Head of Department Medical Biology. Head of Sera and Vaccine Department, Assistent Professor

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1 Curriculum vitae PERSONAL INFORMATION Anna Lutyńska WORK EXPERIENCE April 2016 Present Head of Department Medical Biology The Cardinal Stefan Wyszyński Institute of cardiology, Department Medical Biology (Poland) Studies on genetic, immunology and cell markers in the course of cardio-vascular diseases April 2014 March 2016 Head of Sera and Vaccine Department, Assistent Professor Head of Sera and Vaccine Department (Poland) Experience in the national control of vaccines, immunologicals and biologicals within lot release procedures fulfilling norms demanded by Polish Accreditation Centre and EDQM. July 1997 March 2014 Research Associate National Institute of Public Health - National Institute of Hygiene, Department of Sera & Vaccine Evaluation, Warszaw (Poland) Experience in the national control of vaccines, immunologicals and biologicals within lot release procedures fulfilling norms demanded by Polish Accreditation Centre and EDQM. The routine duties cover testing, releasing vaccines and other biopreparations; development, validation and application of methods suitable for measuring the vaccine quality. October 1994 May 1997 Assistant Department of Clinical Microbiology at the Memorial Children s Health Centre, Warsaw (Poland) EDUCATION AND TRAINING May 2011 May 2012 postgraduate trainig in project management research and development Higher School of Economics and Innovation in Lublin (Poland) January 1994 March 1997 PhD National Institute of Hygiene (Poland) January 2004 June 2011 Associate Professor National Institute of Public Health- National Institute of Hygiene, Warsaw (Poland) ADDITIONAL INFORMATION Expertise - vaccinology - vaccine quality testing and evaluation (in vivo and in vitro models) - preclinical studies of vaccines effectiveness - evaluation of biomarkers important in development of cardio-vascular diseases Publications 1. Dzierżanowska D., Gzyl A., Rożynek E., Augustynowicz E., Wojda U., Celińska-Cedro D., Sankowska M., Wadstrom T.: PCR for identification and typing of Helicobacter pylori isolated from children. J Physiol Pharmacol 1996; 47: Gzyl A., Berg D. E., Dzierżanowska D.: Epidemiology of caga/vaca genes in H. pylori strains isolated from children and adults. J Phys Pharmacol 1997; 48: /3/17 European Union, Page 1 / 5

2 3. Rożynek E., Dzierżanowska D., Celińska-Cedro D., Gzyl A., Jeljaszewicz J.: Antimicrobial resistance of H. pylori in Poland. APUA Newsletter 1998; 16: Dzierżanowska D., Murawska B., Patzer J., Gzyl A.: Application of molecular techniques for diagnosis of Helicobacter pylori infections. Mikrobiol Med 1998; 2: Gzyl A., Dzierżanowska D., Rożynek E., Celińska-Cedro D., Dura W., Berg D. E.: PCR-based diagnosis of H. pylori infection in Polish children and adults. J Med Microbiol 1999; 48: Gzyl A., Augustynowicz E.: Technical aspects of random amplified polymorphic DNA (RAPD) technique in genotyping of bacterial strains. Acta Microbiol Pol 1999; 48: Gzyl A., Augustynowicz E., Dzierżanowska D., Rożynek E., Dura W., Celińska-Cedro D., Berg D.E.: Genotypes of Helicobacter pylori in Polish population. Acta Microbiol Pol 1999; 48: Augustynowicz E., Gzyl A., Dzierżanowska D.: Epidemiological studies of HCMV infection in children by restriction analysis of long-pcr products. Acta Microbiol Pol 1999; 4: Wysokińska T., Bucholc B., Kudelski Z., Janaszek W., Banach W., Gzyl A., Słowikowska G., Ślusarczyk J.: Evaluation of combination effect of simultaneous vaccination with DTP and Haemophilus influenzae type b coupled to tetanus carrier. Central Eur J Immunol 1999; 24: