Entrepreneurship

At HepaSwitch, we believe science should not end at discovery. By focusing on real-world implementation, we turn research into solutions that make a tangible impact. For us, applicability is not a limitation - it’s the strength that drives meaningful change.

About us

We are a team of students driven by the belief that science should not end at discovery, but should find its way into real-world applications. At the beginning of our project, when we first started seriously considering the path toward commercialization, we took part in various events to better understand the essence of translating scientific research into practice - especially within the field of biotechnology.

The more time we spent exploring this area, the clearer it became that commercialization is neither obvious nor simple. Behind every innovative idea lies a complex process of validation, strategy, and adaptation to real market needs. As students working on our project within a university research institute, we quickly realized that bridging the gap between academic research and societal impact requires much more than strong science - it also demands entrepreneurial thinking, persistence, and the ability to learn from experts across disciplines.

Despite these challenges, we did not give up. On the contrary - we set ourselves the goal of shaping this project in such a way that commercialization would become its natural extension. Already at an early stage, we joined the incubation program of the Innovation Hub Foundation, the largest organization in Poland supporting startups. There, we learned how crucial it is to have a solid plan and, above all, a strong and committed team-the very foundation of every successful project.

Later, we had the opportunity to participate in the Cebioforum conference, the biggest biotechnology conference in Central and Eastern Europe. It was there that we engaged directly with representatives of biotech and health-tech startups from around the world, testing our ideas and confronting them with the experiences of others. These discussions with startup founders, technology professors, and innovation hub representatives further strengthened our conviction that we had chosen the right path. We realized that we are not alone in facing challenges, and even highly experienced teams often need to adjust their vision as their startups evolve.

At the same time, as representatives of the academic community, we want to set new standards in Poland for the commercialization of university research. We aim to show that applicability is a strength, not a weakness, and to demonstrate a clear path for transforming scientific discoveries into real-world solutions. Even at this early stage, we are confident that HepaSwitch has the potential to become a model project, bridging the gap between science and society while inspiring others to follow a similar path.

Especially as students, we want to demonstrate that age is not a barrier to innovation - that transformative ideas and world-changing solutions can emerge from young people when given the opportunity to take the first steps. We see our project as the initial step toward changing the reality of Polish universities in STEM fields, showing that students can lead the way in translating scientific discoveries into real-world impact.

Problem statement

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and one of the deadliest cancers worldwide. It is the 6th most common cancer overall and the 3rd leading cause of cancer-related deaths, with a five-year survival rate of only 18%. HCC most often develops in the context of chronic liver disease - particularly cirrhosis or fibrosis - caused by viral hepatitis (B, C, D), non-alcoholic steatohepatitis (NASH), alcoholic liver disease, or toxin exposure. In fact, up to 90% of patients with HCC also suffer from cirrhosis, which complicates treatment and reduces tolerance to existing therapies.

The disease is frequently diagnosed late: 40-60% of patients are identified at advanced stages (BCLC C/D), when curative options such as resection or transplantation are no longer possible. At this stage, current systemic therapies deliver only modest benefits, with median progression-free survival of 6.8 months - comparable to glioblastoma, one of the most aggressive cancers known.

If no effective interventions are introduced, the global incidence and mortality of liver cancer are projected to increase by more than 55% between 2020 and 2040. This growing health crisis highlights a clear unmet need:

there is strong demand for therapies that are not only effective but also selective and safe

capable of addressing the dual challenge of cancer progression and underlying liver dysfunction. Meeting this need offers a transformative opportunity to improve survival and quality of life for millions of patients worldwide.

Solution

That is why we are developing HepaSwitch, a breakthrough mRNA-based therapy designed specifically for hepatocellular carcinoma (HCC). HepaSwitch harnesses the precision of synthetic biology to remain inactive until it encounters RNA sequences unique to liver cancer cells. Upon detection, the toehold switch activates the translation of gasdermin, a protein that selectively induces cancer cell death, sparing healthy tissue. To ensure targeted action, the therapy is delivered via lipid nanoparticles (LNPs), which naturally accumulate in the liver and minimize off-target effects. By combining molecular specificity with organ-targeted delivery, HepaSwitch directly addresses the dual challenges of late-stage diagnosis and limited treatment safety in patients with compromised liver function. This innovative approach has the potential to redefine standards in HCC therapy, transforming scientific discovery into a real-world solution that saves lives.

Minimal Viable Product (MVP):

Concept Overview

Our MVP, HepaSwitch, represents the first tangible step toward transforming our therapeutic concept into a functional product. It is a selective mRNA-based system designed to target hepatocellular carcinoma (HCC) cells while remaining inactive in healthy hepatocytes. The system relies on a toehold switch mechanism that recognizes specific HCC-associated mRNA markers and triggers the translation of gasdermin, a protein that induces pyroptosis - a highly immunogenic form of programmed cell death.

Experimental Design and Validation

To validate our MVP, we encapsulated the therapeutic mRNA in lipid nanoparticles (LNPs) and tested its function in vitro using hepatocellular carcinoma cell lines alongside healthy hepatocyte controls.

We used a GFP reporter construct to confirm the specificity and selectivity of our toehold switch system. The selective activation of GFP in HCC cells demonstrated that the switch responds exclusively to the presence of target mRNA sequences, confirming the feasibility of cell-type-specific translation control.

