Maria Di Marzo - European Medicines Agency

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Curriculum Vitae
PERSONAL INFORMATION
Maria Di Marzo
WORK EXPERIENCE
November 2009–Present
Permanent position - Scientific Administrator
Agenzia Italiana del Farmaco (AIFA) - Rome, (Italy)
- Scientific administrator and Quality assessor for centralised procedures (first marketing
authorisations and variations to the marketing authorisation)
- Scientific administrator and Quality assessor of national authorisation procedures for
radiopharmaceuticals (Member of the AIFA Working Group on Radiopharmaceuticals)
- Linguistic revision of centralised products information
- Quality assessor of Investigational Medicinal Products Dossier (IMPD)
- Participation to the plenary meetings of the Quality Working Party (QWP) - EMA as 'Observer'
November 2005–November 2009
Temporary position - Scientific Administrator
Agenzia Italiana del Farmaco (AIFA) - Rome, (Italy)
- Scientific administrator and Quality assessor for centralised procedures (first marketing
authorisations and variations to the marketing authorisation)
- Member of the AIFA Working Group on Radiopharmaceuticals since Feb. 2009
- AIFA Contact person for the PIM (Product Information Management) project - EMA
- Linguistic revision of centralised products information
September 2003–November 2005
One-year contracts - Researcher
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A., (Italy)
Reasearch activities:
Drug discovery of new molecules with antitumoral activity: rational design, synthesis, purification and
structural characterization. Analytical techniques used: HPLC, LC-MS, 1H e 13C-NMR, mass
spectrometry. Optimization of synthetic routes for scale-up.
February 2002–October 2002
Ph.D. Placement
Lab. Prof. JM Lehn - ISIS - Université Louis Pasteur, Strasbourg, (France)
Reasearch activities:
Design of bi-functional monomers for dynamic polymerisations. Development of synthetic routes to
novel peptide analogues. Studies of reversible polymerisations for applications in biological and
materials science.
EDUCATION AND TRAINING
–October 2008
Master Degree in Scientific and Regulatory Assessment of New
Medicines
University of Tor Vergata, Rome, (Italy)
Scientific and regulatory assessment of new medicinal products
–March 2003
PhD degree in Pharmaceutical Sciences
University of Salerno, DIFARMA, Fisciano , (Italy)
Design of novel pseudopeptides based upon Anandamide model (lipidic endogen mediator of the
cannabinoid system). Solid-phase peptide-like synthesis. Analytical characterization (HPLC, 1D & 2DNMR, Electrospray-MS). Supervision and training of undergraduate students
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Curriculum Vitae
–March 1999
Maria Di Marzo
Degree in Pharmaceutical Chemistry and Technology
University “Federico II” - Naples, (Italy)
Pharmaceutical chemistry, organic chemistry, pharmacology, analytical chemistry/laboratory practice,
pharmaceutical technology and legislation, biochemistry, microbiology, biology, physics etc.
1-y research project: applied different extraction techniques to lyophilised marine sponges. Purified
new cytotoxic macrocyclic metabolites using different chromatographic techniques (MPLC, HPLC).
Elucidated metabolites structures by 1D-, 2D-NMR and Mass Spectrometric techniques
ADDITIONAL INFORMATION
Expertise
Assessment of the quality section (chemicals) of the medicinal products' applications for the first
marketing authorisations and for the variations to the marketing authorisation.
Assessment of Investigational Medicinal Products Dossier (IMPD - chemicals).
Linguistic revision of centralised products information.
Publications
- M. Di Marzo, A. Casapullo, G. Bifulco, P. Cimino, A. Ligresti, V. Di Marzo, R. Riccio and L. GomezPaloma. "Synthesis, conformational analysis and CB1 binding affinity of hairpinlike anandamide
mimetics of pseudopeptide nature”. J. Pept. Science 2006, 12, 575-591.
- G. Giannini, M. Marzi, R. Pezzi, T. Brunetti, G. Battistuzzi, M. Di Marzo, W. Cabri, L. Vesci, C. Pisano.
“N-Hydroxy-(4-oxime)-cinnamide: A versatile scaffold for the synthesis of novel histone deacetilase
(HDAC) inhibitors”. Bioorganic & Medicinal Chemistry Letters (2009) 19, 2346–2349.
