Q&A: From Lab to Clinic—Leveraging Organ-on-Chip and AI to Improve Therapeutic Development

In an interview with the Pharmaceutical Technology® Group, Silvia Scaglione, PhD, director of research at the National Research Council in Italy and founder of React4Life, an Italy-based biotech company specializing in organ-on-chip technology, discusses how organ-on-chip platforms are pushing drug development forward, from the preclinical stage onward. She emphasizes that the bio/pharmaceutical industry is undergoing a transformational period in translational R&D on the back of organ-on-chip systems. Further, there is significant potential to reshape preclinical testing approaches and personalized medicines globally.

How are organ-on-chip technologies transforming preclinical drug development?

PharmTech Group: What impact is seen from dynamic human tissue systems in preclinical testing compared to traditional in-vivo methods?

Dr. Scaglione: The impact is really huge and amazing, because the use of dynamic human organ-on-chip platforms are really changing the use of and the adoption of alternative experimental models during [the] preclinical stage. Indeed, for the first time, it's possible to reduce the time and cost typically spent during the preclinical stage, and, moreover, we can also reduce the failure in [the] clinical stage due to the wrong experimental setup. [We] have also introduced something related to the personalized approach, because we can really host and grow—personalized—the patient-derived tissue samples and test different therapies for selecting the best therapy for that patient, for that disease. So, it's really a revolutionary impact.

How crucial are advanced models in enabling precise control and increasing the reliability and predictability of drug permeation data?

It's really important to have the possibility to control and quantify the readout [of data] during the use and adoption of organ-on-chip platform[s] because, just [as] an example, when you use a gut-on-a-chip platform, you have the possibility to measure the barrier function of the gut, and, at the end, you can discriminate if you are working with a healthy tissue model versus an IBD [inflammatory bowel disease] or Crohn’s disease intestinal models. So, the possibility to properly control, measure, and quantify the readout enables [us] to control the experiment, to decouple different behaviors, and to discriminate healthy versus pathological diseases. And, of course, related to these there is a possibility to properly quantify the efficacy of new treatments by analyzing the effect of this therapy on the tissue.

Can AI and multi-organ platforms redefine the future of personalized therapeutics?

From an industry perspective, how does the integration of tissue models into multi-organ systems reshape testing approaches for oral drug efficacy?

It is really important to have the possibility to work with multi organ connections. That is what is possible using our MVO proprietary organ-on-chip platform because we can fluidically connect multiple organs like gut versus skin, gut versus brain, or gut cancer. This is amazing because, for the first time, you can control and observe the effect of the therapy not only on the local organ, but using a holistic perspective. So, analyzing, for instance, a therapy orally administered but also evaluating its effect on a target tissue, which might be far from the gut. In this case, we can introduce a systemic approach, which is revolutionary for increasing the reliability of the readout.

What are the primary ways that validated tissue platforms are currently supporting innovation of microbiome-based therapies?

Well, the microbiome modulates a lot of biological and pathological things in our body, so the possibility to introduce microbiome within the organ-on-chip [system] enables [us] to unlock new testing and new complex disease modeling. Just an example, we have co-cultured gut microbiota into the gut-on-chip platform, which was critically connected to the cancer model, and we have successfully demonstrated what is observed in clinics—that is the fact that the dysbiosis in the gut might drastically reduce the efficacy of the anti-cancer drug treatment, and this is due to the crosstalk between microbiota [and] local and systemic organs.

How are AI and localized supply strategies strengthening biopharma resilience?

How is the biologics sector reimagining supply chains to protect against rising tariffs, geopolitical shocks, and global disruptions?

This is really a critical point because we have [the] understanding that the geopolitical situation might also drastically affect industrial decision[s]. What we have done in React4Life is to internalize completely the supply chain. So, at the moment, the product of React4Life is fully made in Italy. We have decided to select our supplier among the suppliers of the Italy ecosystem in order to facilitate a more robust and stable relationship. I don't know if it's the same choice of pharma compan[ies], but for sure, this is what we have done.

What role do AI and digital technologies play in accelerating drug discovery and improving manufacturing efficiency? What are some unresolved barriers to full adoption of these technologies?

AI definitely is a key point, and, in some cases, I will say also it's a buzzword used just because it's important and mandatory to be used in drug testing. What is my experience is that it's really important to adopt also in-silico approaches like machine learning and AI-based approaches, but, also in the past, before the massive AI adoption, drug testing has adopted in-silico solutions during the drug testing to accelerate and improve the reliability of the selection of the niche and lead candidates.

Click here to view a related video interview with Dr. Scaglione during CPHI Frankfurt, which runs Oct. 28–30, 2025.

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About the speaker

Silvia Scaglione, PhD, Director of Research, CNR, and Chief Scientist, React4Life

Since 2010, Dr. Scaglione has been a permanent researcher at the National Council of Research in Italy, becoming a senior researcher in 2021 and leading the tissue engineering team. In 2017, she founded React4Life, an Italian biotech company that develops organ-on-chip technologies to accelerate translational research and improve the reliability of drug testing. React4Life has won several international projects and awards, including the EU Innovation Radar Award for Best Health Technology and the CPHI Award in 2023. Dr. Scaglione is also an ambassador for the European Innovation Council. She received her PhD in bioengineering from the University of Genoa (Italy) and was a visiting scientist at the University Hospital of Basel (Switzerland).