Curriculum Vitae

PERSONAL INFORMATION Jessica Mwinyi

WORK EXPERIENCE

November 2016- Present Clinical Assessor Medical Products Agency (Sweden) Clinical Assessor for the approval of therapeutics in Sweden and the EU

May 2014- Present Assoc.Prof./lecturer and senior researcher Uppsala University (Sweden) Supevisor/Co-supervisor to several PhD- and Master's students Student teaching Resarch areas: Pharmacoepidemiolgical studies including pharmacogenetic and -epigenetic data for therapy outcome prediction in neuropsychiatric diseases (migraine, depression) and obesity associated diseases (hypertension, diabetes, NAFLD)

October 2008-April 2014 Lecturer, scientist and physician University of Zurich, UniversitätsSpital Zurich (Switzerland) scientific co-supervsion of PhD- and Masters students Research: the microRNA dependent regulation of drug and bile acid transporters Teaching

January 2011-March 2012 Physician University Hospital Zurich, Department of Gastroenterology and Hepatology (Switzerland) Study physician in pharmaceutical industry driven phase III studies in the area of inflammatory bowel diseases Academically driven epidemiological studies on IBD risk and IBD treatment outcome prediction

September 2005-September 2008 Physician Karolinska Hospital (Sweden) Advisory work in treatment optimisation in the Stockholm area Therapeutic drug monitoring Study physician in pharmaceutical industry driven phase I studies at the Karolinska Trial Alliance (KTA), Stockholm, Sweden

May 2007-October 2007 Physician Karolinska Hospital, Department of Neurology (Sweden) Clinical rotation to the Department of Neurology, Karolinska Hospital patient care

April 2004-October 2010 PhD student Karolinska Institutet (Sweden) Experimental and clinical research on the pharmacogenetics and transcriptional regulation of the CYP2C family

August 2003-March 2004 Associate Study Director (Physician) 3ClinicalResearch AG, Berlin, therapeutical research competence center, now Parexel)

30/12/2020 European Medicine Agency Page 1/6 (Germany) Performance of pharmaceutical industry driven phase I-III clinical studies according to GCP guidelines: Inclusion and supervision of healthy volunteers and of patients with hepatitis, HIV and asthma

June 2002-July 2003 Physician Institute of Clinical Pharmacology, Charité, Berlin, Germany (Germany) Research: The impact of CYP1A1, GSTM1 and GSTT1 polymorphisms on susceptibility to pharyngeal cancer (topic of M.D. thesis) The impact of OATP-C polymorphisms on the pharmacokinetics of pravastatin

Therapeutic drug monitoring Teaching

January 2002-June 2003 Physician Internal Medicine, Dep. of Nephrology, Charité, Berlin (Germany) Clinical rotation to the Department of Nephrology, Charité, Berlin patient care

EDUCATION AND TRAINING

April 2014- Present Assoc. Prof./lecturer in Clinical Pharmacology Uppsala University (Sweden) Assoc. Professor (swedish "lektor i klinisk farmakologi") obtained in February 2016 at Uppsala University

October 2008- Present Lecturer in Clinical Pharmacology () Since May 2013 Lecturer (german: "Privatdozentin, Klinische Pharmakologie"), obtained at the University of Zurich, Switzerland

January 2002-May 2008 Medical Specialist in Clinical Pharmacology Deutsche Ärztekammer Berlin (Germany) Specialist in Clinical Pharmacology obtained in Berlin, Germany, May 2008 Specialist in Clinical Pharmacology acknowledged by the BAG (Switzerland) and the Socialstyelsen (Sweden) in 2010

April 2004-October 2010 PhD in Molecular Genetics Karolinska Institutet (Sweden) PhD studies at the Karolinska Institutet Stockholm, Sweden Title of the PhD thesis: CYP2C19 and CYP2C9: New aspects of pharmacogenetics and transcriptional regulation

October 2001-July 2007 M.Sc. Bioinformatics Free University of Berlin (Germany) Studies of Bioinformatics Title of the Master thesis: Evolution of the CYP2C family: Impact on functional divergence and pharmacogenetics a bioinformatical study approach

September 1995-November 2001 Graduation as physician (Staatsexamen) Charité, Humboldt University Berlin (Germany)

30/12/2020 European Medicine Agency Page 2/6 Medical studies at the free University Berlin, Humboldt University Berlin, Germany, at the Basildon University Hospital, Basildon (Essex), U.K. (2 months), and at the Karolinska Institute, Stockholm, Sweden (6 months)