Following validation of selectivity, we monitored pyroptotic markers - including IL-1β, IL-18, HMGB-1, ATP, and LDH release - to evaluate the therapeutic functionality of HepaSwitch. This step allowed us to assess whether the activation of our system leads to effective, immunogenic cell death specifically in HCC cells.

Strategic Value and Scalability

HepaSwitch MVP serves as a proof of concept for a new generation of selective mRNA therapeutics. By demonstrating specific activation and targeted cytotoxicity, this version provides critical data to guide future optimization and preclinical development.

Beyond HCC, our platform’s modular design allows for adaptation to other cancer types, simply by reprogramming the toehold switch to detect alternative disease-specific mRNA markers. This scalability positions HepaSwitch as a versatile therapeutic framework with potential applications across oncology.

Business and Translational Perspective

From an entrepreneurial standpoint, our MVP acts as a technology validation milestone - bridging academic innovation with commercial viability. It establishes experimental evidence of selectivity, functionality, and delivery feasibility, which are crucial parameters for early-stage investment and partnership opportunities.

By validating HepaSwitch at the MVP stage, we lay the groundwork for future preclinical studies, licensing discussions, and startup incubation, moving our concept closer to real-world therapeutic impact.

Development plans

We know how important it is to be well-prepared and to understand every element of our project, especially when addressing potential investors and future partners. That is why, alongside building the scientific foundation of HepaSwitch, we are also focusing on a clear development strategy. Our aim is not only to validate the technology in the lab but also to map the steps necessary for preclinical studies, regulatory pathways, and potential commercialization.

By approaching our project with this mindset, we ensure that HepaSwitch is developed not just as an academic proof-of-concept, but as a viable therapeutic innovation with real-world impact. This holistic preparation strengthens our credibility, demonstrates awareness of market and medical needs, and lays the groundwork for successful translation of our science into tangible solutions.

Business Model Canvas

This canvas is wider than your screen. Expand the window (or rotate your device) to see the full model.
Whom will you work with to run the business? Name your partners and the roles they will take on.
  • Academic institutions and research labs
  • Pharmaceutical and biotech companies
  • Regulatory consultants and legal advisors
  • Grant agencies and funding bodies
  • Manufacturing partners (CDMOs)
What are the tasks and activities to keep the business running every day?
  • Research and development (R&D)
  • Clinical trial planning and execution
  • Regulatory and quality assurance activities
  • Collaboration management with hospitals and research partners
  • Marketing and scientific communication
What are the tangible and intangible things you will use to make the product?
  • Laboratory facilities and equipment
  • Biological materials and reagents
  • Scientific know-how and expertise
  • Intellectual property (IP)
  • Clinical and academic partnerships
  • Regulatory knowledge - Understanding of approval pathways (EMA, FDA) and compliance standards
What need are you trying to address? What value will your product bring to the target audience?
  • Personalized therapy for hepatocellular carcinoma (HCC)
  • Increased treatment efficacy with reduced side effects
  • Enables precision medicine in liver cancer treatment
  • Potential to reduce healthcare costs long-term
Where will your product be available? List the ways you plan to reach your target audience.
  • Partnerships with hospitals and cancer treatment centers
  • Direct B2B outreach to pharmaceutical and biotech companies
  • Medical conferences and scientific congresses
  • Patient advocacy groups and nonprofit health organizations
  • Peer-reviewed publications and scientific journals
What relationships will you establish with each customer segment?
  • Partnerships with hospitals and cancer treatment centers
  • Direct B2B outreach to pharmaceutical and biotech companies
  • Medical conferences and scientific congresses
  • Patient advocacy groups and nonprofit health organizations
  • Peer-reviewed publications and scientific journals
Who is your target market?
What are the characteristics of your early adopters? List the groups that you expect to use your product.
  • Pharmaceutical companies and biotech firms
  • Patients diagnosed with hepatocellular carcinoma (HCC)
  • Clinical researchers and academic institutions
  • Oncologists specializing in liver cancer
  • Healthcare payers and insurance providers
How will you generate income? Show a pricing model of your product or service and include other revenue sources, such as sales and subscription fees.
  • Licensing fees from pharmaceutical or biotech partners
  • Direct sales of personalized therapy kits or companion diagnostics
  • Contract research and co-development funding
What are the fixed and variable costs of launching your product?
Consider the cost at each stage - from setting up and hiring all the way to marketing and distribution.
  • Fixed costs include laboratory setup and equipment, IP protection and patent filing, regulatory fees, core team salaries, and office infrastructure. These are essential for establishing the foundation of the project and remain stable over time.
  • Variable costs cover raw materials and reagents, manufacturing, packaging, logistics, marketing, and clinical validation. They depend on the production scale and commercialization phase.
  • In the early stages, costs are mostly fixed (setup and research), while in later phases -especially during production and distribution -variable costs dominate, driven by scaling and market activities.

SWOT

SWOT

PESTEL

PESTEL

Market size

Market size

Timeline

Timeline

Milestones

Milestones

Sales model

Our sales model is based on a business-to-business (B2B) strategy, with a clear pathway from early-stage research to market implementation. The development begins with preclinical and early clinical phases (Phase I/II), during which our team establishes the proof of concept, safety, and initial efficacy of the technology. At this stage, the project’s value is primarily scientific and innovative, creating a foundation for collaboration with larger industry players.

