Chief Executive Officer
Donato Bonifazi
Donato is the Chief Executive Officer of CVBF.
Work experience:
He is Coordinator of EPTRI (European Paediatric Translational Research Infrastructure). He has been President of the Italian Association of CROs (AICRO) between 2018-2020, and Trial Leader of two EU-funded multinational clinical trials (DEferiprone Evaluation in Paediatrics and GAbapentin for Paediatric Pain, both funded within the FP7-Health) between 2011-2017. He is Chair of the Events&Training Working Group of the EUCROF (European Clinical Research Organizations Federation) and member of the Coordinating Group at the Enpr-EMA (the European Network of Paediatric Research at the European Medicines Agency) representing the TEDDY European Network of Excellence for Paediatric Research, in his role of Board Member. He is between the founders of INCiPiT, the Italian Network for paediatric clinical trials, and of the two YPAGs (Young Persons Advisory Groups) in Italy and Albania.
Education:
Donato holds a Master’s Degree in Management, Marketing specialisation from LUISS University. He earned a Master in “Competences and technique for personnel selection” at SDA Bocconi. He carried out the Advanced Course “FP7 – Financial and Project Management” at Europa Media of Budapest. He is a certified Project Manager
Clinical Research Director
Mariagrazia Felisi
Mariagrazia currently works at CVBF Clinical Research Director participating in the CVBF projects ensuring the respect of high quality standards. She is teacher in numerous courses in her field of expertise.
Work experience:
She has conducted research in the paediatric field, where she approached the sectors of clinical pharmacology, pharmacovigilance, management of disease registries which ultimately led her to acquire extensive knowledge and expertise in the field of clinical research. She has been participating in numerous national and international research projects, playing the leading role in many activities related to clinical trials.
Education:
Master’s Degree in Life Science, she received her PhD in clinical pharmacology from the University of Bari and her Master degree in Pharmacovigilance from the University of Florence.
Administrative Director
Rosa M. D'Ignazi
Rosa is the Administrative Director at CVBF, involved in administrative, financial and legal issues, and Contract Manager.
Work experience:
Rosa has a strong experience as Administrative Manager in previous experiences with companies and associations.
Education:
Master’s Degree in Corporate Lawyer at Alma Laboris Business School. Political science course at University of Bari “Aldo Moro”. She attended a training course in Operation Marketing and the IFOA training course “Business management and Human Resources Organization”.
Regulatory Advice Leader
Giovanni Migliaccio
Giovanni Migliaccio is the Regulatory Advice Leader of the CVBF.
Work experience:
His interest in science developed around stem cell proliferation and differentiation mechanisms. He spent two years as Post Doc at the University of Washington (Seattle, WA) and 5 years as Associate Scientist at the New York Blood Center (New York, NY). He continued his studies at the Istituto Superiore di Sanità (ISS) in Rome resulting in more than 150 scientific publications over the years. He is involved in the regulatory aspects of using cultured cells as part of human therapies and acts as an expert for the Italian government in the area of Cell and Gene Therapies. He is also an expert for these products for the European Medicines Agency (EMA). He was also the Chair of the CTP group at the European Department for Quality of Medicines (EDQM) from 2010 to 2018. Giovanni is a member of the Board of Directors of the European Paediatric Translational Research Infrastructure (EPTRI).
Education:
Master’s Degree in Biological Science at the University of Naples. He obtained a PhD in Biological science in 1977 at the University of Naples Federico II.
Medical Director
Manika Kreka
Manika works at the Tirana branch office of CVBF as Medical Director, and is involved in multinational clinical trials as Medical Expert.
Work experience:
From 2004 she works as a lecturer in Faculty of Technical Medical Sciences, University of Medicine in Tirana. She holds the Vice Dean’s position and is a professor of Pediatrics and Medical genetics. She works as a pediatrician in University Hospital Center” Mother Teresa” Tirana, Center of Congenital Blood Diseases. In 2011 she becomes Doctor of Science (PhD) in Pediatrics and from 2016 she is Associated Professor. She has been Principal Investigator in a multicentric clinical study (DEferipron Evaluation in Paediatrics). She is writer of scientific articles and publications, and author of some academic textbooks: Textbook of Medical Genetics and elements of molecular biology, Textbook of Pediatrics (both for University students) and two monographs (one in English and one in Albanian).
Education:
She attended university studies in Faculty of Medicine, in Tirana University (Albania). She obtained the diploma of Medical Doctor in 1998. During 1999-2003 she attended the post graduated school on pediatrics residency in Tirana, Albania.
Biostatistics Leader
Giorgio Reggiardo
Giorgio Reggiardo is the Biostatistics Leader at CVBF.
Work experience:
He is trained in epidemiology, biostatistics, multivariate analysis, Bayesian inference, meta-analysis, “big data” analytics, and clinical trial design. Since 1997 he has served as lead statistician for Phase I-IV clinical trials to provide statistical support for study design and statistical analysis, including pharmaceutical industry-sponsored successful Marketing Authorizations (AIC) submissions. He has expertise in the design and analysis of clinical trials, controlled randomized trials, power calculations, generalized estimating equations, survival analysis, and regression methodology. His expertise includes processing and analysing data using SAS, R, SPSS, BMDP, NCSS-PASS, NQuery and EquivTest. He wrote SAS Macros and R functions that carry out data management and statistical procedures, and he presented statistical methodological work in several professional conferences. Since 2012 he has been involved as a statistician in two International Pharmacovigilance Department for the detection of emerging signals of interest for pharmacovigilance (Statistical approach to Signal Detection Analysis). Since 2013 he has been actively involved in the Italian CDISC User Network group in collaboration with IBiG (Italian Biostatistics Group) and SAS Institute.
Education:
Master’s Degree in Biological Science in 1991 at the University of Genoa. PhD in Medical Statistics and Epidemiology in 1995 at the University of Pavia (Italy).