Integrated Human Practices

Introduction

In ALSense, we understood from the very beginning that developing a biosensor for ALS could not rely on science alone. The challenges of this disease are not only biological but also social, ethical, and political. That is why we placed people at the center of our work, engaging directly with patients, clinicians, caregivers, researchers, associations, and policymakers.

ALS is a devastating condition, with limited therapeutic options, a high socio-economic burden, and complex care needs that have been recognized at the national level with the approval of the Spanish “Ley ELA” in 2024. These realities shaped our responsibility: to build a project that is not only scientifically rigorous, but also socially meaningful and aligned with the ecosystem that surrounds ALS.

Throughout our journey we have interacted with a wide range of stakeholders:

Patients and families: who shared with us their lived experiences and made clear the urgency of earlier and more accessible diagnosis.
Hospitals and healthcare professionals: who guided us on the clinical and practical implications of implementing new diagnostic tools.
Academic and research experts: who helped us ensure our approach is innovative and evidence-based.
Associations and foundations: who work tirelessly to improve quality of life and visibility for the ALS community.
Regulatory and ethical advisors: who reminded us that biosafety, integrity, and compliance are essential to move from idea to impact.

Beyond these categories, we intentionally engaged with the key stakeholders that ALS patients encounter along their journey, in order to capture the mant perspectives on ALS within an international context.

On the political side, we carried out an overview of the current landscape and developed an improved legislative proposal. The purpose was to present a law that guarantees both comprehensive care and a fair diagnosis, and that also recognises the rights of families and caregivers, who are often left behind.

This inclusive approach shaped ALSense as more than a technical prototype. It became a response to urgent unmet needs, informed by diverse voices, embedded in real-world dynamics, and grounded in social responsibility.

“Human Practices is the study of how your work affects the world, and how the world affects your work.”

— Peter Carr, Director of Judging

iGEM Human Practices Criteria

How did we integrate Human Practices work throughout the project?

From the very beginning, our team reflected on all the possible value propositions of ALSense. We chose not only to map the value chain of the biosensor itself but also to integrate the patient diagnostic journey, acknowledging the complexity of ALS and the central role of those affected. Throughout the iGEM cycle we engaged with neurologists, multidisciplinary ALS units, patients and families, hospital directors, psychologists, associations, activists, IP experts, and regulators.

For example, neurologists guided our biomarker selection, patients emphasized the urgency of affordability and accessibility, and regulators helped us align with biosafety requirements. These conversations demonstrated that our biosensor occupies a real and necessary place in the diagnostic timeline, with a multidimensional impact: clinical, psychological, and social.

Our first objective has always been to be by and for the patient. For this reason, we also designed a political strategy that incorporates our biosensor into a basic legislative proposal, alongside a policy paper that communicates internationally the political state of ALS: how far it has come, and what remains to be done.

Finally, ethics was embedded from the start. We conducted a bioethical analysis of our project and developed a communication guide for physicians, ensuring that our solution is not only technically feasible but also responsible in the way it will be delivered to patients. Importantly, all these proposals could be built and presented thanks to the many encounters we had with different stakeholders, whose perspectives and insights we highlight later in this section.

What example do we pretend to set?

ALSense demonstrates that Human Practices can go beyond stakeholder interviews and truly shape the trajectory of a scientific project. By integrating patients’ voices, healthcare professionals, and policy structures, we built a model for embedding innovation into an ecosystem as complex as ALS.

Our work shows future iGEM teams that even with a highly specialized disease, it is possible to design strategies that balance science, ethics, and politics. We believe our example is inspiring because it shows that teams can act as catalysts of change: not just proposing technologies, but actively contributing to societal debates and legislative frameworks.

Moreover, by being in direct contact with the ALS community, we were able to understand the daily realities of the disease and the challenges it poses. The emotions we experienced in each of these encounters are the same ones we aim to transmit through our project. This leads us to a recommendation for future teams: whatever your project may be, always strive to convey reality and emotions, as they are what allow you to connect more deeply with your audience.

How is our work documented so others can build upon it?

We made sure to document both our outcomes and our reasoning to maximize reproducibility and reuse. In particular, our wiki includes:

A detailed explanation on how we built both the biosensor value chain and the patient diagnostic journey.
How we designed our stakeholder engagement matrix and our own template for stakeholder meetings, adapting the Socio-Technical Integration Research (STIR) framework.
How we created our bioethical guide for clinicians.
How we developed our policy overview and legislative proposal.

By sharing templates, frameworks, and reflections, we aim to support future iGEM teams in designing their own HP strategy. We also highlight the role of the ALS community, which has been uniquely supportive and collaborative, reminding future teams to carefully analyze their target community: sometimes it hides incredible opportunities for partnership and inspiration.

How thoughtfully was it implemented? How well did they explain the context, rationale, and prior work?

Our HP work was implemented through well-defined objectives and iterative cycles of engagement, reflection and integration. At every stage, the specific context of ALS provided a strong rationale for embedding Human Practices, guiding us to address not only the medical urgency of the disease but also its social and political dimensions. This ensured that our approach was both evidence-based and socially responsible.

To avoid duplicating efforts, we carefully reviewed prior work, including clinical guidelines, official reports, and patient observatories, and built directly upon this work to generate outputs that were complementary, actionable, and impactful.

How did we incorporate different stakeholder views?

We analyzed the entire ALS ecosystem and compiled a comprehensive list of stakeholders: patients, caregivers, neurologists, psychologists, social workers, associations, foundations, regulatory advisors, policymakers, project managers, investors, and rehabilitators. Each provided insights that directly shaped our project—refining technical design, aligning with clinical workflows, identifying ethical risks, and envisioning political pathways.

For example, conversations with patients helped us realize that our work could not stop at developing a biosensor: it also needed to include a broader action plan from the very first day of the diagnostic journey. Interactions with ALS unit heads were essential to refine our biomarker selection and understand their diagnostic and prognostic value.

Another highlight was engaging with entrepreneurs who had recently launched startups. Their advice on mistakes to avoid and strategies to adopt was invaluable, especially in shaping the entrepreneurship component of our project.

To what extent did they convince you that their Human Practices activities helped create a project that is responsible and good for the world?

We demonstrate responsibility by addressing ALS not only as a scientific challenge but also as a societal one. Through iterative Human Practices activities, we ensured that our biosensor is aligned with clinical needs, ethical standards, and political realities.

Stakeholder input directly influenced technical design, bioethical frameworks, and policy proposals, resulting not just in a prototype, but in a roadmap for real-world implementation. This roadmap incorporates patients’ voices, promotes social good, and aims to reduce diagnostic delays, improve quality of life, and empower families.

In this sense, Human Practices has been central to making ALSense a project that is both scientifically rigorous and truly responsible, creating tangible positive impact for the ALS community and beyond.

Behind ALS Diagnosis

Imagine a domino table. The tiles are lined up, the board is clear, and the goal is simple: reach the end without leaving a single piece behind.

But in this game, the tiles don’t hold numbers — they hold symptoms, tests, emotions, and medical decisions. And the player isn’t just one person — it’s patients, doctors, families, and researchers, all trying together to decode the board of ALS.

The Invisible Piece

The game begins with a tile so subtle it almost goes unnoticed. At first glance, it seems harmless — ordinary. But hidden within it is a sign: weakness in the hand, a stumble while walking, difficulty pronouncing a word.

The player tries to place it, but the others don’t see it. “It’s probably stress, fatigue, maybe a small injury…” someone says. The tile fits, but no one realizes the game has already begun.

Needs at this stage:

Awareness campaigns to help recognize early signs.
Rapid access to specialized medical care — so the player doesn’t wait too long for their turn.

The Diagnostic Labyrinth

Now the table is filled with options. Each player places a different tile: electromyography, MRI, genetic analysis, neurological exams… But none fit perfectly. There’s no single test that reveals ALS. The player gets trapped in a maze of exclusions, crossing out one disease after another.

Time passes. The hand grows heavier.

Uncertainty weighs more than the tiles themselves.

Needs at this stage:

Faster and more accurate diagnostics — to avoid losing precious turns.
Advanced technology and medical resources to minimize uncertainty.
Emotional support during the waiting process — every move comes with anxiety and exhaustion.

The Piece That Changes the Game

At last, a tile fits. But when it does, silence fills the room. The diagnosis is on the table: ALS.

The player stares at it, unsure whether to keep playing or stop. Receiving this tile is a profound emotional blow. Now the board is not only medical — it’s deeply human. Fear, confusion, and the need for support become the new rules of the game.

Needs at this stage:

Empathetic support communities that help sustain the game.
Clear and accessible information, so the player knows what moves remain.

ALSense — The Piece of Change

But something new appears on the table. Someone places a different tile — brighter, sharper, built with science and hope. That title is ALSense.

When it falls, the entire game shifts. It’s no longer just about diagnosing — it’s about doing it earlier, faster, more precisely, and with humanity. Now, every previous piece — the invisible one, the labyrinth, the moment of impact — finally connects.

Our Mission:

Deliver faster, more innovative diagnostic solutions.
Expand medical and emotional support resources.
Raise awareness and understanding of ALS, so the next game starts with more knowledge and less waiting.

Endgame

In dominoes, every piece matters. In ALS, too.

Every scientific breakthrough, every shared story, every earlier diagnosis — is a tile that falls in sequence, opening the path toward a future where the board no longer ends with the words “no way out.”

Stakeholders

We firmly believe that anticipating challenges and learning from experienced voices provides the strongest foundation for our project. By doing so, we avoid unnecessary pitfalls and open space for new opportunities to emerge. Guided by this philosophy, our Human Practices team began its work by identifying the core elements that shape our project and the needs that arise along the way. This first step allowed us to define the most relevant stakeholders to engage with throughout our journey.

To structure this process, we started by focusing on the product itself and its value chain. Much like other iGEM teams that have used a supply chain approach to map stakeholders, we wanted to understand every perspective that could interact with our biosensor across its full lifecycle—from design and engineering, to clinical use, and finally, to its real-world impact on patients. This approach ensured that we constantly re-evaluated our decisions, refining the device while staying committed to our ultimate goal: reducing the diagnostic delay of ALS.

But we went one step further. We realized that our project does not only deal with the future of a biosensor—it is inherently tied to the patient journey. We mapped the chain of interactions that an ALS patient typically experiences from the very first suspicion of symptoms through their long diagnostic process. This mapping exercise made one thing clear: only by considering the real journey of the patient can we measure the true value of an earlier diagnosis.

For example, when meeting with patients, we avoided technical words like biomarkers or aptamers. Instead, we described ALSense as “a simple blood test that looks for small signs of nerve damage and changes in the body that usually appear long before doctors can detect them with current tools.”

We used a fire analogy: “current tests only notice the fire when the walls of the house are already burning, which means there is little time left to protect them. ALSense, on the other hand, acts like a smoke detector that notices the first traces of smoke—giving us time to act before the damage becomes too radical.”

To explain the cryptic peptides, we used another image: “normally, proteins are like perfect rectangles. But in ALS, a strange ‘little hat’ is added on top of some of them. This unusual piece should not be there, and ALSense is designed to detect exactly that hat.” Patients told us these metaphors helped them visualize something that otherwise feels very abstract and highly technical.

After establishing our dual chains—the product supply chain and the patient journey—we needed a way to prioritize insights. For this, we adapted Mendelow’s Matrix, a strategic tool that maps stakeholders according to their level of interest and influence over a project. This helped us decide who required more attention, communication, and engagement at each stage.

Our matrix in detail

INTEREST= How directly a stakeholder is affected by the project. For example, a patient has high interest because the biosensor could improve their diagnosis.

INFLUENCE= The degree to which a stakeholder can impact the project’s success through support, approval, or resources. For example, a health regulator has high influence because their approval is required to use the biosensor.

Levels of Interest

High: Stakeholders directly affected or highly benefited by the project (patients, physicians).
Medium: Indirect or professional interest; they may support the project, but are not the primary target.
Low: Limited connection to the problem; the project’s impact on them is marginal.

Levels of Influence

High: Have decision-making power, resources, approval capacity, or influence in key networks.
Medium: Can partially support or block the project, but lack final decision-making authority.
Low: Their ability to influence the project is limited or negligible.

Stakeholder Mapping

Patients & families
Interest: High (directly affected by ALS diagnosis and progression)
Influence: Medium (they provide voice, visibility, and real needs, but lack technical decision-making power).
Neurologists & clinicians
Interest: High (the biosensor could improve their clinical practice)
Influence: High (they can validate the device, recommend it, and facilitate its adoption in hospitals).
ALS researchers
Interest: Medium (indirect benefit through data generation or scientific collaboration)
Influence: High (they can support technical development, generate evidence, and connect us with academic networks).
Patient associations
Interest: High (they represent patients and advocate for their rights)
Influence: Medium (they can mobilize public opinion and support implementation, but do not regulate or develop technology).
Biotechnology industry
Interest: Medium (commercial or strategic potential, but no personal impact)
Influence: High (they can scale the technology, invest, or license).
Health regulators
Interest: Low (not directly affected nor users of the biosensor)
Influence: High (their approval is essential for integration into the healthcare system).

The stakeholder analysis is a dynamic process that will be reviewed periodically by asking questions such as: “Have priorities or needs changed? Is it necessary to include new stakeholders? And is effective communication being achieved with each group?”

