<H4id="ent-heading"text="If not as a e´special prize, then why?"/>
<H4id="ent-heading"text="If not as a special prize, then 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.
<H4id="ent-course-heading"text="Question 1: Idea Validation"/>
<H4id="ent-inter-heading"text="Question 1: Idea Validation"/>
<H5text="What we asked the Founders"/>
<pclassName="ask-p">How did you test the marketability of your scientific idea - how did you get a first impression that there is a need for your product or service? </p>
<H5text="What the Founders had to say "/>
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@@ -50,7 +51,7 @@ export function HPEntrepreneur(){
<H5text="Learnings and Implications for our project "/>
<p>As the iGEM Team of Bielefeld University, we have access to excellent research infrastructure. A concrete next step for us could be leveraging the university's cell culture and gene editing facilities to develop an advanced proof-of-concept. Additionally, collaborating with other departments within Bielefeld or partner institutions could help us perform in vivo studies. This would allow us to validate our lipid nanoparticle delivery system and present strong preliminary data for future investors or partners. </p>
<H4id="ent-course-heading"text="Question 3: Transition from Research to Commercialization "/>
<H4text="Question 3: Transition from Research to Commercialization "/>
<H5text="What we asked the Founders"/>
<pclassName="ask-p">What were the biggest challenges in the transition from exploring a scientific idea to a commercial start-up? Looking back, are there certain steps you would have taken earlier or differently? </p>
<H5text="What the Founders had to say "/>
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@@ -62,7 +63,7 @@ export function HPEntrepreneur(){
<p>Both founders emphasized the challenge of securing funding and building a clear business model. At Bielefeld University, we should consider exploring partnerships with industry early, such as biotech firms or pharmaceutical companies. A concrete next step could be identifying relevant funding programs like EXIST or EU grants, which could help bridge the gap between our university research and commercialization. Developing a business model tailored to RNA-based therapeutics for cystic fibrosis will also be critical to attract investors. </p>
<pclassName="ask-p">What sources of funding did you use in the early stages of your company? Were there any special funding programs or investors that specialized in biotechnology start-ups? </p>
<H5text="What the Founders had to say "/>
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@@ -73,7 +74,7 @@ export function HPEntrepreneur(){
<H5text="Learnings and Implications for our project "/>
<p>Both founders highlighted the importance of securing diverse funding sources early on. A concrete next step could be collaborating with the university’s startup support services to identify potential investors, especially those with biotech experience. Additionally, exploring non-traditional sources such as industry-sponsored research collaborations could provide crucial initial funding to support the development of our cystic fibrosis gene therapy. </p>
<H4id="ent-course-heading"text="Question 5: Team Building "/>
<H4text="Question 5: Team Building "/>
<H5text="What we asked the Founders"/>
<pclassName="ask-p">What qualifications and skills were particularly important when building your team? Did you bring in experts from industry or other areas? </p>
<H5text="What the Founders had to say "/>
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@@ -85,7 +86,7 @@ export function HPEntrepreneur(){
<p>Both founders stressed the importance of combining technical expertise with business acumen. At Bielefeld University, we should focus on building a diverse team that includes not only scientists skilled in RNA therapeutics and gene editing but also individuals with experience in business development and regulatory affairs. A concrete next step could be reaching out to the university’s business and legal faculties to bring in experts who can help us navigate commercialization and regulatory processes. </p>
<pclassName="ask-p">What regulatory challenges did you face in your start-up process, and how did you overcome them? What advice would you give to other start-ups in terms of compliance with regulations and laws? </p>
<H5text="What the Founders had to say "/>
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@@ -96,7 +97,7 @@ export function HPEntrepreneur(){
<H5text="Learnings and Implications for our project "/>
<p>Both founders highlighted the complexity of regulatory compliance, particularly in biotech. For our project, we need to integrate regulatory considerations early, especially regarding clinical trials and safety standards for gene therapies. A concrete step would be to consult with experts in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), ensuring that our lipid nanoparticle system meets the necessary regulations. Additionally, early engagement with regulatory bodies could smooth the path to eventual clinical trials. </p>
<H4id="ent-course-heading"text="Question 7: Market Entry and Networking "/>
<H4text="Question 7: Market Entry and Networking "/>
<H5text="What we asked the Founders"/>
<pclassName="ask-p">What role did networks and partnerships play when you entered the market? How did you acquire your first customers or partners, and which strategies were particularly successful? </p>
<H5text="What the Founders had to say "/>
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@@ -108,7 +109,7 @@ export function HPEntrepreneur(){
<p>Both founders stressed the importance of building networks and partnerships early. For our project, we should focus on developing relationships with industry experts and potential partners through conferences, pitch events, and biotech startup programs. A concrete next step could be to participate in networking events where we can present our RNA-based therapy and gain valuable contacts in the pharmaceutical industry. This could also help us identify early customers or strategic partners to accelerate market entry. </p>
<pclassName="ask-p">How did you secure your intellectual property rights? What steps were necessary to obtain patents or licenses? </p>
<H5text="What the Founders had to say "/>
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@@ -119,7 +120,7 @@ export function HPEntrepreneur(){
<H5text="Learnings and Implications for our project "/>
<p>Both founders emphasized the importance of securing IP early, especially when working with universities or external partners. For our project, we should develop a clear patent strategy for our RNA-based cystic fibrosis therapy. A concrete next step would be to consult with IP experts to ensure our technology is well protected. Negotiating early IP agreements with the university or external collaborators is crucial to safeguard our innovations while allowing room for future developments. </p>
<pclassName="ask-p">Were there moments when you had to adapt or completely change your original idea? What were the triggers, and how did you deal with them? </p>
<H5text="What the Founders had to say "/>
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@@ -130,7 +131,7 @@ export function HPEntrepreneur(){
<H5text="Learnings and Implications for our project "/>
<p>Both founders discussed the importance of remaining adaptable to feedback and market needs. For our project, we must be open to making strategic adjustments based on the feedback we receive from clinical trials, investors, or partners. A concrete next step would be to establish a flexible business plan that allows for pivots, such as focusing on specific subtypes of cystic fibrosis patients or adjusting our lipid nanoparticle delivery system to meet evolving technological or regulatory requirements. </p>
<pclassName="ask-p">Did you have something like a long-term vision for your company and, if so, how did you reconcile this vision with the short-term goals? </p>
<H5text="What the Founders had to say "/>
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@@ -159,7 +160,7 @@ export function HPEntrepreneur(){
<p>As we aim to move towards clinical trials, GXP ensures that our product development pipeline is both ethical and compliant with international safety standards, which will be key in discussions with investors and regulatory bodies. By embedding these principles early, we not only enhance the quality and reliability of our data but also lay a foundation for future clinical applications. </p>
<H5text="Next Steps"/>
<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>