Entrepreneurship.tsx

import { ButtonOne } from "../../../components/Buttons";
import { H4, H5 } from "../../../components/Headings";


export function HPEntrepreneur(){

    return(
        <div className="col">
        <div className="row align-items-center" style={{marginTop: "5vh", marginBottom: "5vh"}}>
            <div className="col">
                <ButtonOne openclass="ent-cycletab" text="Overview" open="ent-overview"></ButtonOne>
            </div>
            <div className="col">
                <ButtonOne openclass="ent-interview" text="Interviews with Founders" open="ent-interview"></ButtonOne>
            </div>
            <div className="col">
                <ButtonOne openclass="ent-interview" text="Next Steps" open="ent-next"></ButtonOne>
            </div>
        </div>
          

        <div id="ent-overview" className="ent-interview" style={{display: "block"}}>
            <H4 id="ent-heading" text="If not as a e´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. 
            </p>
            <H4 id="ent-heading" text="Our Entrepreneurship"/>
        </div>
        <div id="ent-interview" className="ent-interview" style={{display: "none"}}>
            <H4 id="ent-course-heading" text="Question 1: Idea Validation"/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory tested the marketability of their idea through participation in scientific conferences. Engaging with other scientists and presenting their own research allowed them to gauge the interest and needs within the field. Direct feedback from these events helped them assess whether their product was aligned with market demand and if they needed to modify or accelerate certain aspects of development.     
            </p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale validated their idea by seeking feedback from both the scientific community and industry professionals at conferences and networking events. They noticed growing interest in RNA therapeutics, particularly for lung delivery. The challenges surrounding delivery systems, especially highlighted during the COVID-19 pandemic, confirmed that there was a strong market demand for their technology, which motivated them to move forward with commercialization.</p>
            <H5 text="Learnings and Implications for our project "/>
            <p>For our project, a concrete next step would be to actively seek feedback from cystic fibrosis research communities and biotech conferences. We should continue to present our RNA-based gene therapy approach to experts in gene editing and delivery systems, specifically asking for input on our delivery mechanism using lipid nanoparticles (LNPs). This early engagement could help identify whether our approach addresses a real unmet need in cystic fibrosis treatment and refine our product to better meet clinical and patient needs. 
            </p>
            <H4 id="ent-expert-heading" text="Question 2: Proof-of-Concept"/>
            <H5 text="What we asked the Founders"/>
            <p className="ask-p">How did you develop the first proof-of-concept before you had investors? Did you work with universities or research institutions to get access to laboratories and equipment? </p>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory was aware of the demand for DNA early on, as the founders had already produced DNA for customers during their previous work. Initially, they collaborated with academic partners and customers to meet the demand for plasmid DNA, which helped them establish a proof-of-concept. Over time, they shifted from primarily working with academic institutions to collaborating more with the research-based pharmaceutical industry, while maintaining their connections with universities. </p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale developed their proof-of-concept through collaborations with universities. They started with in vitro cell culture models and later advanced to more complex systems, such as air-liquid interface models and precision-cut lung slices. Additionally, they performed an in vivo study and had access to human lung tissue samples, which helped them validate their technology in a relevant clinical context before seeking investors. </p>
            <H5 text="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>

            <H4 id="ent-course-heading" text="Question 3: Transition from Research to Commercialization "/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>One of the major challenges was ensuring that their idea was marketable, which is never entirely clear at the beginning. Another significant challenge was securing capital for development. They emphasized the importance of spending only what was available and highlighted the role of research funding programs (EU or national) in supporting early-stage biotech companies. Looking back, they might not have done things differently but emphasized the importance of careful financial planning and making sure the product has a potential market.</p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>For RNhale, the biggest challenge was securing sufficient funding, as transitioning from university-based research to the private sector requires a strategic approach to bridging this gap. They also mentioned that developing a clear business model earlier on could have sped up the process. Another challenge was forming partnerships with industry at an earlier stage, which might have eased both the funding process and commercialization efforts.</p>
            <H5 text="Learnings and Implications for our project "/>
            <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>


            <H4 id="ent-course-heading" text="Question 4: Funding "/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>In the early stages, funding programs for start-ups did not exist as they do today. PlasmidFactory relied on traditional sources like their local bank and creative solutions like purchasing second-hand equipment through platforms like eBay. Their first customers also played a key role, as the revenue from initial sales allowed them to reinvest in the business and further its growth.</p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale initially relied on public funding from university grants and government programs such as GrowBio and EXIST, which provided crucial pre-seed support. As they transitioned into a private company, they secured additional funding through the European Union’s EIC Transition grant. They also attracted venture capital from firms specializing in biotech, such as the Hightech-Gründerfonds and international investors like Karma Fund and Wellington, who understood the long timelines and high costs associated with biotech development.</p>
            <H5 text="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>

            <H4 id="ent-course-heading" text="Question 5: Team Building "/>
            <H5 text="What we asked the Founders"/>
            <p className="ask-p">What qualifications and skills were particularly important when building your team? Did you bring in experts from industry or other areas? </p>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>For PlasmidFactory, honesty, commitment, and hard work were crucial. The initial team consisted of lab technicians, biochemists, and biologists. Over time, they expanded to include employees from various fields, such as biotechnology and even non-scientific areas like business administration and marketing. Bringing in someone with industry experience was seen as particularly valuable, as industry operates differently from academic environments. </p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale emphasized the need for a balance between technical expertise and business acumen when building their team. They prioritized operational alignment and recruited individuals skilled in biologics manufacturing, in vitro and in vivo performance, and business development. They also brought in external experts, such as a patent attorney, regulatory advisors, and preclinical specialists. Many of these connections came from networking and startup bootcamps, which provided valuable resources for building a well-rounded team. </p>
            <H5 text="Learnings and Implications for our project "/>
            <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>