One of the ways we approached patients was through structured surveys. To ensure responsible handling of sensitive medical information, we implemented an optional anonymization protocol, in accordance with the bioethics recommendations reviewed with the bioethics mentors who supported our project and by the General Data Protection Regulation (Regulation (EU) 2016/679, GDPR) and the Spanish Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD). This process guaranteed that patient testimonies could inform our project without compromising privacy.

For further details on how we collect, store, and manage personal data, please visit our Biosafety page .

How did we track each contact?

Once we had defined our Mendelow Matrix, we created an initial list of key contacts. To make sure every interaction was properly documented, we developed a standardized meeting template that any team member could easily complete after a stakeholder meeting.

Taking inspiration from the advice of previous iGEM teams, we adapted the Socio-Technical Integration Research (STIR) framework, which allowed us to systematically capture insights from every conversation. STIR is a method designed to structure dialogue between scientists and stakeholders, ensuring that social, ethical, and technical perspectives are not overlooked during project development. By embedding this framework into our template, we were able to go beyond simply recording meeting notes—capturing instead how each stakeholder’s input shaped our decisions.

This process not only improved our Human Practices strategy, but also connected us with the experience of past iGEMers who generously shared their approaches with us. In the same spirit, we want to give back: here we share both the layout of our stakeholder meeting template and the full dossier of stakeholder interactions from the very first iGEM UIC Barcelona team (2025).

Take a look at our Stakeholders Segmentation (PDF)

Surveys as a Bridge to the ALS Community

To broaden our reach and ensure that a diversity of voices could shape our project, we designed a set of surveys aimed at engaging key stakeholders in the ALS ecosystem. These surveys allowed us to systematically collect insights, identify unmet needs, and integrate lived experiences into the design of ALSense.

We developed three different surveys: “ALS as experienced by families and caregivers,” “ALS as experienced by hospitals,” and “ALS as experienced by patients.” Each of them was carefully designed to be accessible and straightforward, using multiple-choice formats to reduce barriers to participation. All procedures complied with data protection requirements, as detailed in our Biosafety section.

Our outreach efforts were strengthened by the support of patient associations and other active stakeholders, who helped us distribute the surveys. Despite this, the response volume was smaller than we initially expected. Yet this apparent limitation became one of our greatest learnings: quality matters far more than quantity. The answers we did receive were of exceptional depth and sincerity, providing us with perspectives that we could not have anticipated.

Together with the meetings we conducted across the ALS ecosystem, the surveys provided us with valuable realities and factors that transformed our understanding of both ALS and ALSense. The following sections present the conclusions we derived from these surveys—insights that not only shaped our technical design but also grounded our project in the lived realities of those most affected.

1) Families and Caregivers: Lessons that Shaped ALSense

When listening to families and caregivers, we quickly understood that their experience goes far beyond the clinical definition of ALS. They are the ones who live through the uncertainty of the diagnostic odyssey, carry the emotional and financial burden of care, and accompany the patient through every decline. For us, their voices were not only testimonies, but a compass that guided how ALSense should be designed and implemented.

One of the most striking findings was the ambivalence about early diagnosis. While some relatives clearly expressed that knowing earlier would have helped them prepare, most were unsure. This revealed a crucial insight: an early test alone is not enough—it must be delivered together with an action plan. Otherwise, it risks becoming another source of anxiety rather than relief.

When asked what information they would have wanted at the moment of diagnosis, their answers were unambiguous: “a plan, resources, and clear explanations.” Families did not want more complexity or abstract information; they wanted practical guidance from day one. This insight led us to identify a key unmet need for our future Human Practices work: pairing ALSense with a “First-Day Pack”—a concise, accessible set of next steps including (1) a 48-hour to 1-month roadmap, (2) contacts for local ALS units and associations, (3) plain-language explanations of what the result means, and (4) quick-start information on benefits and legal rights.

The emotional weight was also strongly present in their answers. Words such as “love”, “positivity”, but also “hard” and “drama” describe the contradictory reality of caregiving. This duality reminded us that our communication must be both scientifically precise and emotionally sensitive. ALSense is not only a diagnostic tool; it is an entry point to hope, planning, and dignity.

Families also described the biggest challenges of caregiving: feeling powerless while witnessing decline, becoming the main caregiver of a fully dependent person, facing economic strain, and struggling to support their loved one on “bad days.” From these accounts, we learned to frame ALSense not only as a medical innovation, but as a time-saver and access-enabler: earlier results mean earlier access to social benefits, professional support, and clinical trials—resources that directly reduce both burden and uncertainty.

Finally, open comments emphasized two recurring aspirations: “more resources and public research” and “a closer, faster accompaniment.” These remarks confirmed that ALSense must stand not only as a device, but also as a catalyst for systemic improvement. That is why we propose parallel initiatives such as (i) co-developing educational modules for caregivers with associations, (ii) integrating our tool into hospital–association bridges to ensure warm handoffs, and (iii) using real-world caregiver metrics (time to benefits, time to home-care initiation) as outcome indicators in ALSense pilots.

In summary, caregivers taught us that ALSense must go beyond diagnosis. It must act as the first step of a coordinated response that acknowledges emotional realities, provides immediate practical tools, and helps families access the right support without losing precious time. Thanks to their input, we now see our biosensor not as an isolated test, but as the beginning of a structured journey towards earlier clarity, action, and dignity.

Summary of Survey Responses (PDF)

2) Hospitals and Clinicians: Insights for ALSense

The perspective of hospitals and clinicians highlighted the scientific and structural barriers that still limit the ALS diagnostic process today. They emphasized that the system relies too heavily on electromyography (EMG), a test that in many regions of Spain suffers from long waiting times and a shortage of trained specialists. In practice, this leads to months of delay for patients and families who are already facing uncertainty.

Clinicians also stressed a conceptual problem: most current tools are designed to rule out other conditions, rather than to positively confirm ALS. They see value in any technology that shifts this paradigm and allows doctors to diagnose earlier and with greater certainty. In their view, ALSense could help fill this gap.

Hospitals pointed out the urgent need for new biomarkers that capture the prodromic phase of the disease and help to stratify patients into subgroups, reflecting the heterogeneity of ALS. They envisioned ALSense as most useful in two moments: (i) as a confirmation tool in neurology consultations, when the suspicion of ALS first arises, and (ii) as a monitoring tool after diagnosis, to follow progression and guide treatment decisions.

When asked what a biosensor must deliver to be trusted, clinicians were unequivocal: high sensitivity and specificity, rapid results, interpretation backed by evidence, and seamless integration into existing neurological protocols. Interestingly, cost was not their main concern—quality and clinical value came first.

Trust, however, will only come with strong validation. Hospitals requested comparisons with existing methods, clinical studies in diverse populations, and above all, clear interpretation protocols. Their feedback directly shaped our validation roadmap: ALSense will be tested in multicentric, head-to-head trials against current standards such as neurofilaments alone and EMG, and will include standardized interpretation guidelines to ensure reproducibility across different hospitals.

Perhaps the most encouraging signal was that 100% of respondents expressed willingness to participate in clinical validation or design discussions. This creates an opportunity to build a national consortium of hospitals around ALSense, aligned with the new Spanish ALS law and the ConELA framework, to accelerate both evidence generation and real-world adoption.

In summary, hospitals reminded us that innovation alone is not enough: ALSense must be robust, evidence-driven, and easy to integrate into existing clinical workflows. Thanks to their input, our biosensor evolved from a promising idea into a realistic candidate for implementation in neurology units, designed to shorten diagnostic delays, empower clinicians, and bring earlier clarity to patients and families.

Summary of Hospital & Clinician Survey Responses (PDF)

3) Patients’ Voices: Living with ALS

The weight of waiting

For many patients, the journey to diagnosis was described as “slow, uncertain, and exhausting.” They often faced months—sometimes years—of tests designed to exclude other conditions rather than to confirm ALS. This diagnostic odyssey leaves them in limbo, suspended between suspicion and confirmation. Patients told us clearly: the earlier the diagnosis, the earlier they can adapt, plan, and fight back.

Receiving the diagnosis

When asked about the moment of diagnosis, words such as “shock,” “fear,” and “sadness” were frequent. Yet, patients also spoke about the importance of how the diagnosis is delivered. They valued empathy, clear explanations, and immediate guidance on next steps. This reinforced our belief that ALSense must not only provide a result, but also be embedded in a supportive clinical pathway that ensures no patient receives a “cold” answer without context or direction.

Living with ALS

Daily life with ALS, as described by patients, is a gradual process of adaptation. “You lose strength, but you learn to live differently,” one said. Still, the challenges are immense: mobility, communication, swallowing, breathing, and the emotional impact of depending on others. Despite this, patients highlighted the importance of maintaining positivity, dignity, and independence wherever possible.

What patients need most

Patients emphasized three recurrent needs:

Faster diagnosis with certainty – to reduce the painful waiting period.
Access to resources and therapies early on – from physiotherapy to communication devices, before the disease progresses too far.
Clear, centralized information – not fragmented across different professionals or institutions, but explained in a simple, unified manner.

Beyond medicine

Interestingly, many patients stressed that what matters is not only medical treatment, but time and support: time to apply for social benefits, to adapt their homes, to prepare their families, and to explore participation in clinical trials. This directly shaped one of our commitments: ALSense must act as a gateway to action, helping patients gain access to care, benefits, and trials earlier than today’s system allows.

A vision of hope

Despite the hardship, patients also spoke of hope. Some expressed gratitude for research efforts, for visibility campaigns, and for being listened to. Their feedback reminded us that ALSense is not simply a biosensor—it is part of a broader ecosystem of hope, advocacy, and empowerment.

Summary of Patient Survey Responses (PDF)

ALSense Supply Chain

From the beginning, we have recognized that technology alone is not enough; it must be guided by the lived experiences of patients and the expertise of healthcare professionals. Throughout the project, we conducted multiple meetings with key stakeholders—including patients, caregivers, neurologists, ALS unit professionals, and industry experts—to gather insights and feedback. These interactions have been essential in shaping our understanding of the diagnostic journey and the unmet needs that persist in ALS care.

This part it’s based on our designed Stakeholder Supply Chain that maps who we contact at each stage of the biosensor’s pathway. The model is organized into Checkpoints, each representing a critical phase in the patient and product journey (from early suspicion, to diagnosis, to follow-up care). At each Checkpoint, we classify the insights gathered, focusing on practical and actionable feedback rather than exhaustive transcripts. This method has allowed us to filter complexity into clear priorities.

So far, we have engaged with more than 50 stakeholders, including families and hands-on healthcare providers. Their contributions have not only helped us refine the scientific and clinical aspects of our biosensor, but also highlighted future directions—such as the need for a “First-Day Pack” (commented before) that offers patients and families immediate guidance after diagnosis.

This extensive outreach has enriched our project with diverse perspectives, ensuring that ALSense is not only a technological innovation, but also a socially aligned solution that has the potential to transform the ALS diagnostic pathway.

• Unmet medical need

This checkpoint focuses on defining the medical gap our project seeks to address. Beyond shaping the initial design of our biosensor, it was also essential to gain a deeper understanding of the ALS diagnostic process in order to identify precisely where our solution could have the greatest impact. At this stage, we establish the conceptual framework of the product, outlining its core components and intended functions. To ensure that these foundations are both scientifically sound and clinically relevant, we engage with researchers and experts who help validate our approach and confirm its feasibility.

Dr. Ricardo Rojas, Consultant Neurologist – Hospital de Sant Pau

Description. Dr. Rojas is a senior neurologist with over 20 years of experience and leader of the Multidisciplinary MND Clinic at Hospital de Sant Pau in Barcelona. He has a strong clinical background in ALS and offered valuable insights into both diagnostic and patient stratification strategies.

Key points meeting.

Suggested focusing less on early diagnosis and more on stratifying ALS patients according to cellular pathways, which could support future personalized therapies.
Highlighted that earlier diagnosis has limited clinical value at present due to the absence of curative treatments.
Proposed developing methods to distinguish between TDP-43 and TAU pathology, which could also help differentiate ALS from frontotemporal dementia.
Warned about legal and ethical considerations if working with human samples.

Impact. Although his feedback made us briefly consider shifting our focus to patient stratification, we decided to remain on the early diagnosis path after reviewing scientific and clinical relevance. His insights, however, reinforced the importance of biomarker specificity (e.g., TDP-43 vs. TAU) and alerted us to potential legal requirements when using human samples.

Raquel Barajas Azpeleta, Head of Research – Fundación Luzón

Description. Raquel Barajas leads the Research Department at Fundación Luzón, one of Spain’s most influential ALS-focused organizations. With experience overseeing diverse ALS research projects, she provided a broad perspective on current unmet needs in the field and how our project could fit within the ALS research ecosystem.

Key points meeting.

Clarified that funding from Fundación Luzón is typically directed toward projects at more advanced stages of development.
Offered to support ALSense through visibility and networking, helping us connect with other stakeholders who might provide resources or collaboration opportunities.
Emphasized the importance of linking diagnostic innovation with patient impact to make the project more relevant in the ALS ecosystem.

Impact. Her feedback helped us refine our understanding of the unmet medical need from a societal and patient-driven perspective, beyond the purely clinical. While direct funding is not an option at this stage, Fundación Luzón remains a key ally for communication, advocacy, and potential partnerships. This reinforced the importance of embedding ALSense not just in research pipelines, but also in the wider ALS community to ensure that the project addresses real-world needs.

Pol Andrés Benito, Researcher – IRB Lleida

Description. Pol Andrés Benito is a neuroscientist at IRB Lleida specializing in neurodegeneration, particularly in the role of TDP-43 dysregulation in ALS. His expertise makes him a key reference for understanding the molecular basis of the disease and the potential of cryptic peptides as diagnostic biomarkers.