Once this foundation is established, the next step is to secure partnerships with pharmaceutical and biotechnology companies. These partners take over the advanced clinical development, regulatory processes, large-scale production, and global commercialization. By transferring responsibility for late-stage development to established industry leaders, we reduce the risks and costs associated with long-term product introduction while simultaneously accelerating the pathway to the market.

Revenue is generated through three complementary streams. The first consists of upfront payments provided by the industry partner at the moment of technology transfer or licensing. The second includes milestone payments tied to the successful achievement of predefined clinical or regulatory stages. Finally, long-term revenue is secured through royalties, typically in the range of 5-10% of product sales, ensuring sustainable financial returns.

This model allows us to combine academic innovation with industrial expertise, creating a realistic and scalable entrepreneurship pathway. By leveraging strategic partnerships, we can maximize the impact of our research, secure funding for future innovation, and contribute to the translation of synthetic biology into tangible medical solutions.

Customer Overview

As we mentioned in the Human Practices section, we engaged in a series of discussions with medical professionals, oncologists, clinicians, and biotechnology experts to better understand the needs, expectations, and challenges faced by our potential customers. These consultations provided us with invaluable insights into the current limitations in hepatocellular carcinoma (HCC) diagnosis and treatment, enabling us to design our project with a clear clinical purpose and practical application. Through conversations with representatives from the biotech and pharmaceutical industries, we also gained a deeper understanding of commercialization pathways, regulatory frameworks, and market expectations. These insights allowed us to shape HepaSwitch into a solution that not only demonstrates strong scientific innovation but also aligns with the realities of healthcare systems and industry practices. Consultations with oncologists and clinicians were particularly important, as they helped us identify real clinical gaps, define potential use cases, and evaluate the feasibility of implementing our technology in medical settings. Altogether, these collaborations strengthened our understanding of our end users and reinforced our mission to develop a patient-centered, accessible, and sustainable biotechnology innovation.

Funding & Financial Growth

Over the past few months, our team has successfully secured over €120,000 in combined funding through grants and fundraising initiatives. This accomplishment highlights both the innovative potential of our project and the trust we have built within the scientific and entrepreneurial communities. These funds have been crucial in advancing our research, supporting our entrepreneurial development, and enabling investment in key areas such as team training, experimental validation, and business strategy. Moreover, through this process we have also gained valuable experience in financial management and fund security, allowing us to ensure that our resources are used effectively and sustainably to maximize our project’s long-term impact.

Financing Opportunities

As a synthetic biology project aiming to develop a targeted and personalized therapeutic switch for hepatocellular carcinoma (HCC), HepaSwitch fits perfectly into several national and international biotech funding and acceleration programs. Below is an overview of the most promising ones:

  • SMART Pathway (Ścieżka SMART) - FENG

    What it is:
    SMART Pathway is a major funding instrument under Poland's European Funds for a Modern Economy (FENG). It supports R&D projects that include not only development, but also validation, commercialization and scaling.

    Why HepaSwitch fits:
    HepaSwitch involves a multidisciplinary innovation in synthetic biology and cancer therapeutics — making it an ideal candidate for a SMART Path project. The ability to design a custom therapeutic switch for liver cancer falls under the priority areas of personalized medicine and biotech.

    What it offers:

    • Funding up to 70% of eligible costs
    • Support for clinical validation and pre-commercialization
    • Guidance in intellectual property strategy and market entry
  • NCBR - National Centre for Research and Development (Poland)

    Programs:
    Thematic Programs (e.g., MedTech, Health-related calls)

    Why HepaSwitch fits:
    Our project is deeply rooted in scientific research and aims to bring a novel cancer therapeutic approach to clinical reality. It aligns with NCBR’s mission to translate high-tech solutions into the Polish and EU medical market.

    What it offers:

    • Up to 80% project co-financing
    • Financial support for prototype development, in vitro/in vivo validation, and technology readiness level (TRL) advancement
    • A path from academic idea to market-ready application, especially if supported by a spin-off or startup
  • ABM - Medical Research Agency (Agencja Badań Medycznych)

    What it is:
    ABM provides dedicated grants for the development of new drugs, therapies, diagnostics, and clinical research infrastructure.

    Why HepaSwitch fits:
    HepaSwitch proposes a targeted gene circuit to be used in liver cancer cells—effectively a new class of gene therapy. This fits ABM’s calls for breakthrough medical technologies with potential to address oncological diseases.

    What it offers:

    • Financing of pre-clinical and early-phase clinical trials
    • Support for regulatory preparation
    • Possibility to connect with clinical partners and trial networks in Poland
  • EIC - European Innovation Council (Horizon Europe)

    What it is:
    EIC supports the entire innovation journey—from deep-tech proof-of-concept to commercialization—through three main programs: Pathfinder, Transition, and Accelerator.

    Why HepaSwitch fits:

    • At TRL 3-4, HepaSwitch could apply to EIC Pathfinder for novel gene circuit development.
    • Upon successful validation, we could apply to EIC Transition to develop scalable production and in vivo models.
    • Later, the EIC Accelerator could help bring the therapeutic to market with grant + equity support.

