Head of Project Development Area
Arianna Bertolani
After graduating in Pharmaceutical Biotechnology at the University of Milan and receiving a PhD in Chemical Engineering and Industrial Chemistry at the Politecnico di Milano, Arianna obtained a Master in Health Management (MiMS) at SDA Bocconi. Thanks to her background and previous work experience, she has gained a mix of skills ranging from the development and management of basic, clinical, and pharmacoeconomic research projects to the design and implementation of training courses. She currently holds the role of CRO Development Manager at CVBF, where she is the main point of contact for new potential customers and business opportunities.
Chief Executive Officer
Donato Bonifazi
Donato Bonifazi (MEcon), is an economist specialised in European Project Management and a certified Project Manager (CEPAS n. 9/2016). He is Trial Leader of two EU-funded Projects (DEferiprone Evaluation in Paediatrics and GAbapentin for Paediatric Pain, both funded within the FP7-Health), each involving more than 20 clinical centers from all over Europe and some Mediterranean countries.
He is President of AICRO, the Association of Italian Contract Research Organisations and member of the Paediatric Working Group of the EUCROF (European Clinical Research Organizations Federation). He is also member of the Working Group “Clinical Trial Preparedness” at the Enpr-EMA (the European Network of Paediatric Research at the European Medicines Agency) and coordinator of the TEDDY – European Network of Excellence for Paediatric Clinical Research, an independent Research Network (category 1 network member of Enpr-EMA), composed by 50 partners from 20 EU and non-EU countries aimed at facilitating the performance of good quality paediatric studies and research.
Donato Bonifazi is Project coordinator of EPTRI (European Paediatric Translational Research Infrastructure – GA 777554, INFRADEV-1-2017) aimed to create the framework for a new Research Infrastructure (RI) intended to enhance technology-driven paediatric research in drug discovery and early development phases to be translated into clinical research and paediatric use of medicines. He is also involved in the PedCRIN (Paediatric Clinical Research Infrastructure Network – GA 731046, INFRADEV-3-2016) project as WP3 Leader, dedicated to the development of tools to facilitate paediatric clinical trials.
Social Media Manager
Sandra Brasil
After graduating in Biochemistry and receiving a PhD in Pharmacy (field of Molecular and Cellular Biology) from the University of Lisbon, Portugal, Sandra worked as a post-doc in developing new therapies for Rare Diseases. She was also a researcher and patient advocate at the international network CDG & Allies – PPAIN (Professionals and Patient Associations International Network). She has experience in science communication and developing scientific content in lay language for all audiences.
Clinical Trial Archivist
Elisa Cattani
Elisa is Pavia’s Office Manager. She in charge of managing human resources, internal communication and material resources of CVBF offices based in Pavia. Since 2016, she is also a Trial Archivist, collecting and storing all the documentation related to clinical studies of which CVBF either is the Sponsor or acts as CRO.
Patient Advocacy and Communication Manager
Maria Cavallo
Master of Fine Arts Degree in Set and Costume Design. Expert in communication with paediatric patients and experienced in the preparation of informative packages and assent forms in several European projects (DEEP, GAPP, TEDDY).
She is responsible for Communication Area in CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche). She’s team leader for the KIDS Bari, the first Young Persons Advisory Group in Italy.
Scientific Advisor
Adriana Ceci
Past-President and Board Member of Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Adriana Ceci had her academic carrier at the Aldo Moro University of Bari as researcher and PhD in Paediatrics and PhD in Clinical and Laboratory Haematology; she has been also lectured in many academic courses in the field of Paediatric and Regulatory Sciences.
She is Chair of scientific Committees in Paediatric Networks (INCIIPIT, the Italian Network of paediatric research and c4c – the pan-european paediatric clinical trial Network). Is Board member and funder member of TEDDY (Task-force in Europe for Drug Development for the Young–EU FP6) still running as Network of excellence for paediatric Research, participant in many research projects at national and international level. She is also Scientific Counselor of the Thalassemia Foundation ‘L. Giambrone’ Board and involved in international projects on Thalassemia and other haemoglobinopathies.
