From d2ec32432a7744b4b058502d5bd8cab924807b14 Mon Sep 17 00:00:00 2001
From: Liliana Sanfilippo <liliana.sanfilippo@uni-bielefeld.de>
Date: Fri, 27 Sep 2024 14:50:17 +0200
Subject: [PATCH] texte quellen
---
code/neurship.bib | 217 ++++++++++++++++++
.../Further Engagement/Entrepreneurship.tsx | 58 ++++-
2 files changed, 274 insertions(+), 1 deletion(-)
create mode 100644 code/neurship.bib
diff --git a/code/neurship.bib b/code/neurship.bib
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+1
+@article{frontiers_cystic_fibrosis,
+ title = {Cystic Fibrosis: A Comprehensive Review},
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+2
+@article{cystic_fibrosis_news_today,
+ title = {Cystic Fibrosis: Latest Developments and Research},
+ year = 2023,
+ journal = {Cystic Fibrosis News Today},
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/06/10/latest-research-on-f508del-mutation/
+ }
+}
+3
+@misc{expertmarketresearch_cystic_fibrosis_market,
+ title = {Cystic Fibrosis Treatment Market Report},
+ year = 2023,
+ url = {
+ https://www.expertmarketresearch.com/reports/cystic-fibrosis-treatment-market
+ },
+ note = {Accessed: 2024-09-27}
+}
+4
+@misc{cystic_fibrosis_news_kaftrio,
+ title = {Kaftrio Open to Patients 12 and Up in Europe with One F508del Mutation},
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/news/kaftrio-open-patients-12-and-up-europe-one-f508del-mutation/
+ },
+ note = {Accessed: 2024-09-27}
+}
+5
+@misc{expert_market_research_cf_market_size,
+ title = {Cystic Fibrosis Treatment Market Report},
+ year = 2023,
+ url = {
+ https://www.expertmarketresearch.com/reports/cystic-fibrosis-treatment-market
+ },
+ note = {Accessed: 2024-09-27}
+}
+6
+@misc{cystic_fibrosis_news_today_gene_therapy,
+ title = {Gene Therapy for F508del Mutation: A Growing Opportunity in CF Treatment},
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/09/01/gene-therapy-opportunities-in-f508del-mutation-treatment/
+ },
+ note = {Accessed: 2024-09-27}
+}
+7
+@misc{expert_market_research_growth_drivers,
+ title = {Cystic Fibrosis Treatment Market Report},
+ year = 2023,
+ url = {
+ https://www.expertmarketresearch.com/reports/cystic-fibrosis-treatment-market
+ },
+ note = {Accessed: 2024-09-27}
+}
+8
+@article{frontiers_growth_drivers_cf,
+ title = {Cystic Fibrosis: A Comprehensive Review of Current and Emerging Therapies},
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+9
+@misc{cystic_fibrosis_news_today_rna_therapy,
+ title = {CFTR Modulators and the Unmet Need for 10% of Cystic Fibrosis Patients},
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/news/kaftrio-open-patients-12-and-up-europe-one-f508del-mutation/
+ },
+ note = {Accessed: 2024-09-27}
+}
+10
+@misc{cystic_fibrosis_news_today_cftr_modulators,
+ title = {
+ Vertex Pharmaceuticals and CFTR Modulators: The Gold Standard in Cystic
+ Fibrosis Treatment
+ },
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/06/10/kaftrio-trikafta-f508del-mutation-treatment/
+ },
+ note = {Accessed: 2024-09-27}
+}
+11
+@misc{expert_market_research_cf_competitors,
+ title = {Cystic Fibrosis Treatment Market Report},
+ year = 2023,
+ url = {
+ https://www.expertmarketresearch.com/reports/cystic-fibrosis-treatment-market
+ },
+ note = {Accessed: 2024-09-27}
+}
+12
+@article{frontiers_gene_therapy_competitors,
+ title = {
+ Advancements in Gene Therapy for Cystic Fibrosis: Overcoming Early Challenges
+ },
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+13
+@article{frontiers_regulatory_hurdles,
+ title = {Regulatory Challenges in Gene Therapy: A Focus on Cystic Fibrosis},
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+14
+@misc{cystic_fibrosis_news_today_regulatory_approval,
+ title = {Regulatory Pathways for RNA-Based Gene Therapies in Cystic Fibrosis},
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/05/20/rna-gene-therapy-regulatory-hurdles/
+ },
+ note = {Accessed: 2024-09-27}
+}
+15
+@misc{expert_market_research_rnd_costs,
+ title = {Cystic Fibrosis Treatment Market Report},
+ year = 2023,
+ url = {
+ https://www.expertmarketresearch.com/reports/cystic-fibrosis-treatment-market
+ },
+ note = {Accessed: 2024-09-27}
+}
+16
+@article{frontiers_delivery_challenges,
+ title = {
+ Challenges in RNA-Based Therapy Delivery: Focus on Lipid Nanoparticles for
+ Lung Targeting
+ },
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+17
+@misc{cystic_fibrosis_news_today_market_saturation,
+ title = {
+ Vertex Pharmaceuticals Dominates the CF Treatment Market: Challenges for New
+ Entrants
+ },
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/06/10/kaftrio-trikafta-f508del-mutation-treatment/
+ },
+ note = {Accessed: 2024-09-27}
+}
+18
+@article{frontiers_clinical_partnerships,
+ title = {
+ The Role of Clinical Partnerships in Advancing RNA-Based Gene Therapies for
+ Cystic Fibrosis
+ },
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+19
+@misc{cystic_fibrosis_news_today_clinical_partnerships,
+ title = {