    What it offers:

    • Up to €3-4 million (Pathfinder) for research
    • Up to €2.5 million (Transition) for validation and business planning
    • Up to €17.5 million (Accelerator) to scale, including equity investment via EIC Fund
  • European Biotech Accelerators & Incubators
    • BioInnovation Institute (Denmark)

      Provides funding, mentorship, and access to industry-grade labs.

      How HepaSwitch fits: It can benefit from the Venture Lab program to mature its therapeutic platform and attract seed funding.

    • Venture Kick (Switzerland)

      Non-dilutive grant up to €2.8M for university spinouts.

      How HepaSwitch fits: If based at or partnered with a Swiss academic institution, it could apply early as a research spinout with a commercialization plan.

    • Creative Destruction Lab (Europe/Canada/USA)

      Mentoring for early-stage, science-based companies.

      How HepaSwitch fits: Ideal for strategic validation of our business model, IP approach, and investment readiness.

    What they offer collectively:

    • Non-dilutive grants or early equity
    • Mentorship from biotech VCs and pharma
    • Access to labs and validation infrastructure
  • U.S.-Based Biotech Programs
    • IndieBio (SOSV)

      World-class biotech accelerator; $250k+ in funding.

      How HepaSwitch fits: Fits SOSV’s focus on disruptive synthetic biology. We can accelerate go-to-market strategy and attract U.S. seed investment.

    • Illumina Accelerator

      Sequencing-based biotech support, including lab access and equity investment.

      How HepaSwitch fits: HepaSwitch’s design depends on genomic insight into HCC; Illumina’s genomics platforms are crucial to optimizing targeting strategies.

    • StartX (Stanford-affiliated)

      Equity-free support for medtech/biotech startups.

      How HepaSwitch fits: If partnered with Stanford researchers or aligned institutions, it could benefit from business guidance and VC access.

  • NCBR-NAP Accelerator (USA Expansion Program)

    What it is:
    An NCBR-backed soft-landing accelerator in Nevada and Silicon Valley for Polish deep-tech startups, including biotech.

    Why HepaSwitch fits:
    As a synthetic biology startup solving unmet needs in liver cancer treatment, we could use the NCBR-NAP program to prepare for U.S. trials, pitch to U.S. VCs, and build regulatory strategy.

    What it offers:

    • Mentoring and business validation in U.S. market
    • Access to investor and biotech networks
    • Support for legal/IP scaling and FDA pathway planning

Financial Timeline (3-year projection)

Total Costs (3 yrs)
$3.21M
HCC Market 2025
$2.2B
Market Growth (CAGR)
7-9%
Yr 5 Revenue (proj.)
$45-90M
Costs (R&D, mfg.)
Revenue trajectory
📊 Operating Costs (3 years)

Year 1: $581,391 (start) + $880,692 = $1.46M
Year 2: $880,692
Year 3: $880,692
TOTAL: $3,208,736

Main components: salaries ($1.76M), indirect costs ($608K), lab equipment ($374K), research materials ($267K)

Market Potential

Global HCC 2025: $2.2B; 2030: $3.3B (CAGR 8.8%)
Patients/yr: ~900k; Target 5%: 45k

At $1,000-2,000 per therapy → $45-90M/yr at 5% share

Revenue Scenarios

Conservative (2% market): Yr4-5: $15-25M → Yr6-7: $35-50M

Optimistic (5% market): Yr4-5: $45-60M → Yr6-7: $80-100M

Key Milestones

EMA / FDA approvals, M&A checkpoints, competition response, commercialization ramp-up.

Cost estimate

We have prepared a cost estimate outlining the projected expenditures for the next three years. This budget was developed based on the knowledge and guidance we gained through our collaboration with the University of Warsaw Incubator - Entrepreneurship Center, which has supported us at every stage of the project, particularly in the context of entrepreneurship. Their mentorship helped us understand the financial planning required to move a research project toward real-world implementation, ensuring that our budget reflects both scientific and operational needs for the coming years.

📎 Attachment
Risk analysis

Recognizing the importance of anticipating potential challenges, we have placed strong emphasis on comprehensive risk analysis. Understanding possible obstacles at an early stage is essential for effective project management and long-term success. Therefore, we conducted a detailed risk assessment to ensure that our team is as well-prepared as possible to address and mitigate potential issues.

