Entrepreneurship
In this section, we outline our business strategy to transition our CALIPSO project into a robust startup. Our company's focus centers around utilizing CALIPSO as a flexible foundation for creating innovative cancer treatments. CALIPSO is a platform that integrates various modules (anchoring, biosensing, and anticancer drug production) into a unified system targeting tumor cells via liposomal delivery. Subsequently, drug candidates tailored to specific types of cancer are developed using the CALIPSO platform.
We demonstrate the innovation, feasibility, and scalability of our project by identifying target customers and users, and closely monitoring resources, milestones, and risks. Additionally, we have made predictions to estimate treatment costs, fundraising and return on investment to ensure a viable, affordable and sustainable solution.
Our reflection on entrepreneurship is organized across three pages: the Entrepreneurship page, the Implementation page and the Sustainability page.
As explained on our Description page, there is a growing need for more specific and less side-effect-inducing treatments. Even with existing liposome-based treatments, where the active anticancer drug is directly encapsulated in the liposome, undesirable effects can still occur. These side effects can be explained by one problem associated with liposomes as a vector: their stability in the body. At body temperature, the phospholipid membrane can become leaky and allow the encapsulated drug to escape before reaching targeted cells. In light of these paths for improvement, with CALIPSO we decided to combine targeting strategies involving HER2 or/and IDH1 mutation with in situ drug activation. This integration aims to address the issue of the current therapeutic liposomes. See the design here.
Primary Customers
It is common practice for leading pharmaceutical companies to enter into partnerships. Merck, the multinational pharmaceutical and healthcare company, believes that partnering is a key for building patient-centric solutions that may help millions of people around the world [1]. The company, but as many others, collaborates with strategic partners to gain access to the latest technology platforms, and develop novel therapeutics that have clear differentiation potential. We strongly believe that CALIPSO meets the expectations of these pharmaceutical companies. We propose a versatile platform to create multiple specific drug candidates for different types of diseases, simply by changing the recognition markers and the encapsulated prodrug. Therefore, exploiting our innovative and patented technology represents a great opportunity for the pharmaceutical companies to stay ahead of their competitors in the therapeutic development market.
Our technology's primary customer will be the pharmaceutical industry, responsible for making these medications available to patients using the drug candidates produced by our platform. Our aim is to foster a close relationship with our pharmaceutical partner through ongoing discussions and negotiations. We will ensure that all conditions are met before finalizing contracts and sales. Additionally, we will prioritize regular exchanges and transparent communication, focusing on monitoring compliance, royalties, development, and reporting obligations to ensure a successful partnership.
CALIPSO’s end users
While pharmaceutical companies are our direct clients, our ultimate focus is on the patients - the end-users of our technology. One of the essential and non-negotiable conditions we will impose on pharmaceutical companies developing drug candidates from our platform is to ensure the treatment's affordability and eligibility for coverage by the majority of health insurance plans worldwide.
Added value of our versatile platform
We present engineered liposomes as an innovative platform that adjusts to its environment. Unlike current therapeutic liposomes, the drug is activated and released locally to eliminate tumor cells while minimizing damage to healthy cells and thus reducing side effects. Also, the modularity of our system allow applications even beyond cancer treatment by plugging targeting, biosensing or drug production modules that are specific to a diseased area in the body. Finally, we propose a technology that will be protected by a patent. This intellectual protection not only ensures our company's long-term viability but also boosts the recognition and credibility of our treatment, guaranteeing lasting access to reliable therapy worldwide.
Product value chain
Our product value chain summarizes all the steps from discovery to the drug's commercialization and distribution. According to an article published in 2021 by Avetta Marketing [2], the pharmaceutical value chain typically consists of the following stages:
Figure 1: The entire pharmaceutical value chain.
This initial stage involves identifying new therapeutic targets, discovering new molecules, and conducting preclinical studies to assess their effectiveness and safety. It also includes clinical trials to test the drug on animals and human volunteers to evaluate its effectiveness, tolerance, and potential side effects.