- Giannini, G., Marzi, M., Di Marzo, M., Battistuzzi, G., Pezzi, R., Brunetti, T., Cabri, W., Vesci, L.,
Pisano, C., Exploring Bis-(indolyl)methane moiety as an alternative and innovative CAP group in the
design of Histone Deacetylase (HDAC) inhibitors, Bioorganic & Medicinal Chemistry Letters, (2009)
19, 2840-2843.
Patents (I'm not beneficiary of them):
- International Publication Number/Date: US007851621B2/ 14.12.2010. Inventors: M. Marzi, M. Di
Marzo. “Synthesis of deoxybiotinyl hexamethylendiamine-DOTA”.
- International Publication Number/Date: US007816386B2/ 19.10.2010. Inventors: C. Pisano, G.
Battistuzzi, M. Di Marzo, G. Giannini, M. Marzi, L. Vesci, F. Zunino, R. Pezzi. “Cinnamic,
Phenylpropionic and Phenylpropanoic acid derivatives useful as anti-tumour agents”.
- International Publication Number/Date: US008053460B2 / 08.11.2011. Inventors: C. Pisano, G.
Battistuzzi, M. Di Marzo, G. Giannini, M. Marzi, L. Vesci, F. Zunino. “Indole derivatives having antitumour activity”.
Projects
Memberships
Other Relevant Information
Languages:
Mother tongue: Italian
Other languages: English (Good reading, writing, verbal skills)
French (Good reading, writing, verbal skills)
Additional education/training:
- European Pharmacopoeia Training Session on Radiopharmaceutical Preparations"- Strasbourg 25/09/2014.
- Joint Regulators/Industry QbD Workshop, EMA, London. 28-29/01/2014 (partecipation in
preparation of one case study presented)
- Joint Regulators/Industry QbD Workshop, EMA, London. 28-29/01/2014 (partecipation in
preparation of one case study presented)
- V Congresso Nazionale del Gruppo Interdisciplinare di Chimica dei Radiofarmaci - Bertinoro (FC) –
(National Congress on Chemistry of Radiopharmaceuticals), 24-25/05/2013
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Curriculum Vitae
Maria Di Marzo
- Workshop on Paediatric Formulations II. EMA, London. 08/11/2011.
- Giornata di studio teorico-pratica sulla preparazione e usi clinici di radiofarmaci SPECT e PET in
medicina nucleare. Università Cattolica S.Cuore - Policlinico Universitario “A.Gemelli”. Rome.
05/10/2011.
- Training for Assessors (Oncology). 14-25/03/2011. EMA, London.
- TOPRA Annual symposium 2001. Regulatory science and market access to medicines in Europe.
Rome. 13-14/10/2011.
- XVIII Corso Introduttivo di Farmacoepidemiologia. ISS, Rome. 08-12/03/2010.
- Evento ECM: Piano nazionale di farmacovigilanza in corso di pandemia influenzale. AIFA.
22/12/2009.
- ‘Quality by Design’ Training Seminar. EMA, London. 28-29/09/2009.
- Evento ECM: I radiofarmaci: futuro della medicina nucleare (MI) 17/06/2009.
- PIM (Product Information Management) training course. EMA, London 01- 02/07/2008.
- Training of Quality Assessors. EMA, London 19/12/2007.
- PIM (Product Information Management) Train the Trainer training. EMA, London. 15/01/2007 e
12/02/2007.
- PIM simulation Workshop 1 e 2. EMA, London. 21-22/11/2006.
- New Assessors Training. EMA, London. 21-22/11/2006.
- GMP Basic Training. AIFA, Rome. 06-07/11/2006.
- La convalida analitica nel settore farmaceutico. PEC and Pharmades. Pomezia (RM). 0406/10/2006.
- Ricerca Clinica e Innovazione nel Settore Farmaceutico. Rome - 09/05/2006.
- Medicinal Chemistry Summer School - University of Nottingham. 04-08/07/2005.
- Innovative Combinatorial Approaches and Technologies. Practical Training Course in Florence.
University of Florence. 09-11/04/2003.
- XXVI Corso estivo “A. Corbella”- Seminars in Organic Synthesis. Comunicazione orale dal titolo:
“Disegno, sintesi e valutazione farmacologica di nuovi peptidi ad attività cannabinoide” - University of
Milan. 18-22/06/2001.
- V Corso di Spettrometria di Massa per Dottorandi (Mass Spectrometry course for PhS students).
University of Siena. 11-16/03/2001.
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