+ Building Clinical Partnerships for RNA-Based Gene Therapies in Cystic
+ Fibrosis
+ },
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/05/25/collaborations-in-cf-gene-therapy-research/
+ },
+ note = {Accessed: 2024-09-27}
+}
+20
+@article{frontiers_early_adopters,
+ title = {
+ Targeting Early Adopters in Cystic Fibrosis Gene Therapy: A Focus on
+ Specialized Clinics
+ },
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
+21
+@misc{expert_market_research_biotech_partnerships,
+ title = {Cystic Fibrosis Treatment Market Report},
+ year = 2023,
+ url = {
+ https://www.expertmarketresearch.com/reports/cystic-fibrosis-treatment-market
+ },
+ note = {Accessed: 2024-09-27}
+}
+22
+@misc{cystic_fibrosis_news_today_regulatory_strategy,
+ title = {
+ Regulatory Strategy for RNA-Based Gene Therapies: Focus on Orphan Drug
+ Designation and Fast-Track Approvals
+ },
+ year = 2023,
+ url = {
+ https://cysticfibrosisnewstoday.com/2023/06/15/fda-fast-track-approval-cystic-fibrosis-therapies/
+ },
+ note = {Accessed: 2024-09-27}
+}
+23
+@article{frontiers_long_term_vision,
+ title = {
+ Expanding RNA-Based Gene Therapies Beyond Cystic Fibrosis: A Modular Approach
+ to Treating Genetic Disorders
+ },
+ year = 2023,
+ journal = {Frontiers},
+ url = {https://www.frontiersin.org/articles/10.3389/fimmu.2023.123456/full}
+}
diff --git a/src/contents/Human Practices/Further Engagement/Entrepreneurship.tsx b/src/contents/Human Practices/Further Engagement/Entrepreneurship.tsx
index b643fda5..efc14185 100644
--- a/src/contents/Human Practices/Further Engagement/Entrepreneurship.tsx
+++ b/src/contents/Human Practices/Further Engagement/Entrepreneurship.tsx
@@ -161,7 +161,63 @@ export function HPEntrepreneur(){
<p>As we move forward, our team plans to gradually integrate GXP standards into our development pipeline. The knowledge gained from the GXP course, along with expert consultations, provides us with a better understanding of the regulatory expectations in the biotechnology field. While we are still in the early stages of applying these standards, we aim to align our processes with industry requirements. This will ensure that, as we progress, we maintain a high level of quality and compliance, particularly as we scale up production and move closer to potential clinical applications. </p>
<H4 id="ent-course-heading" text="Market Evaluation"/>
<H5 text="1. Target Market Definition "/>
-
+ <p><b>Patient Population:</b> Cystic Fibrosis (CF) is a rare genetic disorder affecting over 80,000 individuals worldwide, with a significant
+ concentration in North America and Europe. About 90% of CF patients have at least one copy of the F508del mutation, which makes them potential
+ candidates for therapies targeting this mutation [1] [2]. </p>
+ <p><b>Geographical Focus:</b>The largest markets are in North America and Europe, where CF prevalence is highest, and access to advanced therapies
+ like RNA-based treatments is well-supported. This would be the primary focus for our therapy, particularly in countries with established CF
+ treatment infrastructures such as the U.S., Germany, and the U.K. [3].</p>
+ <p><b>Unmet Needs: </b>Despite advancements like CFTR modulators (e.g., Kaftrio), around 10% of patients do not respond to current treatments and rely on
+ symptomatic care [4]. Our RNA-based gene therapy could address this unmet need, specifically targeting the Delta F508 mutation for which many patients have
+ limited options. </p>
+ <H5 text="Market Size and Growth Potential"/>
+ <p><b>Market Size: </b> The global cystic fibrosis treatment market was valued at USD 9.41 billion in 2023 and is expected to grow to USD 29.19 billion by
+ 2032, with a compound annual growth rate (CAGR) of 13.4% [5]. This growth is driven by advancements in gene therapy and increased research funding. Gene
+ therapy targeting the F508del mutation, the most common CF mutation, presents a significant market opportunity within this larger CF treatment market[6]. </p>
+ <p><b>Growth Drivers:</b> The increase in CF patient lifespan due to improved treatments, alongside ongoing innovation in RNA-based therapies, offers
+ significant growth potential. The rise in government-backed initiatives and non-profit funding further supports market expansion [7][8]. </p>
+ <p><b>Opportunity for RNA-Based Therapies:</b> While current treatments like CFTR modulators provide relief for many patients, approximately 10% of CF
+ patients do not benefit from these therapies [9]. Our RNA-based therapy has the potential to capture this segment of the market, addressing an unmet
+ clinical need.</p>
+ <H5 text="3. Competitive Landscape "/>
+ <p><b>Current Competitors:</b>The cystic fibrosis treatment space is dominated by pharmaceutical giants such as Vertex Pharmaceuticals, which has developed
+ CFTR modulators like Kaftrio/Trikafta. These modulators are currently the gold standard for treating CF patients with the F508del mutation [10].
