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Who we are

Who we are
INCiPiT is a non-profit Consortium, currently composed of 20 partners, including the main Italian pediatric hospitals and Scientific Institute for Research, Hospitalization and Healthcare (IRCCS), various Research Units dedicated to general hospitals, as well as some research organizations and international networks coordinated by Italian bodies.
Mission and Vision
We are a contact and coordination center for all national and international pediatric clinical trials involving Italian clinical sites, which are clinical excellences in the pediatric field. We are committed to promoting the growth and quality of pediatric clinical trials in Italy. We give concrete support to the planning, conduct and completion of all types of pediatric clinical trials (profit and non-profit).
Objectives and Values
INCiPiT is a facilitator in the implementation of pediatric clinical trials, with the aim of promoting the exchange of knowledge between experts in the sector, offering specialized training opportunities and providing shared tools and guidelines to increase the quality and effectiveness of pediatric clinical research. The Consortium makes the interconnection between its partners its greatest strength, thanks to the sharing of values ​​such as cooperation, ethics and excellence.
Coordination Center Team
Alessandra Simonetti
President
E alessandra.simonetti@opbg.net
Paediatrician, PhD in Immunology and Applied Biotechnology, holder of a Master's Degree in Bioethics in Maternal and Child Health, and Tenured Researcher at the University of Rome Tor Vergata, where she is responsible for five teaching modules across five degree programmes, as well as a First-Level Master's Programme and a Postgraduate Advanced Training Course. She has over 15 years of experience in both industry-sponsored and investigator-initiated clinical trials, as well as in paediatric drug development, acquired at the Clinical Trial Center (CTC) of the IRCCS Bambino Gesù Children's Hospital, where she has been working for more than 20 years. She currently serves as Medical Director of the CTC Phase I Unit. For more than ten years, she contributed as an EMA Expert to the evaluation of Paediatric Investigation Plans (PIPs) and is currently a c4c-S Expert. She also collaborates with the Clinical Studies Area on the development of paediatric medicines, vaccines, and medical devices at the same IRCCS. Since October 2025, she has served as President of INCiPiT (Italian Network for Paediatric Clinical Trials).
Sara Abbate
Clinical Project Manager
E sara.abbate@opbg.net
Pharmacist with Master's degree in Drug Development and Advanced Course in Clinical Research Methodology. Experience in conducting and managing pediatric clinical trials in the context of profit and non-profit research. Clinical Trial Manager in the Clinical Studies Area for the Development and Implementation of Drugs, Vaccines and Medical Devices for pediatric use at the IRCCS Bambino Gesù Children's Hospital.
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Serena Laura Miccoli
Admistrative and Communication Officer
E serenalaura.miccoli@opbg.net
Doctor of International Relations with experience in project management and the coordination of institutional information flows. Through advanced training programmes, she supports internal and external communication activities, ensuring consistency and timely updating of content. She collaborates with institutional offices in their relations with stakeholders and partners, facilitating the effective dissemination of initiatives and enhancing the visibility and impact of project activities.
Board of Directors
Renzo Guerrini
Vice President
E renzo.guerrini@meyer.it
Full Professor of Child Neuropsychiatry at the University of Florence, Director of the Department of Neuroscience and Human Genetics at the Meyer IRCCS Children's Hospital in Florence and of the Paediatric Neurology Unit and Centre for Phase 1 Clinical Trials at the same hospital.
Angela Mastronuzzi
Member of the Board
E angela.mastronuzzi@opbg.net
Pediatric hematologist-oncologist. Head of the Neuro-Oncology Department at Bambino Gesù Children's Hospital. Primary clinical expertise is in the diagnosis and treatment of pediatric patients with hematologic and oncologic conditions, with a particular focus on central nervous system tumors and cancer predisposing syndromes. Extensive knowledge in innovative and personalized treatments with a multidisciplinary approach for pediatric cancer, notably in phase I clinical trials, targeted therapy, cell therapy, and gene therapy.
