Maria Cristina Galli - EMA

Curriculum Vitae
PERSONAL INFORMATION
Maria Cristina Galli
WORK EXPERIENCE
April 1991 – Present
senior researcher
Istituto Superiore Sanità-Roma, (Italy)
assessment of biotechnology as well as ATMP (gene therapy) dossiers (quality) for clinical trial
authorisation and European market authorisation procedures; GMP-GLP inspections in biotech/ATMP
field
EDUCATION AND TRAINING
September 1972 – December
1976
graduate student-Biology
University Bologna, (Italy)
cell biology/human anatomy/physiology/microbiology/virology/citology/genetics
September 1984 – July 1988
Phd student
Università Roma, (Italy)
experimental medicine, molecular oncology, molecular immunology,
ADDITIONAL INFORMATION
Expertise
gene therapy (quality)
biotechnology (quality)
GMO-ERA assessment
GMP inspection
GLP inspection
Publications
Bragaglia, R.B., Cunsolo, A., Guarasci, N., Maldarizzi, F., Mattioli, S., Grilli, S., Galli, M.C.: Steroid
receptors in benign and malignant human breast diseases. IRCS Med. Sci., 5: 69, 1977.
Grilli, S., Bragaglia, R.B., Cunsolo, A., Guarasci, N., Maldarizzi, F., Ferreri, A.M., Eusebi, V., Galli,
M.C.: Recettori citoplasmatici specifici per ormoni steroidi in affezioni mammarie benigne e maligne, in
tessuto ghiandolare normale e in muscolo pettorale. Min. Chir. 33: 817, 1978.
Galli, M.C., Gola, G., Orlandi, C., Rocchetta, R., Nanni, P., Grilli, S., De Giovanni, C.: Steroid Hormone
binding protein in normal and neoplastic human ovary. IRCS Med. Sci. 6: 418, 1978.
De Giovanni, C., Bercovich, E., Martelli, A., Soli, M., Nanni, P., Grilli, S., Galli, M.C.: Steroid Hormone
binding protein in normal and neoplastic human kidney. IRCS Med. Sci. 6: 419, 1978.
Grilli, S., Galli, M.C., Nanni, P., De Giovanni, C., Prodi, G.: Medroxyprogesterone Acetate (MAP): a
specific tracer in determining progesterone binding protein. IRCS Med. Sci. 6: 420, 1978.
Orlandi, C., Prodi, G., Grilli, S., Rocchetta, R., Gola G., De Giovanni, C., Galli, M.C., Bovicelli, L.:
Recettori nel cancro dell'endometrio. Atti del 59° Congresso Nazionale della Società di Ostetricia e
Ginecologia, 1978 pp. 466-480.
Grilli, S., De Giovanni, C., Galli, M.C., Gola, C., Nanni, P., Orlandi, C., Prodi, G., Rocchetta, R.: Steroid
hormone receptors in neoplastic human ovary. Cancer Treat. Rep. 63: 1186, 1979.
Nanni, P., De Giovanni, C., Grilli S., Galli, M.C.: Lack of correlation between glucocorticoid binding
protein occurrence and in vitro glucocorticoid sensitivity in thymus cells from leukaemic AKR mice.
IRCS Med. Sci. 7: 192, 1979.
Prodi, G., De Giovanni, C., Galli, M.C., Gola, G., Grilli, S., Rocchetta, R., Orlandi, C.: 17-beta-estradiol,
5-alfa-dihydrotestoterone, progesterone and cortisol receptors in normal and neoplastic human
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Curriculum Vitae
Maria Cristina Galli
endometrium. Tumori, 65: 241, 1979.
Grilli, S., De Giovanni, C., Galli, M.C., D'Alessandro, L., Tagariello, C., Grassigli, A., Paparopoli, G.,
Nanni, P., Nicoletti, G., Prodi, G.: The simultaneous occurrence of cytoplasmic receptors for various
steroid hormones in male breast carcinoma and gynaecomastia. J. Steroid Biochem., 13: 813, 1980.
Nanni, P., De Giovanni, C., Galli, M.C., Nicoletti, G., Lollini P.-L., Gobbi, M., Bartoli, S., Grilli, S.:
Glucocorticoid binding protein occurrence and glucocorticoid sensitivity in cells from human acute
lymphoblastic leukaemia. IRCS Med. Sci. 8: 624, 1980.