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Risk Description Caused by and Consequences Probability Impact Risk Rating Controls / Mitigation Strategies
Inefficient toehold switch activation Toehold switch may not efficiently recognize HCC-specific RNA sequences, leading to insufficient gasdermin expression and reduced therapeutic efficacy. Medium High Severe Optimize switch design through in-silico modeling and iterative testing; validate specificity using HCC vs. normal hepatocyte models. Collaborate with computational biology experts to refine RNA-RNA interaction prediction.
Uncontrolled gasdermin activation (off-target pyroptosis) Off-target activation in non-cancerous hepatocytes may cause liver inflammation or cytotoxicity. Low Very High Critical Implement multi-layered regulatory control (dual-trigger design); perform in vitro safety testing with non-cancerous liver cells; integrate miRNA-based suppression in healthy tissue.
Inefficient LNP delivery to HCC cells Lipid nanoparticles may not achieve optimal biodistribution or intracellular delivery efficiency in vivo. Medium High Severe Optimize LNP formulation for hepatic targeting; collaborate with formulation experts; perform biodistribution studies using fluorescent LNPs.
mRNA instability / degradation mRNA therapeutic may degrade before reaching target cells, lowering efficacy. High Medium Severe Use optimized 5’ and 3’ UTRs; apply modified nucleosides (e.g., N1-methylpseudouridine); test storage stability and degradation kinetics.
Insufficient preclinical validation Failure to meet preclinical endpoints (safety, efficacy) may delay investor interest and funding. Medium High Severe Partner with CROs experienced in oncology preclinical studies; establish clear TRL milestones; implement robust animal model validation.
Difficulty in IP protection and patentability Overlapping patents or unclear ownership of switch or LNP technology could hinder commercialization. Medium High Severe Early IP consultation with tech transfer offices; file provisional patent as soon as unique sequences and constructs are validated; seek FTO (Freedom to Operate) analysis.
Regulatory uncertainty for mRNA-oncology therapies mRNA-based targeted pyroptosis may face new or unclear regulatory pathways, delaying approval. Medium High Severe Engage regulatory consultants early; align preclinical protocols with EMA/FDA guidance for mRNA therapeutics; maintain transparent documentation.
Insufficient investor readiness / funding gap High R&D and manufacturing costs (~4-5 mln PLN) might exceed available resources, delaying TRL advancement. High High Critical Prepare detailed financial roadmap and milestones; seek mixed funding (grants, VC, angel investors); leverage Innovation Hub Foundation and university incubator networks.
Team experience and scalability challenges As a student-led team, limited experience in biotech entrepreneurship may slow growth and partnerships. Medium Medium Moderate Continue mentorship through incubators; form advisory board of biotech and regulatory experts; engage in accelerator programs.
Ethical / biosafety risks Use of engineered mRNA and gene circuits could raise biosafety or ethical concerns. Low Medium Moderate Conduct full biosafety risk assessments; follow BSL-2 guidelines; engage with bioethics committees for transparency.
Sustainability and production scalability Scaling biomanufacturing may generate environmental or cost inefficiencies. Low Medium Moderate Implement green chemistry practices; partner only with suppliers adhering to sustainability standards; monitor environmental KPIs.

Summary

  • Highest risks: Off-target gasdermin activation, funding gap, preclinical failure.
  • Key mitigations: Early design optimization, strong investor communication, partnerships with CROs and incubators, IP & regulatory guidance.
  • Strategic focus: Translational readiness (TRL 3→5), sustainable biomanufacturing, investor trust building

IP protection strategy

As part of our long-term vision for HepaSwitch, we are carefully exploring the possibility of patenting our biological molecule in the future. Understanding the regulatory landscape around biotechnology patents is crucial to ensure that our innovation is both secure and ethically managed.

To gain deeper insight into intellectual property protection and commercialization pathways, we held consultations with experts from the Center for Innovation of the Warsaw University of Technology and the Technology Transfer and Knowledge Center of the University of Warsaw. These discussions provided us with valuable guidance on how to navigate patent law, safeguard biotechnological projects, and structure potential commercialization efforts responsibly.

This experience not only expanded our knowledge of IP strategy but also reinforced our understanding of how complex and essential intellectual property protection is in the context of biotech innovation.

1. Establish IP governance and responsibilities

Goal

Define internal IP policy and assign responsibilities.

Actions

Create an internal IP committee (PI, project lead, lab representative, TTO liaison). Establish procedures for invention reporting.

Deliverables

Internal IP policy, invention disclosure template.

Timeline

0-1 month

Responsible

Project lead + Technology Transfer Office (TTO)
2.Invention documentation and record keeping

Goal

Secure clear proof of invention (what, who, when).

Actions

Maintain dated lab notebooks, complete an Invention Disclosure Form with experiment details and contributors.

Deliverables

Complete invention disclosure and supporting data.

Timeline

Continuous (initial ASAP)

Responsible

Research team + PI
3.Prior art search and market analysis

Goal

Assess novelty and commercial potential.

Actions

Conduct patent and literature searches, analyze competitors and potential licensees.

Deliverables

Prior art report, patentability recommendations.

Timeline

0-2 months after disclosure

Responsible

TTO + patent attorney or analyst
4.Confidentiality and collaboration management

Goal

Protect know-how before filing.

Actions

Sign NDAs and MTAs with external collaborators, define internal publication policies.

Deliverables

Executed agreements, confidentiality logs.

Timeline

Ongoing (pre-sharing)

Responsible

Administrative team + TTO
5.Freedom-to-Operate (FTO) analysis

Goal

Identify potential infringement risks before commercialization.

Actions

Review existing patents in target markets, assess licensing needs or design-arounds.

Deliverables

FTO report with recommendations.

Timeline

3-6 months before disclosure/preclinical

Responsible

Patent attorney + TTO
6.Strategic decision: Patent vs. trade secret

Goal

Select the best protection path for each component.

Actions

Compare patent and trade-secret advantages, considering cost, scope, and market timeline.

Deliverables

IP protection strategy document listing key elements for patenting.

Timeline

After FTO & prior art review

Responsible

IP committee + legal advisor
7.Drafting and filing of preliminary patent application

Goal

Secure priority date and enable further R&D.

Actions

Prepare detailed description, data, and claims; collaborate with a patent attorney; file in selected jurisdiction.