Key points meeting.

Confirmed that cryptic peptides appear in early ALS, representing a potential tool to fill the diagnostic gap.
Highlighted the unmet need for biomarkers that reduce the diagnostic delay caused by unspecific early symptoms.
Warned that cryptic peptides are not exclusive to ALS, as they can also appear in other TDP-43 proteinopathies.

Impact. Pol’s insights guided us in defining where ALSense could make the greatest impact in the diagnostic process. His feedback reinforced the value of cryptic peptides as part of our conceptual framework, while reminding us that specificity must be improved by combining markers.

Dr. Miguel Ángel Rubio, Neurologist – Hospital del Mar

Description. Dr. Miguel Ángel Rubio is the coordinator of both the Neuromuscular Diseases Unit and the ALS Unit at Hospital del Mar in Barcelona. With extensive experience in clinical research and patient care, he provided critical insights into the unmet diagnostic needs of ALS, particularly regarding biomarker strategies.

Key points meeting.

Provided an in-depth overview of the current ALS diagnostic process, emphasizing its limitations and variability between centers.
Stressed the importance of focusing on biological markers over genetic testing, given the current relevance and accessibility in clinical settings.
Discussed the unmet need for a rapid and specific blood-based diagnostic tool that could complement existing clinical evaluations and accelerate treatment decisions.
Confirmed that, despite current diagnostic delays, early detection tools could provide significant value if linked to therapeutic monitoring or stratification frameworks.

Impact. Dr. Rubio’s clinical perspective guided the selection of relevant biomarkers and reinforced the importance of designing a tool that is clinically actionable, biologically grounded, and implementable within hospital workflows. His insights shaped our understanding of where ALSense can deliver the greatest impact—bridging the gap between early suspicion and confirmed diagnosis, while setting the foundation for future patient stratification.

Take a look at his recommendation letter here

Dr. Bernat Recasens, Neurologist – Hospital del Mar

Description. Dr. Bernat Recasens is a neurologist with clinical and research expertise in ALS and one of the coordinators of the Catalan clinical guidelines for the disease.

Key points meeting.

Confirmed that the diagnostic delay (10–16 months) remains a major unmet need.
Emphasized the necessity of simple and reproducible tools that neurologists can easily integrate into daily practice.
Stressed that any new test must be aligned with multidisciplinary ALS Units, as these are the core of patient management.
Pointed out the value of a diagnostic innovation that not only accelerates detection but also helps differentiate ALS from other neurodegenerative diseases.

Impact. Dr. Recasens’ feedback not only validated the urgent diagnostic unmet need but also gave us a practical view of how ALS Units operate and where ALSense could fit in. His suggestion of a wearable for monitoring also broadened our vision of ALSense’s potential, reinforcing the idea of creating a solution that is both clinically useful today and adaptable for the personalized care of tomorrow.

Dr. Juan Francisco Vázquez Costa, Neurologist – Hospital de Valencia

Description. Dr. Juan Francisco Vázquez Costa is an associate professor at the University of Valencia and a neurologist specialized in motor neuron diseases. With clinical and academic expertise, he shared insights on the limitations of current diagnostic processes and the importance of genetic counseling and patient follow-up.

Key points meeting.

Underlined that ALS cannot be diagnosed without observing progression, which inherently takes time.
Recommended building a probability scout adjusted for age, sex, and renal function (the latter being the only other factor known to influence neurofilament levels).
Stressed the importance of considering anamnesis (clear evidence of disease progression) when evaluating patients.
For first-degree relatives of ALS patients, genetic services are essential, but decisions should be voluntary and tailored to each case.
Noted the issue of incomplete penetrance in genetic forms, highlighting the need for careful counseling.
Recommended closer monitoring of individuals with rapid-progression mutations, particularly SOD1, where early treatment improves efficacy.
Emphasized the value of personalizing diagnostic and follow-up strategies to each patient and family context.

Impact. He emphasized both the limitations of current diagnostics and the opportunities for innovation in earlier detection and personalized monitoring. His insights highlight ALSense’s potential role in building probability-based diagnostic support tools and in contributing to stratification strategies for genetic carriers—particularly where early therapeutic intervention could significantly change outcomes.

Dr. Luis Varona Franco, Neurologist & Researcher – OSI Bilbao Basurto / Biocruces Bizkaia

Description. Dr. Luis Varona Franco is a neurologist at OSI Bilbao Basurto and a researcher at Biocruces Bizkaia. He has extensive clinical and research experience in ALS, contributing both to patient care and to the development of multicenter research initiatives.

Key points meeting. The meeting will take place after the wiki freeze. Topics to be discussed include:

Clinical perspectives on ALS diagnostics and unmet needs.
The potential role of biomarkers in shortening diagnostic delays.
Feedback on ALSense’s strategy and feasibility for hospital integration.

Impact. The outcomes of this meeting will be incorporated in the future as part of ALSense’s continuous stakeholder engagement. Dr. Varona Franco’s expertise is expected to provide valuable clinical insights that will guide the next stages of the project.

• Engineering & design

This checkpoint marks the transition from identifying the unmet medical need to building the first tangible version of our solution. Here, the focus is on translating ideas into an engineered design that integrates all the biological and technological components of the biosensor. Researchers and technical mentors play a crucial role in this stage, ensuring that every element of the design is not only functional but also robust enough to move forward into proof-of-concept validation.

Adrián Torres, Chief Scientific Officer – Aptadel

Description. Adrián Torres is CSO at Aptadel, a biotech startup specializing in aptamer development. With deep expertise in RNA biology and experience bridging research and industry, he provided crucial guidance on the technical and practical aspects of designing aptamers for diagnostic applications.

Key points meeting.

Aptamers can bind small molecules, peptides, and proteins, sometimes surpassing antibodies in affinity and stability, particularly under variable temperature conditions.
Development timelines can range from weeks to months, with the process often outsourced; however, there is always a risk that after several SELEX rounds no binding candidate is obtained.
Costs and sequencing are major factors to consider when planning aptamer development.
Recommended including more than one biomarker target to reduce the risk of failure.

Impact. His guidance led us to confirm that aptamers are the most suitable technology for ALSense given our resources and goals. It also allowed us to anticipate risks, allocate budget and time more realistically, and adopt a dual-biomarker strategy to mitigate potential setbacks. His contribution directly strengthened the feasibility and robustness of our biosensor design.

Toni Viayna, Professor – Universitat Internacional de Catalunya

Description. Antonio Viayna is a professor of Biomolecule Interaction at UIC with expertise in computational and biophysical analysis. His knowledge of in silico modeling tools provided valuable input on how ALSense could integrate computational approaches to support aptamer design.

Key points meeting.

Suggested using docking studies to simulate aptamer or recombinant molecule binding to target proteins.
Recommended specific software tools for structure prediction and modeling, including Dr. Autodoc, Haddock, Claspro for docking, and Swiss Model, AlphaFold, Tasser, Rosetta for homology modeling when sequences are not available.
Highlighted that computational modeling could accelerate the design phase and reduce experimental trial-and-error.

Impact. Toni’s feedback enabled us to incorporate computational modeling as a complementary tool in ALSense’s engineering process. This helps improve biomarker–aptamer selection, optimize biosensor design, and increase efficiency by anticipating binding performance before entering lab-based assays. His guidance ensures our design phase is both innovative and resource-efficient, reinforcing the robustness of ALSense’s engineering strategy.

Dr. Ricardo Rojas, Consultant Neurologist – Hospital de Sant Pau

Description. Dr. Rojas is a senior neurologist with over 20 years of experience and leader of the Multidisciplinary MND Clinic at Hospital de Sant Pau in Barcelona. He has a strong clinical background in ALS and offered valuable insights into both diagnostic and patient stratification strategies.

Key points meeting.

Suggested that beyond diagnosis, the engineering of our test could also consider stratification, since future therapies will likely require identifying patient subgroups.
Pointed out that certain biomarkers (e.g., troponin) are unreliable due to lack of specificity, while neurofilaments and TDP-43 represent more realistic directions.
Emphasized that a useful design should allow differentiation between ALS and frontotemporal dementia (FTD).
Raised the importance of aligning technical design with feasibility of sample access and respecting regulatory requirements for human samples.

Impact. His input influenced how we framed the design phase: prioritizing biomarker combinations that are not only technically feasible but also clinically interpretable. Pushing us to select markers with higher specificity, to think about scalability in a clinical context, and to design ALSense with future adaptability in mind.

Dr. Joan Marc Martínez – Universitat Internacional de Catalunya

Description. Dr. Martínez has a PhD in Biology from UIC Barcelona. His research is focused on molecular biology and microbiology, and he is part of the METADIS group (From cell metabolism to metabolic diseases).

Key points meeting.

Shared TrcHis B plasmid to facilitate our experimentation.
Provided continuous guidance during the experimental process, especially thanks to his expertise in bacterial systems.
Helped troubleshoot when we faced difficulties in experimental procedures and protocols.
Assisted in the interpretation of results, particularly when data were unclear or unexpected.
Gave support in understanding protein truncations and advised on possible approaches to address them.

Impact. Thanks to his expertise, we were able to carry out our experiments with precision and confidence. His advice was particularly valuable when facing unexpected results and technical difficulties.

Dr. Miguel Baena – Universitat Internacional de Catalunya

Description. Dr. Baena is a Postdoctoral Researcher at UIC Barcelona. He works in the field of molecular biology and is involved with the Neurolipid (Regulation of Lipid Metabolism) research group. Within UIC he also serves as Deputy Director of the Department of Biomedical Sciences.

Key points meeting.

Contributed to the design and development of the research strategy, guiding the scientific approach of the project.
Supported the team throughout the project, providing assistance and advice whenever needed.
Played a key role in the construction and validation of plasmid constructs used in the experiments.
Helped in shaping the research direction and integrating the experimental work within the broader scientific context.

Impact. He provided general guidance on the research design and development. His role helped maintain a basic scientific framework for the project and ensured we had access to necessary resources. He helped us navigate the different challenges that appeared throughout the project.

Joël Tekoniemi, Wet Lab Leader – iGEM Stockholm 2021

Description. Joël Tekoniemi was the Wet Lab leader of iGEM Stockholm 2021 and co-developed the aptamer protocol that we are using as the foundation for ALSense. His prior experience and willingness to provide technical advice make him a crucial reference for translating design into practice.

Key points meeting.

Clarified technical aspects of the SELEX protocol, including primer design, wash buffer preparation and flow cytometry application.
Explained the limitations of their work (e.g., not reaching flow cytometry testing) and suggested alternative detection strategies such as ELISA-like fluorescent assays for proteins.
Emphasized the importance of reproducibility and buffer stability, ensuring that our design can be executed consistently.
Encouraged us to contact other SELEX-active researchers to troubleshoot and refine further.

Impact. Joël’s support strengthened our project by giving us direct insight into a tested aptamer protocol. His advice helped us refine our workflow, anticipate experimental pitfalls, and ensure that ALSense’s design stage integrates robust and reproducible methods. This input transforms the project from conceptual biomarker selection to a tangible and feasible experimental design.

• Proof of concept

At this checkpoint, our focus is on transforming the design into experimental evidence. We carry out laboratory tests to validate the feasibility and diagnostic potential of our biosensor, ensuring that the chosen biomarkers and detection strategies work as intended. Through close collaboration with researchers and expert advisors, we refine protocols, troubleshoot challenges, and adjust our approach where necessary. This phase is critical not only for proving the scientific validity of our idea but also for generating the data needed to build credibility and attract future support and investment.

Raquel Barajas Azpeleta, Head of Research – Fundación Luzón

Description. Raquel Barajas leads the Research Department at Fundación Luzón, one of Spain’s most influential ALS-focused organizations. With experience overseeing diverse ALS research projects, she provided a broad perspective on current unmet needs in the field and how our project could fit within the ALS research ecosystem.

Key points meeting.

Stressed that experimental validation is critical for early-stage projects to gain credibility and attract interest from funders or collaborators.
Indicated that Fundación Luzón could become a stronger partner once ALSense has proof of feasibility and tangible results.
Suggested that, until then, they could help by promoting visibility of the project and connecting us with other stakeholders to gather support.

Impact. Raquel’s input reinforced us making clear that generating reliable data is essential to open the door for external partnerships and funding opportunities. While Fundación Luzón may not directly finance us at this stage, their potential role as a connector and amplifier provides strategic value in building trust and positioning ALSense within the ALS ecosystem.

Pol Andrés Benito, Researcher – IRB Lleida

Description. Pol Andrés Benito is a neuroscientist at IRB Lleida specializing in neurodegeneration, particularly in the role of TDP-43 dysregulation in ALS. His expertise makes him a key reference for understanding the molecular basis of the disease and the potential of cryptic peptides as diagnostic biomarkers.

Key points meeting.

Confirmed that cryptic peptides appear in early stages of ALS, making them promising for early detection.
Emphasized that these peptides are of high interest to the scientific community as diagnostic tools.
Warned that cryptic peptides may not be exclusive to ALS, as they can also be detected in other TDP-43 proteinopathies like frontotemporal dementia (FTD).
Discussed technical and clinical challenges, especially obtaining human samples (CSF or serum) at very early stages of the disease.

Impact. Pol’s input helped us refine our experimental roadmap for validating ALSense in the lab. His advice supports troubleshooting strategies, guides the choice of detection methods, and emphasizes the need for strong data to secure credibility and future funding.

