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ENTREPREUNEURSHIP

Entrepreneurship

Introduction and Context

The economic situation surrounding the development of antibiotic treatments is of critical importance, as it not only impacts healthcare but also has broader economic implications. Addressing antibiotic resistance is not only a medical necessity but is also essential for the sustainability of healthcare systems and the overall economy. Moreover, antibiotic resistance has been associated with increased healthcare costs due to the need for more expensive treatments and longer hospital stays. A study published in the journal Health Affairs in 2016 estimated that antibiotic resistance adds approximately $1,383 to the cost of treating a single infection in the United States. The total annual economic burden of antibiotic resistance in the U.S. healthcare system was estimated at $20 billion at that time[3]. Antibiotic-resistant infections often require longer hospital stays and an increased risk of readmission. A study in the United Kingdom found that the cost of treating patients with antibiotic-resistant bloodstream infections was significantly higher than treating those with susceptible infections. The additional cost per patient was estimated at £3,209.[2] The global economic impact of antibiotic resistance is substantial. It affects international trade and travel, as resistant infections can spread across borders. The World Bank estimates that by 2050, antibiotic resistance could lead to a reduction in global GDP by 1.1% to 3.8%, resulting in economic losses of $1.1 trillion to $3.8 trillion per year.[6] Developing effective solutions to combat this issue is not only a medical imperative but also essential for the sustainability of healthcare systems and the broader economy. The application envisaged for the development and marketing of our SuperBugBuster solution would be the deployment of a probiotic. Our dual solution for combating antibiotic resistance would be incorporated into freeze-dried bacteria. Coupled with an inducer that would be a counterpart to this probiotic solution, this preventive system would be treated regularly to combat and counteract, as effectively as possible, any development of antibiotic resistance to carbapenemases in bacteria present in humans. (seeImplementation page )


Market analysis :

To study the possibility of integrating our application and our solution into the market for probiotic treatments to combat antibiotic resistance, we drew up an inventory of our ideas. We also established the various stakeholders who could be involved in and impacted by our application. We then carried out a SWOT analysis of the business model that would be developed in the event of our application being commercialized, in order to define the points to watch out for and be wary of in the development project.


General reflexion about the actual situation of Antibiotic Resistance :

  1. High Economic Costs of Antibiotic Resistance: The economic burden extends to lost productivity and increased mortality rates.
  2. Investment in Research and Development (R&D): Developing novel antibiotics, diagnostics, and therapies to address resistance requires substantial investments in R&D. The economic viability of such investments is challenging due to the lower profitability of antibiotics compared to other pharmaceutical products. This issue is a critical aspect of the global fight against antibiotic resistance[7].
  3. Economic Benefits of New Treatments: The successful development of new antibiotics or alternative treatments can lead to economic benefits by reducing healthcare expenditures and improving patient outcomes.
  4. Incentives for Antibiotic Development: Governments and organizations are exploring various incentives to encourage pharmaceutical companies to invest in antibiotic research, such as market entry rewards and priority review vouchers.
  5. Antibiotic Stewardship Programs: Implementing antibiotic stewardship programs in healthcare settings can help reduce unnecessary antibiotic use, potentially lowering healthcare costs.
  6. Global Economic Impact: Antibiotic resistance is a global issue, and its economic consequences can disrupt international trade and travel, affecting economies worldwide.
  7. Economic Opportunities in Diagnostics: Developing rapid and accurate diagnostic tools to identify antibiotic-resistant infections can lead to cost savings by enabling targeted treatment.
  8. Alternatives to Traditional Antibiotics: Research into non-traditional approaches, such as phage therapy, CRISPR-based treatments, and antimicrobial peptides, may present economic opportunities while addressing resistance.
  9. Health Insurance Costs: The rise of antibiotic-resistant infections can affect health insurance premiums, causing concerns for both individuals and businesses.
  10. Cost-Benefit Analysis: Evaluating the cost-effectiveness of various solutions for antibiotic resistance is essential for informed decision-making in healthcare policy and investment strategies.

