Alberto Morisetti
born in Milan, 20th February 1954
Master degree in Biological Sciences, 1980
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Professional Association of Italian Biologists,(ONB)
European Registered Toxicologist (ERT)
Italian Society Toxicology (SITOX)
Pharmaceutical Industry Association (AFI)
European Society Toxicology (EUROTOX)
Professional experiences:
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Nonclinical CTD review for NDA, planning and monitoring nonclinical studies (2010 to present)
Due diligence anticancer preclinical projects (2010)
Witness at International Court of Commerce Chamber Zurich (2011)
Peer reviewer for Contrast Media and Molecular Imaging (2012)
Expert opinion for pre IND FDA meeting (2012)
Auditor clinical studies bioequivalence (2012)
Previous experiences:
2008-2009 Cell Therapeutics, Europe Bresso (MI),
Toxicology & Animal Care Director.
In charge of managing Toxicology of oncology projects:
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issuing non clinical development plans in view of regulatory requirements
conducting intramural GLP and exploratory toxicology, and safety pharmacology studies
monitoring extramural GLP studies
reviewing/approving technical documents (protocols, reports, SOPs)
issuing regulatory documents (IB, CTD, IND, etc)
responsibility of Animal Facilities, authorization of Ministry of Health for animal experiments
2006-2008, Bracco Imaging
Head of Pharmatox and Imaging Laboratories at the site of Colleretto Giacosa (TO).
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Group constituted of two Units (PharmaTox and Imaging) each headed by a senior scientist.
PharmaTox comprised of three Laboratory heads and three technicians with the same
functions as in the previous location. Imaging devoted to screening of new molecules for
imaging by magnetic resonance in rodents and efficacy/distribution studies. Comprised of two
scientists, one senior technician. The function refers to the Head of Research Center and
interacts with Quality,Regulatory, Chemistry, Manufacturing.
In charge of Dept budget and organisation of non-clinical development plan of new
compounds, both by performing in-house studies and on contract (CROs, Universities).
Review of study documentation (protocols, amendments, reports) and interactions with Study
Directors, Principal Investigators, Quality Assurance Unit.
In charge of documentation for registration (summaries, Expert Report, IMPD, IB).
Team member/team leader in development teams 1998- 2008.
Frequent interactions with other Company Research Centres in Princeton (US) and Geneva
(Switzerland).
Meetings with health authorities: FDA (2002, 2005), MPA (2004), ISS (2004, 2005) for IND, NDA
meetings.
Responsible for the Research Projects and responsible for the experiments in the authorization
by the Ministry of Health for animal use.
Nonclinical Expert as per Annex I of Directive 2001/83/EC.
1999-2006, Bracco Imaging, Milan
Head of Pharma-Tox Development (group of 20 people) and Head of Test Facility (Direttore Centro di
Saggio)
GLP-compliant Test Facility, recognised by the Italian Ministry of Health, for toxicology,
pharmacology and pharmacokinetics.
Staff (1 Senior scientist, 5 Professionals, 14 technicians) organised in three main Sections:
Toxicology, Pharmacology and Pharmacokinetics. Additionally, a small group of cell biology and
animal models. Service functions: Animal Care Unit, Archives and Documentation/ Regulatory
pharmatox, Secretery.
1988-1999, Bracco SpA, Milan
Head of Toxicology Labs, performing in vivo and in vitro GLP and exploratory safety studies.
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In charge of protocol, reports, SOP supervision, coordination of Study Directors, contribution to
regulatory documentation (Expert Report, IND, etc)
1984-1988: Smith-Kline Beecham Zambeletti Milan
Study Director for general tox, GLP, reporting,
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Head biometrics
1983-1984: Farmitalia-Carlo Erba Research Center
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Study Director for teratology
1981-1983: toxicologist at DOW-Lepetit Research Center in Gerenzano Milan
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general tox, teratology, GLP.
National working groups
- Since year 2004 national roundtable for revision of DL116/92 (pdl5442- on. Schmidt) and subsequent
modifications (pdl C.1842/S.53 on. Della Vedova) as company delegate in Farmindustria
- Since year 2004 company delegate in Federchimica Technical and Scientific Department, Safety, Health
and Environment Service, focused on REACH
PUBLICATIONS
Rosati G., Morisetti A. and Tirone P (1992). Toxicity in animals and safety in humans of contrast media: The
predictive value of animal studies. Toxicology Letters, 64/65. 705-715
Morisetti, A. Tirone, P. Luzzani, F and de Haën C (1994)Toxicological safety assessment of iomeprol, a new
X-ray contrast agent. European Journal of Radiology 18 Suppl 1 S21-S3
Rosati G., Morisetti A. and Tirone P (1994) Tossicità nell'animale e sicurezza nell'uomo. Il valore predittivo
degli studi preclinici Rivista di Neuroradiologia 7: 595-600.