January 2001-May 2004 MD Thesis Charité, Humboldt University Berlin (Germany) Thesis title: Assoziation von genetischen Polymorphismen des Cytochrom P450 1A1 (CYP1A1) sowie der Glutathiontransferasen M1 (GSTM1) und T1 (GSTT1) zum Risiko des Pharynxkarzinoms

ADDITIONAL INFORMATION

Expertise Clinical Assessor at the Swedish Medical Products Agency (focus vaccines) Pharmacogenetics and -epigenetics Pharmacoepidemiology Therapy efficacy and safety evaluation Clinical Trial Management Biostatistics

Publications a. Peer-reviewed original articles: 1. Ciuculete DM, Voisin S, Kular L, Jonsson J, Rask-Andersen M, Mwinyi J, Schiöth HB. meQTL and ncRNA functional analyses of 102 GWAS-SNPs associated with depression implicate HACE1 and SHANK2 genes. Clin Epigenetics. 2020 Jul 2;12(1):99. doi: 10.1186/s13148-020-00884-8. 2. Ciuculete DM, Voisin S, Kular L, Welihinda N, Jonsson J, Jagodic M, Mwinyi J, Schiöth HB. Longitudinal DNA methylation changes at MET may alter HGF/c-MET signalling in adolescents at risk for depression.Epigenetics. 2020 Jun-Jul;15(6-7):646-663. doi: 10.1080/15592294.2019.1700628 3.Pisanu C, Lundin E, Preisig M, Gholam-Rezaee M, Castelao E, Pistis G, Merikangas KR, Glaus J, Squassina A, Del Zompo M, Schiöth HB, and Mwinyi J (2019) Major depression subtypes are differentially associated with migraine subtype, prevalence and severity. Cephalalgia. 2020 Apr;40(4):347-356. doi: 10.1177/0333102419884935 4.Kanders SH, Pisanu C, Bandstein M, Jonsson J, Castelao E, Pistis G, Gholam-Rezaee M, Eap CB, Preisig M, Schiöth HB, and Mwinyi J (2019) A pharmacogenetic risk score for the evaluation of major depression severity under treatment with antidepressants. Accepted for publ. in Drug Development Research 5.Syk M, Ellström S, Mwinyi J, Schiöth HB, Ekselius L, Ramklint M, Cunningham JL. (2019) Plasma levels of leptin and adiponectin and depressive symptoms in young adults. Psychiatry Res. 2019 Feb;272:1-7 6.Boström AE, Chatzitoffis A, Ciuculete DM, Flanagan JN, Krattinger R, Bandstein M, Mwinyi J, Kullak-Ublick GA, Görts Öberg K, Arver S, Schiöth HB, Jokinen J. (2019) Hypermethylation-associated downregulation of microRNA-4456 in hypersexual disorder with putative influence on oxytocin signaling: A DNA methylation analysis of miRNA genes. Epigenetics. 2019 Sep 22:1-16. 7.Skuladottir GV, Oskarsdottir H, Pisanu C, Sjödin M, Lindberg J, Mwinyi J, Schiöth HB. (2018) Plasma stearoyl-CoA desaturase activity indices and bile acid concentrations after a low-fat meal: association with a genetic variant in the FTO gene. Diabetes Metab Syndr Obes. 2018 Oct 9;11:611-618 8.Ciuculete DM, Boström AE, Tuunainen AK, Sohrabi F, Kular L, Jagodic M, Voisin S, Mwinyi J, Schiöth HB. (2018) Changes in methylation within the STK32B promoter are associated with an increased risk for generalized anxiety disorder in adolescents. J Psychiatr Res. 2018 Jul;102:44-51. doi: 10.1016/j.jpsychires.2018.03.008. 9.Pisanu C, Preisig M, Castelao E, Glaus J, Cunningham JL, Del Zompo M, Merikangas KR, Schiöth HB and Mwinyi J (2017) High leptin levels are associated with migraine with aura.