Stakeholder Analysis :

Stakeholder analysis is a vital process in project management and strategic planning. It involves identifying, assessing, and understanding the various individuals, groups, or organizations that have a vested interest in the outcome of a project. These stakeholders can significantly influence the project's success, and their needs, expectations, and concerns must be carefully considered and managed throughout the project's lifecycle. Ultimately, the goal is to empower project managers and teams to foster positive relationships with stakeholders, navigate complexities, and achieve project success while considering the diverse needs and perspectives of those involved.

Primary Stakeholders: Secondary Stakeholders: Key Decision-Makers: Supporters: Opponents: External Partners: Community Representatives: Communication and Engagement Strategy:
Academic Advisors: Professors and academic mentors who guide and oversee the project's progress. Local Community: Residents and local businesses in the vicinity of the university who may be indirectly affected by the project's activities. Regulatory Authorities: Government agencies responsible for biosafety and ethical regulations that may impact the project's progress. Public Health Organizations: Organizations focused on public health and antimicrobial resistance prevention, which may support and promote the project's goals. Bioethical Activists: Individuals or groups concerned about the ethical implications of genetic modification and biotechnology. Biotechnology Companies: Companies specializing in synthetic biology and genetic engineering that may collaborate with or provide resources to the project. Local Government: Local government officials and representatives who may need to be informed about and engaged with the project's activities. Develop clear and transparent communication channels to keep stakeholders informed about project progress.
University Administration: INSA Lyon's leadership and administrative staff who provide institutional support and resources. Medical Researchers: Researchers in the field of antibiotic resistance and synthetic biology who could benefit from the project's findings and solutions. Ethics Committees: Institutional or external committees responsible for reviewing and approving research involving genetic modification and biosecurity. INSA Lyon Alumni: Alumni of INSA Lyon who may take an interest in and support the project as part of the university's community. Environmental Advocates: Groups focused on environmental conservation who may have concerns about the project's ecological impact. Healthcare Institutions: Hospitals and healthcare providers with an interest in potential treatments for antibiotic-resistant infections. Patient Advocacy Groups: Organizations representing patients affected by antibiotic-resistant infections. Engage in regular discussions with regulatory authorities and ethics committees to address concerns.
Funding Agencies: Organizations or entities providing financial support for the project, such as grants, sponsorships, or research funds. Pharmaceutical Industry: Companies in the pharmaceutical sector with an interest in potential treatments for antibiotic resistance. Collaborate with local community representatives to address any potential environmental or safety concerns.
Seek partnerships with pharmaceutical companies and healthcare institutions to leverage resources and expertise.
Provide updates to funding agencies and academic advisors on research outcomes and milestones.
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Risk Analysis :

Finally, analyzing the risks associated with our project of using a probiotic treatment system to combat carbapenem antibiotic resistance using CRISPR-Cas9 and Bac Protac system is crucial for successful project management. Below, we have outlined the risk analysis that identifies potential risks, their impacts, and mitigation strategies.