Morisetti, A. La Noce, A. Luzzani, F Preclinical testing results of iomeprol show promise. Diagnostic imaging
Europe, Suppl. June 1995, p.10-14.
Luzzani, F, Morisetti, A. Bussi, S., Tirone P. Neurotolerability of non-ionic X-ray contrast media: the role of
chemotoxicity. Invest Radiol. 31, 6: 338-344, 1996.
Aime, S. Botta, M. Calabi, L. Crich S.G, Morisetti A. and Terreno E. Solution Structures and Relaxometry of
Novel DOTA-like Ln(III) Complexes Featuring Improved Tolerability. Volume 1996 Issue S1 , Pages 1 - 1896
(1996) Supplement: Fourth Scientific Meeting April 27 - May 3, 1996, New York, New York, U.S.A.
Luzzani, F, Morisetti, A., Tirone P. Early and late deaths as a discriminating factor in acute toxicity studies.
Pharmacol. Res 35, Suppl.110; 1997.
Valenti, R. Motta, A. Merlini, S Morisetti, A. Tirone, P. Iopiperidol, a new non-ionic iodinated contrast
medium with promising anticoagulant and antiplatelet properties. Acad. Radiology, 1999.
Chimoto, T. Sagami, F. Morisetti, A. Bussi, S., Tirone P. General toxicity study of gadobenate dimeglumine
(E7155)- single dose intravenous and intracisternal toxicity study in rats. The Journal of Toxicological
Sciences, Vol. 24, Supp. I, 1-6, 1999.
Sekido, T. Sagami, F. Morisetti, A. Bussi, S., Tirone P Masters R.General toxicity study of gadobenate
dimeglumine (E7155)- single dose intravenous toxicity study in dogs. The Journal of Toxicological Sciences,
Vol. 24, Supp. I, 7-18, 1999.
Aoki, T, Sagami, F. Morisetti, A. Bussi, S., Tirone P Masters R.General toxicity study of gadobenate
dimeglumine (E7155) -4-week repeated dose intravenous toxicity study followed by 4-week recovery
period in rats. The Journal of Toxicological Sciences, Vol. 24, Supp. I, 19-39, 1999.
Katsutani, N. Sagami, F. Morisetti, A. Bussi, S., Tirone P. Mandella R. C General toxicity study of gadobenate
dimeglumine (E7155) -4-week repeated dose intravenous toxicity study followed by 4-week recovery
period in dogs. The Journal of Toxicological Sciences, Vol. 24, Supp. I, 41-60, 1999.
Okada, F. Sagami, F. Morisetti, A. Bussi, S., Tirone P, J. K Baguley.Reproductive and development toxicity
study of gadobenate dimeglumine (E7155)- fertility study in male rats by intravenous administration. The
Journal of Toxicological Sciences, Vol. 24, Supp. I, 61-69, 1999.
Kawaguchi,T. Sagami, F. Morisetti, A. Bussi, S., Tirone P. Baguley, J. K. Reproductive and development
toxicity study of gadobenate dimeglumine (E7155)- combined study of effects on fertility and embryo-fetal
toxicity in female rats by intravenous administration. The Journal of Toxicological Sciences, Vol. 24, Supp. I,
71-78, 1999.
Kawaguchi, T. Sagami, F. Morisetti, A. Bussi, S., Tirone P. Baguley, J. K. Reproductive and development
toxicity study of gadobenate dimeglumine (E7155)- study of embryo-fetal toxicity in rabbits by intravenous
administration. The Journal of Toxicological Sciences, Vol. 24, Supp. I, 79-87, 1999.
Hakura, A. Sagami, F. Morisetti, A. Bussi, S., Tirone P. Fassio, F.Mutagenicity study of gadobenate
dimeglumine (E7155)- reverse mutation assays in S. typhimurium and E. Coli tester strains. The Journal of
Toxicological Sciences, Vol. 24, Supp. I, 89-94, 1999.
Toritsuka N; Daimon H; Sawada S; Sagami F; Tirone P; Morisetti A; Bussi S; Adams K. Mutagenicity study of
gadobenate dimeglumine (E7155)- chromosome aberration test with human lymphocytes in culture. The
Journal of Toxicological Sciences, Vol. 24, Supp. I, 95-101, 1999.