Once clinical trials are successfully completed, the drug manufacturer submits a marketing authorization application to regulatory agencies such as the European Medicines Agency (EMA) in Europe the Food and Drug Administration (FDA) in the United States. These agencies review safety and efficacy data to decide if the drug can be marketed.
After receiving regulatory approval, the drug can be manufactured on a large scale. This stage involves producing the active ingredients, formulating the final drug, and manufacturing it in facilities compliant with Good Manufacturing Practices (GMP) to ensure product quality and safety.
After manufacturing, the drug is distributed to pharmacies, hospitals, and other healthcare providers. The distribution process can be complex, often involving wholesalers and logistics companies to transport products to the final points of sale.
This stage involves promoting the drug to healthcare professionals, patients, and the general public. Pharmaceutical companies use marketing strategies to raise awareness about the drug's benefits and encourage its prescription and use.
Finally, the drug is prescribed by healthcare professionals and dispensed to patients for their treatment. How the drug is used and monitored throughout its use contributes to managing potential side effects and the effectiveness of the treatment.
After discussing with Mr. Yves Dudal, the founder of three pharmaceutical startups (currently CEO of Perseo Pharma), we identified the various challenges and resources needed to complete this value chain. Since CALIPSO will be a young startup with limited resources at the beginning, we will focus on the first part of the chain (R&D and preclinical and clinical trials). Preclinical and clinical trials will be conducted with the help of specialized Contract Research Organizations (CROs) , and the semi-quantitative production required for these trials will be entrusted to Contract Manufacturing Organizations (CMOs).
Based on R&D and innovation, our company will have its own value chain, which can be divided as presented on figure 2 below. After phase II clinical trials, the platform will be sub-licensed to a larger company for large-scale production of the drug candidate.
Figure 2: CALIPSO value chain.
Intellectual property
With CALIPSO, we plan to file a patent for our platform that can generate multiple drug candidates. For this patent application to be valid, our invention must meet three essential conditions: it must be novel, subject to a new application, and involve inventive activity. We believe that CALIPSO meets these three conditions due to its unique engineering and design that differentiate it from existing treatments (Added value of our versatile platform).
We conducted prior searches to ensure our product meets the eligibility criteria. Following a search within the PATENTSCOPE database [3], no patents related to liposome-based drug delivery systems combining specificity and local drug production were found. The latest accessible study on various drug delivery systems, in 2013, confirmed that as of that date, no such technology had been developed yet, and it was presented as a new challenge to address [4]. As explained by a project manager at Toulouse Tech Transfer (TTT), TTT will be in charge of confirming that our technology is patentable and will process the patent deposit on the INPI (National Industrial Property Institute) website. They will cover all the fees. We know that if our technology depends on patented molecules, we would have to pay to use these molecules.
We will patent CALIPSO platform once the proof of concept has been validated. Data belongs to our institution due to the project's internship origin. So, we will negotiate an exclusive exploitation license for our start-up. The patent and the operating license are the two main elements that a potential investor or buyer will examine. Therefore, it is essential that the patent is robust, and the license agreement we sign with our institution is well-negotiated. We will seek assistance from a law firm specializing in biotechnology intellectual property. Following INPI analysis, TTT will decide in which countries we should protect our technology. We are confident in effectively protecting our invention at the European level through a European patent. Then, we would like to expand this protection internationally using the Patent Cooperation Treaty (PCT) system with the World Intellectual Property Organization (WIPO). The PCT will allow us to extend the patent application process to multiple countries - as the USA, Canada, China, and many others - simplifying the filing procedure in countries not covered by the European patent. This approach will help us protect our CALIPSO innovation on a global scale and maximize its commercial value.
Regarding our HER2+ targeted drug candidate, we will need to file another patent. Unlike the first patent on the CALIPSO platform which belongs to our institution, we will file our second patent for our own R&D conducted at the Pierre Potier Cancer Center so that the rights belong to us.