  1. Technical Risks:
    • Risk: Technical challenges in implementing CRISPR-Cas9 and Bac Protac systems effectively to target antibiotic resistance genes.
    • Impact: Delays in project milestones, increased resource consumption.
    • Mitigation: Conduct comprehensive feasibility studies and pilot experiments, involve experienced researchers, and have backup technical strategies.
  2. Regulatory and Ethical Risks:
    • Risk: Stringent regulations and ethical concerns related to genetic modification in probiotics.
    • Impact: Regulatory hurdles, potential public opposition, project delays.
    • Mitigation: Engage with relevant regulatory authorities and ethics committees from the project's early stages. Ensure compliance with all guidelines and standards.
  3. Funding Risks:
    • Risk: Insufficient funding for the project's duration.
    • Impact: Interruption of research, inability to meet objectives.
    • Mitigation: Develop a comprehensive budget plan, actively seek grants, and explore partnerships with funding organizations.
  4. Market and Commercialization Risks:
    • Risk: Limited market acceptance or competition from other similar products.
    • Impact: Difficulty in commercializing the probiotic product.
    • Mitigation: Conduct market research to identify potential customers and their needs. Collaborate with industry experts for market insights.
  5. Intellectual Property Risks:
    • Risk: Lack of adequate protection for project-related intellectual property.
    • Impact: Risk of IP infringement or loss of competitive advantage.
    • Mitigation: Seek legal counsel to establish IP protection strategies and file necessary patents.
  6. Biosafety Risks:
    • Risk: Accidental release of genetically modified probiotics into the environment.
    • Impact: Environmental contamination, negative public perception.
    • Mitigation: Implement strict biosafety protocols, adhere to containment measures, and conduct rigorous risk assessments.
  7. Collaborative Risks:
    • Risk: Challenges in collaborating with external partners or organizations.
    • Impact: Hindered progress, misaligned objectives.
    • Mitigation: Clearly define roles and responsibilities, establish communication protocols, and maintain open dialogue with collaborators.
  8. Resistance Development Risks:
    • Risk: Development of resistance to CRISPR-Cas9 and Bac Protac systems.
    • Impact: Reduced treatment effectiveness, potential exacerbation of antibiotic resistance.
    • Mitigation: Continuously monitor for resistance development and adapt treatment strategies accordingly.
  9. Public Perception Risks:
    • Risk: Misunderstanding or misinformation regarding the project's goals and implications.
    • Impact: Negative public perception, public opposition.
    • Mitigation: Engage in transparent and effective science communication, involve public health experts to address concerns.
  10. Supply Chain Risks:
    • Risk: Disruptions in the supply chain for essential materials or technologies.
    • Impact: Delays in experiments or production.
    • Mitigation: Diversify suppliers and maintain backup plans for critical resources.

Regularly reviewing and updating your risk analysis throughout the project's lifecycle is essential to ensure timely risk mitigation and project success. Additionally, involving relevant experts and stakeholders in risk assessment and management can enhance the project's resilience against potential challenges.


References :

[1] World Health Organization, "Antimicrobial Resistance: Global Report on Surveillance," 2014. [Online]. Disponible : https://www.ncbi.nlm.nih.gov/books/NBK97140/#:~:text=While%20increasing%20treatment%20heterogeneity%20and,well%20as%20to%20care%20about.

[2] A. E. Tacconelli, N. Magrini, L. Kahlmeter, G. Singh et E. R. Roilides, "Estimating the economic cost of antimicrobial resistance per antibiotic consumed to inform the evaluation of interventions affecting their use," The Lancet Infectious Diseases, vol. 18, no. 3, pp. 318-329, Mar. 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6929930/.

[3] A. Tacconelli and H. Leufkens, "How to ensure the sustainable development of antibiotics in the 21st century," Clinical Microbiology and Infection, vol. 19, no. 8, pp. 705-707, Aug. 2013. [En ligne]. Disponible : https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(14)65363-5/fulltext.

[4] Imperial College London, "Scientists discover approach to fighting antibiotic resistance," Imperial College London, 2019. https://www.imperial.ac.uk/news/234060/scientists-discover-approach-fighting-antibiotic-resistance/.

[5] Ministère des Solidarités et de la Santé, "L'antibiorésistance : pourquoi est-ce si grave ?," Ministère des Solidarités et de la Santé, [En ligne]. Disponible : https://sante.gouv.fr/prevention-en-sante/les-antibiotiques-des-medicaments-essentiels-a-preserver/des-antibiotiques-a-l-antibioresistance/article/l-antibioresistance-pourquoi-est-ce-si-grave.

[6] Centre-Val de Loire, "Présentation de M. CARENCO," Centre-Val de Loire, 2022. [En ligne]. Disponible : https://www.centre-valdeloire.fr/sites/default/files/media/document/2022-12/2022.10.13%20-%20presentation%20M.%20CARENCO.pdf.

[7] Review on Antimicrobial Resistance, "Tackling Drug-Resistant Infections Globally: Final Report and Recommendations," Wellcome Trust, 2016. https://documents1.worldbank.org/curated/en/323311493396993758/pdf/final-report.pdf.

[8] Centers for Disease Control and Prevention (CDC), "Antibiotic Resistance Threats in the United States, 2019," U.S. Department of Health and Human Services, Atlanta, GA, 2019.