Toritsuka N; Daimon H; Sawada S; Sagami F; Tirone P; Morisetti A; Bussi S; Fassio F. Mutagenicity study of
gadobenate dimeglumine (E7155)- micronucleus test in rat bone marrow cells. The Journal of Toxicological
Sciences, Vol. 24, Supp. I, 103-106, 1999.
Mikami, T. Daimon, H. Sagami, F. Morisetti, A. Bussi, S., Tirone P, Yamada, Y. Kimura, H. Goto K. Muscular
irritation study of gadobenate dimeglumine (E7155) in rabbits. The Journal of Toxicological Sciences, Vol.
24, Supp. I, 107-114, 1999.
Morisetti A., Bussi, S. Tirone P. Toxicological safety evaluation of gadobenate dimeglumine 0.5M solution
for injection (MultiHance), a new MRI contrast medium. Journal of Computer Assisted Tomography, 23
(Suppl. 1): S207-S217,1999.
A. Morisetti, G. Alfieri, P. Tirone Effects of non ionic iodinated contrast media on red blood cell morphology.
In vitro study by scanning electron microscopy. Pharmacology and Toxicology, 85 (Suppl II): 29, 1999.
Anelli, P.L., Lattuada, L., Lorusso, V., Lux,G., Morisetti, A., Morosini, P. Conjugates of Gadolinium Complexes
to Bile Acids as Hepatocyte-Directed Contrast Agent Resonance Imaging. Journal of Medicinal Chemistry.
2004, vol. 47, no14, pp. 3629-3641
Bussi, S. Morisetti A., Margins of safety of intravascular contrast media: body weight, surface area or
toxicokinetic approach. Arh Hig Rada Toksikol, Vol. 56, No. 2, 157-160, 2005
Anelli, P.L., Brocchetta M., Lorusso, V., Manfredi G., Morisetti, A., Morosini, P., Murru, M., Visigalli, M. Bile
Acid at Work: Development of a new Intravascular MRI Contrast Agent. Medicinal Inorganic Chemistry"
Chap. 9 - ACS Symposium series 903 edited by JL Sessler et al, 2005
Setti, I. Celeste, R., Mariani G. Dal Fiume, D., Morisetti, A., Lorusso, V. High performance liquid
chromatographic determination of the magnetic resonance imaging contrast agent Gadolcoletate ion in
human plasma, urine and feces. Journal of chromatography B, 835 (2006) 1-15
de Haën, C. Anelli, P.L. Lorusso, V. Morisetti, A. Maggioni, F. Zheng, J. Uggeri, F. Cavagna F.M..Gadocoletic
Acid Trisodium Salt (B22956/1). A New Blood Pool Magnetic Resonance Contrast Agent With Application in
Coronary Angiography. Investigative Radiology, Volume 41, Number 3, March 2006.
Ramponi, S, Grotti, A. Morisetti, A. Vultaggio, S. ,Lorusso V. Effects of iodinated contrast media on
endothelium: an in vitro study. Toxicology in vitro 21(2007): 191-196
Bussi, S. Fouillet, X. Morisetti A..Toxicological assessment of gadolinium release from contrast media.
Experimental and Toxicologic Pathology 58 (2007) 323-330.
Parolini, C, Marchesi, M Lorenzon, P Castano, M Balconi, E Miragoli, L Chaabane, L Morisetti, A Lorusso, V
Martin, B J. Bisgaier, C L. Krause, B Newton, R S. Sirtori, C R. Chiesa, G. Dose-Related Effects of Repeated
ETC-216 (Recombinant Apolipoprotein A-I Milano/ 1-Palmitoyl-2-Oleoyl Phosphatidylcholine Complexes)
Administrations on Rabbit Lipid-Rich Soft Plaques In Vivo Assessment by Intravascular Ultrasound and
Magnetic Resonance Imaging Journal of the American College of Cardiology Vol. 51, No. 11, 2008
Ramponi, S; Rebaudengo, C; Cabella C; Grotti , A; Vultaggio, S; Aime, S; Morisetti, A; Lorusso, V Contrastenhanced MRI of murine sponge model for progressive angiogenesis assessed with gadoteridol (ProHance)
and gadocoletic acid trisodium salt (B22956/1).Journal of magnetic resonance imaging : JMRI
2008;27(4):872-80
POSTERS AND ORAL PRESENTATIONS
European Discussion Group Society of Toxicologic Pathologists. Annual meeting and scientific discussion:
"Safety assessment : regulations, extrapolations and common sense". Dijon, 28-29 November 1991. Oral
communication: "Regulations for preclinical studies on contrast agents in Italy". A. Morisetti.