Augustynowicz E., Gzyl A., Ślusarczyk J.: Molecular epidemiology survey of toxinogenic Clostridium perfringens strain types by multiplex PCR. Scand J Infect Dis 2000; 32: Gzyl A., Augustynowicz E., van Loo I., Ślusarczyk J.: Temporal nucleotide changes in pertactin and pertussis toxin genes in Bordetella pertussis strains isolated from clinical cases in Poland. Vaccine 2002; 20: Augustynowicz E., Gzyl A., Ślusarczyk J.: Detection of enterotoxigenic Clostridium perfringens with a duplex PCR. J Med Microbiol 2002; 51: Hryniewiecki T, Gzyl A., Augustynowicz E., Rawczyńska-Englert I.: Development of broad-range polymerase chain reaction (PCR) bacterial identification in diagnosis of endocarditis. J Heart Valve Dis 2002; 11: Gzyl A. Augustynowicz E., Rabczenko D., Gniadek G., Ślusarczyk J.: Pertussis in Poland. Int J Epidemiol 2004; 33: Gzyl A., Augustynowicz E., Gniadek G., Dulny G., Rabczenko D., Ślusarczyk J.: Sequence variation in pertussis S1 subunit toxin and pertussis genes in Bordetella pertussis strains used for the whole-cell pertussis vaccine produced in Poland since Efficiency of the DTwP vaccine induced immunity against currently circulating B. pertussis isolates. Vaccine 2004; 22: Augustynowicz E., Gzyl A., Gniadek G., Ślusarczyk J.: Fenotyp i genotyp szczepów z rodzaju Clostridium wytwarzających neurotoksyny botulinowe. Med Dośw Mikrobiol 2003; 55: Augustynowicz E., Gzyl A., Szenborn L., Banys D., Gniadek G., Ślusarczyk J.: Comparison of usefulness of random amplified polymorphic DNA (RAPD) and amplified fragment length polymorphism (AFLP) in epidemiological studies on the nasopharyngeal carriage of nontypeable Haemophilus influenzae. J Med Microbiol 2003; 52: Gzyl A.: Laboratory assessment problems of the efficacy of acellular pertussis vaccines. Przegl Epidemiol 2004; 58: Gzyl. A.: Safety and efficacy of acellular pertussis vaccines. Pediatria Polska 2004; 79: Gzyl A., Gniadek G., Augustynowicz E., Rabczenko D., Husejnow B., Zawadka M., Ślusarczyk J.: Increase in the incidence of pertussis and quality of whole-cell pertussis component of the DTP vaccine produced in Poland. Part I. Potency of DTP vaccine. Przegl Epidemiol 2004; 58: Gzyl A., Gniadek G., Augustynowicz E., Rabczenko D., Husejnow B., Zawadka M., Ślusarczyk J.: Increase in the incidence of pertussis and quality of whole-cell pertussis component of the DTP vaccine produced in Poland. Part II. Consistency of control and production. Przegl Epidemiol 2004; 58: Gzyl A., Augustynowicz E., Gniadek G., Ślusarczyk J.: Potency of pertussis component in the DTP vaccine an overview of three-decade study in Poland. Biologicals 2004; 32: Gzyl A., Augustynowicz E., Mosiej E., Zawadka M, Gniadek G, Nowaczek A, Slusarczyk J.: Amplified fragment length polymorphism (AFLP) versus random amplified polymorphic DNA (RAPD) as a new tools for inter- and intra-species differentiation within Bordetella. J Med Microbiol 2005; 54: Augustynowicz E., Szenborn L., Banyś D., Nowaczek A., Gzyl A., Ślusarczyk J.: Problemy diagnostyczne przy identyfikacji szczepów Haemophilus influenzae kolonizujących jamę nosowogardłową dzieci. Med Dośw Mikrobiol 2005; 57: Augustynowicz E., Nowaczek A., Szenborn L., Banyś D., Gzyl A., Dąbrowski W., Samet A., 6/3/17 European Union, Page 2 / 5

