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Curriculum vitae PERSONAL INFORMATION Kerstin Wickström WORK EXPERIENCE February 1992–June 2000 Scientist, Project Leader, Manager Pharmacia Ophthalmics, Pharmacia Pharmaceuticals, Pharmacia & Upjohn, Pharmacia Corporation (Sweden) Research, development mainly ophthalmology. September 2000–Present Clinical assessor, Senior Expert, Delegate SAWP Medical Products Agency (Sweden) Assessment of MAA, Scientific advice (national, CHMP), Clinical Trials applications. Mainly ophthalmology. EDUCATION AND TRAINING January 1987–January 1992 Ph.D. University of Uppsala (Sweden) Ocular inflammation, biomarkers, non-clinical models ADDITIONAL INFORMATION Expertise Ophthalmology, Clinical Trials, Drug development, Some non-clinical, assessment of MAAs, scientific advice/protocol assistance. Delegate SAWP for ophthalmology Publications Wickström K, Betnér I 1991: Analysis of polyamines and their acetylated forms with 9fluorenylmethylchloroformate and reversed phase HPLC. J Liq Chromatogr 14, 675-698. Wickström K, 1991: Polyamines in rabbit aqueous humor after surgical trauma to the eye. Curr Eye Res 10, 463-469. Wickström K, Carlsson AC, Larsson B, Selén G, Lindqvist C, 1991: Ionizing radiation prevents posterior capsule opacification. TSL/ISV-91-0050; ISSN 0284-2769. Wickström K, 1992: Polyamine and histopathological changes after unilateral endotoxin-induced uveitis and its contralateral effects. Acta Ophthamol 70, 506-514. Wickström K, Lundgren B, Törngren L, Östberg C, 1992: Aqueous humor polyamines and alkaline phosphatase activity in endotoxin-induced uveitis: Correlations to diverse leukocyte subsets. Ophthalmic Res 24: 175-180. Wickström K, 1992: Thesis: Aqueous humor polyamines in the acute phase ocular inflammatory response, University of Uppsala. Wickström K, Madsen K 1993: The effect of transforming growth factor -alpha (TGFalpha) on rabbit and primate lens epithelial cells in vitro. Curr Eye Res 12:1123-1128. Laurell CG, Wickström K, Zetterström C, Lundgren B 1997 Inflammatory response after endocapsular phacoemulsification or conventional extracapsular extraction in the rabbit eye. Acta Ophthalmol Scand 75:401-404. Wallentin N, Wickström K, Lundberg C 1998 Cataract surgery in the rabbit affects TGF-ß and lens epithelial cell proliferation in vitro. Invest Ophthalmol Vis Sci. Invest Ophthalmol Vis Sci 39:1410-1418. Nishi O, Nishi K, Wickström K 2000 Preventing lens epithelial cell migration using intraocular lenses with sharp rectangular edges. J Cataract Refract Surg. 26:1543-1549 Wickström K, 2008 Acute bacterial conjunctivitis--benefits versus risks with antibiotic treatment. Editorial Acta Ophthalmol. 86:2-4. Nichols K et al., The International Workshop on Meibomian Gland Dysfunction. Report of the Clinical Trials Subcommittee IOVS 2011 52: 2065-2085. 17/10/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 1 / 3 Curriculum vitae Kerstin Wickström Author of several additional conference abstracts Projects 1996 Organizer of Ophthalmological workshop JERMOV (Ophthalmology conference) 1996 Industrial representative/coordinator for EU-application, Ophthalmology 1997 Organizer of Ophthalmological workshop at ARVO (Ophthalmology conference) 2008-2009 Expert Group, Need for non-human primates in biomedical research. SCHER, EU Commission 2009-2010 CHMP ad hoc group Preservatives in eye drops 2009-2011 Workshop Meibomian Gland Dysfunction, Tear Film & Ocular Surface Society 2010 Advisor for academic, observational trial (Depts of Ophthalmology, Västmanlands sjukhus, Västerås and University Hospital, Örebro, Sweden) evaluating quality of life in subjects with diabetic macular oedema. 2011-2012 CHMP ad hoc group Phosphate buffers in eye drops 2011 Co-organiser EU Regulatory Workshop – Ophthalmology, EMA, London Memberships 2008- Referee Acta Ophthalmologica 2009-2013 Member of Tear Film & Ocular Surface Societies Medical & Scientific Advisory Board Selected invitations as speaker/lecturer/panelist (since start at the MPA): Non-clinical testing of biotechnology products, BIRA & ESRA Biotech Workshop, London 2003 Working with the regulators at a pre-clinical stage: A regulatory authority perspective, Biologics Safety, London 2003 Early development of antibody therapy, a regulatory perspective. Karolinska Institutet, Stockholm, 2004 Lecturer, Approval procedures/Regulatory Pharmaceutical Education, University of Uppsala, 20062011 Active metabolites. Swedish Academy of Pharmaceutical Sciences, Mölndal, 2004 Positive or negative opinion? Medical Products Agency and ophthalmological drugs. Swedish Ophthalmological Society Annual Meeting, Växjö, 2007 Pharmacological treatment of children with glaucoma. The Swedish Society of Medicine Annual Meeting, Stockholm 2007 Clinical Research in Europe, International Society of Ocular Pharmacology & Therapeutics, Budapest 2008 Endpoints in clinical trials – the EU view & Medical Devices in Europe, International Society of Ocular Pharmacology & Therapeutics, Rome 2009 Expert panel, Meibomian gland dysfunction Regulatory Meeting, Tear Film & Ocular Surface Society, 2010 Clinical trials in meibomian gland dysfunction, World Ophthalmology Congress, Berlin 2010 Endpoints in clinical trials, International Society of Ocular Pharmacology & Therapeutics, Macau 2010 and Vienna 2011 “Generic” eye drops. Swedish Ophthalmological Society, Glaucoma section Annual Meeting, Stockholm 2012 The Global Ophthalmic Regulatory Environment: The Pathway from Innovation to Approval - Panelist, Ophthalmology Futures, Amsterdam 2013 Presenter of several conference abstracts within the area of ophthalmology 1993-2000 Other Relevant Information Summary of selected additional courses/assignments: 1993 Project Management, Wenellgruppen, Bro, Sweden 1996 Industrial Pharmaceutical Development, Swedish Academy of Pharmaceutical Sciences 1996 Fundamentals of Biochemistry, Centre Professional Advancement, Haag 1996 Fundamentals of Molecular Biology & Genetic Engineering, Centre Professional Advancement, 17/10/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 2 / 3 Curriculum vitae Kerstin Wickström Haag 1997 Manager and Leader in Pharmacia & Upjohn, Krusenberg, Sweden 1998 Research Project Management, Pharmacia & Upjohn, Sweden 2003 Ophthalmology, Medical school, S:t Erik’s Eye Hospital, Sweden 2006 Glaucoma, Institute for Professional Education for Medical Doctors, Stockholm 2008-2009 Pharmaceutical medicines, Karolinska Institute, Stockholm, Sweden 17/10/16 © European Union, 2002-2015 | http://europass.cedefop.europa.eu Page 3 / 3