XXV Congresso nazionale della Società Italiana di Farmacologia. Taormina Giardini Naxos 14-18 October
1990. Poster : "Factors influencing the acute toxicity of paramagnetic contrast agents". A. Morisetti, P.
Tirone.
VI International Congress of Toxicology. Rome, June 28-july 3, 1992. Poster: " The contribution of osmotic
load, volume and time required for administration to the toxicity of X-ray contrast media" A. Morisetti, S.
Bussi, F. Bertani, M. Grandi, P. Tirone and C.de Haën.
XXXV Congresso SIRM. IV Incontro mediterraneo di radiologia. Genova, 8-12 November 1992. Oral
communication: "Iomeprolo, nuovo mezzo di contrasto non-ionico per mielografia. I. Valutazione
preclinica. A. La Noce, A. Morisetti, P.Tirone.
XVIII Congress of the european society of neuroradiology(ESNR). Sweden Stockholm, 8-11 September 1992
. Oral communication: "Iomeprol: a new non-ionic contrast agent for myelography. Preclinical
investigations". A. La Noce, A. Morisetti, P.Tirone.
Xth Annual Scientific Meeting of the European society for magnetic resonance and medicine in biology
(ESMRMB). Rome, 3-6 June 1993. Poster: "Gd-BOPTA/Dimeg: passage through the damaged blood-brain
barrier" A. Morisetti, A. La Noce, M. L. Pelaprat, P. Tirone and C.de Haën.
XVIIIth International congress of Radiology. Singapore, 23-28 January 1994. Oral communication : Iomeprol:
pharmacokinetic interspecies scaling. V. Lorusso, A. Morisetti, P. Tirone and C.de Haën.
Investigative Radiology 1994 Volume 29, Suppl. 2, S108-S110. Proceedings of the Contrast media research
symposium. San Antonio, Texas October 3-8 1993. "The factor time in acute intravenous toxicity studies of
contrast media". C.de Haën, A. Morisetti, F. Bertani, and P. Tirone .
XXXVI Congresso nazionale SIRM (Associazione italiana di radiologia medica). Milano 21-25 May 1994.
Poster: Iomeprolo. La tollerabilità sistemica e la neurotollerabilità." A. Morisetti, P. Gastaldi and P. Tirone.
X Congresso nazionale Società Italiana di Tossicologia. Pavia, 21-24 September 1994. Poster: "
Neurotollerabilità dei mezzi di contrasto. Ruolo del volume, dell'osmolalità e del punto di
somministrazione. S. Bussi, P. Gastaldi, A. Morisetti , P. Tirone.
XIth Annual Scientific Meeting of the European society for magnetic resonance and medicine in biology
(ESMRMB). Wien, 20-24 April 1994 Poster: "Compatibility of Gd-BOPTA/Dimeg with human blood . In vitro
study" R. Valenti, A. Morisetti, P. Tirone.
VIth International Congress of Nephrotoxicity and Carcinogenicity. Noordwijkerhout, the Netherland, 22 24 September 1994. Poster and invited lecture: Renal Histology after Single Dose of Iodinated Contrast
Media in Mice. Comparison between Monomers and Dimers. A. Morisetti, S. Bussi, G. Alfieri and P. Tirone.
Rontgen centenary congress. 100 years of X-rays. Birmingham, UK, 12-16 June 1995. Oral communication:
Non-ionic contrast media: preclinical toxicity data and human safety. A. Morisetti, V. Lorusso and P. Tirone.
First Conjoint Postgraduate Course , International Uroradiology '96, Zurich, Switzerland, 14-20 June 1996.
Invited paper: "Renal responses in the rat after single intravenous injection of monomeric and dimeric
contrast media. The role of osmolality." Morisetti A, Alfieri G and Tirone P. Bracco SpA, Milano Research
Center.
Seminar on renal physiology and contrast agents, Visby, Gotland 19-20 September, 1996 Invited paper"
Renal tubular cell vacuolisation after injection of iodinated monomeric and dimeric contrast media .
Preclinical findings". A. Morisetti, G. Alfieri, V Lorusso, P. Lorenzon and P.Tirone.
47th annual general & scientific meeting. The Royal Australasian College of Radiologists". Perth (Aus) 5-9
October 1996. Oral communication: Scanning Electron Microscopy in Safety Assessment of Contrast Media.
Effects of Non Ionic Contrast Media on Red Blood Cells. Morisetti A, Alfieri G and Tirone P.