Past member of the Paediatric Committee at the European Medicine Agency (EMA) and of the Italian Ministry of Health – Commissione Unica del Farmaco, she also served as member of the “Commissione Nazionale del Sangue”, “Commissione per la Sperimentazione Clinica” at the Minister of Health, and other ministry technical commissions. She was also member of the CONI Antidoping Committee and of the Commissione Farmaco e Bambino appointed to Agenzia Italiana del Farmaco (AIFA).
Former member and Vice-President of the Commissione Sanità of the Italian Parliement and also member of the European Parliament where she founded the EU Parliamentary Inter -Group on Health that she coordinated for 5 years.
She is referee of several international journals and author of more than 140 indexed publications mainly dealing with orphan and paediatric medicines, blood disease, thalassemia, paediatrics, regulatory issues.
Clinical Research Associate and Regulatory Officer
Ornela Cullufe
Ornela Cullufe is the Office Manager of Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se huaj, Albanian Branch Office. She is involved in the Development and Networking activities and also in Regulatory and Pharmacovigilance area. She has been part of monitoring activities in the multicentric clinical study DEferiprone Evaluation in Paediatrics. She is one of the Team Leaders of the first YPAG (Young People Advisory Group) in Albania named KIDS Albania part of iCAN (International Children’s Advisory Network). She obtained her master’s degree in Pharmacy in 2014 from University of Medicine in Tirana (Albania). Prior joining CVBF, Ornela worked as pharmacist with extensive background in patient care, pharmacology, communication and implementation of health care programs.
Clinical Research Associate
Arlinda Demeti
Arlinda Demeti holds a Master of Science degree in Pharmacy from the University of Tirana, Albania, and a Master of Arts in Health Sciences at the University of Lucerne, Switzerland with a major in Health Services and Systems Research.
She joined Consorzio per Valutazioni Biologiche e Farmacologiche – Albanian Branch Office as a Clinical Trial Assistant and she is also appointed as Clinical Research Associate for the German and Swiss sites in the cASPerCF study. Previously, Arlinda has been working under the Directorate of Health and Social Projects at the Ministry of Health and Social Protection in Albania where she was involved in several health projects focusing on the digitalisation of Albanian Health System (e-referral, e-prescriptionin, human resource management system, e-social services registry).
Further, Arlinda was part of the research unit at the Swiss Paraplegic Center in Notwill/Switzerland where she also performed practical work in the biobanking laboratory with the latest methodologies and devices to isolate cells, DNA, RNA. In addition, she has been working as retail pharmacist and technical manager pharmacist for 4 years in Albania in both pharmacy and pharmaceutical warehouse.
Moreover, Arlinda held the position of project coordinator of an EU funded project focusing on promoting entrepreneurship skills and entrepreneurial learning among young people and women in Albania.
Accounting Manager
Giusi Di Leo
Degree in Political Sciences, political-administrative address. Long-term experience in company-administrative secretariat and in the reporting of financed regional, European and national projects. From April 2012 she is Administrative Assistant for the CVBF.
Clinical Project Manager
Ana Dilo
Holds a Master degree in Pharmacy from University of Medicine Tirana (Albania) and a Master of Advanced Studies in Toxicology from University of Geneva (Switzerland). Previously worked as a pharmacist and the last role was Regulatory affairs & Pharmacovigilance responsible in a pharmaceutical company. Role in CVBF: Clinical trial assistant.
Quality Assurance Head
Mariagrazia Felisi
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. Qualified Person for PharmacoVigilance (QPPV) registered in EUDRAVIGILANCE, she is currently Projects Director at Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF). She is in charge of Pharmacovigilance and Quality Assurance in several paediatric clinical trials. She is lecturer of the Master in Regulatory Affairs of the University of Pavia and she also holds lectures in numerous national and international courses in her fields of expertise.
Clinical Research Associate and Data Manager
Maria Paola Felisi
Technical diploma (commerce field). Administration and financial reporting in funded projects, Clinical Trial Assistance and trial documentation archiving with experience in Quality Assurance, ISO System, and data entry.
