate. Many side effects can be associated with methotrexate when treating RA patients, from mild to severe or discontinuation of the treatment, which varies from the most common gastrointestinal toxicity effects to the less frequent malignant diseases. These drugs have also proven to be ineffective. First, the drug just relieves symptoms associated with the disease such as joint pain, exhaustion, redness, and swelling. Finally, it slows the progression of further joint damage easing RA manifestations but it doesn’t stop the damage course.

While DMARDs have been standard for rheumatoid arthritis treatment, their frequently associated complications and their lack of complete cure have been major concerns. Super, on the other hand, offers a safer treatment pathway for RA patients along with its high effectiveness.

Discussion about intellectual property protections

To turn our approach into a reality, we needed to learn how to secure a "patent" for our work so that we could protect our intellectual property. As a result, we started our research and worked to learn the knowledge necessary to do so.

First, we began our in-depth investigation to determine the fact that our medication is patentable.A deep patent search was the first step in our patenting procedure. To save money on conducting a formal search, we chose to do it informally by following the USPTO's DIY patent search instructions(24).

Following the patent search, the next step is to submit a patent application to the United States Patent and Trademark Office. Our product is currently in the process of being patented due to our patent application. We chose to start by doing a provisional patent application describing our project as “A novel modular therapeutic platform for ACPA positive rheumatoid arthritis based on exosomal delivery of CRISPR Cas system targeting B-cell activating factor receptor (BAFF-R) gene within the auto-reactive B-cell ” to establish a priority date for our drug in order to prevent anyone from stealing our idea, the correspondingly nonprovisional patent application will be filled within twelve months.

Instead of taking individual patents from countries that are a part of the European Patent Convention (EPC)(25), we will file an application for a European patent concurrently because it is a quicker and more affordable solution. A single European patent application will also cover all 39 of the continent's members. Additionally, To assess the strength of our intellectual property protection and get overall guidance, we have consulted with Dr.Kerishah, (Lawyer & patent attorney at Kirshah IP). In our discussion, he has advised that the entire workflow is patent-able and he will help us to file a provisional patent before we present at the giant jamboree in Paris and speak at other engagements.

(more details on the integrated human practices page)

Finally, in order to protect our team's intellectual property moving forward, we will request formal consent from faculty members and individuals before moving on with our own independent development of this technology. We have also asked that everyone participating in the development process sign non-disclosure agreements so that all information would be protected by a patent to ensure that our technology is not released without our consent.

Commercialization Strategy & Partnership

Our first step is to contact all of the Egyptian authorities who are in charge of monitoring product safety in order to obtain their approval. Certification is the basic building block for obtaining companies' confidence in our proposed drug. We can boost the trust and credibility of the drug manufacturing companies by obtaining approvals and certification from all competent administrative authorities and related entities to gain licensure for our product. In return for this, when the appropriate authorities support our product, we will not only gain approvals to launch our drug in the market but they will make sure that it is secure and efficient, as well.

After receiving clearance for the validity of our method in treating rheumatoid arthritis from the qualified and responsible authorities in Egypt, we will follow a set of strategies to carry out our plan promoting our method in treating rheumatoid arthritis on a larger scale by proceeding with further animal studies and clinical trails. After proving the success and safety of our drug through the clinical and in-vivo trials, we will then seek out organizations that are looking for unconventional, effective, and cost-efficient ways to treat rheumatoid arthritis. Which represents an essential step in order to market our innovative therapeutic approach.

We had to carefully consider how to present and persuade major worldwide pharmaceutical and medical companies of the benefits of our product. These businesses operate internationally and have numerous branches, which will aid in spreading the word about the medicinal product more widely. In addition, these businesses are also well-connected to the government and are well-versed in all the specifics that we would need to cover. Therefore, it will enable us to make several crucial decisions to help our product become known as the most significant rheumatoid arthritis treatment option on the market.

Reaching out to government organizations and medical officials to persuade them of the legitimacy and efficacy of the licensed drug is also crucial. It has a huge favorable influence on the health of diseased people, as well as on their productivity and standard of living, all of which have a big positive impact on the nation's economy.

It is a fantastic opportunity to market our product by attending significant international conferences in the areas of medicine, pharmacy, and synthetic biology in general, as well as conferences addressing chronic diseases and autoimmune diseases in particular. The excellent benefits of our therapeutic solution over competing rheumatoid arthritis treatment options are given through these conferences, whether they are local or international. This is done through posters, designs, and videos explaining our project's idea for treating the disease. This is a fantastic chance to persuade investors and representatives of significant worldwide pharmaceutical businesses to present at these conferences. and make an effort to arrange a meeting with them so we can discuss the matter further.