Laura Mangiarini
Member of the Board
E laura.mangiarini@pentafoundation.org
Senior Manager with 10 years of experience, I coordinated international and multicenter clinical research projects, managing large and multidisciplinary teams. I have specific skills in the field of rare diseases and pediatric medicine. I regularly interact with the European Regulatory Agency (EMA), WHO and key opinion leaders. Previously, I gained several years of experience at GSK where I coordinated early and late drug discovery programs and developed/implemented new technologies.
Anna Arbo
Member of the Board
E anna.arbo@burlo.trieste.it
Director of Pharmacy at Institute for Maternal and Child Health “IRCCS Burlo Garofolo in Trieste, has over 15 years of professional experience in hospital pharmacy roles. She holds a degree in pharmaceutical chemistry and technology from the University of Trieste, a specialization in hospital pharmacy from University of Padova and specializations in public health management. She serves on various committees related to clinical trials, ethics, and quality assurance. Member of the Steering Committee for the Graduate Course in Pharmaceutical Chemistry, lecturer at School of Hospital Pharmacy University of Milan and School of Clinical Pharmacology at University of Trieste.
Scientific Committee
Paolo Rossi
President of Scientific Commitee
E paolo.rossi@opbg.net
Professor Emeritus of Pediatric Sciences at the University of Rome Tor Vergata, he coordinates the Clinical Research Center for Pediatric Drug Development at the IRCCS Bambino Gesù Children's Hospital. He led the INCiPiT Consortium from 2017 to February 2024, contributing to the development of collaborative networks and methodological approaches for clinical research in the pediatric field.
Francesca Rocchi
Member of the Scientific Committee
E francesca.rocchi@opbg.net
Pharmacist and pharmacologist with extensive regulatory experience gained at AIFA and EMA, she serves as Senior Scientific Manager for clinical trials and pediatric drug development. A member of the EMA Paediatric Committee, she heads the Regulatory Affairs Service within the Clinical Research Area of Bambino Gesù Children's Hospital. She served as President of the INCiPiT Consortium from 2024 to September 2025.
Alessandra Pugi
Member of the Scientific Committee
E alessandra.pugi@meyer.it
Hospital pharmacist and Head of the Clinical Trial Office at the IRCCS Meyer Children’s Hospital in Florence, she has been active in clinical research for more than ten years, focusing on the operational and regulatory management of both industry-sponsored and investigator-initiated clinical studies. Her work combines pharmaceutical expertise with in-depth knowledge of authorization processes, contributing to the development of pediatric clinical trials at both national and international levels.
Giusepppina Sgandurra
Member of the Scientific Committee
E giuseppina.sgandurra@fsm.unipi.it
Associate Professor at the University of Pisa and the IRCCS Fondazione Stella Maris, she leads the INNOVATE Laboratory and the REHAB CHILD Center of Excellence, dedicated to technology-assisted rehabilitation in childhood and adolescence. She coordinates national and international projects focused on the early diagnosis and rehabilitation of motor disorders. She is recognized among the 500 Italian experts in Artificial Intelligence applied to clinical practice and has been awarded the title of Knight of the Italian Republic.
Alberto tommasini
Member of the Scientific Committee
E alberto.tommasini@burlo.trieste.it
Pediatrician and Lecturer in Pediatrics and Pathology at the University of Trieste, he coordinates the Immunopathology Laboratory at the IRCCS Burlo Garofolo. He combines clinical practice with biological research, focusing on genetic defects of the immune system. His translational approach aims to transform clinical observations into molecular analyses to develop personalized therapies beyond standard treatment protocols.
INCiPiT Patient and Public Involvement (PPI) Representative
Lindsey Hunter
Patient and Public Involvement (PPI) Representative
E lindsey.hunter@pentafoundation.org
Head of Network, Education & Training at Penta Foundation ETS, with over 15 years of experience in health research projects and programmes. In her role, she promotes meaningful and ethical Patient and Public Involvement (PPI), leading the development and implementation of inclusive PPI strategies across research programmes. She also serves as the organisation’s Designated Safeguarding Lead for PPI activities, ensuring that such initiatives are conducted in a safe, equitable, and ethical manner.