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Domenico Romagnuolo
Interview with the Pharma Senior Client Manager of Engineering.
With over 25 years of consulting experience, Domenico Romagnuolo has been responsible since 2025 for developing the Pharmaceutical market business of the ENG Group.
Domenico holds a degree in Electronic Engineering from the Politecnico di Milano and has gained his entire professional experience in Management Consulting and System Integration firms, including Ernst & Young Consultants, Deloitte Consulting, and NTT Data.
He has led major IT & Digital Transformation initiatives for Italian and international companies in the Pharma, Food & Beverage, Consumer Business, and Retail sectors.
The impacts are significant and range from a marked reduction in drug development costs and timelines to the acceleration of discovery processes and a considerable increase in the efficiency of clinical trial phases.
Combined with the use of the patient’s Digital Twin, this means, for example, that compared to a traditional time-to-market of 12–15 years, current forecasts predict these timelines could be cut in half. This is because generative AI drastically reduces the time required in the initial stages of pharmaceutical research, and the computational design of new molecules which traditionally took years can now be completed in months or even weeks.
AI can perform virtual screenings of millions of chemical compounds, identify early on the molecules most likely to succeed, and reduce the number of necessary laboratory experiments.
Furthermore, it is estimated that AI could reduce development and trial times by 30-50% and lower the cost per drug, making research on rare diseases or less profitable markets economically sustainable.
However, several open issues remain: computational predictions still require laboratory validation, the quality of available datasets affects the accuracy of results, and there remains a great deal of uncertainty surrounding regulatory aspects.
It represents one of the most promising innovations in pharmaceutical research. First and foremost, it allows the simulation of how different patient profiles will respond to a drug even before clinical trials begin. This makes it possible to identify subgroups of patients who are more likely to benefit, exclude those at risk, and reduce the failure rate of trials.
Digital Twins also make it possible to simulate different experimental protocols to identify optimal dosages for specific subgroups, the ideal timing of administrations, and the most effective drug combinations.
This ability to virtually test multiple configurations enables entry into the clinical phase with already optimized protocols, further increasing the chances of success.
All of this has tangible economic impacts, as it reduces the time needed to complete clinical phases and significantly lowers experimentation costs.
Another interesting aspect concerns the real-time physiological parameters collected from wearable devices which, combined with a patient’s complete clinical history, allow the prediction of adverse events before they manifest clinically, enabling preventive interventions that enhance participant safety during trials.
Despite the clear advantages, significant challenges remain: the intrinsic biological complexity of the human body requires sophisticated models capable of capturing the enormous individual variability, while privacy and data management issues related to creating digital twins demand special ethical and legal attention. Nevertheless, the patient Digital Twin is already showing concrete results in key therapeutic areas such as oncology, cardiology, and metabolic diseases fields where treatment personalization is essential for therapeutic success.
At Engineering, we adopt an end-to-end approach to Digital Twins that covers the strategic, tactical, and operational dimensions within an organization’s ecosystem, recognizing that creating a digital twin requires the ability to collect vast amounts of data from heterogeneous sources, in a compliant way, and to use them within a reliable, secure, and risk-free environment to research and evaluate optimal operational scenarios.
It is a fundamental milestone in the use and exchange of health data among EU Member States. This innovation will bring tangible benefits to patients, healthcare professionals, researchers, policymakers, and industry operators.
The regulatory framework represents a step forward in patients’ rights to access their own digital medical records, enhancing transparency. Moreover, it enables the secondary use of health data for research and innovation while ensuring strong privacy protections.
In this context, digital technologies such as AI serve as the backbone of this regulation, transforming vast amounts of data into valuable insights, accelerating medical research, drug discovery, and the development of personalized treatments.
From an infrastructural perspective, cloud technology facilitates collaboration by allowing, for instance, patients to use their data across different countries and laboratories to work on diverse datasets from various populations.
Completing the picture is, of course, cybersecurity, a key element to ensure that sensitive health data are exchanged securely and in full compliance.
The pharmaceutical industry operates in a sector designated as critical under the new NIS2 Directive, which aims to strengthen the security of the entire system through the implementation of concrete measures to prevent cyber risks.
These measures have a significant impact on processes, systems, and supply chains, and pharmaceutical companies are already taking action starting with assessing their own scope of application and implementing a structured cybersecurity program.
This is not merely a technological adjustment but a true cultural shift toward a new awareness of risks and an advanced approach to cybersecurity management.
At Engineering, we support the leading players in the pharmaceutical industry with our deep domain and technological expertise, as well as our recognized experience in integrating systems such as ERP, CRM, and MES.
These platforms, essential for ensuring process control, operational continuity, and regulatory compliance throughout the entire product lifecycle, are also true enablers for the application of AI and GenAI solutions capable of unlocking the value of corporate data, optimizing decision-making flows, and accelerating innovation.
Generative AI and Digital Twin technologies are transforming pharmaceutical research, reducing development time and costs, and enabling more personalized and safer medicine.
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