Dr. Marco Straccia

Pro Anima scientific Committee: As a co-founder of the consulting agency FRESCI that foster the power of scientific research and innovation, and accelerate the change towards the adoption of more human-relevant methods in biomedical research and to better assess chemical risk, can you introduce your background to our readers and explain what brought you to create FRESCI?

Dr Marco Straccia: Everyone has a sick friend or family member and most of us will get sick sooner or later. Healthy aging is still a privilege for few. That has been the reality around me since a young age. Already at high-school, I decided to focus on biomedical research with the clear focus of accelerating the process of generating therapeutic solutions to help patients with no treatment options hope and poor quality of life. As soon as I started working in a lab, I’ve been trained as a neuroscientist and I’ve been working on several neurodegenerative diseases from the Spinal Muscular Atrophy, Glioblastoma, Alzheimer’s and Huntington’s Disease, and neuroinflammation in general. To study pathophysiological features of these diseases and test therapeutic strategies from small molecules to cell therapy. I’ve been using several models like cell-free assays, rodent models, primary cultures, cell lines and diverse human stem cells, and human tissues in several experimental paradigms and different research groups in the EU.

During my last post-doc contract, I’ve seen how the bench science, when done correctly, can really generate new solutions and therapeutic hopes for people. However I was frustrated about the inefficiency of the system in many steps of the value chain. The academia has a lot of high state of the art knowledge, but it mostly lacks the two main skills: 1) there’s a lack understanding what is really needed outside the academia (we see know more patient associations and pharmas interaction with academic researchers, but it’s still not sufficient); 2) there’s a general lack of skills of transferring highly valuable scientific knowledge in a well-characterised proof-of-concept that can easily been uptaken by the actors outside the academia (industries, policy makers, regulators, etc.)

So I decided to help in this bridging activity. I soon realise that as scientist it was not sufficient my background as scientist to face such challenge, and this is why I went through a MBA to acquire the knowledge of how the world outside the academia is working, and I deliberately chosen a general MBA not focused in science to clearly understand how other industries have solved similar challenges, from automotion to construction and many others. I strongly believe in cross-contamination and in being out of our comfort zone.

This experience made me understand that taking a solution from a lab bench to the patients requires many more skills than just robust science (which is a must) and also it requires many more people than scientists to make things happen. This is when FRESCI started flourishing by adding people with a diverse set of skills to tackle as many variables are present, but with a common mission.

Pro Anima scientific Committee: What links does FRESCI specifically forge with the European Commission, especially the institutions involved in the transition towards more relevant, animal-free innovations and science, such as the Joint Research Center, the ECVAM, as well as the regulatory agencies (ECHA, EMA, EFSA)? What came or will come out of it?

Dr Marco Straccia: At FRESCI, we really work at the interface between science and policy across the European ecosystem. Our collaboration with the Commission and the different EU agencies isn’t about lobbying or informal advocacy, it’s about participating in clear, transparent processes that help make innovation more human-relevant and effective.

We try to connect what’s happening on the ground, in laboratories, startups, and research projects, with what’s being discussed at the policy and regulatory levels. In other words, we bridge the different layers of the system, from the very technical to the strategic, to help decision-makers see the full picture of what’s actually moving in the field and provide practical tools to enable a faster use of human biology based models for human health, from safety assessment applications to their use for boosting the translational power of therapies under development.

In practical terms, we work through tenders and we support and assist the EC work in the field of 3R and initiatives that map and operationalise human biology – based models. Most of the work we carry out for the European Commission is publicly available, like the biomedical reviews on four disease areas, policy reports, and the very soon available BimmoH.

So in essence, our role is to connect the dots, helping the transition toward more relevant, human-based science become something concrete, coordinated, and actionable.

We really like to help to get things done.

We bridge the different layers of the system, from the very technical to the strategic, to help decision-makers see the full picture of what’s actually moving in the field and provide practical tools to enable a faster use of human biology based models for human health, from safety assessment applications to their use for boosting the translational power of therapies under development.

Pro Anima scientific Committee: A couple of weeks ago, FRESCI delivered BimmoH, the largest, highly curated, AI-powered database of human biology-based models to the EC-JRC. This is the first-of-its-kind worldwide. Can you tell us more about this platform, why and how it came to life?

Dr Marco Straccia: BimmoH is the first public, largest, continuously updated, and highly curated knowledge database of human biology – based experimental models. Powered by interpretable AI and machine learning, it is designed to structure and consolidate information about models that support biomedical research.