3 Ślusarczyk J.: Badania transmisji szczepów Haemophilus influenzae typu b krążących w populacji dzieci w przedszkolach i domach dziecka. Med Dośw Mikrobiol 2005; 57: Mosiej E., Gzyl A., Ślusarczyk J.; Analiza metodą RAPD genetycznej zmienności szczepów z rodzaju Bordetella. Med Dośw Mikrobiol 2005; 57: Augustynowicz E., Szenborn L., Banyś D., Nowaczek A., Gzyl A., Ślusarczyk J: Diagnostic difficulties in identification of Haemophilus influenzae colonising the nasopharynx of children. Med Dośw Mikrobiol 2005; 57: Mosiej E., Gzyl A., Ślusarczyk J.: Genetic diversity analysis of isolates belonging to Bordetella pertussis, Bordetella parapertussis and Bordetella bronchiseptica species. Med Dośw Mikrobiol 2006; 58: Augustynowicz E., Szenborn L., Samet A., Banyś D., Śledzińska A., Gzyl A., Rybak B., Nowaczek A., Ślusarczyk J: Study on genetic diversity of genes encoding main adhesins among nontypeable Haemophilus influenzae strains isolated from children in Poland. Med Dośw Mikrobiol 2006; 58: Gzyl A., Augustynowicz E., Zawadka M., Rabczenko D., Ślusarczyk J.: Evaluation of whole-cell and acellular pertussis vaccines effectiveness in clearance of experimental B. pertussis infection in mice. Med Dośw Mikrobiol 2007; 59: Gzyl A., Augustynowicz E., Zawadka M., Rabczenko D., Ślusarczyk J.: Analysis of chosen parameters of immuno response in mice immunized with whole-cell or acellular pertussis vaccines and challenged with B. pertussis strains harbouring different ptxs1/prn allele genes combinations. Med Dośw Mikrobiol 2007; 59: Gzyl A., Wojciechowska-Oczko M., Jarząb B., Augustynowicz E., Mosiej E., Ślusarczyk J.: Application of DNA microcarriers for evaluation of mice splenocytes genes expression after immunization with pertussis vaccines and challenged with different B. pertussis strains. Med Dośw Mikrobiol 2007; 59: Augustynowicz E., Szenborn L., Samet A., Śledzińska A., Gzyl A., Kielan A., Ślusarczyk J: Study of genetic diversity of nontypeable Haemophilus influenzae strains isolated from healthy children and patients with infection symptoms. Med Dośw Mikrobiol 2007; 58: Augustynowicz E., Szenborn L., Gzyl A., Ślusarczyk J: Occurrence of potentially invasive nontypeable Haemophilus influenzae strains isolating from children attending day-care centres and orphanages. Med Dośw Mikrobiol 2007; 58: Hallander H., Advani A., Riffelmann M., von Konig C.H.W., Caro V., Guiso N., Mooi F.R., Gzyl A., Kaltfold M.S., Fry N.K., Mertsola J., He Q.: Bordetella pertussis strains circulating In Europe In 1999 to 2004 as determined by Pulsed-Field gel Electrophoresis. J Clin Microbiol 2007; 10: Rogalska J., Augustynowicz E., Gzyl A., Stefanoff P.: Sources of information and knowledge on childhood immunisations among Polish parents. Przegl Epidemiol 2010; 64: Rogalska J., Augustynowicz E., Gzyl A., Stefanoff P.: Parental attitudes towards childhood immunisations in Poland. Przegl Epidemiol 2010; 64: Nowicki M., Kaba J., Mosiej E., Lutyńska A., Augustynowicz E., Rzewuska M. Binek M., Szalus- Jardanow O, Stefańska I., Frymus T. Fingerprinting of Corynebacterium pseudotuberculosis strains using Random Amplified Polymorphic DNA (RAPD) and Amplified Fragment Length Polyporphism (AFLP) techniques. Bull Vet Inst Pulawy 2011, 55, Mosiej E., Augustynowicz E., Zawadka M., Dąbrowski W., Lutyńska A.: Strain variation among Bordetella pertussis isolates circulating in Poland, after 50 years of whole-cell pertussis vaccine use. J Clin Microbiol. 2011; 4: Zawadka M., Polak M., Rabczenko D., Mosiej E., Augustynowicz E., Lutyńska A. Effectiveness of the whole-cell pertussis vaccine produced in Poland against different Bordetella parapertussis isolates in the mouse intranasal challenge model. Vaccine. 2011;29: Kallonen T, Grondahl-Yli-Hannuksela K, Elomaa A, Lutyńska A, Fry NK, Mertsola J, He Q. Differences in the genomic content of Bordetella pertussis isolates before and after introduction of pertussis vaccines in four European countries. Infect Genet Evol 2011, 11: Lutyńska A., Wiatrzyk A., Mosiej E., Zawadka M. Immunogenicity and reactogenicity of acellular pertussis vaccines intended for adolescent and adults. Przegl. Epidemiol., 2011; 65, Krysztopa-Grzybowska K., Brzezińska S., Augustynowicz-Kopeć E., Zwolska Z., Augustynowicz E., Lutyńska A. The capacity of Mycobacterium complex species and M. bovis BCG substrains specific identification implications for optimized PCR-based diagnostics in adverse events following vaccination suspected cases. Pol J Microbiol 2012, 61, Krysztopa- Grzybowska K., Brzezinska S., Augustynowicz-Kopeć E., Polak M., Augustynowicz E., 6/3/17 European Union, Page 3 / 5