            <H4 id="ent-course-heading" text="Question 6: Regulatory Challenges "/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory emphasized the strict regulations in the biotech and pharmaceutical industries, particularly in the field of genetic engineering. They highlighted the importance of adhering to laws from the start. Since the founders didn’t have extensive expertise in regulatory compliance, they overcame this challenge by collaborating with institutions like universities and research centers, which provided the necessary regulatory knowledge.</p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale faced significant regulatory challenges, particularly in meeting the strict requirements for clinical testing. They needed to conduct preclinical studies under Good Laboratory Practice (GLP) conditions and ensure their product was manufactured under Good Manufacturing Practice (GMP). To navigate these regulations, they worked with external advisors and contract research/manufacturing organizations (CROs and CMOs). They recommended integrating regulatory considerations early in the development process and maintaining close contact with regulatory experts and authorities to prevent delays and ensure compliance.</p>
            <H5 text="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>

            <H4 id="ent-course-heading" text="Question 7: Market Entry and Networking "/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory's strategy was simple: demonstrate scientific expertise to build trust. This approach helped them gain credibility and attract customers. They emphasized patience, noting that success can take a long time—sometimes up to 10 years—but perseverance and maintaining strong relationships with partners and customers were key to their success.</p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>Networks and partnerships were critical for RNhale's market entry. They leveraged connections from their university affiliations, startup bootcamps, and conferences to build relationships with industry experts. Their first customers and partners were acquired through these networks. Participating in startup accelerators and pitch events allowed them to showcase their business model and technology, which helped secure partnerships and build credibility in the RNA therapeutics field.</p>
            <H5 text="Learnings and Implications for our project "/>
            <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>


            <H4 id="ent-course-heading" text="Question 8: Intellectual Property (IP) "/>
            <H5 text="What we asked the Founders"/>
            <p className="ask-p">How did you secure your intellectual property rights? What steps were necessary to obtain patents or licenses? </p>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory highlighted the importance of keeping ideas confidential in the early stages to prevent others from taking them. They discussed three strategies: recording the idea as a deed with a notary, registering it as a utility model for lower-cost protection, and eventually pursuing a full patent, initially focusing on Germany and possibly a few other countries. In licensing agreements, they ensured that fees were only due to the technology owner once the startup earned money from it.</p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale secured their intellectual property through university licensing and strategic patent filings. Early work was patented by the university, and they secured exclusive rights to use the technology for commercialization through a licensing agreement. For later developments, they took a strategic approach, filing priority patents to protect novelty and expanding patent claims within the 12-month window to cover commercially relevant aspects. They emphasized the importance of negotiating IP agreements early, especially when working with universities, and planning a robust patent strategy.</p>
            <H5 text="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>

            <H4 id="ent-course-heading" text="Question 9: Pivoting "/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory did not experience a major pivot in their business model but emphasized the importance of constant dialogue with customers. In some cases, customers did not initially accept their ideas, but rather than giving up, they remained patient and revisited the discussion with references from other satisfied clients to build credibility. </p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale had to adapt their original idea several times. One significant pivot was shifting from providing a service for lipid nanoparticle formulation to developing their own proprietary therapeutic product for severe asthma. Feedback from investors and participation in startup bootcamps revealed a stronger market demand for a product-driven approach with a clear exit strategy. This led them to revise their business model while still leveraging their core technology.</p>
            <H5 text="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>

            <H4 id="ent-course-heading" text="Question 10: Long-term Vision "/>
            <H5 text="What we asked the Founders"/>
            <p className="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>
            <H5 text="What the Founders had to say "/>
            <p><b>PlasmidFactory (Martin Schleef)</b></p>
            <p>PlasmidFactory had a long-term vision from the beginning, which was to produce pharmaceutical-grade plasmid DNA (GMP). However, the process of building and certifying a GMP facility was costly and time-consuming. To manage short-term goals, they developed an intermediate quality standard called “high quality,” which allowed them to supply starting materials for pharmaceutical vector production. It took them 25 years to open their first GMP facility, demonstrating their focus on long-term planning while balancing immediate milestones.</p>
            <p><b>RNhale (Benjamin Winkeljann)</b></p>
            <p>RNhale’s long-term vision was to develop RNA-based therapeutics, particularly for respiratory diseases. They reconciled this vision with short-term goals by breaking their vision into actionable milestones, such as developing a lead candidate for severe asthma. Alongside their core therapeutic focus, they offered small-scale manufacturing services to generate revenue and build credibility. This dual approach helped them maintain momentum while working towards their larger goal of establishing a pipeline of RNA therapeutics. </p>
            <H5 text="Learnings and Implications for our project "/>
            <p>Both founders highlighted the importance of aligning short-term goals with a long-term vision. For our project, we must ensure that while focusing on immediate milestones, such as demonstrating the efficacy of our RNA-based therapy, we maintain sight of our broader goal: revolutionizing cystic fibrosis treatment. A concrete next step would be to break down our long-term vision into actionable short-term goals, such as optimizing our delivery system and securing regulatory approvals, while building a sustainable pipeline for future RNA therapeutics. </p>   
        </div>



        <div id="ent-next" className="ent-interview" style={{display: "none"}}>
            <H4 id="ent-course-heading" text="GXP in the context of clinical trials "/>
            <H4 id="ent-course-heading" text="Market Evaluation"/>
            
        </div>

    </div>
    )
}