It was born out of a very practical need, to address three pain points our ecosystem kept encountering again and again.

• First, fragmentation: knowledge on organoids, organs-on-chip, and other advanced in vitro and in silico models is scattered across papers, repositories, protocols, and grey literature, making it incredibly hard to get a complete picture.
• Second, fitness-for-purpose: users, whether researchers, regulators, or funders, need to know which model is appropriate for which decision context, and what evidence supports its use.
• And third, usability: policymakers, assessors, and developers need a fast and explainable way to navigate this constantly expanding massive body of evidence in the scientific literature.

BimmoH is designed to accelerate model selection, study design, and acceptance dialogues in human health research. It makes scientific information on human-relevant models accessible, structured, and easy to explore. Different stakeholders can use it in different ways: scientists and researchers can find the right model for a given disease or organ system; pharma companies can identify which models are ready for uptake; and funders can pinpoint where the real gaps are, where human-relevant models still need to be developed or validated.

As for how it came to life, this idea actually goes back several years. Around 2018 – 2019, the Joint Research Centre launched the first tenders on mapping human biology – based models, and FRESCI was involved in four of them. Even back then, we could already see that by the time a report was finished, the field had already moved on with new models, new data, new papers. So we started thinking: we need a living system, not just static reports.

After consulting many stakeholders, we decided to create something public, a tool that the entire ecosystem could access. Not a commercial product, but an enabling platform. Together with my friend François Busquet (Altertox), back in 2021, we successfully pitched the idea to a Member of the European Parliament, who strongly believed in the vision. The proposal was rated with the highest score by the European Commission, and was subsequently approved and funded. That pilot eventually led, in 2023, to the public tender managed by the European Commission, which our consortium won and that’s how BimmoH was conceived.

So it’s really the result of a long, collaborative effort, starting from a shared vision: to make human-relevant science more visible, more connected, and ultimately more impactful.

BimmoH is designed to accelerate model selection, study design, and acceptance dialogues in human health research. It makes scientific information on human-relevant models accessible, structured, and easy to explore. 

Pro Anima scientific Committee: The roadmap of the European Commission to phase out animal testing is expected for the first quarter of 2026. As our Committee, you have been following the process since the beginning, and participated in the discussions. What are your expectations with this roadmap and its implementation? According to you, what would be the main challenges pending to the roadmap so as to make it and its implementation successful? Do you think the EU could learn from other initiatives such as the US modernization Act?

Dr Marco Straccia: First of all, on whether Europe can learn from other initiatives like the US Modernization Act, I’d actually say the US learned a lot from Europe. The EU has been leading for decades in developing non-animal approaches, building strong science, and setting guidance through bodies like EURL-ECVAM. What the US did very effectively was to take those ideas, build on top of them and move faster: they streamlined decision-making, aligned agencies, and backed it with targeted funding. So yes, there are lessons to exchange, but mostly about speed, coordination, and implementation.

Now, regarding the European Commission’s roadmap expected in early 2026, my main expectation is that it should finally bring coherence. We don’t need another high-level statement of intent; we need a pragmatic, actionable framework that eliminates fragmentation.

A credible roadmap, in my view, should do three things:

1. Define clear end-states for each use case.
2. Set concrete “who does what, and by when”.
3. Align funding, standards, and skills so that adoption can truly scale beyond pilot projects.

There are also some key challenges that will determine whether the roadmap succeeds:

• Validation and acceptance: shifting from rigid, method-level validation to context-of-use-based qualification, supported by robust comparative performance datasets.
• Standards and interoperability: we need common data models, ontologies, and reporting checklists so evidence can be compared and reused.
• Incentives and procurement: well built funding calls and public procurement must all clearly reward the use of human-relevant approaches.
• Skills and capacity: we need to upskill regulators, decision-makers, funders and sponsors across EU Member States and fund reference hubs for training and inter-laboratory studies.
• Digital infrastructure: sustained support for shared data spaces and AI tools like BimmoH is essential to keep evidence current and accessible. Here we need centralised solutions, not yet another example of fragmentation.
• SME pathway clarity: startups developing new models need predictable, simplified routes to regulatory acceptance.

From the US experience, we can also take inspiration from their regulatory sandboxes, context-of-use guidance, and funding models linked to demonstrable uptake. These elements create an environment where innovation can be tested and adopted quickly, without waiting for years of formal validation cycles.

I really hope the roadmap will turn Europe’s excellent science into coordinated action, consolidating what we already have, making it usable, and giving this transition the speed and clarity it deserves.

