<H4id="ent-heading"text="Collaborations as part of a integrated human practice - but why?"/>
<p>Collaboration is at the heart of innovative science, especially in projects with significant societal and clinical implications such as ours. By actively engaging with stakeholders across disciplines, we ensured that our work addressed real-world needs and took ethical and practical considerations into account.</p>
<p>For example, partnerships with patients and advocacy groups provided a deeper understanding of living with CF and shaped our patient-centered approach. Discussions with medical professionals highlighted the clinical challenges and regulatory requirements we needed to address. Collaborating with other iGEM teams allowed us to share methodologies, refine protocols, and integrate diverse expertise into our project.</p>
<p>These interactions didn't just guide the scientific direction of our work - they emphasised the wider impact of synthetic biology. By combining our technical efforts with stakeholder input, we ensured that our solutions were not only innovative, but also feasible, ethical and impactful. Collaboration thus became the foundation of a truly integrated human practice, bridging the gap between science, society and application.</p>
<H4id="ent-heading"text="Our Collaborations"/>
<p>In conclusion, the entrepreneurial journey of developing RNA-based gene therapy for Cystic Fibrosis, as outlined in our experiences and interviews with industry founders, demonstrates that entrepreneurship is not only an interesting possibility but a necessary avenue to transform scientific innovation into real-world solutions. Our approach has been shaped by the challenges and opportunities in the biotech field, from understanding regulatory frameworks like GxP to navigating complex market dynamics and funding challenges. </p>
<p>Through key interviews, such as the one with Nicole Friedlein, we have gained insights into the pivotal role of regulatory standards in scaling our project. The completion of GxP training by one team member reflects our commitment to ensuring compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), both of which are essential for advancing from proof-of-concept to clinical trials. This foundation is crucial for building investor confidence and meeting regulatory requirements.</p>
<p>Additionally, market evaluations reveal a significant opportunity for our therapy, particularly targeting the unmet needs of Cystic Fibrosis patients who do not respond to current treatments like CFTR modulators. The growing gene therapy market presents a strong case for our innovation, although we are aware of the competitive landscape dominated by companies like Vertex Pharmaceuticals. Our unique value lies in providing a more permanent solution for patients not served by existing treatments. </p>
<p>Interviews with founders from companies such as PlasmidFactory and RNhale have provided valuable lessons on transitioning from research to commercialization. The importance of building networks, securing diverse funding sources, and maintaining flexibility to adapt to market feedback are key takeaways that will guide our next steps. Establishing strategic partnerships and seeking early engagement with regulatory bodies will be essential as we prepare for clinical trials and eventual market entry.</p>
<p>To align our long-term vision of revolutionizing Cystic Fibrosis treatment with immediate milestones, we will continue optimizing our lipid nanoparticle delivery system, pursuing regulatory compliance, and engaging with the Cystic Fibrosis community to refine our product. Our focus on both the scientific and business aspects ensures that we are building a strong foundation for success in bringing this innovative therapy to market, improving the lives of patients with Cystic Fibrosis. </p>
<H4id="ent-heading"text="Collaborations as part of a integrated human practice - but why?"/>
<p>Entrepreneurship is not only an interesting possibility but necessary to turn our ideas and results into a real product that can help people. </p>
<p>That is why in this section we focus on the aspects of entrepreneurship that are crucial for the potential successful realisation of our project to develop new therapies for Cystic Fibrosis. A pivotal moment was our interview with Nicole Friedlein, which gave us valuable insights into the challenges and opportunities in the field of biomedical innovation. The discussions in the interview encouraged us to look more closely at the regulatory requirements, which is why one team member completed a GxP course and subsequently trained the team in this area. In addition, we conducted further interviews in the area of entrepreneurship to gain a better understanding of the practical aspects of business development. These experiences not only enriched the scientific depth of our project, but also sharpened our perspective on the practical implementation and market launch of new therapies.
</p>
</div>
<H5text="Biosafety and Security"/>
<p>Early in our project, we faced challenges working with human biomaterials, particularly cultivating primary human nasal epithelial cells from both CF patients and controls. To address these, we made three key contributions:</p>