Nanni, P., De Giovanni, C., Galli, M.C., Nicoletti, G., Lollini, P-L, Gobbi, M., Bartoli, S., Grilli, S.:
Glucocorticoid binding protein determination by different tracers in human leukaemic cells. IRCS Med.
Sci. 8: 625, 1980.
Martelli, A., Soli, M., Bercovich, E., Prodi, G., Grilli, S., De Giovanni, C., Galli, M.C.: Correlation
between clinical response to anti androgenic therapy and steroid hormone receptors in human
prostatic cancers. Urology 16: 245, 1980
Reggiani, A., Bercovich, E., Soli, M., Grilli, S., Galli, M.C.: Le dosage des recepteures hormonaux pour
la DHTR dans la programmation de la therapie du cancer de la prostate. Acta Urol. Belg. 48: 79,
1980.
Prodi, G., Nicoletti, G., De Giovanni, C., Galli, M.C., Grilli, S., Nanni, P., Gola, G., Rocchetta, R.,
Orlandi, C.: Multiple steroid hormone receptors in normal and abnormal human endometrium. J.
Cancer Res. Clin. Oncol. 98: 173, 1980.
Galli, M.C., De Giovanni, C., Nicoletti, G., Grilli, S., Nanni, P., Prodi, G., Gola, G., Rocchetta, R.,
Orlandi, C.: The occurrence of multiple steroid hormone receptors in disease-free and neoplastic
human ovary. Cancer, 47: 1297, 1981.
Nanni, P., De Giovanni, C., Galli, M.C., Grilli, S., Lollini, P.-L., Nicoletti, G., Prodi, G.: Minor
histocompatibility antigens do not enhance BALB/c anti-SV40 TASA response. Brit. J. Cancer, 44:
588, 1981.
Nicoletti, G., Galli, M.C., De Giovanni, C., Grilli, S., Nanni, P., Lollini, P.-L., Bartoli, S., Bassi, P., Prodi,
G.: The simultaneous occurrence of cytoplasmic receptors for steroid hormones in normal and
pathological female breast tissues. IRCS Med. Sci. 9: 445, 1981.
Nanni, P., Nicoletti, G., Prodi, G., Galli, M.C., De Giovanni, C., Grilli, S., Lollini, P-L, Gobbi, M., Cavo
M., Tura, S.: Glucocorticoid receptors and in vitro sensitivity to steroid hormones in human
lymphoproliferative diseases and myeloid leukemia. Cancer, 49: 623, 1982.
Nicoletti, G., Nanni, P., De Giovanni, C., Galli, M.C., Lollini, P.-L., Prodi, G., Bartoli, S., Grilli, S.:
Evidence of the progestin binding protein in mononuclear cells from peripheral blood of patients with
leukemia or normal donors. J. Exp. Clin. Cancer Res. 4: 423, 1983.
Arfellini, G., Bartoli, S., Colacci, A., Mazzullo, M., Galli, M.C., Prodi, G., Grilli, S.: Comparative
interaction of dichloroethane and dibromoethane with rat and mouse nucleic acids. IRCS Med. Sci.,
11: 81, 1983.
Arfellini, G., Bartoli, S., Colacci, A., Mazzullo, M., Galli, M.C., Prodi, G., Grilli, S.: In vivo and in vitro
binding of 1,2-dibromoethane and 1,2-dichloroethane to macromolecules in rat and mouse organs. J.
Cancer Res. Clin. Oncol. 108: 204, 1984.
Santoni, A., Piccoli, M., Velotti, F., Testi, R., Galli, M.C., Herberman, R.B., Frati, L.: Regolazione in vivo
dell'attività citotossica naturale (NK) da parte dell'interferon e di alcuni suoi induttori. Therapeutica, 2:
109, 1985.
Santoni, A., Velotti, F., Testi, R., Galli, M.C., Herberman, R.B., Frati, L.: Mechanisms for in vivo
expansion of natural killer cells. In: Natural immunity cancer and biological response modification, E.
Lotzova e R.B. Herberman Eds., Karger, New York, 1986, pp. 124-130.
Reynolds, C.W., Young H.A., Galli M.C., Ortaldo, J.A.: Analysis of T-cell receptor genes in humans
and rat LGL. Natural Immunity and Cell Growth Regulation, June 1986, pag. 154.
Testi, R., Galli, M.C., Piccoli, M., Herberman, R.B., Frati, L., Santoni, A.: Sequential metabolic events
and morphological changes during in vivo LGL activation and proliferation. Cell. Immunol., 102: 78,
1986.