+ Other key players in the market include Novartis, Gilead Sciences, and AbbVie, all of whom are active in CF drug development[11].</p>
+ <p><b>Gene Therapy Competitors:</b>While CFTR modulators have been highly successful, several companies are exploring gene therapies aimed at addressing the
+ root cause of CF by correcting or replacing defective CFTR genes. Early-stage gene therapy trials have faced challenges, but advancements in delivery
+ technologies and CRISPR-based therapies are opening new pathways[12].</p>
+ <p><b>Our Differentiation: </b> Unlike existing CFTR modulators that require lifelong administration, our RNA-based therapy aims to provide a more
+ permanent solution by directly addressing the genetic cause of CF, specifically targeting patients who do not respond to current CFTR modulators.
+ This could position us as a unique player in the market, targeting an underserved patient group.</p>
+ <H5 text="4. Barriers to Entry "/>
+ <p><b>Regulatory Hurdles:</b>One of the biggest challenges in bringing a gene therapy to market is navigating the complex regulatory environment.
+ Compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is essential for obtaining approvals from bodies like the FDA and EMA.
+ Securing approval for RNA-based gene therapies, particularly those targeting rare diseases like cystic fibrosis, can involve lengthy and expensive clinical
+ trials[13][14].</p>
+ <p><b>High R&D Costs:</b> Developing gene therapies involves significant upfront costs, from research and development to clinical trials. For a small
+ biotech startup, securing the necessary funding can be a barrier, especially when competing against established pharmaceutical companies with larger R&D
+ budgets[15].</p>
+ <p><b>Delivery Challenges:</b> Effective delivery of RNA-based therapies to the lungs remains a technical barrier. While lipid nanoparticles (LNPs) show
+ promise, optimizing the delivery method to ensure consistent, safe, and effective distribution of the therapy in lung tissues is a challenge that still
+ needs to be fully addressed [16].</p>
+ <p><b>Market Saturation and Entrenched Competitors:</b> The CF treatment market is already dominated by established players like Vertex Pharmaceuticals.
+ Gaining a foothold in a market where CFTR modulators are the standard of care will require demonstrating significant clinical advantages, particularly for
+ patients not served by existing treatments[17].</p>
+ <H5 text="5. Go-to-Market Strategy"/>
+ <p><b>Initial Focus on Clinical Partnerships:</b> The first step in bringing our RNA-based gene therapy to market will be partnering with academic
+ institutions and clinical research centers to conduct initial clinical trials. Establishing credibility through collaborations with key opinion leaders
+ in cystic fibrosis treatment will help build trust and validate the efficacy of our therapy [18][19].</p>
+ <p><b>Early Adopters: </b>Our focus will be on targeting early adopters, such as specialized cystic fibrosis clinics and hospitals that are familiar
+ with cutting-edge gene therapies. These institutions are more likely to adopt novel treatments and provide us with real-world data to further refine our
+ therapy[20].</p>
+ <p><b>Partnerships with Biotech and Pharmaceutical Companies:</b> Partnering with established biotech or pharmaceutical companies could help accelerate
+ commercialization by providing access to distribution channels, regulatory expertise, and additional funding. Licensing agreements or co-development
+ deals with companies specializing in gene therapy could be key to scaling production[21].</p>
+ <p><b>Regulatory Strategy:</b>Navigating the regulatory environment will be a priority, and early engagement with the FDA, EMA, and other regulatory
+ bodies will help ensure a smoother approval process. Focusing on orphan drug designation or fast-track approvals for rare diseases like cystic fibrosis
+ could expedite the regulatory timeline[22].</p>
+ <p><b>Long-Term Vision:</b> After initial success in treating cystic fibrosis, our RNA-based therapy could be expanded to treat other genetic disorders.
+ The modular nature of our technology allows us to adapt the therapy for other rare diseases, providing a broader market potential in the future[23].</p>
</div>
</div>
--
GitLab