Dr. Miguel Ángel Rubio, Neurologist – Hospital del Mar

Description. Dr. Miguel Ángel Rubio is the coordinator of both the Neuromuscular Diseases Unit and the ALS Unit at Hospital del Mar in Barcelona. With extensive experience in clinical research and patient care, he provided critical insights into the unmet diagnostic needs of ALS, particularly regarding biomarker strategies.

Key points meeting.

Expressed strong confidence in TDP-43 as one of the most relevant biomarkers for ALS diagnostics, despite technical challenges in its detection.
Highlighted HERV-K as another promising marker, though its measurement in blood remains difficult.
Emphasized the diagnostic and mechanistic potential of cryptic peptides, encouraging further exploration.
Suggested that stratifying patients according to biomarker levels (e.g., HERV-K, TDP-43) could increase experimental value and future therapeutic applicability.
Recommended prioritizing biomarkers beyond genetic markers, since these may have more immediate clinical relevance for proof-of-concept validation.

Impact. His emphasis on TDP-43 reinforced our decision to include it in the experimental panel, alongside cryptic peptides and HERV-K, ensuring we test biomarkers that combine scientific robustness with clinical relevance. His guidance shaped the way we refine protocols, troubleshoot challenges, and design experiments that can generate convincing early data to validate ALSense and attract further support.

• Regulatory pathway & quality assurance

This checkpoint ensures that our biosensor can move from the lab into real-world healthcare settings. We work hand in hand with legal advisors and regulatory experts to navigate the complex requirements of the IVDR framework and related standards. Their guidance allows us to align our design and validation processes with international norms, from ISO 13485 quality management to CE-IVD certification. Building this solid regulatory foundation is key to guaranteeing safety, reliability, and clinical acceptance, ultimately enabling ALSense to become a trusted diagnostic tool for ALS.

AEMPS – Medical Devices Division (Conchi Rodríguez, Laura Figueroa, Ramón Lorenzo, Raquel) & Sol Ruiz

Description. Through the support of Sol Ruiz, we were able to meet with four members of the AEMPS (Spanish Agency of Medicines and Medical Devices) team specialized in medical devices. Their expertise was fundamental to help us navigate the regulatory framework that governs diagnostics under the European IVDR (In Vitro Diagnostic Regulation).

Key points meeting.

Guided us on how to orient our project within Spanish and European legislation.
Recommended specific chapters and annexes of the IVDR that are most relevant for ALSense, allowing us to understand which obligations and requirements to prioritize.
Helped us to start shaping a regulatory roadmap aligned with CE-IVD marking, clinical evidence requirements, and quality assurance standards.
Clarified the roles of different regulatory actors (AEMPS, Notified Bodies, and EU frameworks) in the certification process.

Impact. Thanks to AEMPS’ guidance, we gained clarity on which legal documents, annexes, and requirements to focus on at our stage. Their advice allowed us to structure a realistic regulatory roadmap and ensured that our design and validation strategy already takes compliance into account, paving the way for future certification and clinical adoption. If you want to see the total impact, we encourage you to look for our business plan.

Conchi Torrejón – ClarkeModet

Description. Senior Regulatory Consultant.

Key points meeting.

Validated the main structure of our IVDR regulatory pathway.
Pointed out specific critical requirements and annexes we must not miss in order to ensure compliance.
Recommended aligning regulatory steps with both technical validation and IP milestones.

Impact. She gave us confidence that our roadmap is aligned with IVDR expectations and reduces risks of delays or non-compliance in the future.

• Adoption in healthcare systems

Beyond proving its scientific validity, successful adoption requires alignment with hospital workflows, procurement committees, and reimbursement policies. We engage with healthcare providers, decision-makers, and payers to demonstrate the clinical and economic value of early ALS detection, supported by health technology assessment (HTA) and cost-effectiveness studies. Establishing trust among neurologists, ALS units, and healthcare systems is key to ensuring that ALSense transitions from an innovative prototype to a standard diagnostic tool accessible to all patients.

Antoni Gilabert, Dr. Pablo Villoslada Díaz & Jaume Raventós – Hospital del Mar

Description. This multidisciplinary meeting brought together senior leaders from Hospital del Mar —Dr. Antoni Gilabert (Chief Innovation Officer), Dr. Pablo Villoslada (Head of Translational Neurosciences), and Dr. Jaume Raventós (General Director). Their combined expertise in clinical neurology, innovation management, and hospital administration offered ALSense a comprehensive view of how to navigate clinical validation, hospital adoption, and market access.

Key points meeting.

Protect the core biomarker concept with a solid patent strategy to define our value proposition clearly.
Develop a strong commercialization strategy, balancing ambition with realistic market entry.
Prepare a concrete and conservative business plan, built to scale gradually while maintaining credibility.
Validate the biosensor through clinical professionals to secure trust and credibility.
Focus on value-based pricing rather than production costs — hospitals and health systems will pay if ALSense demonstrates measurable efficiency and impact.
Consider innovative procurement models (e.g., pilot programs, public-private partnerships) where initial risk is shared with hospitals. For instance, offer early pilot units to demonstrate clinical and economic value before full adoption.
Demonstrate results within six months to justify hospital purchase decisions.
Position ALSense for B2B adoption through hospital networks and public healthcare entities (e.g., CatSalut).

Impact. This meeting was pivotal in shaping ALSense’s go-to-market vision. The insights from Hospital del Mar’s leadership reframed our understanding of adoption—from selling a diagnostic device to proving measurable value in patient outcomes and system efficiency. Their recommendations will guide our future collaborations with hospitals, define our pricing model, and inspire a value-based narrative for institutional buyers. Most importantly, they validated ALSense’s innovation potential within the healthcare ecosystem and opened the path toward a future recommendation letter from Hospital del Mar, reinforcing credibility for both investors and clinical partners.

Joan Grasas, Early-Stage Healthtech Expert – Institut Català de la Salut

Description. Joan Grasas is an entrepreneurship and healthtech innovation expert with over 18 years of experience in the biomedical sector. He has co-founded an IVD spin-off, advised multiple early-stage startups, and held leadership roles at EIT Health Spain and the Institut Català de la Salut (ICS). His expertise combines technology transfer, business development, and healthcare system integration.

Key points meeting.

Will advise us on bridging research and entrepreneurship, ensuring ALSense follows a realistic path from lab to market.
Expected to provide insights on commercialization strategies, early-stage fundraising, and system-level adoption of diagnostics.
Brings experience in innovation transfer within public healthcare systems, aligning with how ALSense could enter services like CatSalut.

Impact. The meeting will take place after the wiki freeze, but his expertise is expected to guide ALSense in defining a scalable business strategy and a roadmap for adoption in healthcare systems. His input will be essential for shaping our commercialization and sustainability strategy, complementing the clinical and regulatory insights gathered so far.

• General project management

While not a direct step in the value chain, project management acts as an enabler that ensures we can remain on it and move forward effectively. It provides the structure to coordinate scientific, clinical, regulatory, and business activities under a unified roadmap, with clear milestones, deliverables, and risk management strategies. By engaging with accelerators, mentors, and advisors who have already navigated this process, we gain valuable guidance and avoid common pitfalls. This continuous learning, combined with transparent communication and cross-functional collaboration, strengthens our foundation and guarantees that ALSense progresses sustainably towards its long-term impact.

Cristina Tarragó, Senior Project Lead – Ferrer Internacional

Description. Cristina Tarragó is Senior Project Lead in Global R&D Portfolio Management at Ferrer, where she oversees strategic planning for clinical development and translational research projects. Actively involved in ALS clinical trials such as ADORE and FAB122, she combines a scientific, regulatory, and business perspective. Her expertise connects the pharmaceutical, clinical, and patient-centered dimensions of ALS innovation, making her a strategic advisor for ALSense.

Key points meeting.

Stressed the importance of anchoring biomarkers in clear clinical endpoints, ensuring ALSense data reflects disease severity and progression.
Highlighted the tofersen case as an example of coherence between biomarker readouts and clinical response.
Recommended developing two parallel roadmaps — a standard one for long-term validation and a smaller-scale one with realistic milestones and shared responsibilities.
Advised strengthening connections with regulatory agencies and patient communities to accelerate validation.
Suggested exploring primary care centers (CAPs) as future partners in early detection, emphasizing training and implementation needs.
Introduced us to Mariona Serra (GOODGUD), sharing that their experience in diagnostic kit development could guide us in design, scaling, and regulatory navigation.
Discussed the feasibility of integrating “altruistic kit numbers” (patients + controls) to support validation.
Reinforced the value of comparative validation against established biomarkers, like infarction tests, to position ALSense credibly.
Encouraged us to use tools like the EDUCALS diagnostic poster and to refine the ALS patient journey mapping.

Impact. Her guidance helped us transform our roadmap from an academic plan into an operational framework grounded in clinical logic, regulatory foresight, and cross-sector collaboration. By integrating her recommendations, ALSense now operates with clearer priorities, realistic milestones, and a stronger connection between scientific goals and implementation strategy. This structured yet adaptive approach ensures that our project remains aligned with industry standards while continuously learning from mentors and accelerators—turning management into a true enabler of sustainable progress and long-term impact.

Fran Antequera & Jaume Ros – ATG SynBio Spain

Description. Fran Antequera, President of ATG SynBio Spain and Head of the AgroTech Center at Misión Andalucía. Jaume Ros, Biomedical Scientist at Cambridge University and Innovation, Steering Committee ATG SynBio Spain, and Business Development associate at Biocat.

Key points meeting.

Supported us during the initial brainstorming and project selection, helping ensure we chose the most promising direction.
Provided technical advice during the experimental phase, assisting with design considerations.
Reviewed and followed up on our fundraising strategy and the development of our pitch.
Played a central role in shaping our entrepreneurship strategy, guiding us on how to make ALSense attractive to investors and partners.
Helped us with key contacts in the ecosystem, broadening our network of potential collaborators and supporters.

Impact. Their mentorship has been fundamental in giving ALSense both technical rigor and entrepreneurial vision. By helping us refine our fundraising approach, strengthen our pitch, and connect with the right people, they accelerated our learning curve and gave us the tools to grow strategically. Beyond specific advice, Fran and Jaume inspired us to see ALSense not just as a scientific project, but as a scalable and impactful venture, shaping the way we present ourselves and chart our path forward.

Javier Salgado Aguilera & Daniel Jiménez Rey – Co-founders of BioLynx

Description. Javier Salgado and Daniel Jiménez, co-founders of BioLynx, are young biotech entrepreneurs recognized for their leadership. With experience as Harvard Medical School interns and founders of a fast-growing scientific platform connecting students, researchers, and startups, they embody the new generation of biotech founders combining science, communication, and business acumen.

Key points meeting.

Introduced their guiding principle: “never leave a meeting without something — feedback, a contact, or a new opportunity.”
Gave strategic advice on how to approach funding, highlighting the value of persistence and networking in the early stages.
Helped us identify how each conversation can generate exponential value, encouraging us to turn every meeting into a learning or partnership opportunity.
Have provided continuous follow-up since the beginning of our iGEM journey, supporting ALSense’s growth mindset and communication strategy.
Shared insights on personal branding, storytelling, and visibility to help position ALSense within the Spanish biotech ecosystem.

Impact. Javier and Daniel have played a key motivational and strategic role in shaping ALSense’s entrepreneurial and funding approach. Their mentoring pushed us to think beyond the lab, to build connections intentionally, and to transform every interaction into progress. Thanks to their guidance, ALSense has developed a more dynamic, opportunity-driven vision — one focused on persistence, community, and creating visible impact within the biotech innovation landscape.

Óscar Porcel, Managing Partner & Co-founder – Solutia Life Sciences

Description. Óscar Porcel is the Managing Partner and Co-founder of Solutia Life Sciences, a consultancy specialized in executive search and business development for the biotech, pharma, and medtech industries. With extensive experience in leadership, recruitment, and strategic management, he provided ALSense with valuable mentorship focused on the human and organizational side of innovation.

Key points meeting.

We presented the full ALSense project, receiving detailed feedback on how to make the entrepreneurship and business sections more compelling.
Shared actionable advice on team leadership, especially in managing a group of 12 people of different ages, backgrounds, and motivations.
Highlighted the importance of building cohesion, accountability, and motivation to ensure the team’s long-term performance.
Encouraged us to think about the continuity and future of ALSense beyond the iGEM competition, envisioning it as a long-term project with growth potential.
Expressed strong interest in following our journey and supporting future decision-making as the project evolves.

Impact. Óscar’s insights brought a new perspective to ALSense — one centered on leadership, team dynamics, and sustainable growth. His guidance helped us strengthen the human side of our entrepreneurship strategy, ensuring that our technical innovation is matched by effective management and communication. By helping us reflect on continuity, motivation, and structure, he provided the foundation for turning ALSense from a student project into a cohesive, enduring venture.

Judi Giró, Co-founder – The Blue Box

Description. Judi Giró is the co-founder of The Blue Box, a biotech startup that developed an AI-based device for early breast cancer detection. With her experience in transforming a university project into an internationally recognized medtech company, she provided key strategic insights for ALSense’s entrepreneurial path.

Key points meeting.