Stevens, R.L., Otsu, K., Weis, J.H., Tantravahi, R.V. Austen, K.F., Henkart, P.A., Galli, M.C., Reynolds,
C.W.: Cosedimentation of chondroitin sulphate A glycosaminoglycans and proteoglycans with the
cytolytic secretory granules of rat large granular lymphocytes (LGL) tumor cells, and identification of a
mRNA in normal and transformed LGL that encodes proteoglycans. J. Immunol., 139: 868, 1987.
Galli, M.C. Espressione di geni durante l’attivazione in vitro con interleuchina-2 delle cellule natural
killer. 1988. Dissertazione conclusiva, Dottorato di ricerca in Medicina Sperimentale; depositata presso
la Biblioteca Nazionale di Roma e presso la Biblioteca Nazionale di Firenze.
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Curriculum Vitae
Maria Cristina Galli
Santoni, A., Palmieri, G., Procopio, A., Velotti, F., Testi, R., Morrone, S., Galli, M.C., Gismondi, A.,
Paolini, R., Punturieri, A., Giuffrida, A.M., Piccoli, M., Frati, L.: Mechanisms involved in the activation
and function of natural killer cells. Ital. J. Medic., 4: 59, 1988.
Galli, M.C., Smith, M.J., Young, H.A., Reynolds, C.W., Ortaldo, J.R.: Differential regulation of IL-1
genes expression in human CD3- large granular lymphocytes. Cell. Immunol. 131: 184-190, 1990.
Giuffrida, A., Galli, M.C., Gismondi, A., Santoni, G., Piccoli, M., Cavallo, G., Tubaro, E., Frati, L.,
Santoni, A.: Augmentation of mouse natural killer (NK) activity by GM-1/P, a processed form of
monosialoganglioside GM-1. Immunopharmac. Immunotoxic., 12: 545-563, 1990.
Galli, M.C., Giardina, P.J.V., Migliaccio, A.R., Migliaccio, G.: The biology of stem cell factor, a new
hematopoietic growth factor involved in stem cell regulation. Int. J. Clin. Lab. Res., 23: 70-77, 1993.
Crema, A., Fabozzi, G., Galli, M.C.: Sequences homologous to LAR in the upstream promoter of
human globin gene. Experimental Hematology, 21, 1071, 1993.
Galli, M.C., Pini, C.: Norme regolative europee per l’autorizzazione delle specialità medicinali per uso
umano ottenute con procedimenti ad alta tecnologia, incluse le biotecnologie. Notiziario dell’Istituto
Superiore di Sanità, giugno 1994.
Galli, M.C.: GMP progressive implementation in the production of gene therapy products for early
phase clinical trials: a regulatory contribution from Italy”. International Conference on vectors for gene
therapy, Brussels, 1998
Galli, M.C., Cappelli, A.M.: “Farmacopea Europea: guida alla traduzione e glossario di termini utilizzati
nelle monografie dei prodotti biologici e relativi metodi”. Strumenti di riferimento n. 13, ISS, 1999
Galli, M.C.: Gene therapy clinical trials in Italy: regulatory aspects. Abstract book International
Workshop “Gene Therapy early phase clinical trials: Regulations, safety issues and suitability of
preclinical animal models”, 2000, pg11
Galli, M.C.: Garanzia della qualità per le preparazioni allestite in farmacia. Atti del 1° Convegno
Nazionale della S.I.F.A.P.; Notiziario S.I.F.A.P., n.2, maggio-giugno 2001
Galli, M.C.: Aspetti regolatori ed etici della terapia genica. In: Terapia genica, di Lollini, De Giovanni,
Nanni, edito da Zanichelli, ottobre 2001.
Galli, M.C., Carè,A.,Cianfriglia, M., Crescenzi, M., Dogliotti, E., Federico, M., Meneguz, A., testa, U.:
Linee guida sulla sperimentazione di fase I con medicinali sperimentali per terapia genica somatica.
Not. Ist. Super. Sanità 17 (7/8), 15-27, 2004.
Galli, M.C., Sbrenni, S., Neroni, M.: Linee guida per l’attuazione di un sistema di assicurazione della
qualità in un laboratorio di prova. Rapporti ISTISAN 06/6, 2006.
Galli, M.C.: Scientific challenges in gene therapy. In Challenges in New Advanced Therapy, eds.
Nisticò, Papaluca-Amati, Brasseur, Roma, 2008.
