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

Francesca Rocchi

President

E francesca.rocchi@opbg.net

Pharmacist pharmacologist by training. Senior scientific manager with strong regulatory background in clinical research and Paediatric drug development, gained working for years in AIFA (Italian medicine Agency) and EMA (European medicine Agency). She is a member of the EMA PDCO (Paeditric committee) representing healthcare professionals. Responsible for Regulatory Affairs at Bambino Gesù Children's Hospital - Clinical trials Area for the development of medicines, vaccines and devices for Paediatric use.

Elisabetta Bigagli

INCIPIT Pharmacovigilance Representative in c4c

E elisabetta.bigagli@unifi.it

Post-Doc researcher in pharmacology and toxicology at the University of Florence and INCiPiT referent for pharmacovigilance.

Lucia Di Maggio

Clinical Trial Specialist

E lucia.dimaggio@incipit-pediatric.net

Specialist in the Clinical Trials conduction and management. Her experience in profit and no profit research fuels her current duties that range from managing Start Up processes relevant to clinical budgets and coordinating activities of c4c EU-funded project.

Giulia Neccia

Communication Specialist

E giulia.neccia@opbg.net

Expert in Communications. Master in International Marketing and Management at St. Jospeph’s University Philadelpia – GEMA Business School

Silvia Fioravanti

Administrative Officier

E silvia.fioravanti@incipit-pediatric.net

Graduated in Biomedical Engineering. Master's degree in Administration, Finance and Control

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.

Anna Benedetta Del Signore

Clinical Project Manager

E anna.benedetta.delsignore@incipit-pediatric.net

Master's degree in Healthcare Management at the Catholic University of the Sacred Heart, Rome. Management of profit and non-profit studies from the start-up phase to the end of study phase of approximately 5 years in both a hospital and pharmaceutical context; Expertise in Health Economics and Outcomes Research and Real-World Evidence Coordination of the activities of the European Project c4c-Conect4children .

Federica Sfrorza

Quality Assurance

E federica.sforza@opbg.net

Master in GXP Quality Systems and ISO. Expert in developing and managing quality systems for conducting clinical trials at the highest level of compliance with current regulations. Always implementing continuous improvement in the quality of clinical trials in order to achieve reliable and accurate data and ensure the safety and well-being of study subjects.

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.