4 Lutynska A. Descendant of daughter Brazilian BCG Moreau substarin in Poland. Vaccine 2012, 30, Szaluś-Jordanow O., Chrobak D., Pyrgiel M, Lutyńska A., Kaba J., Czopowicz M., Witkowski L., Kizerwetter-Świda M., Binek M., Frymus T. PFGE and AFLP genotyping of Staphylococcus aureus subsp. anaerobius isolated from goats with Morel's disease. Arch Microbiol He Q, Barkoff AM, Mertsola J, Glismann S, Bacci S; European Bordetella expert group (EUpertstrain); European surveillance network for vaccine-preventable diseases (EUVAC.NET). High heterogeneity in methods used for the laboratory confirmation of pertussis diagnosis among European countries, 2010: integration of epidemiological and laboratory surveillance must include standardization of methodologies and quality assurance. Euro Surveill 2012 Aug 9;17(32). 46. Krysztopa-Grzybowska K, Paradowska-Stankiewicz I, Lutyńska A. The rate of adverse events following BCG vaccination in Poland. Przegl Epidemiol 2012;66(3): Lutyńska A., Mosiej E., Zawadka M., Polak M., Augustynowicz E. The study of genetic variation of Bordetella pertussis strains in the aspect of whooping cough increase rate. Probl Hig Epidemiol 2012, 93, Augustynowicz E., Lutyńska A. Detection of the adventitious agents in the evaluation of vaccine safety. Przegl Epidemiol 2012, 66, Lutynska A., Augustynowicz E., Wiatrzyk A. problems with use of dietary supplements containing probiotics. Probl Hig Epidemiol 2012, 93, Lutyńska A, Krzysztof K, Wysocki MJ. Initiative of introducing the applications of genetics for public health purposes in Poland. Przegl Epidemiol. 2012;66(1): Zawadka M, Lutyńska A. Immunogenicity and reactogenicity of acellular pertussis vaccines intended for adolescent and adults. Przegl Epidemiol. 2012;66(1): Advani A., Hallander H.O., Dalby T., Krogfelt K.A., Guiso N., Njamkepo E., Wirsing von Könnig C.H., Riffelmann M., Mooi F.R., Sandven P., Lutynska A., Fry N.K., Mertsola J., He Q. Pulsed-field gel electrophoresis analysis of Bordetella pertussis isolates circulating in Europe in 1998 to J Clin Microbiol 2013, 51, Krysztopa-Grzybowska K, Brzezińska S, Augustynowicz-Kopeć E, Polak M, Lutyńska A. Multiplex-PCR as an identity assay for Mycobacterium bovis BCG Moreau descendants. Biologicals. 2013, 41, Wiatrzyk A, Polak M, Czajka U, Krysztopa-Grzybowska K, Lutyńska A. Phenotypic and genotypic characterization of probiotic bacterial strains used in medicinal products. Med Dosw Mikrobiol. 2013, 65, Augustynowicz E, Zawadka M, Wiatrzyk A, Rabczenko D, Lutyńska A. The studies of elimination of nontypeable Haemophilus influenzae strains using the animal model of infection. Med Dosw Mikrobiol. 2013, 65, Szaluś-Jordanow O, Chrobak D, Pyrgiel M, Lutyńska A, Kaba J, Czopowicz M, Witkowski L, Kizerwetter-Świda M, Binek M, Frymus T. PFGE and AFLP genotyping of Staphylococcus aureus subsp. anaerobius isolated from goats with Morel's disease. Arch Microbiol. 2013, 195, Zawadka M., Rabczenko D., Lutyńska A. Evaluation of Bordetella pertussis strains toxicity in vitro using CHO cell lines Med. Dosw. Mikrobiol. 