Galli, M.C., Neroni M., Sbrenni S.: Role of Proficiency Testing and External Quality Assessment in
building a quality assurance system in regulatory testing laboratories: auditors’ experience. 6th
EURACHEM Workshop on PT/EQA in Analytical Chemistry, Microbiology and Laboratory Medicine,
Roma, 2008.
Galli, M.C., Migliaccio G., Carella C.: “Le sperimentazioni cliniche di fase I dei Prodotti Medicinali per
Terapie Avanzate”, Atti del Workshop “Terapia cellulare e cell factories”, Il Sole 24 ore-Sanità, 2009
Galli, M.C., Regulatory considerations for translating gene therapy: a European Union perspective.
Sci. Transl. Med.1, 6ps6, 2009
The Committee for Advanced Therapies (CAT), Schneider CK, Salmikangas P, Jilma B, Flamion B,
Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B,
Gudmundsson K, O'Donovan M, Migliaccio G, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH,
Hystad M, Fal AM, Lima BS, Moraru AS, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A,
Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R,
Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z,
Macaleenan N, Galli MC, Gulbinovic J, Berchem G, Menezes-Ferreira M, Vilceanu N, Hrubiško M,
Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, Vandendriessche T, Ljungman P,
D'Apote L, Oliver-Diaz O, Büttel I, Celis P., Challenges with advanced therapy medicinal products and
how to meet them. Nat Rev Drug Discov. 2010 Mar;9(3):195-201.
The Committee for Advanced Therapies (CAT), Schneider CK, Salmikangas P, Jilma B, Flamion B,
Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B,
Gudmundsson K, O'Donovan M, Migliaccio G, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH,
Hystad M, Fal AM, Lima BS, Moraru AS, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A,
Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R,
Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z,
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Curriculum Vitae
Maria Cristina Galli
Macaleenan N, Galli MC, Gulbinovic J, Berchem G, Menezes-Ferreira M, Vilceanu N, Hrubiško M,
Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, Vandendriessche T, Ljungman P,
D'Apote L, Oliver-Diaz O, Büttel I, Celis P.,use of unregulated stem-cell based medicinal products. The
Lancet, accepted for publication, 2010
Galli MC.: Regulatory and scientific considerations for the follow up of patients treated with Gene
Therapy Medicinal Products: an EU perspective. Reg.Rap. 2010, vol.7(9),17-19
Galli MC., Todde S.: La classificazione ambientale, Capitolo del libro: la qualità nella preparazione dei
radiofarmaci, a cura di Lucignani, Uccelli, Viglietti, Springer-Verlag editore, 2011
Belardelli F., Rizza P., Moretti F., Carella C., Galli. M.C. e Migliaccio G.: Translational research on
Avanced Therapies, Ann.Ist.Sup.Sanità, 2011. Vol.47, n.1, pg.72-78
Galli, M.C.: Long term follow up of cancer patients treated with Gene Therapy Medicinal Products
2012, Journal of Gene Medicine, DOI: 10.1002/jgm.2638.
Galli, M.C.: Common issues in characterizing and manufacturing cell and gene-based therapies,
Histology and Histopathology, 27,pg.26, 2012
G.Migliaccio, M.C.Galli, “ Nuovi approcci alla medicina traslazionale: aspetti regolatori e scientifici
dello sviluppo di medicinali per terapie avanzate”, (2012) Rapporti ISTISAN 12/37
F.Moretti, M.C.Galli, “Ruolo dell’ISS nei programmi di formazione per la promozione
della ricerca traslazionale in oncologia”, (2012) Rapporti ISTISAN 12/37
Aiuti A., Cossu G., de Felipe P., Galli M.C., Narayanan G., Renner M., Stahlbom A., Schneider C.K.
and Voltz-Girolt C.: The Committee for Advanced Therapies’ of the European Medicines Agency
reflection paper on management of clinical risks deriving from insertional mutagenesis, Human Gene
Therapy Clinical Development 24:47–54 (June 2013)
Galli, M.C.: Regulatory issues in developing advanced therapy medicinal products with stem cells in
Europe, in "Native and induced pluripotent stem cell standardization", in press River Publishers, , 2013
Galli, M.C.: ATMPs for cancer immunotherapy: a regulatory overview, in press Meth.Mol.Biol, 2013
Projects
Memberships
Other Relevant Information
Member of Scientific Editorial Board of the international scientific journal "Human Gene Therapy
Clinical Development"
regularly asked as lecturer in University courses on gene therapy/GMP/GMO issues
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