Deliverables

Application number and priority date.

Timeline

Within 6 months of decision

Responsible

Patent attorney + TTO
8.Publication and communication management

Goal

Prevent loss of novelty through premature disclosure.

Actions

Implement “publication hold” procedures, align conferences, preprints, and social media communications with patent timelines.

Deliverables

Publication calendar aligned with IP goals.

Timeline

Continuous

Responsible

PI + communications lead + TTO
9.International expansion — PCT and national phases

Goal

Protect the invention in key global markets.

Actions

Decide on PCT filing or direct national applications; select target jurisdictions (EU, US, JP, CN, etc.).

Deliverables

PCT application or national filings; cost plan for maintenance.

Timeline

Within 12 months of priority

Responsible

TTO + patent attorney
10.Supporting data for claim validation

Goal

Generate experimental evidence to strengthen claims.

Actions

Conduct preclinical studies and reproducibility tests to demonstrate specificity, selectivity, and therapeutic efficacy of the toehold switch system.

Deliverables

Experimental reports, safety and efficacy data.

Timeline

6-24 months (parallel to prosecution)

Responsible

R&D team
11.Commercialization model — licensing or spin-out

Goal

Prepare for ethical and sustainable technology transfer.

Actions

Develop IP pitch decks, licensing term sheets, business model (licensing, co-development, or tech sale).

Deliverables

Investor materials, commercialization roadmap.

Timeline

12-36 months (aligned with R&D)

Responsible

TTO + business team
12.Patent maintenance, monitoring, and enforcement

Goal

Manage the patent portfolio and defend IP rights.

Actions

Pay maintenance fees, monitor competing patents, and prepare enforcement strategies if infringement occurs.

Deliverables

Maintenance calendar, monitoring reports.

Timeline

Ongoing (annual updates)

Responsible

TTO + patent attorney
13.Continuations and improvements

Goal

Expand IP coverage and protect incremental innovations.

Actions

File follow-up applications for improvements (delivery systems, formulations, therapeutic combinations).

Deliverables

Broader IP portfolio.

Timeline

As new data emerges

Responsible

R&D + patent attorney
14.Ethics, compliance, and accessibility

Goal

Ensure legal, biosafety, and social responsibility compliance.

Actions

Address Nagoya Protocol, biosafety, and ethical standards; design access-oriented licensing clauses for fair use.

Deliverables

Compliance checklist, ethical access plan.

Timeline

Parallel to commercialization planning

Responsible

TTO + ethics officer
Sustainable development goals

Long-Term Impact

At HepaSwitch, we believe that every innovation carries both great potential and great responsibility. While developing our selective mRNA-based therapy for hepatocellular carcinoma (HCC), we carefully considered not only its medical and scientific benefits but also its possible long-term societal, ethical, and environmental impacts. Below, we summarize the positive outcomes our solution aims to achieve, as well as the potential challenges we remain committed to addressing responsibly.

Positive Long-Term Impacts
  1. Targeted and effective cancer therapy
    HepaSwitch introduces a selective mRNA-based system that specifically targets hepatocellular carcinoma (HCC) cells, minimizing harm to healthy tissue and improving patient outcomes.
  2. Fewer side effects compared to conventional treatments
    By using a precision molecular switch, our therapy reduces systemic toxicity and improves patients’ quality of life.
  3. Advancement in personalized medicine
    HepaSwitch demonstrates the potential of toehold switch-based regulation as a modular platform adaptable to other cancer types, paving the way for more personalized and adaptive therapies.
  4. Contribution to global healthcare innovation
    Our approach encourages the development of safe, efficient RNA-based therapeutics, expanding access to next-generation cancer treatments.
  5. Reduced healthcare costs in the long term
    More effective and targeted therapies can decrease relapse rates and hospitalization needs, ultimately easing the economic burden on patients and healthcare systems.
Potential Long-Term Risks and Challenges
  1. Immune response and safety concerns
    As with all mRNA-based technologies, there is a potential risk of unintended immune activation or inflammation. Our team is committed to thorough preclinical safety testing.
  2. Off-target effects
    Toehold switch regulation requires precise sequence design. There is a possibility of off-target activity, which we aim to minimize through computational modeling and validation.
  3. Ethical and regulatory challenges
    Emerging RNA therapies may raise questions around bioethics, equitable access, and data security. We prioritize transparency and collaboration with regulatory authorities to address these issues responsibly.
  4. Production and delivery limitations
    Efficient delivery of mRNA to the liver remains a technological challenge. We continue to explore optimized delivery vectors to ensure stability, efficiency, and safety.

Social Impact

Positive Social Impact

The HepaSwitch project represents a meaningful step toward democratizing access to advanced medical diagnostics. By developing a synthetic biology-based system capable of detecting hepatocellular carcinoma (HCC) with high precision and affordability, the project directly addresses one of the world’s most urgent healthcare challenges — late cancer detection.

Improved Health Equity

HepaSwitch can contribute to reducing global health inequalities by offering an accessible diagnostic solution suitable for low- and middle-income countries, where HCC incidence is highest and access to advanced testing remains limited. The platform’s cost-effectiveness allows for implementation in settings with limited infrastructure, making early diagnosis achievable for broader populations.