Emphasized that creating a company is not a milestone but a necessity to protect innovation through patents.
Acknowledged that we are starting in a challenging time for entrepreneurship, but stressed the importance of persistence and clarity of purpose.
Advised us to define patient segmentation precisely and to always design with the end user in mind.
Introduced the concept of phantom shares (≈0.8%) as a way to reward contributions without diluting ownership.
Shared her patent strategy: file a provisional patent (12 months) followed by a PCT (+18 months) to extend protection internationally.
Highlighted the value of having a small, focused team that learns fast and adapts quickly.
Reinforced a core mindset: “Make something people want.”
Urged us to keep two main priorities: (1) knowing exactly who the consumer is, and (2) obtaining clinical evidence to prove value.
Recommended exploring “The Art of Prioritization” from Silicon Valley to improve focus and execution.

Impact. Judit’s mentorship reframed how we view entrepreneurship and company creation within ALSense. She taught us that building a company is not the goal but the vehicle that enables protection, credibility, and scalability. Her guidance sharpened our strategic focus on clinical validation and user-centered design—reminding us that success depends on solving a real problem for a defined user. Thanks to her experience, we now have a clearer roadmap for patent strategy, team structure, and prioritization, aligning ALSense with the standards of high-impact biotech ventures.

Luis Grande, Secretary General – Real Academia de Medicina de Cataluña (RAMC)

Description. Luis Grande serves as Secretary General of the Real Academia de Medicina de Cataluña (RAMC), an institution that brings together leading medical professionals and researchers in Catalonia. His role connects academia, research, and policy, making him a valuable contact for establishing institutional collaborations.

Key points meeting.

Offered to help identify academic and research profiles in neuroscience and related fields within institutes affiliated with the RAMC.
Proposed a new strategy for contacting institutional stakeholders, leveraging the Academy’s network to strengthen ALSense’s visibility.
Shared insights on the Academy’s role in Catalonia and how it supports research dissemination, education, and recognition of biomedical innovation.

Impact. His support provides ALSense with a strategic entry point into Catalonia’s institutional ecosystem. By connecting us with neuroscience experts and academic partners, he helps expand our scientific network and credibility. This collaboration strengthens ALSense’s presence in the biomedical community and opens new opportunities for recognition and institutional partnerships.

You can take a look at the recommendation letter here (PDF)

• Funding strategy

Funding is not a single step in our value chain, but a continuous driver that enables us to move through it. Throughout the project we have been aware that each phase—scientific development, clinical validation, regulatory approval, and market adoption—requires tailored financial resources. The strategy that has allowed us to reach this stage is described in detail in our Fundraising section. At this checkpoint, however, we highlight the key meetings and interactions with investors, accelerators, and funding bodies that have shaped our vision for long-term sustainability. These exchanges have helped us map out future financing pathways, from grants and seed capital to partnerships and strategic investment, ensuring that ALSense can realistically evolve from an iGEM project into a viable healthcare solution.

Daniel Oliver, CEO – Capital Cell

Description. Daniel Oliver is the CEO and Founder of Capital Cell, Europe’s first equity crowdfunding platform specialized in biotech and health innovation. With years of experience connecting early-stage biotech projects to investors, he offered valuable insights on how ALSense can structure its fundraising strategy and communicate its value proposition more effectively.

Key points meeting.

Presented ALSense’s project and received feedback on our fundraising strategy, focusing on how to make it more attractive to investors.
He acknowledged that current market conditions are challenging for raising funds but encouraged us to prepare strategically for upcoming windows of opportunity.
Discussed our organizational activities and community engagement efforts, highlighting the importance of maintaining visibility and credibility before launching a campaign.
Advised us to refine our crowdfunding message, ensuring that the narrative balances scientific rigor with emotional connection and real-world impact.
Explained what makes a project appealing to investors and crowdfunding platforms like Capital Cell: a clear value proposition, credible milestones, and a tangible market entry path.
Provided detailed feedback on our project summary document, helping us make it more concise, investor-oriented, and aligned with financial expectations.

Impact. Daniel’s feedback helped ALSense reshape its fundraising and communication strategy, shifting our focus toward investor readiness and narrative clarity. His advice on how to frame ALSense’s mission, align milestones with funding stages, and connect emotionally with potential backers has been key to building a more credible and compelling investment proposition. Thanks to his guidance, ALSense now approaches fundraising not just as financial support, but as a strategic process of trust-building, storytelling, and long-term partnership creation.

Luis Ruiz Ávila – Biotech Entrepreneur & Investor

Description. Luis Ruiz Ávila is a biotech entrepreneur, investor, and mentor with over 25 years of experience transforming biomedical research into market-ready solutions. He is the CEO of Leukos Biotech, President of Aquilón Cyl, and a mentor at EIT Health’s Mentoring & Coaching Network, where he supports emerging healthtech startups across Europe.

Key points meeting.

Has provided continuous mentorship since the early stages of ALSense, helping us frame our project as a viable startup concept from day one.
Before outreach began, he guided us in defining stakeholder groups — investors, institutions, and potential partners — and in crafting the right approach for each.
Supported us in the follow-up of investor and stakeholder meetings, reviewing outcomes and suggesting next steps to strengthen relationships.
Collaborated closely with our team on the design and refinement of the crowdfunding campaign, including reviewing and editing the presentation materials and public summary.
Shared his expertise on investor psychology and biotech fundraising cycles, emphasizing the importance of timing, credibility, and storytelling in attracting funding.
Encouraged us to focus on long-term partnerships rather than short-term capital, to ensure strategic growth aligned with our mission.

Impact. Beyond helping us structure our crowdfunding campaign, he taught us how to think like entrepreneurs — understanding what investors look for, how to communicate scientific value in business terms, and how to transform feedback into strategy. His ongoing support has given ALSense both the confidence and the structure to pursue financing sustainably, ensuring that our fundraising efforts evolve hand in hand with our scientific and clinical progress.

AGAUR – Agència de Gestió d’Ajuts Universitaris i de Recerca (Generalitat de Catalunya)

Description. AGAUR is the Catalan Government agency responsible for managing scholarships, research grants, and innovation funding programs. It plays a key role in supporting scientific and technological projects at both academic and entrepreneurial levels. Our interaction focused on identifying potential funding opportunities for ALSense and understanding the eligibility conditions for future calls.

Key points meeting.

Explored available funding instruments from the Generalitat de Catalunya that could support R&D, technology transfer, or early-stage innovation.
Reviewed the main requirements and eligibility criteria for applying, including the need for institutional affiliation and specific project maturity levels.
Discussed timing of calls and documentation needed to prepare for upcoming application rounds.
Established the importance of keeping AGAUR’s programs on our funding radar to align our milestones and structure future submissions effectively.

Impact. This meeting helped ALSense build a clearer understanding of the regional funding landscape and the pathways to access public support within Catalonia. By identifying the right programs early and clarifying the application process, we can now strategically plan when and how to apply for AGAUR grants. This positions ALSense to benefit from public funding opportunities that can accelerate our transition from research to validation and, ultimately, market readiness.

Cristina González – ClarkeModet

Description. Innovation Sales Consultant.

Key points meeting. She advised us on how to align fundraising with our innovation milestones to build credibility and adapt our strategy depending on the stage of development (from early-stage grants to later-stage investment). Cristina stressed the role of IP as a key enabler for biotech financing and guided us to distinguish between public vs. private and individual vs. consortium opportunities. She explained that grant lines focus on future expenses, while fiscal incentives (R&D+i deductions) apply retrospectively, and both require a technical report (“what I want to finance”) and an economic report (submitted at application and justification). Importantly, she emphasized that double financing of the same expense is not allowed. Regarding equity rounds, she reminded us of the dilution they imply, while also introducing the concept of TAXLIST—a mechanism that allows investors to participate through fiscal deductions without causing dilution.

Impact. Her advice helped us refine our strategy linking our roadmap to a realistic financial plan and increasing our chances of attracting investors and institutional support.

Álvaro Sánchez & Joan Mercadal – Nara Capital

Description. Álvaro Sánchez and Joan Mercadal represent Nara Capital, a venture capital fund focused on early-stage investments in health, biotechnology, and deeptech. The firm typically invests from the seed to pre–Series A stages, prioritizing companies that already have a proof of concept or minimum viable product (MVP). Their experience provided ALSense with a clear understanding of what professional investors look for in emerging biotech startups.

Key points meeting.

They explained how investors evaluate companies, emphasizing that fundraising should start only once a validated MVP exists.
They shared the five key pillars that define an investable company:

Team – strong commitment, complementary skills, and clear execution capacity.
Business plan & model – realistic, scalable, and market-oriented.
Technical feasibility – solid proof of concept and scientific validation.
Financial metrics – sustainable projections and cost structure.
Pitch quality – clarity, credibility, and storytelling.

They described Nara Capital’s investment strategy: focusing on startups in therapeutics, medical devices, diagnostics, and digital health that can demonstrate proof of concept.
They outlined the core traits of a successful biomedical company: product utility, preclinical validation, intellectual property protection, strong team, defined market, and awareness of competition.
Finally, they advised us to strengthen our financial metrics and pitch narrative to prepare ALSense for future investor rounds.

Impact. The meeting with Nara Capital provided a realistic framework for investor readiness, helping us understand the tangible milestones required before seeking funding. Their feedback has guided us to reinforce our proof-of-concept validation, team structure, and financial narrative to increase investor confidence. This discussion clarified that investment is not driven solely by innovation potential but by execution credibility and strategic alignment, shaping our long-term roadmap for building ALSense into a truly investable venture.

Marta Arisa Muns – Head of Innovation and Knowledge Transfer (CTC-VR, UIC Barcelona)

Description. Marta Arisa is the Head of Innovation and Knowledge Transfer at the Centre de Transferència de Coneixement i Valorització de la Recerca (CTC-VR) within UIC Barcelona. She oversees innovation management, intellectual property, and the valorization of research results, acting as a crucial link between academia, industry, and funding agencies.

Key points meeting.

Reviewed our project roadmap and provided valuable feedback on next steps toward valorization.
Discussed funding opportunities and innovation grants that could support ALSense during early development stages.
Guided us on intellectual property protection, emphasizing the importance of timing and confidentiality before publication or disclosure.
Suggested aligning our biosensor development with technology transfer pathways to facilitate future patenting or licensing.
Recommended exploring collaborative frameworks with the university’s innovation office for joint dissemination or co-funding.

Impact. Marta’s insights strengthened our understanding of how to translate scientific innovation into protected, fundable technology. Her guidance helped us define an early IP strategy and identify potential funding channels, ensuring that ALSense’s research advances can be effectively safeguarded and transformed into real-world impact.

María Fernández Albizuri – Innovation Development Lead, Hospital Clínic de Barcelona

Description. María Fernández Albizuri is the Innovation Development Lead at Hospital Clínic de Barcelona, where she drives strategies for implementing technology-driven healthcare projects and supports the development of biotech and medtech startups. With a background in business management (IESE EMBA) and over eight years of experience in healthcare innovation, she has guided ALSense in shaping the financial and strategic backbone of its entrepreneurship plan.

Key points meeting.

Supported us in strengthening the financial modeling of ALSense, emphasizing the need to include revenue projections alongside cost structures (COGS, fixed and variable costs) to define our break-even point.
Offered to review our Excel financial models or guide us in creating them if time constraints allowed.
Helped refine our Funding Needs & Use of Proceeds, clarifying how to align future financing rounds with realistic milestones.
Assisted in customer identification and segmentation, ensuring that ALSense’s business model reflects the priorities of hospitals, healthcare systems, and research partners.
Encouraged us to ground our financial plan in the existing TAM–SAM–SOM analysis, ensuring internal consistency between market potential and revenue expectations.

Impact. María’s mentorship has been crucial in reinforcing the financial credibility of ALSense. Her guidance helped us move beyond conceptual planning and build a solid, data-driven foundation for our business strategy. By integrating financial metrics, customer segmentation, and funding allocation, ALSense is now positioned to present itself as a more mature and investable project, with a clear understanding of its costs, revenues, and growth trajectory. Her support bridges the gap between healthcare innovation and financial viability — turning our entrepreneurship plan into a roadmap that investors can trust.

• IP Strategy

Intellectual property is not only about patents—it is about securing the freedom to operate and ensuring that ALSense can grow without risks. Thanks to the guidance of specialized advisors, we have been able to identify which aspects of our biosensor can be protected, and the most suitable strategy to do so. This checkpoint also involves learning how to communicate our project clearly in conferences or wiki, meetings with investors, and public events without disclosing sensitive details that could compromise future protection. By defining an IP roadmap early, we lay the foundation for a solid long-term strategy that safeguards our innovation while enabling collaboration and investment.

ZBM Patents & Trademarks

Description. ZBM Patents & Trademarks is a leading European firm specializing in patents, trademarks and IP strategy. Their multidisciplinary team of scientists and patent attorneys provides expert guidance to protect and enhance technological innovation worldwide.

Key points meeting.

No information or details about an invention can be discussed or disclosed without a formal confidentiality or service agreement in place.
Public disclosure prior to filing a patent application should be strictly avoided.
Multiple patenting routes and strategies are available — it requires an individual assessment to determine the most appropriate protection approach.

Impact. It’s important to have a strategic approach to intellectual property management. We discussed confidentiality as a fundamental step before any disclosure and explored how each innovation requires a patenting strategy to ensure optimal protection.

Marta Arisa Muns – Head of Innovation and Knowledge Transfer (CTC-VR, UIC Barcelona)

Description. Marta Arisa is the Head of Innovation and Knowledge Transfer at the Centre de Transferència de Coneixement i Valorització de la Recerca (CTC-VR) within UIC Barcelona. She oversees innovation management, intellectual property, and the valorization of research results, acting as a crucial link between academia, industry, and funding agencies.