Clinical Research Associate and Data Manager
Paola Gandini
Paola Gandini is graduated in Biology and she has attended a master in Regulatory Disciplines. She currently covers the role of Data Manager at CVBF and she is involved in several multinational studies in the field of pediatric and rare diseases. Main activities: CRF designing, data cleaning and data reporting. Moreover, she interfaces day-by-day with clinical sites for any issue related to data management.
Project Development Manager
Bonka Georgieva
Bonka Georgieva is a WP2 internal reference person within the H2020 ID-EPTRI Project. She graduated from the University of Veliko Turnovo ‘St. Cyril and St. Methodius’ with master degree in ‘Cooperative Management’. She participated in one-year Erasmus-programme scholarship with technical-economic address at the University for Foreigners Perugia. After graduation, she moved to Italy where she had different work experiences in international relations between Italy and Bulgaria as well as on different EU Projects. She is an expert in project management and financing of FP7 and H2020 projects. She speaks three languages including Bulgarian, Italian and English.
Medical Expert
Manika Kreka
She attended High School in her hometown and finished it on 1992 with excellent results. She did successfully the competition and gained the right to follow university studies in Faculty of Medicine, in Tirana University (Albania). She obtained the diploma of Medical Doctor on 1998 with excellent results.
During 1999-2003 she attended the post graduated school on pediatrics residency in Tirana, Albania.
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. Since 2015 she is a Medical Director in Consorzio per Valutazioni Biologiche e Farmacologiche in Tirana (part of CVBF Italy).
She has been part of many round tables and scientific sessions regarding haemoglobinopathies inside Albania and abroad. She has an enormous activity regarding writing of scientific articles and publications. She is Principal Investigator in a multicentric clinical study (DEferipron Evaluation in Paediatrics).
She is 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).
Data Manager and Biostatistician
Giulia Maggi
I obtained my degree in Mathematics and the PhD in Mathematics and Statistics at the University of Pavia. I worked as a data manager in clinical environment and then as a biostatistician at the University of Milan dealing in particular with the statistical evaluation of immune variables as prognostic biomarkers in tumor patients and clinical databases management.
In CVBF I am working as a biostatistician and I am collaborating with the data management and the clinical research area.
Senior Clinical Research Associate
Silvia Maestroni
Degree in Drug Biotechnology, PhD in Molecular Medicine and Master of first level in Data Management for Clinical Research.
I have several years of experience in pre-clinical research as post-doctoral fellow and in clinical research as CRA, working and interacting with national and European centers.
In CVBF I am working as CRA and I am collaborating with the trial operations and medical writing area.
Senior Regulatory Officer and EudraVigilance Specialist
Senior Regulatory Officer
Cristina Manfredi
Cristina is Coordinator of the Regulatory & Pharmacovigilance Area and Pharmacovigilance Deputy at CVBF.
Registered in EudraVigilance and Safety Contact in different paediatric clinical trials, she provides support to Project Managers and liaises with external parties on regulatory and pharmacovigilance needs and aspects.
Working at CVBF since 2004, she has also gained experience in project management.
Cristina holds a Master’s Degree in Marketing Communication and since she started her employment at CVBF she has attended specific training courses focused on the activities she is involved with and coordinates.
Scientific Director
Giovanni Migliaccio
Giovanni Migliaccio is the Scientific Director of the Consorzio per Valutazioni Biologiche e Farmacologiche, (CVBF Pavia, IT) and a Senior Advisor for the European Translational Medicine Research Infrastructure (EATRIS, Amsterdam NL).
He obtained a PhD in Biological science in 1977 at the University of Naples (Italy). 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.
Financing Manager and Regulatory Officer
Marina Montanaro
Degree in Business administration. She is the Coordinator of the Administrative Unit and Office Manager at CVBF. Expert in financial reporting for FP7 and Horizon 2020 Projects, she is member of the Project Management Team for FP7 projects and Horizon 2020 Projects. Member of the Project Management Team and Financial Manager of ID-EPTRI Project, Administrative Manager of the DEEP Project, member of the DEEP Trial Management Team.