Empowerment through Knowledge and Innovation

Beyond medical utility, the project promotes a culture of innovation and entrepreneurship among young scientists. It demonstrates that academic research can evolve into real-world applications, motivating students to engage in responsible science and problem-solving. This contributes to shaping a new generation of scientists aware of both scientific and social responsibilities.

Public Awareness and Education

By engaging with the public through educational campaigns, presentations, and collaboration with innovation hubs, the HepaSwitch team helps raise awareness about liver cancer prevention and the potential of synthetic biology in modern healthcare. This dialogue between science and society strengthens public trust in biotechnology and promotes science literacy.

Long-term Societal Benefits

Earlier and more accurate detection of liver cancer not only improves individual health outcomes but also decreases the socioeconomic burden of late-stage cancer treatment. This leads to a more sustainable healthcare system and greater productivity within affected populations.

Potential Negative or Risk Factors

While HepaSwitch offers significant social benefits, responsible innovation also requires recognizing potential risks and ethical challenges:

Unequal Access and Affordability Gaps

Even with efforts to make diagnostics affordable, disparities may persist between high-income and low-income healthcare systems. Implementation might initially favor regions with stronger biomedical infrastructure, potentially reinforcing existing inequalities.

Data Privacy and Ethical Concerns

As with any biomedical technology involving patient data and molecular diagnostics, ensuring ethical handling of genetic and medical information is crucial. Inadequate regulation or misuse could lead to privacy risks or discrimination in healthcare access.

Commercialization Pressure

The growing commercialization of academic projects might shift focus away from social good toward profit-driven priorities. It’s important that HepaSwitch maintains its commitment to accessibility and social responsibility as it progresses toward market implementation.

HepaSwitch has the potential to transform the social landscape of cancer diagnostics by improving accessibility, inspiring scientific entrepreneurship, and promoting health education. However, the project’s success will depend not only on technological advancement but also on its ability to maintain ethical integrity, transparency, and inclusivity. By anticipating and addressing social risks early, HepaSwitch can serve as a model of how synthetic biology can responsibly improve human health while respecting societal values.

Business plan

Below, we have attached the complete business plan, which is focused on outlining all the essential steps required for the development of HepaSwitch - from proof-of-concept, through preclinical and clinical validation, to potential market entry. This structured approach ensures that every stage is carefully considered, increasing the likelihood of successful translation from research to real-world application.

Business plan (PDF)

Pitch deck

In the following section, we present our pitch deck, which summarizes the essence of HepaSwitch in a clear and accessible way. The goal of this material is to explain not only what our solution is, but also why it matters - highlighting the problem we address, the innovation behind our approach, and the potential impact on patients and healthcare. By condensing the most important aspects of our project, the pitch deck serves as a tool to communicate with potential partners, mentors, and investors, showing the real-world value and future of our idea.

Pitch deck (PDF)

Current team

We built our team by focusing on the unique skills and abilities of each member, with the primary goal of creating a truly interdisciplinary group. To better understand our strengths, weaknesses, and potential gaps, we made use of personality assessments such as the 16 Personalities test and the Gallup Strengths test. These tools provided us with valuable insights into individual traits and team dynamics, allowing us to maximize our collaboration and efficiency. In addition, we consulted with experts in team building and management, which helped us refine our approach. As a result, we established a well-balanced and effective team prepared to tackle the scientific and organizational challenges of the project.

Team personality distribution (pie chart)
Distribution of Personality Types

The bar chart illustrates the distribution of 16 personality types within the team. It highlights which profiles are most and least common, helping to identify the team’s overall balance between analytical, creative, and organizational traits.

Gallup strengths themes coverage (pie chart)
Correlations Between Traits

The heatmap presents correlations between personality traits. Positive values (red) indicate traits that tend to increase together, while negative values (blue) suggest contrasting behaviors. This helps uncover underlying relationships within the team’s mindset.

Gallup strengths themes coverage (pie chart)
Average Personality Profile

The radar chart shows the team’s average scores across the five personality dimensions: Energy, Mind, Nature, Tactics, and Identity. Peaks and valleys reveal dominant characteristics and potential areas of complementarity within the team.

Gallup strengths themes coverage (pie chart)
Personality Trait Scores by Type

The horizontal bar charts compare average trait scores for each personality dimension across different types. This helps visualize how specific traits vary between groups - for example, which types score higher in Energy or Tactics.

Gallup strengths themes coverage (pie chart)
Correlation Between Traits

The heatmap presents correlations between personality traits. Positive values (red) indicate traits that tend to increase together, while negative values (blue) suggest contrasting behaviors. This helps uncover underlying relationships within the team’s mindset.

Gallup strengths themes coverage (pie chart)
Proportion of Personality Types

This pie chart visualizes the relative proportion of each personality type. It provides a quick overview of diversity across team members and shows how evenly personality types are represented.

Gallup strengths themes coverage (pie chart)
UMAP Visualization of Team Members

This UMAP projection reduces multidimensional personality data into two dimensions, showing the relative similarity between team members. Clusters represent groups with similar personality structures, while outliers highlight unique individual perspectives.