We also intend to host numerous scientific conferences and invite the largest number of investors interested in the medical, pharmaceutical, and synthetic biological industries, as well as important international companies interested in exploring and implementing new ideas for the treatment of various diseases, as well as representatives from the public and private sectors. Through these conferences, all the advantages of our therapeutic product compared to competing treatments for rheumatoid arthritis will be discussed. In addition, real-life examples of people whose conditions improved after receiving the medication will be used.

Our therapy approach has the major advantage that its scientific underpinnings are geared toward treating all autoimmune illnesses, not just rheumatoid arthritis. As a result, we reasoned that when our product demonstrated its effectiveness in treating rheumatoid arthritis and achieved economic momentum as the leading technique for treating the ailment, we may consider addressing the subject more widely to include additional autoimmune conditions.

Company

Mission and Goal

The "SUPER" foundation team believes it is our duty to contribute to improving the lives of those affected by rheumatoid arthritis while also preventing and curing the disease. By promoting research and enhancing other people's access to healthcare, our aim will be fulfilled. We also envision a world without rheumatoid arthritis and all of its negative manifestations.

Cost Analysis

In order to accurately determine the economic feasibility of this project, it is crucial to conduct a thorough analysis of the required investment and ongoing production costs. This cost is directly related to the production of our drug and must be cautiously evaluated. To begin with, we need to consider the capital costs. These are one-time expenses associated with purchasing the equipment needed for drug production. The cost of each piece of equipment must be considered, as well as any installation or assembly fees required. In addition to capital costs, we must also calculate the total capital investments required for this project. This includes the cost of setting up the manufacturing units, engineering costs, working capital, and crisis management fees. Each of these expenses should be carefully considered and factored into the overall investment required for this project. Finally, we must calculate the total costs of the manufacturing process. This includes the cost of materials required to produce 1000 units of our drug, as well as any labor or energy costs associated with the process. After taking into account all of the factors we can compute the original cost of our drug as well as the ultimate profit, margins, and return on investment. This will assist us in determining whether our project is financially feasible and viable. It is critical to thoroughly examine these costs in order to make informed decisions about the project's future.

Revenue Consideration

Regarding the profit and margins mentioned above it will depend that one company will adopt our drug from the early stages after reaching the proof of concept phase. The company will be responsible for bringing the drug into the market until it reaches the healthcare workers who are going to prescribe it to the patients.

The investment and production costs must be covered by the suppliers themselves. According to our market analysis, the drug will cover a large portion of patients around the world suffering from rheumatoid arthritis with a total addressable market of 2.88 million patients. Obviously, the drug will cover its expenses of production adding that it is a complete treatment for RA and the patients are not satisfied by current treatment modalities provided by the survey results (check-in human practices sector)

Knowing that health insurance companies and governments cover completely or partially the cost of treatment which could continue for many years. A new novel approach that cures the disease would save a lot of expenses to them even if the approach is relatively expensive it will save years of spending on DMARDs and other RA drugs.

SWOT Analysis

To determine the viability of entering the rheumatoid arthritis market, our team conducted a SWOT analysis, which assessed our strengths, weaknesses, opportunities, and threats.

Timeline

We at AFCM Egypt put a lot of effort into designing and creating "SUPER" proof of concept this year. We contributed our approach's mechanism to the test in vitro. We want to make our proof of concept safer and more efficient by the year 2024. After that, we will begin performing pre-clinical tests on animal models in order to establish an initial, secure dose for the first study among people and evaluate the potential toxicity of the drug. The drug's mean residence time, which is dependent on the therapy's metabolism, absorption, excretion, and distribution will also be calculated. We will make every effort to complete the pre-clinical trials by the end of 2025.

We want to begin the first phase of clinical research in 2026, which will test drug safety on a small number of people. The following year, we will begin phase two clinical trials to determine the efficacy of our medicine among 100 to 300 participants. This phase should last till 2028. The third phase compares the safety and effectiveness of the new treatment to that of the current standard treatment. This phase is anticipated to be completed by the end of 2031 if our medicine is more effective and has fewer negative effects.

The final step is phase four, which tries to evaluate the medicine's performance in real-world circumstances, research the long-term risks and advantages of using the treatment, and identify any unusual adverse effects.

Business Model Design

Translating our value proposition and technological innovation, A business model is a simple tool for visualizing all essential building components of one's business and for easily defining and communicating our venture.

Marketing plan

References

• Chauhan K, Jandu JS, Brent LH, Al-Dhahir MA. Rheumatoid Arthritis. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023.