Key points meeting.

Revised our project roadmap and provided feedback on aligning IP and innovation milestones.
Helped us understand the administrative steps for protection under UIC’s framework.
Encouraged us to coordinate with the VRIT office to ensure consistency between funding, IP, and spin-off preparation.

Impact. Her advice reinforced the institutional dimension of ALSense’s innovation path. Thanks to Marta’s support, we built a structured plan linking our technical work to real valorization and IP protection steps within UIC, securing long-term strategic alignment.

Luis Ruiz Ávila – Biotech Entrepreneur & Investor

Description. Luis Ruiz Ávila is a biotech entrepreneur, investor, and mentor with over 25 years of experience transforming biomedical research into market-ready solutions. He is the CEO of Leukos Biotech, President of Aquilón Cyl, and a mentor at EIT Health’s Mentoring & Coaching Network, where he supports emerging healthtech startups across Europe.

Key points meeting.

The meeting focused on understanding how to protect the key elements of ALSense and define what is truly novel within our biosensor.
He explained the importance of freedom to operate (FTO) — ensuring that our solution can be developed and commercialized without infringing existing patents.
Highlighted the need to balance visibility and confidentiality, teaching us how to communicate our innovation effectively in presentations, competitions, and publications without disclosing protectable details.
Helped us identify which components (biomarker panel and aptamer design) could form the basis of a potential patent claim.
Recommended establishing an IP monitoring process to track potential competitors and ensure our differentiation over time.
Encouraged us to align our IP roadmap with future fundraising and spin-off creation, as investors value early clarity in ownership and protection strategy.

Impact. This mentorship session was crucial in defining ALSense’s intellectual property positioning. Thanks to Luis’s guidance, we gained a clear understanding of how to transform our biosensor concept into a protectable and strategically valuable innovation. His advice shaped both our communication strategy—what to reveal and what to keep confidential—and our long-term IP roadmap, ensuring that ALSense evolves with solid legal and strategic foundations for future partnerships, licensing, and investment.

Sara Hernández Ortega, PhD – Innovation Strategist & Associate Professor

Description. Sara Hernández Ortega is an innovation strategist and professor with extensive experience in healthcare innovation, translational research, and strategic project development. She currently works at Hospital Clínic de Barcelona and collaborates with UIC Barcelona, where she supports multidisciplinary initiatives that bridge science, clinical needs, and entrepreneurship. Her expertise lies in helping early-stage health projects structure innovation strategies and communicate them effectively to investors and industry partners.

Key points meeting.

Participated in the joint meeting with ZBM Patents & Trademarks, focusing on aligning ALSense’s communication strategy with proper IP protection.
Helped us refine our entrepreneurship roadmap by balancing scientific storytelling and business relevance.
Reviewed our pitch deck and communication materials, ensuring that our narrative is consistent, investor-oriented, and aligned with protection goals.
Provided strategic feedback on presentation flow, emphasizing how to connect unmet needs, value proposition, and IP strength.
Reinforced the importance of developing a clear and coherent business identity that integrates science, protection, and social purpose.

Impact. Sara’s guidance was instrumental in refining the strategic and communicative pillars of ALSense. Her insights helped us ensure that our message remains scientifically rigorous yet investor-ready, while protecting sensitive elements of our innovation. Thanks to her mentorship, ALSense strengthened the coherence between its entrepreneurial strategy, IP communication, and long-term positioning, ensuring credibility across both scientific and business audiences.

Leonardo Casado – ClarkeModet

Description. IP Consultant.

Key points meeting. He advised us on how to present ALSense in conferences and investor pitches without compromising IP, and highlighted the need for an IP roadmap aligned with the project’s evolution. Leonardo also pointed out the importance of defining when to file the patent (under the spin-off or the startup), since this will require negotiating its transfer. Finally, he stressed the need to clearly identify our tangible assets and their exploitation strategy to strengthen long-term sustainability.

Impact. Finally, he ensures ALSense is protected while maintaining flexibility to collaborate and attract investment. By defining a clear IP pathway, we secured one of the pillars for long-term sustainability and competitiveness.

You can explore our dossier containing all the meeting templates we used throughout the project, already filled with details from each interaction. 📄 Our Stakeholders PDF

ALSense Patient Journey

From the very beginning, we understood that technology alone is not enough. ALSense needed to be shaped by the lived experiences of patients, families, and healthcare professionals. Guided by our Stakeholder Supply Chain, we organized our interactions into key Checkpoints—from the appearance of first symptoms, through diagnosis, and into follow-up care.

At each stage, we focused on collecting practical and actionable insights rather than overwhelming details. This process helped us refine our biosensor and uncover future directions, such as the creation of a “First-Day Pack” that could support families immediately after diagnosis.

In this way, ALSense is not only a technological innovation, but a socially aligned solution that has the potential to transform the ALS diagnostic pathway.

1) ALS Unit

One of our key objectives was to connect with the ALS ecosystem within Spain’s major hospitals, ensuring broad representation and diverse feedback. We are proud to share that we successfully established contact with leading hospitals such as Hospital del Mar (Barcelona), Hospital Bellvitge (Barcelona), Hospital Germans Trias i Pujol (Barcelona), OSI BILBAO BASURTO (Bilbao), Hospital General Universitario Gregorio Marañón (Madrid), Vall d’Hebron (Barcelona), Hospital Universitari i Politècnic La Fe (Valencia) & Hospital Universitari Son Espases (Balearic Islands) who are following our progress with interest.

Below, we present a map of Spain that shows all the ALS Units we have identified across different regions, based on the Mapa de recursos sanitarios de ELA (2023) published by the Spanish government.

Working closely with these units is essential to make ALSense both feasible and accessible. The region where a patient lives strongly influences the speed and accuracy of diagnosis, as not every community has specialized ALS Units. Ensuring our biosensor can be integrated across multiple hospitals is therefore a priority for equitable access.

2) Rehabilitations & psychotherapy

Once an ALS diagnosis is made, patients experience a cascade of changes that affect their physical, psychological, and social lives. With this in mind, we wanted to explore how a rapid, specific, and early diagnostic tool like ALSense could impact patient care—not only clinically, but also in terms of rehabilitation and psychological support.

Although we have already initiated contact with rehabilitation services and mental health professionals, meetings will take place after the wiki freeze due to scheduling challenges. We look forward to presenting these insights at the Jamboree, as they will be critical in understanding the broader impact of ALSense on quality of life.

3) Patient associations & foundations

After diagnosis, patient associations and foundations play a vital role in providing ongoing support, facilitating access to care, and helping families navigate financial and legal assistance. For ALSense, these organizations have been key partners: they opened doors for us to connect with hospitals, patients, and the broader ALS community in Spain.

We are especially grateful to have worked alongside:

Fundación Luzón (Madrid)

Scope: National (Spain)
Focus: Advocacy, research funding, patient support, and awareness campaigns.
Key Role: Acts as a unifying platform in Spain, connecting patients, families, researchers, and policymakers. Provides grants and pushes for legislative changes such as the Ley ELA.
Impact in our project: Included in our national mapping of ALS associations, Fundación Luzón has helped amplify the visibility of our project by sharing our surveys through its communication network. Additionally, it has provided occasional technical guidance for our research and remains a key contact for future outreach and advocacy collaborations.

Fundació Miquel Valls (Barcelona)

Scope: Catalonia
Focus: Direct patient and caregiver support, psychological assistance, home visits, and care coordination.
Key Role: The main reference ALS foundation in Catalonia, closely linked with ALS Units in hospitals such as Bellvitge or Hospital del Mar.
Impact in our project: We have been in contact with several of their professionals. Fundació Miquel Valls is part of our national mapping of ALS associations, supporting the dissemination of our surveys and connecting us with socio-healthcare professionals and hospital networks relevant to our research.

ConELA

Scope: National (Spain)
Focus: Federation of regional ALS associations. Coordinates advocacy at the national level, ensures representation in healthcare and political spheres.
Key Role: Acts as the main advocacy voice for the ALS community in Spain, influencing public policy and promoting legislative initiatives such as the Ley ELA to improve care access and research funding.
Impact on our project: We established direct contact with its president, Fernando Martín, who has been instrumental in advancing the Ley ELA within Spain’s political framework. Through ConELA, we have expanded our national network of contacts and gained support for the political and institutional aspects of our project, strengthening the alignment of ALSense with Spain’s broader ALS advocacy landscape.

ELA Balears

Scope: Balearic Islands
Focus: Local patient and family support, awareness campaigns, fundraising events.
Key Role: Serves as the main reference point for the ALS community in the Balearic region, connecting patients with healthcare providers and aligning with national advocacy efforts through ConELA.
Impact in our project: Through conversations with one of their team members, we gained a clearer understanding of how ALS care is managed within the Balearic Islands. This collaboration allowed us to connect with the physician responsible for most ALS diagnoses in the region and with local social-health professionals. ELA Balears also helped disseminate our stakeholder forms—although, as seen elsewhere, patient participation remains a challenge.

ADELA

Scope: Madrid and central Spain
Focus: Patient support services, occupational therapy, legal and administrative support, and awareness.
Key Role: One of the oldest and most established ALS associations in Spain, ADELA has built a strong reputation for delivering high-quality support services and acting as a reference for other regional associations.
Impact in our project: ADELA is part of our mapping of national ALS associations and has supported the dissemination of our surveys. Their long-standing experience in patient-caregiver programs provides valuable insights into real-world patient needs, helping us better align ALSense with the daily challenges faced by families living with ALS.

DalecandELA

Scope: National impact, founded in Galicia
Focus: Awareness campaigns, fundraising, and solidarity events with a youthful, dynamic approach.
Key Role: Known for creative campaigns (sports, music, cultural events) that bring ALS visibility to broader audiences.
Impact in our project: Has helped us strengthen the visibility and communication side of ALSense. By learning from their creative strategies and involving them in our mapping of ALS associations, we have been able to design outreach actions that go beyond the clinical sphere, making our project more relatable and accessible to society at large.

Swim for ELA

Scope: Origin in Catalonia, national awareness reach
Focus: Sports-based awareness and fundraising (notably open-water swimming challenges).
Key Role: Uses sports events as a platform to raise awareness and funds, engaging younger communities.
Impact in our project: Swim for ELA is included in our mapping of ALS associations and awareness initiatives. Their innovative approach has inspired us to integrate sport-linked visibility actions into our outreach strategy, reinforcing the social impact dimension of ALSense and connecting with communities that extend beyond the traditional healthcare environment.

ANELA

Scope: Navarra
Focus: Local patient and family support, advocacy in the regional healthcare system, awareness events.
Key Role: Ensures ALS visibility and patient support at a regional level, feeding into ConELA’s national framework.
Impact in our project: ANELA officially endorsed ALSense through a letter of recommendation , recognizing its potential to transform ALS diagnosis by enabling earlier detection and improving patient outcomes. Their collaboration helps us validate the medical and social relevance of our technology, and their willingness to promote ALSense within their network reinforces our credibility within both the medical and patient communities.

ELA Andalucía

Scope: Andalusia
Focus: Support for ALS patients and families, collaboration with regional hospitals and rehab centers, awareness campaigns.
Key Role: Acts as a central hub for patient care and advocacy in southern Spain, promoting collaboration between healthcare providers, families, and local institutions.
Impact on our project: Through ELA Andalucía, we have been able to reach and engage the Andalusian ALS community, strengthening our understanding of patient and caregiver realities in this region. Their collaboration opens the door to collecting real testimonials and conducting interviews, enriching the human perspective of our project and reinforcing the social dimension of ALSense’s development.

4) Patient & Familiars

This checkpoint places patients and their families at the center of our value chain. ALSense is designed to reduce diagnostic uncertainty and shorten the long delays they currently face, giving them access to earlier treatments, clinical trials, and social resources. Ultimately, patients are not just end-users, but co-creators of the impact ALSense seeks to achieve.

Through our conversations with patients and their families, we have absorbed the depth of their emotions and witnessed how they confront this diagnosis with courage and resilience. This project has been more than scientific — it has been a true masterclass in life. In total, we had the privilege of speaking with 10 patients and relatives, and below we share some of the stories that have moved and inspired us the most.

Adan Garrido

Adan, diagnosed with ALS in 2020, shared his journey as a young patient facing the uncertainty and emotional toll of the diagnostic process. From the first signs of weakness in his thumb to receiving the final diagnosis, his story gave us a firsthand understanding of the challenges patients endure while waiting for answers. His testimony inspired our commitment to design a test that delivers clarity and dignity from day one. We were also honored to include his voice in our promotion video, giving visibility to the human side of ALS and the urgency of innovation.

He is one of the first participants in the “Olas con ELA” pilot program, and has faced the physical limitations of ALS, particularly in his arms, with extraordinary courage. Since joining the adapted surf sessions, he has experienced a profound transformation — not only in mobility, but in spirit.

More than just an activity, Olas con ELA has given Adán a new perspective on his illness and a new way to teach his children about life: with attitude, sensitivity, and realism. His story reminds us that strength is not about fighting the waves, but learning to ride them.

Juan Carlos Unzué

Diagnosed with ALS in 2020, former professional football player and coach Juan Carlos Unzué has become one of the most inspiring voices in the ALS community. He has shown that strength is not only found on the field, but in the courage to face life’s most demanding challenges with grace and conviction.

“The key is to accept what you cannot control or change.”