Literature

  1. Balogh, J., Victor III, D., Asham, E. H., Burroughs, S. G., Boktour, M., Saharia, A., ... & Monsour Jr, H. P. (2016). Hepatocellular carcinoma: a review. Journal of hepatocellular carcinoma, 41-53.
  2. Llovet, J. M., Castet, F., Heikenwalder, M., Maini, M. K., Mazzaferro, V., Pinato, D. J., ... & Finn, R. S. (2022). Immunotherapies for hepatocellular carcinoma. Nature reviews Clinical oncology, 19(3), 151-172.
  3. Bruix, J., & Sherman, M. (2005). Management of hepatocellular carcinoma. Hepatology, 42(5), 1208-1236.
  4. Befeler, A. S., & Di Bisceglie, A. M. (2002). Hepatocellular carcinoma: diagnosis and treatment. Gastroenterology, 122(6), 1609-1619.
  5. Yang, J. D., & Roberts, L. R. (2010). Hepatocellular carcinoma: a global view. Nature reviews Gastroenterology & hepatology, 7(8), 448-458.
  6. Bruix, J., Gores, G. J., & Mazzaferro, V. (2014). Hepatocellular carcinoma: clinical frontiers and perspectives. Gut, 63(5), 844-855.
  7. El-Serag, H. B., Marrero, J. A., Rudolph, L., & Reddy, K. R. (2008). Diagnosis and treatment of hepatocellular carcinoma. Gastroenterology, 134(6), 1752-1763.
  8. Hartke, J., Johnson, M., & Ghabril, M. (2017, March). The diagnosis and treatment of hepatocellular carcinoma. In Seminars in diagnostic pathology (Vol. 34, No. 2, pp. 153-159). WB Saunders.
  9. Chen, Z., Xie, H., Hu, M., Huang, T., Hu, Y., Sang, N., & Zhao, Y. (2020). Recent progress in treatment of hepatocellular carcinoma. American journal of cancer research, 10(9), 2993.
  10. Galle, P. R., Foerster, F., Kudo, M., Chan, S. L., Llovet, J. M., Qin, S., ... & Zhu, A. X. (2019). Biology and significance of alpha‐fetoprotein in hepatocellular carcinoma. Liver international, 39(12), 2214-2229.
  11. Hanif, H., Ali, M. J., Susheela, A. T., Khan, I. W., Luna-Cuadros, M. A., Khan, M. M., & Lau, D. T. Y. (2022). Update on the applications and limitations of alpha-fetoprotein for hepatocellular carcinoma. World journal of gastroenterology, 28(2), 216.
  12. Chakraborty, E., & Sarkar, D. (2022). Emerging therapies for hepatocellular carcinoma (HCC). Cancers, 14(11), 2798.
  13. Zhang, Y., Xie, F., Yin, Y., Zhang, Q., Jin, H., Wu, Y., ... & Gao, J. (2021). Immunotherapy of tumor RNA-loaded lipid nanoparticles against hepatocellular carcinoma. International journal of nanomedicine, 1553-1564.
  14. Green, A. A., Silver, P. A., Collins, J. J., & Yin, P. (2014). Toehold switches: de-novo-designed regulators of gene expression. Cell, 159(4), 925-939.
  15. Yu, P., Zhang, X., Liu, N., Tang, L., Peng, C., & Chen, X. (2021). Pyroptosis: mechanisms and diseases. Signal transduction and targeted therapy, 6(1), 128.
  16. Vande Walle, L., & Lamkanfi, M. (2016). Pyroptosis. Current Biology, 26(13), R568-R572.
  17. Chen, B., Yan, Y., Yang, Y., Cao, G., Wang, X., Wang, Y., ... & Wang, Y. (2022). A pyroptosis nanotuner for cancer therapy. Nature Nanotechnology, 17(7), 788-798.
  18. Kew, M. C., & Popper, H. (1984, May). Relationship between hepatocellular carcinoma and cirrhosis. In Seminars in liver disease (Vol. 4, No. 02, pp. 136-146). © 1984 by Thieme Medical Publishers, Inc..
  19. Huang, D. Q., Mathurin, P., Cortez-Pinto, H., & Loomba, R. (2023). Global epidemiology of alcohol-associated cirrhosis and HCC: trends, projections and risk factors. Nature reviews Gastroenterology & hepatology, 20(1), 37-49.
  20. Llovet, J. M., Brú, C., & Bruix, J. (1999). Prognosis of hepatocellular carcinoma: the BCLC staging classification. In Seminars in liver disease (Vol. 19, No. 03, pp. 329-338). © 1999 by Thieme Medical Publishers, Inc..
  21. D’Avola, D., Iñarrairaegui, M., Pardo, F., Rotellar, F., Marti, P., Bilbao, J. I., ... & Sangro, B. (2011). Prognosis of hepatocellular carcinoma in relation to treatment across BCLC stages. Annals of surgical oncology, 18(7), 1964-1971.
  22. Burdette, B. E., Esparza, A. N., Zhu, H., & Wang, S. (2021). Gasdermin D in pyroptosis. Acta Pharmaceutica Sinica B, 11(9), 2768-2782.
  23. Sachs, J. D. (2020). Sustainable development goals. Health of People, Health of Planet and Our Responsibility: Climate Change, Air Pollution and Health, 391.
  24. Fund, S. (2015). Sustainable development goals. Available at this link: https://www. un. org/sustainabledevelopment/inequality.
  25. United Nations DPI. (2017). The sustainable development goals. Stylus Publishing, LLC.