30/12/2020 European Medicine Agency Page 3/6 Cephalalgia. 2017 Apr;37(5):435-441. 10. Xu J, Boström AE, Saeed M, Dubey RK, Waeber G, Vollenweider P, Marques-Vidal P, and Mwinyi J*, Schiöth HB* (2017, shared last author) A genetic variant in the catechol-O-methyl transferase (COMT) gene is related to age-dependent differences in the therapeutic effect of calcium-channel blockers. Medicine (Baltimore). 2017 Jul;96(30):e7029. 11.Pisanu C, Preisig M, Castelao E, Glaus J, Pistis G, Squassina A, Del Zompo M, Merikangas KR, Waeber G, Vollenweider P, and Mwinyi J*, Schiöth HB* (2017, shared last author) A genetic risk score is differentially associated with migraine with and without aura. Hum Genet. 2017 Aug;136(8):999-1008. 12.Boström AE, Ciuculete DM, Attwood M, Krattinger R, Nikontovic L, Titova OE, Kullak-Ublick GA, Mwinyi J, Schiöth HB. A MIR4646 associated methylation locus is hypomethylated in adolescent depression. J Affect Disord. 2017 Oct 1;220:117-128. 13.Mwinyi J, Boström A, Fehrer I, Othman A, Waeber G, Marti-Soler H, Vollenweider P, Marques-Vidal P, Schiöth HB, von Eckardstein A, Hornemann T. Plasma 1-deoxysphingolipids are early predictors of incident type 2 diabetes mellitus. PLoS One. 2017 May 4;12(5):e0175776. 14.Mwinyi J*, Pisanu C*, Castelao E, Stringhini S, Preisig M, and Schiöth HB (2017) Anxiety disorders are associated with low socioeconomic status in women but not in men. Women's Health Issues. 2017 May - Jun;27(3):302-307. 15.Ciuculete DM, Boström AE, Voisin S, Philipps H, Titova OE, Bandstein M, Nikontovic L, Williams MJ, Mwinyi J and Schiöth HB (2017) A methylome-wide mQTL analysis reveals associations of methylation sites with GAD1 and HDAC3 SNPs and a general psychiatric risk score Transl Psychiatry. 2017 Jan 17;7(1):e1002. 16.Mwinyi J, Boström A, Pisanu C, Murphy SK, Erhart W, Hampe J, Moylan C and Schiöth HB (2016) Identification of system specific NAFLD dependent methylation-transcription changes in gene networks controlling lipid metabolism, energy expenditure and vitamin D homeostasis. BBA Molecular and Cellbiology of Lipids. 17. Ciuculete D.M., Bandstein M., Benedict C., Waeber G., Vollenweider P., Lind L., Schiöth HB, and Mwinyi J. (2016) A Genetic Risk Score is Significantly Associated with Statin Therapy Response in the Elderly Population. Accepted for publication in Clinical Genetics. 18. Skuladottir GV, Nilsson EK, Mwinyi J, and Schiöth HB (2016), One-night sleep deprivation induces changes in the DNA methylation and serum activity indices of stearoyl-CoA desaturase in young healthy men. Lipids in Health and Disease 2016 Aug 26;15(1):137. 19. Schiöth HB, Boström A, Murphy HK, Moylan C and Mwinyi J (2016) Non-alcoholic fatty liver disease induces shifts in the methylation and transcription of genes involved in bile acid homeostasis and drug metabolism. BMC Genomics. 17:462. 20. Nilsson EK, Boström A, Mwinyi J and Schiöth HB (2016) The effects of sleep deprivation on genome wide DNA methylation profiles and RNA expression. OMICS. 20(6):334-42. 21. Krattinger R, Boström A, Lee SM, Thasler WE, Schiöth HB, Kullak-Ublick GA, Mwinyi J (2016) Bile acids induce profound changes in the expression of microRNAs and of genes involved in lipid, bile acid and drug metabolism. Life Sciences. 156:47-56. 22. Krattinger R, Boström A, Schiöth H, Thasler W, Mwinyi J and Kullak-Ublick G (2016) MicroRNA- 192 suppresses the expression of the farnesoid X receptor. American Journal of Physiology - Gastrointestinal and Liver Physiology. 310(11):G1044-51 23. Boström A, Mwinyi J, Voisin S, Wu W, Schultes B, Zhang K and Schiöth HB (2016) Genomewide methylation approach reveals novel CpG sites associated with essential hypertension. BMC Medical Genomics. 9:20. 24. Bandstein M, Mwinyi J, Ernst B, Thurnheer M, Schultes B and Schiöth H (2016) A genetic variant in proximity to the gene LYPLAL1 is associated with lower hunger feelings and increased weight loss following Roux-en Y gastric bypass surgery. Scandinavian Journal of Gastroenterology. 51(9):1050-5 25. Bandstein M, Voisin S, Nilsson EK, Schultes B, Ernst B, Thurnheer M, Benedict C, Mwinyi J, Schiöth H (2016) A genetic risk score is associated with weight loss following Roux-Y gastric bypass

