The Evolution of Drug Delivery Systems
Hybrid-ENDS Inhalation Systems and CDSS Decision Support for Personalized Tapering
medical.information@pharma-edge.com
Hybrid - Electronic Nicotine Delivery Systems (H-ENDS) represent an integrated drug delivery platform for the
controlled inhalation-based administration of nicotine, designed in accordance with the applicable requirements
of Regulation (EU) 2017/745 (MDR).
The system consists of a DTx combination of a medical inhalation device and Software as a Medical Device (SaMD)
and is in accordance with the classification rules set out in Annex VIII of the MDR.
The H-ENDS architecture is based on a medical-grade inhalation device developed in compliance with
General Safety and Performance Requirements (GSPR) and biocompatibility standards under ISO 10993.
The device is natively integrated with a proprietary Clinical Decision Support System (CDSS),
which provides decision support functionalities for the management of nicotine exposure.
The (CDSS) is designed to support controlled tapering of nicotine administration by monitoring,
validating, and recording each delivery event, thereby enabling traceability, auditability,
and consistency with the predefined clinical protocol.
The system incorporates a deterministic Linear Tapering algorithm intended to progressively modulate nicotine
delivery based on temporal and behavioral parameters. This approach is designed to support a gradual reduction
in exposure and maintain pharmacodynamic stability throughout the treatment period.
The functional integration between hardware and software enables comprehensive tracking of administration
events and supports a closed-loop therapeutic management framework.
The system is designed to generate Real World Evidence (RWE) to support clinical evaluation and post-market clinical
follow-up (PMCF) activities in accordance with MDR requirements.
Hybrid ENDS introduces a new paradigm of digitally regulated Drug Delivery, where technology is not just a
support tool but an integral part of the therapeutic act.
The platform represents a highly innovative solution in the context of precision medicine (PM),
enabling a model of controlled, traceable, and adaptive administration compliant with MDR
standards (REG. EU 2017/475).
Mission
Pharma Edge aims to develop a regulated technological framework for inhalation-based drug delivery systems by integrating
medical-grade hardware and certified software components.
The objective is to support the development of controlled, traceable, and personalized therapeutic protocols aligned with
current scientific evidence and regulatory requirements under Regulation (EU) 2017/745.
Team
Francesco Paolo Di Tota, Human Physiopathology Biologist with a PhD in Biotechnological Applications
(Bioinformatics specialization) and a master’s degree in Big Data from the University of Bari.
Throughout his career, he has developed a strong background in basic immunology research at the University of Milan-Bicocca,
contributing to internationally recognized publications in leading journals such as Blood and The Journal of Immunology.
He has served as Director of two Clinical Analysis Centers in Milan and Bari, gaining extensive healthcare management
experience. He also worked for three years as an industrial researcher at IBM, focusing on biological traceability in the
wine supply chain and viral databases.
Thanks to this multidisciplinary experience, he currently works as a specialist consultant in Data Science and Big Data for
leading industries and banking institutions, while coordinating the technological development and architecture of the
NicotinZ asset.
Marco Feligioni, Graduated in Pharmaceutical Chemistry and Technology (CTF) with a PhD in Pharmacology. He is Associate Professor of Pharmacology at Link Campus University in Rome and an expert in both basic and translational clinical research. Since 2003, he has been actively involved in scientific research in the field of neuroscience. He is Director of a laboratory at the EBRI Institute (“Rita Levi-Montalcini” Foundation) in Rome, where he conducts research on neurodegenerative diseases, and also directs a laboratory at the IGEA Clinic in Milan, focused on the identification of biomarkers for human neurorehabilitation and neurodegenerative disorders. He is the author of more than 70 publications in international neuroscience journals, with an H-index of 32, and serves as a peer reviewer for several scientific journals. He is also a member of the editorial boards of Frontiers and Scientific Reports (Nature Portfolio). Currently, he is also CEO and Scientific Director of Peptitec, a Biopharma startup focused on the development of a peptide in the preclinical stage for retinal neuroprotection in glaucoma.
Marco Feligioni, Graduated in Pharmaceutical Chemistry and Technology (CTF) with a PhD in Pharmacology. He is Associate Professor of Pharmacology at Link Campus University in Rome and an expert in both basic and translational clinical research. Since 2003, he has been actively involved in scientific research in the field of neuroscience. He is Director of a laboratory at the EBRI Institute (“Rita Levi-Montalcini” Foundation) in Rome, where he conducts research on neurodegenerative diseases, and also directs a laboratory at the IGEA Clinic in Milan, focused on the identification of biomarkers for human neurorehabilitation and neurodegenerative disorders. He is the author of more than 70 publications in international neuroscience journals, with an H-index of 32, and serves as a peer reviewer for several scientific journals. He is also a member of the editorial boards of Frontiers and Scientific Reports (Nature Portfolio). Currently, he is also CEO and Scientific Director of Peptitec, a Biopharma startup focused on the development of a peptide in the preclinical stage for retinal neuroprotection in glaucoma.