Risk analysis
Each project has its share of unpredictability, often due to unforeseen events, or not having enough information at the planning stage. It's crucial for the success of CALIPSO, that all our predictions are as accurate as possible. This helps us stay on track and avoid unexpected problems. When building a business plan, it is important to evaluate the major risks linked to the product. We decided to evaluate each risk using a five-point Likert scale [5]. Per risk, the scale from 1 (low) to 5 (high) is used to measure the impact, the probability and the non-controllability. By multiplying the three factors, we obtain a risk index, indicating how important the risk is. We have listed in Table 1 all the risks we have identified concerning all the stages from research and development to the production of advanced liposomes using our CALIPSO platform.
| Risks | Probability | Impact | Predictability index | Criticality(product) | ||
| Proof of concept | Unconvincing data | 3 | 5 | 4 | 60 | |
| Legislative & Political | Failure in the patent application | 3 | 5 | 4 | 60 | |
| Loss of license for CALIPSO platform exploitation | 1 | 5 | 1 | 5 | ||
| Refusal of marketing authorization | 3 | 5 | 3 | 45 | ||
| Treatment not covered by social security and/or mutual insurance companies | 2 | 3 | 2 | 12 | ||
| Inflation of raw materials | 3 | 1 | 5 | 15 | ||
| Pre-clinicals trials | Not sufficent fundraising | 3 | 5 | 3 | 45 | |
| Failure of pre-clinicals trials | 3 | 5 | 4 | 60 | ||
| Clinicals trials | Ineligibility for clinical trials | 3 | 5 | 4 | 60 | |
| Not sufficent fundraising | 4 | 5 | 3 | 60 | ||
| Interruption of phase I, II or III clinical trials | 3 | 5 | 3 | 45 | ||
| Too much side effects | 2 | 5 | 3 | 30 | ||
| Less effective treatment than existing therapies | 3 | 5 | 3 | 45 | ||
| Production | Difficulties to upscale functional liposomes production | 1 | 3 | 3 | 9 | |
| Problems with the stability of liposome solutions | 3 | 4 | 3 | 36 | ||
| Too expensive manufacturing | 3 | 4 | 3 | 36 | ||
| Evolution of methods using liposomes against cancer | 2 | 4 | 4 | 32 | ||
| Market | Plagiarism by pharmaceutical companies | 4 | 5 | 3 | 60 | |
| No acquisition of patents by a pharmaceutical company | 3 | 5 | 3 | 45 | ||
| Therapy too expensive for patients | 4 | 4 | 3 | 48 | ||
| Suppliers | Bankruptcy of a supplier | 2 | 2 | 3 | 12 | |
| Environment | High carbon footprint due to production | 2 | 2 | 2 | 8 | |
| Plastic, chemical and biological pollution | 3 | 2 | 2 | 12 | ||
| Management | Poor management | 2 | 3 | 2 | 12 | Number of planned tasks too large for the deadline | 4 | 3 | 3 | 36 |
Table 1: CALIPSO risks evaluation using a five-point Likert scale.
Thus, the most significant risks for our activity are related to the reliability of our proof of concept, the proper protection of our invention, and the obtention of all the necessary funds for preclinical and clinical trials. Since only one in ten treatments successfully pass through phase III clinical trials, it is the most challenging step. If the treatment proves to be less effective or shows significant adverse effects, it could lead to the termination of the clinical trials and, consequently, the end of our business. Furthermore, it is during this crucial phase that fundraising efforts need to be particularly robust to secure the necessary finances for these trials (for more details, please consult our clinical trials section on the Implementation page). Halting a trial would pose a significant obstacle in attracting new investors crucial for continuing the development of CALIPSO.
To minimize these risks, we will implement a very diligent risk management approach.
Figure 3: CALIPSO risk management.