30/12/2020 European Medicine Agency Page 4/6 surgery. Obesity Surgery. Sep;26(9):2183-2189 26. Nilsson EK, Ernst B, Voisin S, Sällman Almén M, Benedict C, Mwinyi J, Fredriksson R, Schultes B and Schiöth HB (2015) Roux-en Y gastric bypass surgery induces genome-wide promoter-specific changes in DNA methylation in whole blood of obese patients. PlosOne. 10(2):e0115186. 27. Manser CN, Frei P, Grandinetti T, Biedermann L, Mwinyi J, Vavricka SR, Schoepfer A, Fried M, Rogler G; Investigators of the Swiss IBD Cohort Study (2014) Risk factors for repetitive ileocolic resection in patients with Crohn's disease: results of an observational cohort study. Inflamm Bowel Dis. 20(9):1548-54. 28. Protic M, Seibold F, Schoepfer A, Radojicic Z, Juillerat P, Bojic D, Mwinyi J, Mottet C, Jojic N, Beglinger C, Vavricka S, Rogler G and Frei P (2014) The effectiveness and safety of rescue treatments in 108 patients with steroid-refractory ulcerative colitis with sequential rescue therapies in a subgroup of patients. J Crohns Colitis pii: S1873-9946(14)00176-7. 29. Schaffner CA, Mwinyi J, Gai Z, Thasler WE, Eloranta JJ and Kullak-Ublick GA (2014) The organic solute transporters alpha and beta are induced by hypoxia in human hepatocytes. Liver Int. doi: 10.1111/liv.12558. 30. Mwinyi J, Vokinger K, Jetter A, Breitenstein U, Hiller C, Kullak-Ublick GA and Trojan A (2014) Impact of variable CYP genotypes on breast cancer relapse in patients undergoing adjuvant tamoxifen therapy. Cancer Chemother Pharmacol. 73(6):1181-8. 31. Biedermann L, Zeitz J, Mwinyi J, Sutter-Minder E, Rehman A, Ott SJ, Steurer-Stey C, Frei A, Frei P, Scharl M, Loessner MJ, Vavricka SR, Fried M, Schreiber S, Schuppler M and Rogler G (2013) Changes in human gut microbiota composition after smoking cessation. PLoS One 8(3): e59260. 32. Biedermann L, Mwinyi J, Scharl M, Frei P, Zeitz J, Kullak-Ublick G, Vavricka SR, Fried M, Weber A, Humpf HU, Peschke S, Jetter A, Krammer G, and Rogler G (2013) Bilberry ingestion improves disease activity in mild to moderate ulcerative colitis: an open pilot study. J Crohns Colitis. 7(4):271-9. 33. Attinkara R, Mwinyi J, Kullak-Ublick GA and Eloranta JJ (2012) FXR single nucleotide polymorphisms in inflammatory bowel disease. BMC Res Notes. 5(1):461. 34. Mwinyi J, Grete-Wenger C, Eloranta JJ, and Kullak-Ublick GA (2012) The impact of PPAR genetic variants on IBD susceptibility and IBD disease course. PPAR Research. 2012:349469. 35. Scharl M, Mwinyi J, Fischbeck A, Leucht K, Eloranta JJ, Arikkat J, Pesch T, Kellermeier S, Mair A, Kullak-Ublick GA, Truninger K, Noreen F, Regula J, Gaj P, Pittet V, Mueller C, Hofmann C, Fried M, McCole DF, and Rogler G (2012) A mutation within an intronic region of protein tyrosine phosphatase non-receptor type 2 is associated with Crohns disease and regulates muramyl-dipeptide-induced cytokine secretion and autophagy. Inflamm Bowel Dis.doi: 10.1002/ibd.21913. 36. Eloranta JJ*, Wenger C*, Mwinyi J, Hiller C, Gubler C, Vavricka SR, Fried M, Kullak-Ublick GA, and the Swiss IBD Cohort Study Group (2011) Association of a common vitamin D-binding protein (DBP) polymorphism with inflammatory bowel disease. Pharmacogenet Genomics. 21(9):559-564. 37. Mwinyi J, Cavaco I, Yurdakok B, Mkrtchian S and Ingelman-Sundberg M (2011) The ligands of estrogen receptor regulate cytochrome P4502C9 (CYP2C9) expression. J Pharmacol Exp Ther. 338(1):302-9. 38. Mwinyi J, Wenger C, Eloranta JJ and Kullak-Ublick GA (2010) Glucocorticoid receptor gene haplotype structure and steroid therapy outcome in IBD patients. World J Gastroenterol. 16:3888-3896. 39. Klein K, Jüngst C, Mwinyi J, Stieger B, Krempler F, Patsch W, Eloranta JJ and Kullak-Ublick GA. (2010) The human organic anion transporter genes OAT5 and OAT7 are transactivated by hepatocyte nuclear factor-1 (HNF-1). Mol Pharmacol. 78(6):1079-87. 40. Mwinyi J*, Cavaco I*, Pedersen RS, Persson A, Burkhardt S, Mkrtchian S and Ingelman-Sundberg M (2010) Regulation of CYP2C19 expression by estrogen receptor alpha. Implications for estrogen dependent inhibition of drug metabolism. Mol Pharmacol. 78:886-94. 41. Mwinyi J*, Nekvindova J*, Cavaco I, Hofmann Y, Pedersen RS, Landman E, Mkrtchian S and Ingelman-Sundberg M (2010c) New insights into the regulation of CYP2C9 gene expression: the