Senior Data Manager and Clinical Research Associate
Rosa Padula
Degree in chemistry, she has several years of experience in Clinical Research. In CVBF she covers the role of Clinical Trial Project Manager and CRA in pediatrics and rare diseases trials, medical device and observational studies. Main area of activities: set-up of local/international project activities according to the company standards and regulations. Managing tasks/activities according to project-specific quality standards as well as relevant SOPs, ICH/GCP and local requirements. Preparation/Review of regulatory documentation for EC/AC submission. Editing and Review of trial documentations: protocol, CRF, ICF, IB. Contract negotiation and finalization with study sites.
Project Development Manager and Biostatistician
Claudia Pansieri
She is a pharmacist who graduated in Chemistry and Pharmaceutical Technology. She obtained a Master of Philosophy in Life and Biomedical Science. Thanks to her last experience as Research Fellow at HUNIMED-Humanitas University and to her previous experience at IRCCS Mario Negri, she developed some skills in project development, clinical epidemiology, longitudinal research, and evidence synthesis (by means of systematic reviews and meta-analyses) to inform health care decisions. She is author and co-author of several scientific publications in national and international journals.
Currently, she works in CVBF as a researcher in the Project Development and Data management/Statistics units.
Communication Manager
Eleonora Passeri
Eleonora Passeri earned a bachelor’s degree in Biological Science and masters degree in Molecular Biology in 2007 – Università degli Studi di Perugia, Italy.
In 2010, she received her PhD in Neuroscience from the University of Tuebingen – Germany, with a focus on the molecular and cellular implications associated with Tinnitus. She did a course on Bioethics at the Università Cattolica del Sacro Cuore – Roma.
From 2011 to 2015, Dr. Passeri did her postdoctoral studies on neuroimmunology and neuropsychiatry in the US at McLean Hospital in Boston (MA), Georgetown University in Washington DC, and Johns Hopkins Hospital in Baltimore (MD).
She later moved back to Italy where she started her collaboration with the European Commission as Expert Evaluator of research proposals. At the same time, she started her patient advocacy work by creating the Rare Special Powers (RSP) movement and her science communication consultancy activity. Later, she became the European Joint Program on Rare Disease (EJP RD) and International Rare Diseases Research Consortium (IRDiRC) Communication Manager.
Currently, she is a board member of Maximizing the Impact of Research in Neurodevelopmental Disorders (MINDDS) a Cost Action project and a member of the Osservatorio sulla Disabilità Umbria.
Senior Clinical Research Associate
Silvia Pulici
Degree in Pharmaceutical Chemistry and Technology, she worked 15 years in a pharmaceutical company first in Pre-Clinical Research, then in Clinical Research as monitor and associate manager for clinical trial management. From 2008, she collaborated with San Matteo Hospital in Pavia, for 9 years, working at the Scientific Secretary of the Ethics Committee. She was involved as part of the Clinical Trial Quality Team of the Hospital in activities for improvement of quality of non-profit studies. She also collaborated in the activation of the San Matteo Phase I Clinical Trial Unit.
In CVBF, she is responsible of Trial Management & Monitoring Area and she collaborates with Quality Assurance for preparation and revision of Standard Operating Procedures. She also acts as Project Manager for profit/non-profit studies.
Research Methodologist Expert and Biostatistician
Head of Bio-Statistics
Giorgio Reggiardo
Giorgio Reggiardo is the Head of Biostatistics Unit of the Centro Valutazioni Biologiche e Farmacologiche (CVBF Pavia, IT) and a Senior Biostatistician.
Degree in Biological Science in 1991 at the University of Genoa (Italy), he obtained a PhD in Medical Statistics and Epidemiology in 1995 at the University of Pavia (Italy).
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.
Senior Clinical Research Associate
Barbara Vitolo
She is responsible for the monitoring area in CVBF. She started as CRA in 2017 and became an expert CRA as per Italian decree in 2018. She maintained this qualification till January 2021, mainly working on oncological studies.
She has a master’s degree in biology and a qualification as Clinical Research Specialist obtained together with the CRA certification. She started her career at the University Hospital as cell biologist in the translational research field. Then she worked in clinical research area as Study Coordinator for the same Hospital.