Through his openness and public advocacy, Unzué has helped transform how society perceives ALS — turning visibility into action, and vulnerability into strength. He reminds us that awareness is not just about understanding a disease, but about recognizing the humanity and dignity of those who live with it every day.

His resilience, optimism, and unwavering commitment to others continue to inspire ALSense’s mission to turn science into hope — to ensure that one day, diagnosis no longer means despair, but possibility.

Idle Cuento

Diagnosed with ALS in 2020, Idle taught us a philosophy of life that has profoundly touched our team: “Avui és el millor dia” — “Today is the best day.”

The phrase was born in the Ebro Delta, during a family walk just days after receiving his diagnosis. His sons were trying to process the news when one of them said:

“We have to take this day by day, as if today were the best day.”

That sentence became the family’s guiding light — a way to embrace the present with gratitude, realism, and love. What began as a moment of shared courage grew into a movement of hope.

Idle and his family decided to turn those words into something tangible: a solidarity T-shirt, designed by @72kilos, printed with special ink that only appears in sunlight — a beautiful metaphor for living fully, even in the face of darkness. Every time the phrase emerges in the light, it reminds us that life is meant to be lived outside, together, today.

Soon after, the message inspired a new chapter: the song “Avui és el millor dia”, composed and performed by Judit Neddermann, with the support of Nina and the Miquel Valls Foundation. The song’s final verse includes Idle’s own voice from an audio note to his son, describing a moment of beauty while watching a murmuration of starlings over the Delta:

“Not every day you’re lucky enough to see the starlings play… what a wonder life is.”

What began as a phrase born from sadness has turned into a wave of solidarity that keeps growing — through concerts, videos, and hundreds of people wearing the message across Catalonia. Idle reminds us that, even in the hardest moments, there is room for light, gratitude, and meaning.

His story captures what ALSense stands for: the will to transform pain into purpose, and science into hope — so that every patient can wake up believing, today is the best day.

Vanessa Rodriguez

Vanessa was diagnosed with ALS at a young age, yet she speaks with the serenity of someone who has transformed fear into purpose. In her own words:

“Supporting this project is vital, because it brings hope — not for me, but for those who, unfortunately, will come after.”

Her message carries both strength and generosity. Vanessa reminds us that innovation is not only about science, but also about solidarity — about giving meaning to what we live through so that others may face it with more clarity, dignity, and time.

Her testimony has deeply moved our team and reinforced our belief that ALSense is not just a diagnostic tool, but a bridge of hope between today’s patients and tomorrow’s discoveries.

The Political Voice of ALS

ALS, like most diseases, is often viewed solely through a medical lens: an illness to be solved in the laboratory. Yet, the reality is that curing any disease is also a deeply political matter. Research funding, access to early diagnosis, and the development of new treatments all depend on political decisions. Moreover, in the case of ALS, where the costs of therapies and caregiving far exceed what families can bear, this political dimension becomes even more critical.

In 2009, the EU Council issued a recommendation on action in the field of rare diseases, such as ALS. This instrument urged Member States to develop and implement plans and strategies in the field of rare diseases and establish. For this reason, we decided to dedicate part of our human practices work to analyzing the political landscape of ALS and exploring possible solutions.

We began by conducting a detailed review and analysis of the ALS legislation itself. Each section was carefully highlighted and annotated with our observations—identifying provisions we fully understood, areas that required further clarification, elements we found overly broad, and aspects we considered particularly effective. This systematic approach allowed us to establish a strong foundation from which to explore the political context surrounding the law.

Our annotated analysis of the legislation can be found here

At the same time, we examined the broader social and political context of ALS in Spain as the basis for developing our own paper, aimed at disseminating knowledge in this area. Our research combined online sources with direct conversations with patients and, most notably, the president of the association ConELA, Fernando Martín Perez, who had actively participated in drafting the current legislation. His insights proved invaluable in deepening our understanding of the political dimensions of ALS, particularly regarding disparities between autonomous communities, the implications of disability grading, and the essential role of caregivers.

Meeting with Fernando Martín Pérez

Description: Fernando is the president of ConELA, the Spanish confederation of ALS organizations. He is also the founding member and manager of the CanELA Association and was one the crucial parties on the drafting of the first ALS law.

Aim: The goal of this meeting was to better understand the political context of ALS in Spain, gather Fernando’s perspective on the current ELA law and its shortcomings, and receive feedback that could help us refine our legislative proposal. His first-hand experience as president of ConELA and contributor to the first ALS legislation made him an essential voice for guiding our approach.

Contributions: Fernando provided valuable insights into how the law is applied in practice. He clarified that most patients already receive a 65% disability rating, making it unnecessary to include this in the legislation, while emphasizing the urgent need to ensure 24-hour care for some patients. He also informed us about the ongoing epidemiological study led by the Luzón Foundation in collaboration with the government, and pointed out that while guidelines for ALS exist, they are not distributed equally to all patients. On territorial inequalities, he stressed that the issue is much more complex than covering travel costs, and cannot be solved so simply at present.

Conclusion: This meeting reshaped our legislative proposal by helping us focus on the most relevant gaps in patient support. Based on Fernando’s feedback, we decided to remove the article on transport costs and redirect those resources toward increasing support for caregivers. We also agreed to include a clear budget line in our proposal. The meeting highlighted the importance of addressing resource allocation and ensuring effective implementation rather than duplicating measures that are already being applied in practice. Overall, Fernando’s input provided both political and patient-centered insights that will significantly strengthen our proposal.

Our paper, which consolidates this information on the political and social context of ALS, can be accessed here

Following this investigation, we decided to draft our own legislative proposal to address the gaps we identified in the existing law. The current legislation focuses almost exclusively on patient care after diagnosis. However, ALS diagnosis is often a long and complex process, taking an average of 12 to 18 months, during which patients face uncertainty, misdiagnoses, and delays in accessing the support they need. This lack of attention to the diagnostic pathway significantly reduces quality of life and postpones early interventions that could improve patient outcomes.

The ultimate goal of our legislation is to respond to the real needs of patients—something we could only uncover through our human practices work. By conducting surveys with ALS patients, we learned, for instance, that many of them would have greatly benefited from clear guidelines immediately after diagnosis, providing information on what to expect and how to navigate the next steps. Recognizing this, we incorporated such guidelines into one of the articles of our proposed law, alongside other measures designed to make the patient journey less isolating and more supported. Also, we received feedback from different experts, such as the president of ConELA.

Moreover, the current law lacks a dedicated budget line, which we consider essential to guarantee that its measures can be effectively implemented rather than remaining purely symbolic. For this reason, we decided to include one in our proposal.

Our annotated updated law can be found here

Bioethical analysis

When we speak of diagnostic devices for devastating diseases such as ALS, the ethical dimension takes on even greater relevance. A diagnostic tool is not just a technological achievement: it can transform people’s lives, shape the course of their decisions, and alter how they face their future.

From the very beginning, ethics was embedded at the heart of ALSense. We did not limit ourselves to developing a biosensor; instead, we integrated the entire patient diagnostic journey. Their insights helped us refine our design, anticipate risks, and ensure that innovation would be accompanied by responsibility, sensitivity, and respect for autonomy.

In this context, the true validity of an advance cannot be measured solely in scientific precision. An early diagnosis can be an opportunity, but it can also become a burden if not accompanied by proper communication, emotional support, and equitable access. That is why, for us, ethical reflection is not an external layer, but an inseparable part of development. We are convinced that biomedical innovation only makes sense when it serves the dignity, freedom, and well-being of people, while also being socially responsible and aligned with the real needs of the ALS community.

Question to think about
Is an early diagnosis without an immediate cure truly an advance, or can it become a burden?

Our answer
The legitimacy of early diagnosis in a disease like ALS cannot be reduced to a simple “yes or no.” The answer depends on the balance between benefit and harm, proportionality, and context of application.

On one hand, early diagnosis can undeniably be an advance. It reduces the uncertainty of long and exhausting diagnostic processes, allows earlier access to multidisciplinary care and palliative support, and opens the door to clinical trials and research initiatives that require confirmed diagnoses. It also enables patients and families to anticipate decisions about personal, legal, and social planning, reinforcing autonomy and a sense of control over the future.

On the other hand, diagnosing without an immediate cure carries risks that cannot be ignored. It may generate anxiety, depression, or feelings of hopelessness when no therapeutic strategy is available to alter the course of the disease. It also raises issues of proportionality: information has value only if it translates into concrete opportunities for care, support, or research that compensate for its emotional burden. Furthermore, false positives or premature implementation without sufficient validation could have devastating consequences, undermining trust in healthcare systems.

The ethical answer is therefore conditional: early diagnosis is only legitimate if it is implemented with strict scientific reliability, supported by clear communication protocols, psychological accompaniment, and respect for patient autonomy. It loses its legitimacy when reduced to a purely technical act, detached from care, or applied in inappropriate contexts (e.g., asymptomatic populations without sufficient prognostic evidence).

In short, early diagnosis can be both an advance and a burden — but it is the ethical framework surrounding it that decides which path it takes. When supported by beneficence, proportionality, justice, and responsible autonomy, it becomes a tool of empowerment and care. When applied without these safeguards, it risks becoming an additional source of suffering rather than relief.

Guiding Principles

To ground our ethical approach in something solid and universally recognized, we relied on the fundamental principles of bioethics. These principles offer a clear framework that guides decision-making and provides the foundation for our reflections.

Autonomy: recognizes the intrinsic dignity of every human being and their capacity to make decisions about their own life and health. It implies that such decisions must be free, conscious, and informed, respecting both the right to know and the right not to know.
Beneficence and non-maleficence: every medical or technological intervention must aim to contribute to the well-being of the person, providing real and proportional benefits relative to the risks and burdens involved. At the same time, it requires avoiding harm, carefully evaluating potential adverse effects of the intervention.
Justice: refers to the fair distribution of the benefits of scientific and medical advances. It requires ensuring that all individuals, regardless of origin or resources, have equal access to diagnostic and care opportunities.
Sociability and subsidiarity: based on the idea that people are not isolated individuals but members of a community. It recognizes that disease also affects families and caregivers, and that society must provide support without replacing the patient’s autonomy, complementing and sustaining their decisions and needs.

Beyond their definitions, these principles raise complex challenges when applied to ALS and early diagnosis. One of the most sensitive questions we faced is the following — and we invite the reader to reflect on it with us:

Question to think about
How can we protect the autonomy of someone who chooses not to know a devastating diagnosis?

Our answer
Protecting autonomy in this context requires more than simply offering or withholding information. Autonomy must be understood as a responsible and supported freedom: the ability to make conscious, informed, and deliberate decisions about one’s health and future.

For some patients, the right to know is central: accessing their clinical truth allows them to make timely decisions about care, participate in research, and plan their personal and family life. However, others may legitimately choose the right not to know, in order to protect their emotional stability, avoid unnecessary distress, or preserve their ability to live in the present without the weight of a devastating prognosis.

Safeguarding this choice demands clear and structured protocols:

Explicit informed consent: that includes the option not to know, with equal validity as the choice to be informed.
Flexible communication processes: where patients can defer, limit, or gradually receive information, rather than facing an all-or-nothing disclosure.
Time and space for reflection: ensuring decisions are free from pressure and adapted to the emotional pace of each patient.
Psychological and social support: so that choosing not to know is not a lonely or fragile stance, but one sustained by professional care and respect.
Respect for reversibility: recognizing that a decision not to know today may evolve, and patients should always retain the option to revisit it in the future.

Ultimately, autonomy in ALS diagnosis cannot be reduced to an abstract principle. It is a practical and lived process of respect, listening, and accompaniment, one that ensures both the right to know and the right not to know are equally protected. Only by embedding this dual respect into diagnostic protocols can innovation remain ethically legitimate, transforming early detection into an act of care rather than an imposition.

If you want to know more

We have prepared a comprehensive ETHICAL IMPACT ASSESSMENT that expands on the principles, dilemmas, and reflections outlined here. This document offers a deeper bioethical analysis of the project, addressing issues such as the legitimacy of early diagnosis, the balance between the right to know and the right not to know, the sensitive communication of results, and mechanisms for continuous ethical review.

The Challenge of Communication

Communicating a diagnosis is never a neutral act: it is a decisive clinical and human moment that deeply shapes how patients and families experience illness. In ALS, where no curative treatment exists, this moment becomes even more delicate. A poorly handled disclosure can cause unnecessary suffering, while a carefully guided conversation can help patients preserve dignity, autonomy, and hope.

To address this challenge, we have drawn on the SPIKES model, an internationally recognized framework originally designed for oncology to guide clinicians in delivering serious or life-changing news. SPIKES provides a structured approach through six stages:

S – Setting: preparing the physical and emotional environment. This includes privacy, adequate time, and the possibility of being accompanied by a loved one.
P – Perception: assessing what the patient already knows, believes, or fears about their condition. This helps avoid assumptions and tailor the communication.
I – Invitation: clarifying how much information the patient wishes to receive. Some may want full disclosure, while others may prefer partial or delayed information — especially crucial in ALS.
K – Knowledge: delivering the information clearly, gradually, and honestly, avoiding technical jargon while remaining transparent about uncertainties and limitations.
E – Emotions: recognizing and responding to emotional reactions, offering empathy, psychological support, and validation of feelings.
S – Strategy & Summary: outlining next steps, summarizing key points, and ensuring the patient leaves with a clear plan and support network, not just a devastating piece of news.