30/12/2020 European Medicine Agency Page 5/6 role of the transcription factor GATA-4. Drug Metab Dispos. 38:415-421. 42. Mwinyi J, Hofmann Y, Pedersen RS, Nekvindova J, Cavaco I, Mkrtchian S and Ingelman-Sundberg M (2010) The transcription factor GATA-4 regulates cytochrome P4502C19 gene expression. Life Sci. 86:699-706. 43. Lofgren S, Baldwin RM, Carleros M, Terelius Y, Fransson-Steen R, Mwinyi J, Waxman DJ and Ingelman-Sundberg M (2009) Regulation of human CYP2C18 and CYP2C19 in transgenic mice: influence of castration, testosterone, and growth hormone. Drug Metab Dispos. 37:1505-1512. 44. Baldwin RM*, Ohlsson S*, Pedersen RS*, Mwinyi J, Ingelman-Sundberg M, Eliasson E and Bertilsson L (2008) Increased omeprazole metabolism in carriers of the CYP2C19*17 allele; a pharmacokinetic study in healthy volunteers. Br J Clin Pharmacol. 65:767-774. 45. Ohlsson Rosenborg S, Mwinyi J, Andersson M, Baldwin RM, Pedersen RS, Sim SC, Bertilsson L, Ingelman-Sundberg M and Eliasson E (2008) Kinetics of omeprazole and escitalopram in relation to the CYP2C19*17 allele in healthy subjects. Eur J Clin Pharmacol. 64:1175-1179. 46. Mwinyi J, Kopke K, Schaefer M, Roots I and Gerloff T (2008) Comparison of SLCO1B1 sequence variability among German, Turkish, and African populations. Eur J Clin Pharmacol. 64:257-266. 47. Gerloff T, Schaefer M, Mwinyi J, Johne A, Sudhop T, Lutjohann D, Roots I and von Bergmann K (2006) Influence of the SLCO1B1*1b and *5 haplotypes on pravastatin's cholesterol lowering capabilities and basal sterol serum levels. Naunyn Schmiedebergs Arch Pharmacol. 373:45-50. 48. Bauer S, Mwinyi J, Stoeckle A, Gerloff T and Roots I (2005) Quantification of pravastatin in human plasma and urine after solid phase extraction using high performance liquid chromatography with ultraviolet detection. J Chromatogr B Analyt Technol Biomed Life Sci. 818:257-262. 49. Mwinyi J, Johne A, Bauer S, Roots I and Gerloff T (2004) Evidence for inverse effects of OATP-C (SLC21A6) 5 and 1b haplotypes on pravastatin kinetics. Clin Pharmacol Ther 75:415-421. b. Review articles: 50. Godoy P, Hewitt NJ, Albrecht U, Andersen ME, Ansari N, Bhattacharya S, Bode JG, Bolleyn.... Mwinyi J...., Yarborough KM, Hengstler JG. (2013) Recent advances in 2D and 3D in vitro systems using primary hepatocytes, alternative hepatocyte sources and non-parenchymal liver cells and their use in investigating mechanisms of hepatotoxicity, cell signaling and ADME. Arch Toxicol. 87(8):1315-530. doi: 10.1007/s00204-013-1078-5. 51. Mwinyi J and Kullak-Ublick GA (2010) Hereditäre Defekte hepatobiliärer Transportproteine. Der Gastroenterologe 5: 39-48.

Projects

Memberships 1. Member of the Swedish Association for Physicians (Sveriges Läkarförbund) 2. Member of the Swedish Society for Physiciens (Svenska Läkaresällskapet) 3. Member of the Swedish Society for Clinical Pharamcology (Svensk förening för klinisk farmakolgi) 4. Alternate in the national reference group for vaccines, Sweden 5. Member of the DGKliPha (German society for experimental and Clinical Pharmacology and Toxicology)

Other Relevant Information

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