• Guo, Q., Wang, Y., Xu, D., Nossent, J., Pavlos, N. J., & Xu, J. (2018). Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone research,p>

• Conigliaro, P., Triggianese, P., De Martino, E., Fonti, G. L., Chimenti, M. S., Sunzini, F., ... & Perricone, R. (2019). Challenges in the treatment of rheumatoid arthritis. Autoimmunity reviews, 18(7), 706-713.

• Conrad, N., Misra, S., Verbakel, J. Y., Verbeke, G., Molenberghs, G., Taylor, P. N., ... & Cambridge, G. (2023). Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. The Lancet, 401(10391), 1878-1890.

• Rheumatoid arthritis - World Health Organization (WHO)

• Ahmad, A., Zaheer, M., & Balis, F. J. (2022). Baricitinib. In StatPearls [Internet]. StatPearls Publishing.

• Nwosu, A. D. G., Chukwu, L. C., Onwuasoigwe, O., Nweze, S. O., & Nwadike, K. (2023). Redefining the Role of Analgesic Adjuvants in Pain Management: A Narrative Review. Indian Journal of Pain, 37(2), 65-73.

• Benjamin, O., Goyal, A., & Lappin, S. L. (2018). Disease modifying anti-rheumatic drugs (DMARD).

• Doumen, M., Pazmino, S., Bertrand, D., Westhovens, R., & Verschueren, P. (2022). Glucocorticoids in rheumatoid arthritis: balancing benefits and harm by leveraging the therapeutic window of opportunity. Joint Bone Spine, 105491.

• Greaves, R. F., Bernardini, S., Ferrari, M., Fortina, P., Gouget, B., Gruson, D., ... & Kricka, L. J. (2019). Key questions about the future of laboratory medicine in the next decade of the 21st century: a report from the IFCC-Emerging Technologies Division. Clinica Chimica Acta, 495, 570-589.

• Abbasi, M., Mousavi, M. J., Jamalzehi, S., Alimohammadi, R., Bezvan, M. H., Mohammadi, H., & Aslani, S. (2019). Strategies toward rheumatoid arthritis therapy; the old and the new. Journal of cellular physiology, 234(7), 10018-10031

• Mankia, K., Di Matteo, A., & Emery, P. (2020). Prevention and cure: the major unmet needs in the management of rheumatoid arthritis. Journal of Autoimmunity, 110, 102399.

• Figus, F. A., Piga, M., Azzolin, I., McConnell, R., & Iagnocco, A. (2021). Rheumatoid arthritis: extra-articular manifestations and comorbidities. Autoimmunity reviews, 20(4), 102776.

• Radu, A. F., & Bungau, S. G. (2021). Management of rheumatoid arthritis: an overview. Cells, 10(11), 2857

• Smeele, H. T., Röder, E., Wintjes, H. M., Kranenburg-van Koppen, L. J., Hazes, J. M., & Dolhain, R. J. (2021). Modern treatment approach results in low disease activity in 90% of pregnant rheumatoid arthritis patients: the PreCARA study. Annals of the Rheumatic Diseases, 80(7), 859-864.

• Drosos, A. A., Pelechas, E., & Voulgari, P. V. (2020). Treatment strategies are more important than drugs in the management of rheumatoid arthritis. Clinical Rheumatology, 39(4), 1363-1368.

• Lin, Y. J., Anzaghe, M., & Schülke, S. (2020). Update on the pathomechanism, diagnosis, and treatment options for rheumatoid arthritis. Cells, 9(4), 880.

• Rheumatoid arthritis - World Health Organization (WHO)

• Frommer, L., & Kahaly, G. J. (2020). Type 1 diabetes and associated autoimmune diseases. World journal of diabetes, 11(11), 527.‏

• An, J., Nyarko, E., & Hamad, M. A. (2019). Prevalence of comorbidities and their associations with health-related quality of life and healthcare expenditures in patients with rheumatoid arthritis. Clinical rheumatology, 38, 2717-2726

• Xu, Y., & Wu, Q. (2021). Prevalence trend and disparities in rheumatoid arthritis among US adults, 2005–2018. Journal of clinical medicine, 10(15), 3289.‏

• Galloway, J., Capron, J. P., De Leonardis, F., Fakhouri, W., Rose, A., Kouris, I., & Burke, T. (2020). The impact of disease severity and duration on cost, early retirement and ability to work in rheumatoid arthritis in Europe: an economic modelling study. Rheumatology advances in practice, 4(2), rkaa041.

• Masur, J. S. (2011). Patent Liability Rules as Search Rules. The University of Chicago Law Review, 187-206

• Hall, B. H., & Helmers, C. (2019). The impact of international patent systems: Evidence from accession to the European Patent Convention. Research Policy, 48(9), 103810.