Sustainability of the innovation
Another important aspect to take into account is the sustainability of our product. According to Richard Adams, sustainability means designing an innovation that benefits society and the environment in the long run, while also making a profit [6]. We can assert that our innovation benefits society as it addresses a critical need: treating cancer while reducing side effects. Our choice on the treatment composition is also ethically driven (GMO-free for instance).
The environmental impact of manufacturing can be minimized through our targeted approach, which reduces the quantity of medication required. Ultimately, our goal is to transform CALIPSO into a personalized medicine. This would lead to a reduction in unnecessary treatments and their associated environmental consequences. When feasible, we will select our drugs based on their environmental impact, as this can offer a competitive advantage in the market. To learn more about our environmental considerations, please consult our page on Sustainability.
Structural organization
The company at its creation: As INSA students, our experiences encompass several domains such as biomedical engineering, process engineering, synthetic and chemical biology, environment, and modeling on the scientific level. In parallel, we have been introduced to entrepreneurship, marketing, finances, law and communication manners. This collective array of expertise promotes an environment of interdisciplinary and innovative thinking, allowing us to evaluate project outcomes from multiple angles (and critically assessing outcomes). These qualities are essential for driving forward scientific research and advancements in the development of CALIPSO.
- • Company's status and operations:
We chose the Simplified Joint-Stock Company status (Société par Actions Simplifiées SAS) for our startup [7]. It is a common type of business structure in France and is similar to a Limited Liability Company in other countries. SAS structure allows us to tailor the company to our specific needs. Flexibility is the key benefit of being a SAS, making it easier to attract investors. Additionally, SAS structure often comes with tax advantages and reduced liability. Each team member will contribute to constitute our initial share capital which could start as low as 1€. It is finally essential to put in place a shareholder agreement that outlines the regulations that govern the operation of the company's ownership, including the determination of the Chief Executive Officer (CEO) and of the various roles.
In the first few years in Toulouse, our company's primary focus will be on R&D to optimize our platform and expand the range of applications derived from this technology. Following the patent deposit, we will initiate (pre)clinical trials in collaboration with Contract Research and Manufacturing Organisations. See the Implementation page, which incorporates our strategy over time.
- • Founders and positions:
Figure 4: start-up members and positions.
- • Procedures:
We will submit all the required documents to the Commercial Court (Tribunal de Commerce) in our jurisdiction. We will ensure the legal validity of our company, by adhering to French business laws and regulations, and by obtaining the necessary licenses for our business activity.
Values & Objectives
Our focus remains on a patient-oriented treatment, designed to minimize burdens. So, humans will be at the heart of our policy, which also applies to our workers, employees, and partners. We are aware that, in order to meet these needs, our activity must be profitable; that is why we will make every effort to ensure the balance between accessibility of our treatments and financial success.
Finally, we will closely monitor our environmental impact by first choosing eco-friendly facilities. The Pierre Potier Center recently led a transformative project focused on sustainability, which notably involved swapping conventional lighting with energy-efficient LED fixtures, upgrading HVAC systems, and improving roof insulation. In addition, they implemented a recycling program for cardboard, paper, white polystyrene, and even for organic waste through anaerobic digestion. We will encourage the use of public transportation and cycling among our employees and aim to make our business trips more environmentally friendly.
We are committed to actively participating in the global movement to create a more sustainable future for humanity. To consult our page on sustainability and sustainable development goals, click here.
Market Analysis
- • SWOT & PESTEL Analysis:
SWOT and PESTEL analysis are indispensable tools for market analysis, giving an understanding from both internal and external viewpoints. SWOT analysis (Figure 5) assesses our internal strengths, weaknesses, opportunities, and threats, allowing us to utilize our advantages and stay ahead in competition. PESTEL (Figure 6), on the other hand, focuses on external factors (political, economic, sociocultural, technological, legal, and environmental) essential for market positioning and adapting to changing conditions.
Figure 5: SWOT Analysis.
The SWOT analysis revealed that our main strength is innovation and the main opportunity is the expansion to many other diseases. Our main weakness is our structural and financial dependency, while insufficient protection of our intellectual property is a definitive threat for us.