Renal contrast retention and histological pictures after injection of non ionic monomeric and dimeric X-ray
contrast media. Preclinical findings. 9th Congress ASEAN Association of Radiology & 6th
Scientific Meeting, Singapore Radiological Society. Singapore, 23-26 January 1997. A. Morisetti, V Lorusso,
G. Alfieri, P. Lorenzon and P.Tirone.
POSTER. QT Regulatory requirements to be suited to compounds. The case of MultiHance. M. Castano, A.
Morisetti. EPHAR 2004 Porto, 14-17 July 2004
POSTER Vascular endothelial permeability of paramagnetic contrast media an in vitro model. S. Ramponi,
M. Castano, A. Grotti, A. Morisetti, S. Vultaggio, V. Lorusso. EPHAR 2004 Porto, 14-17 luglio 2004
Margins of safety of intravascular contrast media: body weight, surface area or toxicokinetic approach. S.
Bussi, A. Morisetti. CROTOX 2004 Plitvice Lakes (Croatia), 26-28 May 2004
POSTER. Toxicity of reproduction for in vivo diagnostics suitability of recent FDA proposal. A.Morisetti, S.
Bussi) CROTOX 2004, Plitvice Lakes (Croatia), 26-28 May 2004
Comparison of three different anaesthetic combinations in rats and mice. S. Ramponi, M. Castano, T.
Fiorillo, A. Grotti, M. Laucello, L. Tassielli, A. Morisetti. Proceedings of the 8th FELASA Symposium 17-20
June 2002, Aachen, Germany
POSTER. Efficacy of Tramadol in pain control and welfare improvement in a rat model of chronic arthritis.(S.
Ramponi, C. Cabella, A. Grotti, P. Landsberg, A. Morisetti, C. Rebaudengo, S. Vultaggio, V. Lorusso).9th
Felasa Symposium, Nantes 14-17 giugno 2004.
POSTER. An in vitro model to assess the endothelial permeability of paramagnetic contrast media. S.
Ramponi, A. Grotti, A. Morisetti, S. Vultaggio, V. Lorusso. 10th International Congress of Toxicology,
Tampere 11-15 luglio 2004.
The Radiological Society of North America, Chicago, Nov 28-Dec 3, 2004. High-Concentration Iomeprol in CT
Angiography: Vessel Enhancement in Anaesthetised Swines. C. Catalano, A. Napoli, A.Morisetti, M. Castano,
M de Rubeis, R. Passariello
POSTER. Influence of paramagnetic contrast media an endothelial permeability and morphology: an in vitro
model. S. Ramponi, A. Grotti, S. Vultaggio, A. Morisetti, G. Alfieri, V. Lorusso.
Oral communication: Cardiovascular Safety Pharmacology: un approccio integrato. A. Morisetti, S. Bussi.
XIV Congresso Nazionale della Società Italiana di Tossicologia. Istituto Superiore di Sanità, Roma, 6-9
febbraio 2006
Oral communication: Valutazione preclinica dei radiofarmaci: considerazioni e proposte sulla draft guidance
FDA. S. Bussi, A. Morisetti. . XIV Congresso Nazionale della Società Italiana di Tossicologia(SITOX). Istituto
Superiore di Sanità, Roma, 6-9 febbraio 2006
Oral communication: Imaging preclinico: un approccio innovativo a Reduction & Refinement.Convegno
Federchimica “R.E.A.Ch. e Metodi Alternativi: applicazioni e partnership pubblico-private. Milano, 21-22
Novembre 2006.
POSTER: Nonclinical Imaging: a novel approach to Reduction and Refinement. A. Morisetti, S. Bussi, L.
Chaabane, M. Castano. 44th CONGRESS OF THE EUROPEAN SOCIETIES OF TOXICOLOGY. Amsterdam, The
Netherlands, 7-10 October 2007
POSTER: Lu-AMBA, A Novel Compound For The Treatment of GRP-r Expressing Cancers: Preclinical Safety
Assessment. S. Bussi, A. Morisetti. Toxicology Letters Volume 172, Supplement 1, 7 October 2007, Pages
S38-S39 Abstracts of the 44th Congress of the European Societies of Toxicology.
Oral communication: Gd determination in rats’ organs upon i.v. administration of Gd-chelates and GdAcetate. Contrast Media Research, Banff, Canada, 16-20 October 2007.
Oral communication : Nonclinical imaging: ricerca e sviluppo tossicologico. XVI Congresso Nazionale della
Società Italiana di Tossicologia(SITOX). Taormina (ME) 21-23 Marzo 21012