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Alessandra Formica
+34 692 594 834 (mobile)[email protected]
EXPERIENCE
2014 Study DirectorHarlan Laboratories, Inc., Barcelona, Spain
GLP-compliant Preclinical Development, Validation, and main StudiesBioanalytical Determination of drugs, biomarkers, and anti-drug antibodiesthrough Ligand Binding Assays
Main Responsibilities: Design & approve Study Plans; draw up the studyquotation & scheduled timelines; implement the studies; ensure provision ofreagents & materials; analyse, evaluate & interpret study results; elaborate& approve a Report; comply with QA regulations; maintain & verify thelab equipment; build up the Sponsors f́idelity and trust; archive the StudyDocumentation & supporting materials; act as Principal Investigator
Activities: Drawing up Study Plans; ensuring good communication with allthe departments involved; timelines planning; ensuring compliance with QApolicies, SOPs & Study Plans, responding to the QA auditors & keeping theHead of Department regularly apprised; supervising the staff under my direc-tion; supervising compliance with the calibration & maintenance plans of theequipment; contributing to creating a good organisational atmosphere andmotivating personnel with a positive attitude and a constant desire to im-prove; attending training courses or seminars and contributing to the trainingof personnel under my direction; liaise with Sponsors, Scientific and technicalpersonnel participating in the studies, Suppliers, Regulating authorities
2006 - 2013 Staff ScientistIntercell AG, Vienna, Austria
GLP- and GCP-compliant Clinical Development, Validation, and main Studies
My tasks mainly focused on Biostatistics in Clinical Trials under GLP andGCP standards. I was responsible for setting up the Statistical Analysis andreport it in the Statistical Analysis Plans, as well as liaise with external CROs.I developed the Statistical analysis methods for the phase III clinical trials onIXIARO, a vaccine against the Japanese Encephalitis Virus.
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2005 Lab Data ManagerIntercell AG, Vienna, Austria
GLP- & GCP-compliant Clinical Development, Validation, and main Studies
My tasks mainly focused on Setting up a tracking system, assay planning,monitoring assay performance, as well as verification, filing, archiving of assayoutput data (images, raw data, reports) according to GLP guidelines. in-house and on-site trainings. *Performance of serological (PRNT, ELISA) andcellular immune assays for immunogenicity monitoring of clinical trials andproduct release testing. Set-up plaque reduction neutralization assay (PRNT)for use in Phase III Clinical Trial.
2002 - 2004 Technical AssistantIntercell AG, Vienna, Austria
GLP-compliant Clinical Development, Validation, and main Studies
My tasks mainly focused on Set-up GLP/GCP Clinical Monitoring lab: GLPLab Operations; Development/testing of Clinical Database; Qualification andmaintenance of equipment; Writing and reviewing of SOPs and reports; Train-ing of technicians from multiple sites (UK, Germany, Austria, Poland); PBMCisolation; Validation and performance of FACS/ELISPOT/radioactive prolif-eration assays for Phase I/II Clinical Trials
EDUCATION
2004 M.Sc. on Complexity and its interdisciplinary applicationsEuropean School of Advanced Studies in Methods for Management of ComplexSystemsIstituto Universitario di Studi Superiori Pavia, ItalyThesis on Clinical Data Mining techniques
1993 - 2001 Bachelor’s degree in Chemistry, Grade: with HonoursUniversity of Bologna, ItalyThesis on Electrochemical Investigation of benzyl amidic rotaxanes transla-tional dynamics
1992 - 1993 AFS Intercultural 1-year Exchange ProgramHigh School Diploma, Grade: with HonoursSt. Lawrence Central High School, Newfoundland, Canada
SCHOLARSHIPS
1992 AFS Scholarship: tuition for a 1-year exchange program in Canada2004 MSc Scholarship: tuition
PROGRAMMING
R, SPSS, LaTex, SoftmaxPro, Visual Basic
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LANGUAGES
English: Native or bilingual proficiencySpanish: Full Professional proficiencyItalian: Native or bilingual proficiencyGerman: Full Professional proficiencyFrench: Limited working proficiencyGreek: Elementary proficiencyCatalan: Elementary proficiency
JOURNAL PUBLICATIONS
Correlation of protection against Japanese encephalitis virus and JE vaccine(IXIARO) induced neutralizing antibody titersVan Gessel Y, Klade CS, Putnak R, Formica A, Krasaesub S, Spruth M, CenaB, Tungtaeng A, Gettayacamin M, Dewasthaly S.Vaccine. 2011 Aug 11;29(35):5925-31
PATENTS
HCV VaccinationsEurope PCT/AT2006/000166The invention relates to a method for preventing or treating Hepatitis C Virus(HCV) infections, wherein a HCV vaccine comprising an effective amount of atleast one HCV T-cell antigen and a polycationic compound comprising peptidebonds is administered to a human individual bi-weekly at least 3 times.
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