Figure 6: PESTEL Analysis.
The PESTEL analysis demonstrated that our project is clearly integrated into society with several points concerning all of its main aspects.
- • Cancer market:
The global cancer treatment market was valued at approximately 158 billion USD in 2020 and is expected to generate a revenue of 268 billion USD by 2026, with a Compound Annual Growth Rate of 9.15% during the forecast period [8]. It is influenced by major players such as AMGEN, AstraZeneca, BAYER, Roche, driving advancements in treatment and research.
The cancer market exhibits a nuanced segmentation.
Firstly, cancer treatments are various, each tailored to combat cancer in unique ways. Traditional chemotherapy is frequently viewed as a cost-effective and straightforward cancer treatment. However, there's an increasing preference for personalized targeted therapies to destroy tumors, despite their higher cost, as they can minimize side effects. So we propose a treatment that addresses this demand, justifying our placement on the following positioning map.
Despite the great potential of liposomes, only 14 treatments in 2022 based on liposome delivery were approved by the FDA [14] . Out of these, six are specifically for treating cancer (Doxil, Caelyx, Myocet, Mepact, Marqibo, Onivyde), while the other eight are for different health conditions. We seek to emphasize the immense interest and credibility of these liposomes-based therapies in revolutionizing drug delivery, encouraging further exploration and advancement in this domain.
Secondly, the cancer market segmentation extends to different cancer types, such as breast, lung, colon, prostate, and more, each demanding specific approaches and medications. Breast cancer, which we can target with our technology, was the major revenue contributor in 2020, and it is anticipated to continue this trend, due to increase in the number of affected populations with early screening on the disease. [15]
Thirdly, when considering end-users, the market serves hospitals, outpatient care centers, and research facilities, indicating a diverse consumer base with varying needs and preferences.
Table 2: Number of cases of breast, stomach and esophageal cancer in France [16], the United States [17], Europe [18] and worldwide [19].
We estimate that our first treatment, developed using the CALIPSO platform and targeting HER2+ cancers, could benefit approximately 1.3 million patients worldwide, including 342,000 in Europe and the United States.
On one hand, our focus has been on patients with breast, stomach, and esophageal cancers, as the overexpression of HER2 is prevalent in approximately 15–30% of breast cancers and 10–30% of gastric/gastroesophageal cancers. We will also include patients with ovarian, endometrial, bladder, lung, colon, and neck cancers, where HER2 overexpression has been reported too. On the other hand, we have estimated the number of patients with these cancers carrying the IDH1 mutation, reported in approximately 3% of cancers. To obtain these estimates, we considered the potential patient population in France, the United States, and Europe, which collectively represent 47.2% and 24.5% of the global pharmaceutical market, respectively. The estimations are based on the number of new patients per year and are sourced from national and international cancer information and monitoring organizations.
Finally, there is the geographical dimension. North America emerges as the current market leader. This is attributed to the region facing a significantly higher cancer prevalence and being a hub for key market players who form alliances and strategic investments to drive advancements and innovations in cancer treatments. Nevertheless, Asia Pacific is expected to have the fastest growing cancer market in the future [20].
Thus, many factors drive the cancer market growth. They mainly include the growing prevalence of cancer worldwide, rising government initiatives for cancer awareness, strong R&D initiatives by key players, and the increasing demand for personalized medicine. But market trends are also influenced by hazard and exceptional events that affect the entire world such as the COVID-19 pandemic. The COVID-19 pandemic has impacted healthcare systems globally and has also had a significant effect on the cancer therapy market, resulting in a 46% decrease in diagnoses of the six most common types of cancer (breast, colorectal, lung, pancreas, stomach, and esophageal cancers). Challenges in screening, postponed surgeries, and difficulties in providing routine cancer care have arisen due to various reasons, including precautionary measures, a lack of personal protective equipment, and a shortage of staff [15].