2014: 66 : Polak M., Zawadka M., Mosiej E., Rabczenko D., Augustynowicz E., Guiso N., Lutyńska A. Colonization of Bordetella pertussis Clinical Isolates that Differ by Pulsed Field Gel Electrophoresis Types in the Lungs of Naïve Mice or Mice Immunized with the Whole-Cell Pertussis Vaccine Used in Poland. Arch Immunol Ther Exp (Warsz) Oct Polak M., Zawadka M., Mosiej E., Rabczenko D., Augustynowicz E., Lutyńska A. Effectiveness of experimental whole-cell pertussis vaccines in murine model. Med Dosw Mikrobiol. 2014; 66: Sadowska-Krawczenko I., Paprzycka M., Korbal P., Wiatrzyk A., Krysztopa-Grzybowska K., Polak M., Czajka U., Lutyńska A. Lactobacillus rhamnosus GG suspected infection in a newborn with intrauterine growth restriction. Beneficial Microbes 2014; 5: Krysztopa-Grzybowska K., Brzezińska S., Augustynowicz-Kopeć E., Augustynowicz E., Lutyńska A. The PCR-based genomic deletion analysis of the RD-regions in the identification of mycobacteria isolated from adverse events following BCG vaccination or TB suspected cases. Polish Journal of Microbiology 2014; 63: Krysztopa-Grzybowska K., Lutyńska A. Advances in the development of new vaccines against tuberculosis. 100 years after the introduction of BCG. Post Hig Med Dosw 2014, 68: Zawadka M., Mosiej E., Polak M., Krysztopa-Grzybowska K., Moskał B., Rokosz N., Rabczenko D., Augustynowicz E., Lutyńska A. Consistency of Bordetella pertussis vaccine seed strains and 6/3/17 European Union, Page 4 / 5

5 potency of whole cell pertussis vaccine still in use in Poland. Biologicals. 2014; 42: Bart, MJ; Harris, SR; Advani, A; Arakawa, Y; Bottero, D; Bouchez, V; Cassiday, PK; Chiang, CS; Dalby, T; Fry, NK; Gaillard, ME; van Gent, M; Guiso, N; Hallander, HO; Harvill, ET; He, QS; van der Heide, HGJ; Heuvelman, K; Hozbor, DF; Kamachi, K; Karataev, GI; Lan, RT; Lutynska, A. et al. Global Population Structure and Evolution of Bordetella pertussis and Their Relationship with Vaccination. MBIO 2014, 5: e Mayrhofer S., Witz U., Birru FH., Gollan D., Gołoś AK., Kneifel W., Domig KJ. Comparison of the CLSI Guideline and ISO/IDF Standard for Antimicrobial Susceptibility Testing of Lactobacilli. Microb Drug Resist 2014 Jun Mosiej E., Zawadka M., Krysztopa-Grzybowska K., Polak M., Augustynowicz E., Piekarska K., Lutyńska A. Sequence variation in virulence-related genes of Bordetella pertussis isolates from Poland in the period Eur J Clin Microbiol InfectDis.2015;34: van Gent M., Heuvelman C., van der Heide H., Hallander H., Advani A., Guiso N., Wirsing von Kőnig C., Vestrheim D., Dalby T., Fry N., Pierard D., Detemmerman L., Zavadilova J., Fabianova K., Logan C., Habington A., Byrne M., Lutyńska A., Mosiej E., Pelaz C., Gröndahl-Yli-Hannuksela K., Barkoff A., Mertsola J., Economopoulou A., He Q., Mooi F. Analysis of Bordetella pertussis clinical isolates circulating in European countries during the period Eur J Clin Microbiol Infect Dis. 2015:34: Gołoś A., Lutyńska A. Thiomersal- containing vaccines a review of the knowledge. Przegl. Epidemiol. 2015; 69: Njamkepo E et all Global phylogeography and evolutionary history of Shigella dysenteriae type 1, Nature Microbiology March 2016, DOI: /nmicrobiol Mikroewolucja podszczepów BCG: Katarzyna Krysztopa Grzybowska, Anna Lutyńska: Postępy Hig Med Dosw (online), 2016; 70: Lutyńska A., Wiatrzyk A., Postupolski J., Augustynowicz E.: Probiotics as dietary supplements and dietary food for special medicinal purposes. The market, definition, legislation and the reality. Farmacja Polska. 2016, 72, 5, Brodzik K., Augustynowicz E., Korzeniowska-Kowal A., Lutyńska A. Application of the MALDI-TOF for identification of Clostridium perfringens strains. Med. Dośw. Mikrobiol., 2016, 68, Projects Memberships Member to the Committee for Medicinal Products for Veterinary Use (CVMP) Other Relevant Information 6/3/17 European Union, Page 5 / 5