In adapting SPIKES to ALS, our focus shifts from “treatment options” —as often emphasized in oncology— to care pathways, clinical trials, psychological support, and family planning. The model becomes not only a method for disclosure but a way to transform diagnosis into an act of care, ensuring that even devastating news is accompanied by compassion, clarity, and responsibility.

These considerations lead us to one of the most sensitive issues we faced: the true meaning of a diagnostic breakthrough when it is not accompanied by humanity. We invite the reader to reflect on this with us.

Question to think about

What is the value of a diagnostic breakthrough if it is not communicated with sensitivity and humanity?

Our answer

Very little. Scientific innovation loses its meaning if the way results are delivered causes harm instead of providing support. Communicating the outcome of an ALS test is not simply giving biomedical data: it is a clinical act that can either help patients and families to regain a sense of clarity or push them into despair.

That is why our approach goes beyond delivering results. It requires:

Preparing the environment: with time, privacy, and the presence of a trusted companion.
Exploring prior perceptions: to adapt the message to what the patient already knows, fears, or expects.
Confirming informational preferences: explicitly respecting the right to know or not to know.
Communicating knowledge: gradually and precisely, using layered explanations and avoiding misleading terms like “positive/negative,” replacing them with compatible, not compatible, or indeterminate.
Providing emotional support: validating feelings and activating resources when distress arises.
Closing with a clear plan: including follow-up appointments, written summaries, and access to support services.

In ALS, where no curative treatment exists and uncertainty is high, sensitivity and humanity are not optional. They are the very conditions that turn a diagnostic innovation into a tool of care rather than a burden.

If you want to know more

We have developed an ETHICAL operational framework that translates these principles into practice. This document outlines how the ALSense biosensor should be applied in a clinical setting, from preparation and communication of results to follow-up and continuous evaluation. It provides concrete guidance for healthcare professionals on consent procedures, the adaptation of the SPIKES model, emotional support strategies, and mechanisms for ethical review. Far from being a closed manual, it is conceived as a dynamic roadmap that will evolve with scientific validation, clinical collaboration, and the voices of patients and associations.

A Living and Revisable Process

Ethics cannot be captured once and for all in a single document, because reality itself is never static. In a project like ALSense, where science advances rapidly, technologies evolve, and patients’ needs change over time, an ethical framework must be understood as a living process rather than a fixed rulebook.

This means that what we commit to today may need to be revised tomorrow in light of new evidence, patient experiences, or clinical realities. Continuous reflection, dialogue, and adaptation are essential to ensure that innovation remains both responsible and relevant. For us, ethics is not an appendix to the project, but a path that must be walked and revisited—a safeguard against rigidity, blind spots, and the risk of overlooking the human dimension in the pursuit of technological progress.

Recognizing ethics as a living process also forces us to confront a practical challenge: how can we make sure that our protocol does not remain a static declaration, but evolves alongside science, clinical practice, and the lived experience of patients?

Our answer

We approach this challenge through a multi-layered system of review and adaptation:

Internal mechanisms:

Regular team reflection sessions where scientists, clinicians, and ethicists jointly analyze recent experiences and dilemmas.
Clinical simulations with standardized patients to rehearse the disclosure of results, identify gaps in communication, and improve the sensitivity of interactions.
Ethical audits embedded into project milestones, where every new technical advance is accompanied by an evaluation of its human and social impact.

External mechanisms:

Ongoing evaluation by a multidisciplinary committee including bioethicists, neurologists, psychologists, patient associations, and caregivers. Their role is to challenge our assumptions, point out overlooked risks, and ensure that patient autonomy and dignity remain central.
Structured feedback loops with patients and families who volunteer to test communication tools, providing first-hand insights into clarity, emotional resonance, and potential improvements.

Future scenarios:

Collaborating with ALS units in reference hospitals, allowing us to test the protocol in real-world diagnostic contexts. For example, piloting the communication pathway in a specialized clinic to see how patients and families respond under actual clinical conditions.
Creating a training module for healthcare professionals (neurologists, nurses, psychologists) based on our protocol, and assessing its impact on communication quality and patient satisfaction.
Integrating longitudinal follow-up: not only assessing the first disclosure of results, but also how patients and families experience the information weeks or months later, adapting the protocol to provide extended support.

In this way, the protocol is not a static guideline but a living framework: tested, challenged, and improved through practice. By combining simulations, expert review, real-world collaboration, and patient feedback, we ensure that ethics remains not a one-time declaration, but a continuous commitment to dignity, responsibility, and relevance.

Our Contribution to the iGEM Community

One of the central goals of Human Practices within iGEM is to generate knowledge, tools, and frameworks that are not only useful for our own project, but that can also support the work of future teams. With this in mind, we have designed an Ethics Protocol Template for the Communication of Clinical Results , a flexible template that can be adapted to different diseases, technologies, and contexts.

Rather than imposing a rigid model, this template provides a structured yet adaptable guide for implementing ethical communication processes. It ensures respect for autonomy, promotes transparency, and guarantees comprehensive support for patients and families.

This contribution is meant to serve not only as a roadmap for ALSense, but also as a transferable framework that other iGEM teams can adopt, adapt, and expand—helping foster a broader culture of ethical responsibility in healthcare innovation.

With this approach, ALSense shows that synthetic biology can go beyond technical solutions, offering tools that integrate care, respect, and dignity at the very heart of innovation.

Meeting with Núria Terribas and Dr. Bernabé Robles

Description: Nuria Terribas, a jurist with more than three decades of experience, is the Director of the Víctor Grífols i Lucas Foundation and the Chair of Bioethics at UVic-UCC. She is widely recognized for her work on ethics committees and her reflections on issues such as responsibility, autonomy, and the ethical challenges of contemporary biomedicine.

Dr. Robles del Olmo, in turn, is a neurologist and Associate Professor of Bioethics and Neurology at UVic-UCC. With extensive clinical and research experience, he has worked in the field of neurodegenerative diseases and care ethics, addressing key topics such as end-of-life decision-making, consciousness, and patient dignity.

Aim: The goal of this meeting was to reflect on the ethical dimensions of developing and applying the ALSense biosensor for ALS detection. We sought Núria’s and Bernabé’s perspectives on its legitimacy in research, its clinical value, and the ethical implications of early diagnosis. Both experts brought complementary expertise: Núria from the field of bioethics and law, and Dr. Robles from clinical neurology and hospital practice.

Contributions: Núria and Bernabé highlighted three main domains to consider: research, clinical practice, and early diagnosis. From a research perspective, they confirmed that ALSense represents a legitimate and ethically sound contribution to biomedical innovation, especially if it evolves toward prognostic biomarkers rather than limited to diagnostic use. In the clinical domain, they emphasized the need for high predictive values, prioritizing specificity over sensitivity to avoid harm caused by false diagnoses. Dr. Robles noted that while ALS is not a medical emergency requiring immediate testing, a rapid and specific tool could accelerate today’s slow diagnostic processes. Both underlined that the true value will emerge if the biosensor also supports patient monitoring and disease progression.

Regarding early diagnosis, they agreed it is not ethically defensible to conduct population-wide screenings in asymptomatic individuals until the test proves reliable in those stages. However, applying the biosensor in symptomatic patients was seen as ethically acceptable, provided that transparency and honesty about limitations are guaranteed.

Another central point was patient communication and autonomy. They stressed the importance of informing patients clearly from the start and allowing them to decide freely whether they want to know the results. Given current gaps in training for complex diagnoses, they welcomed our idea of developing an ethical and communicative roadmap for professionals.

Finally, they explored the role of artificial intelligence, viewing it positively as a way to humanize medicine: by automating analyses, AI could free clinicians’ time for personal interaction with patients. On treatments, they warned against raising unrealistic expectations, as existing options remain limited and modest in effect.

Conclusion: This meeting helped us frame ALSense not just as a technical innovation but as a project requiring strong ethical grounding. ALSense was recognized as ethically legitimate in research, with major future potential if it moves toward prognostic capacity. Clinically, its development must prioritize safety, specificity, and transparency, ensuring patient autonomy and clear communication. The reflections of Núria and Bernabé will guide us in building an ethically robust roadmap for implementing the biosensor, strengthening both the scientific and human dimensions of the project.

Meeting with Salvador Macip

Description: Salvador Macip is a physician, researcher, and science communicator. He holds a PhD in Medicine and Surgery, specializing in oncology and cellular ageing. He is a professor at the University of Leicester (UK) and Director of Health Sciences Studies at the Open University of Catalonia (UOC). He also conducts research at the Pasqual Maragall Foundation (Barcelonaβeta Brain Research Center). His work focuses on biomedicine, scientific ethics, and science communication.

Aim: The purpose of this interview was to reflect on the ethical principles surrounding early ALS diagnosis and the potential role of the ALSense biosensor. We aimed to gather Salvador Macip’s perspective on the legitimacy of early diagnosis without a cure, the added value of such a test, the communication strategies required, and the broader social implications of its implementation. His dual expertise in biomedical research and science communication provided a valuable framework for balancing ethical, clinical, and social dimensions.

Contributions: Salvador highlighted the importance of a patient-centered model in communicating an ALS diagnosis, combining the Anglo-Saxon emphasis on autonomy with the European tradition of involving the family. For a disease without cure, the key is honest and empathetic dialogue: helping patients understand their situation, access symptomatic treatments, and plan their lives with dignity and freedom.

On the legitimacy of early diagnosis, he underlined that even in the absence of curative therapies, patients have the right to know their health status. Early testing offers more time to prepare, access symptomatic interventions, and make informed decisions about personal and family life. He emphasized that reducing uncertainty and providing clarity are, in themselves, strong benefits.

Regarding communication, Salvador insisted on transparency about test limitations, including false positives and negatives. He recommended training professionals with structured communication tools—such as ethical roadmaps—and ensuring immediate psychological support for patients. He stressed that messages should balance realism with hope, reminding patients of ongoing research efforts and potential future therapies. Respecting autonomy also means safeguarding both the “right to know” and the “right not to know,” with the patient free to decide.

On the social dimension, Salvador acknowledged that inequalities in access are inevitable at first, since resources differ across regions and hospitals. However, he proposed that policy changes—such as revising ALS legislation—could help achieve fairer, more homogeneous access. He also highlighted the importance of responsible science communication: informing society clearly, avoiding false expectations, and fostering public trust through accessible, transparent language.

Conclusion: This interview reinforced the ethical legitimacy of early ALS diagnosis, even in the absence of curative treatments, by emphasizing autonomy, dignity, and informed decision-making. Salvador’s insights placed strong weight on transparent communication, psychosocial support, and patient choice, while also stressing the social responsibility of ensuring equitable access and responsible public dissemination. His contribution provides a roadmap for positioning ALSense not only as a diagnostic tool but as an ethically grounded innovation with significant human and social value.

Meeting with Ignacio Macpherson

Description: Ignacio Macpherson Mayol is a Professor of Bioethics at the International University of Catalonia (UIC) and a member of the Bioethics Unit within the Department of Health Sciences. His work focuses on clinical ethics, moral philosophy applied to biomedicine, and ethical reflection on emerging healthcare technologies. He has participated in research and teaching projects related to informed consent, end-of-life decision-making, and health justice.

Aim: The purpose of this meeting was to address the ethical foundations and practical implications of implementing the ALSense biosensor, with a particular focus on informed consent, patient autonomy, and social justice. Ignacio’s expertise in bioethics and law brought a structured framework to evaluate the legitimacy of early diagnosis in incurable diseases, the design of ethical communication tools, and the mitigation of social risks linked to new technologies.

Contributions: Ignacio emphasized that early diagnosis of ALS, even without curative treatments, can be ethically legitimate if grounded in the principles of beneficence, autonomy, non-maleficence, and justice. He argued that offering the option respects the dignity of the patient and their right to decide whether or not they want to know. However, he also stressed that withholding such information paternalistically would undermine patient autonomy.

On informed consent, Ignacio highlighted the importance of using clear, accessible, and narrative-based materials, avoiding technical jargon and integrating explanations of limitations, possible consequences, and the right not to know. Transparency about false positives and negatives is essential, but should be framed in simple, reassuring terms. He also underlined that communication of results should be carried out primarily by physicians trained in ethical communication, with psychological support available if necessary.

From a structural perspective, Ignacio warned of the risks of implementing the test prematurely, before full validation, which could lead to false hope, social inequalities, or even loss of trust. He advocated for justice in access, ensuring that the biosensor does not become an elitist tool. This requires integration into public health systems, progressive distribution through primary care, and collaboration with NGOs when public services cannot fully reach vulnerable populations.

He also proposed concrete tools to guide responsible use: an Ethical Impact Assessment tailored to iGEM projects (a checklist of risks, mitigation, and follow-up), and the creation of a mini internal ethics committee to review ongoing dilemmas. Furthermore, he outlined key elements for a future ethical guide: patient autonomy, mental preparedness, clear indications and contraindications, protocols for communication and follow-up, and explicit exclusion of contexts such as commercial or discriminatory uses.

Conclusion: Ignacio’s contribution provided a comprehensive ethical framework for ALSense, bridging patient-centered principles with social justice concerns. He confirmed that early ALS diagnosis is ethically valid if offered with freedom of choice, transparency, and support. His proposals on informed consent, progressive implementation, and ethical assessment tools equip the project with practical instruments to ensure legitimacy, trust, and fairness. Ultimately, his insights highlighted that ALSense must be developed not only as a biomedical innovation but also as a socially responsible and ethically guided technology.