Network & Close relationships
Our iGEM Toulouse team has a strong network in the biomedical field, as we stand within the Toulouse cancer cluster. By establishing ourselves in the Pierre Potier cancer Center and joining the Eurobiomed ecosystem, by developing partnerships with suppliers for product quality and supply chain reliability, and by collaborating with an IP law firm for protection and with Contract Research and Manufacturing Organizations for efficient trials and cost optimization, we are ensuring the best conditions for our success.
Exit strategy & Long term objectives
The market exit strategy holds a vital importance for our company's profitability and sustainability. After assessing the resources at our disposal and discussing with the founder of three pharmaceutical start-ups, Yves DUDAL, we have opted for the following exit strategy.
We realized that the CALISPO project resulted in the creation of a platform with multiple associated drug candidates, each targeting different types of cancer. Currently, we are developing our proof of concept with one type of cancer (HER2+ cancers with an IDH1 mutation). Once our proof of concept that targets HER2+ cancers is validated, we will proceed to clinical trials up to a Phase II. After these steps are completed, we will sell the patent for this drug candidate to a major pharmaceutical company that has the expertise and resources to handle the entire product value chain, from industrial-scale production to marketing. We may also consider local companies already involved in cancer treatment, such as Sanofi, Pierre Fabre, and many others.
Finances
- • Costs:
Now that our entrepreneurial strategy is defined, we conducted a financial study encompassing all our expenses over a nine-year period. These expenses are categorized into lab consumables and equipment, salaries and training costs, patent filing and licensing fees, membership fees for business incubators, preclinical and clinical trials, and diverse other fees. All theses costs are summarized in the following pdf:
- • Treatment price:
Based on R&D costs and the molecular composition of our liposome formulation, we have evaluated the CALIPSO treatment price to be around 50,000 euros, per dose of 10 mg of Tegafur. The tegafur dose in chemotherapy capsules is approximately 100 mg [13]. Given that our intravenously injected cancer cell-targeting liposomes improve specificity, we divide the required quantity by 10.
The production cost estimate for our advanced liposomes is initially derived from the expenses associated with reagents and compounds in the initial experimental stages. Scaling up production is anticipated to yield a 2 to 3-fold reduction in liposome costs, potentially reducing the production cost per dose to approximately 17,000 euros. However, this estimation and dosing strategy will be refined based on pre-clinical and clinical trial results, aligning with recent targeted therapy prices and market dynamics. We acknowledge the challenge in accurately estimating costs due to the complexity of our specific formulation and our current limitations in knowledge, emphasizing the need for ongoing evaluation and adaptation in our pricing strategy. Additionally, our approach considers the reduction in dosage through the specificity of our treatment, highlighting our unique positioning in the liposomal treatments landscape.
- • Fundraising:
We are actively pursuing a diverse range of capital channels to ensure CALIPSO development.
This includes exploring private and public grants from renowned public organizations, such as the French National Research Agency (ANR) and the French National Institute of Health and Medical Research (INSERM), as well as opportunities through the European Union's European Structural and Investment Funds (ESIF) [24]. These initial sources of funding will support research and development over the first three years of our company. We also aim to participate in innovation competitions, collaborate through public-private partnerships like Concerto Programme and Canceropôle Grand Sud-Ouest, and tap into crowdfunding campaigns and workshops to strengthen our funding prospects [25]
For pre-clinical and clinical trials mainly, valued at around €96 million, we will be seeking private investors. We will be engaging venture capital firms, business angels and corporate incubators. Our strategy involves thorough evaluation of worldwide financial assistance opportunities, and we intend to involve private investors to fuel the growth of CALIPSO, benefiting from their expertise and establishing valuable connections in the healthcare and pharmaceutical industry [26].