Pro Anima scientific Committee: Speaking about the path led by the US, referring to the significant decisions and funding announcements made by the FDA and the NIH, but also regarding other areas in the world, how do you analyse and consider the competitiveness and sovereignty of/in the EU? Do the current / recent and/or upcoming Acts (i.e Biotech Act, AI Act, Strategy for European Life Sciences…), pull the right levers to support European competitiveness in this global race?

Dr Marco Straccia: Europe has world-class science and world-class regulators, but we now need to convert that strength into speed, scale, and investability.

All these ongoing strategic documents and roadmaps and initiatives are all positive and timely steps. They show ambition and leadership. But like many EU strategies, the risk is that they remain too high-level. What matters now is a pragmatic, coordinated, and measurable implementation.

We need to measure success by time-to-decision and uptake rates, not just by documents produced. If this happens, I believe the EU can lead globally.

We spend too long discussing and too little doing. If we want to compete at the global level, we have to bring these top-level frameworks down to the ground.

I actually have some ideas of what to do in our ecosystem, but as I always say, having ideas does not solve problems, execution does. Even if we fail, at least we have tried.

Let me finalise this answer by citing Mr. Mario Draghi, “I don’t know what to do, but do something”.

Pro Anima scientific Committee: How do you see the future (short and long-term) of innovation and FRESCI, and what is your greatest hope?

Dr Marco Straccia: I think we should start by defining what innovation really means, because there’s no innovation if things aren’t adopted and used. In the short term, I see a lot of excitement around new technologies entering the biomedical field and the area of human-relevant models, and some of them have already been around for a while in academic biomedical research. There will be plenty of hype about new tools and breakthroughs, but after this first wave, what will really matter is what lasts: what gets adopted, what genuinely helps researchers and regulators make better decisions, and ultimately what benefits the patients who are waiting for solutions.

In the long term, I believe the real transformation will come from hybrid evidence, combining human biology-based models with AI-enabled data synthesis. As AI-powered tools are integrated at all levels, they will accelerate and standardise the development of new therapies, from preclinical research through late-stage clinical trials and into industrial production. We already see this happening in the private sector, and regulators are beginning to respond, for example, with new guidelines such as the draft Annex 22 on GMPs.

AI isn’t just a trend; it’s already reshaping how we organise and interpret knowledge. Used wisely, it can help us integrate massive amounts of data, understand complex biological systems more deeply, and make science more predictive, reliable, and reproducible.

At FRESCI, we’re contributing to this shift on three fronts.

• First, through data intelligence, expanding platforms like BimmoH and developing explainable AI pipelines for research, policy, and regulatory applications.
• Second, through regulatory strategy, helping sponsors and innovators navigate advanced therapies and the acceptance of non-animal methods with clear, milestone-based roadmaps.
• And third, through what we call science-to-impact orchestration, where we align public, private, and philanthropic actors so that good science consistently translates into good outcomes.

We’re also working on projects that use AI to preserve and transfer expert knowledge, especially in areas where skills are scarce and at risk of being lost. That’s essential, because innovation depends as much on people as it does on technology.

And if I think about my hope for the future, it’s quite simple: that within this decade, Europe normalises human-relevant, data-rich decision-making across research, regulation, and industry, and that we move from pilots to practice, from potential to impact.

I believe my motto for the European innovation ecosystem should be the one from Leonardo da Vinci: “non chi comincia, ma chi persevera” — not who begins, but who perseveres. That’s how real innovation happens.

It’s fitting, I think, to close by citing another Italian, one who, like so many innovators, crossed borders and spent the last part of his life in France.

Dr. Marco Straccia is a neuroscientist, entrepreneur, and expert in human-relevant biomedical innovation. He is the Founder and CEO of FRESCI by Science & Strategy SL, a Spain-based consultancy that bridges science, business, and policy through data intelligence and regulatory strategy. With over 23 years of experience across academia, public research, and industry, Dr. Straccia leads FRESCI in helping EU and national institutions, universities, corporations and startups to making scientific innovation more predictive, sustainable, and socially impactful.

 

FRESCI is a life-science consultancy that bridges science, business, and policy through data intelligence. We help researchers, companies, and institutions turn discoveries into real-world impact — from AI-powered research analysis to regulatory strategy for advanced therapies and human-relevant, non-animal methods. Our mission is simple: to make innovation more predictive, ethical, and effective for patients, industry, and society.