- • Cash flows
As explained earlier, our company strategy is to develop drug candidates using our CALIPSO platform. The aim is to sell patents of drug candidates at the end of the phase II clinical trials to large pharmaceutical companies. These sales will include a freedom-to-operate license for the CALIPSO platform - giving companies the exclusive right to use, produce, optimize and market the drug candidate - upfront and milestone payments. Cumulatively, they can amount to several hundred million euros.
The first type of payment our company can receive is upfront payment. These are payments made in advance, aiming to secure the sales agreement and ensure the commitment of the pharmaceutical company.
The second type of payment would consist of milestone payments. They are specific payments made during the course of a project, based on the achievement of predefined milestones or goals. These milestones could be significant stages, objectives, or accomplishments that represent significant progress or completion of a certain phase of the project [27].
The last type of payment our company will receive corresponds to the royalties.
The royalty rate is specified as a percentage of sales. The licensee must pay a percentage on the net gross revenue they generate by the intellectual property during the validity of the patent of the platform. The royalty rate is negotiated between the parties involved in the sale and typically ranges between 2.6 and 5%. This royalty rate depends on the stage of drug development at the time the licensing agreement is finalized. Generally, companies prefer to fulfill a significant milestone to no longer be obligated to pay royalties to the company.
We aim to negotiate a 5% royalty rate for each contract. The investment made in R&D up to phase II clinical trials is estimated at 99 million euros. The first sale of the drug candidate is projected to occur in 2032, and we anticipate receiving royalties for 11 years until the patent for the platform expires. To amortize the R&D expenses (estimated at 101 million euros), we need to receive 9 million euros per year.
In the Cancer market segment, we estimated that approximately 342,000 new patients could benefit from our medication each year in Europe and the United States. Out of this potential patient base, it is estimated that only 2 to 5% will use our therapy, totaling 10,000 patients.
Treatment sales: The selling price of the treatment is estimated to be around 25,000 euros per dose, based on a gross margin of 40-50%. Therefore, the annual cost of treatment per patient amounts to 100 000 euros with four injections per year. Hence, over the 11 years of commercialization, the sale of the medication should generate approximately 11 billion euros.
Manufacturing and market entry costs: Considering that only 1 in 10 clinical trials results in the commercialization of a drug, pharmaceutical companies typically invest an average of 1 billion euros in clinical trials. Given the manufacturing cost of the medication and the potential number of patients over 11 years mentioned above, the overall production cost of the drug and its commercialization amount to ~3 billion euros.
Return on investment Therefore, the pharmaceutical company will have a return on investment of approximately 8 billion euros. Taking into account the 5% royalties received by our company, we estimate receiving 402 million euros over the 11-year patent validity period, amounting to 36.5 million euros per year. The entirety of the R&D expenses, including the money invested in preclinical trials up to Phase II clinical trials (estimated at 101 million euros), will be recovered within 3 years after marketing our medication.
Reglementation
Our company is committed to complying with the Good Laboratory Practices. As we will be conducting pre-clinical trials on cell cultures in our P2 laboratory, we will be particularly regarding good cell culture practices in addition to the good lab practices. To know more about these Good Laboratories Practices, you can visit the safety page.
We are dedicated to ensuring that the CRO we partner with for Phase I and II clinical trials strictly adheres to the principles of Good Clinical Practice (GCP) set by the International Council for Harmonisation of technical requirements for pharmaceuticals for human use (ICH). GCP involves maintaining ethical conduct, scientifically valid trial design, informed consent, benefit versus risk assessment, data quality, safety monitoring, and employing qualified personnel. Adherence to GCP safeguards the rights, safety, and well-being of trial subjects and ensures credible clinical trial data [28].
Business Model Canvas
Our Business Model Canvas is a visual framework that provides a complete view of our business's key components and how they work together to create and deliver value to our customers.
Figure 8: CALIPSO Business Model Canvas
This comprehensive perspective allows us to integrate and establish effective communication among all stakeholders related to our business and its future.
References
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- [6] Network for Business Sustainability | What is Sustainable Innovation?.
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- [13] Inserm | Immunothérapie des cancers
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