Jan is a Medical Advisor and a qualified specialist in hematology and internal medicine. With over two decades of clinical & regulatory experience,12 of those within in the European regulatory agencies.
Most recently working at the Icelandic Medicines Agency (IMA) where he was part of the Scientific Advice Working Party (SAWP) and the alternate CHMP member for Iceland.
Jan is a highly experienced former clinical assessor, with a deep understanding of the clinical limitations faced in daily medical practice. With the scientific and regulatory expertise needed for the successful development of new medicines.
He provides essential understanding of the clinical regulatory expectations set by the Agencies.
Key Areas Of Expertise
- Specialist in hematology and internal medicine
- Extensive experience as clinician at the Karolinska University hospital haematology unit
- Drug development and EU regulatory requirements
- Clinical assessor mainly in oncology and haematology
- SAWP experience
- CHMP experience
- PRIME experience
- Research in tumour biology
- Associate professor in medicine at Karolinska Institutet, Stockholm
Before NDA
Jan worked as clinician at the haematology unit at the Karolinska University Hospital, Stockholm, for two decades and during this period he acted as head of the haematology clinical trial unit for more than six years.
For the last twelve years, he was working as a clinical assessor at the Swedish Medical Products Agency, with several years as therapeutic team leader in oncology and haematology, and the Icelandic Medicines Agency.
He was a member of the EMA Scientific Advice Working Party (SAWP) for many years and the Icelandic alternate member of the Committee for Human Medicinal Products (CHMP) 2021-2022.
Recent Publications
Sjöberg J, Halthur C, Kristinsson SY, Landgren O, Nygell UA, Dickman PW, Björkholm M. Progress in Hodgkin lymphoma: a population-based study on patients diagnosed in Sweden from 1973-2009. Blood. 2012;119:990-6.
Liu C, Xu D, Han H, Fan Y, Schain F, Xu Z, Claesson HE, Björkholm M, Sjöberg J. Transcriptional regulation of 15-lipoxygenase expression by histone h3 lysine 4 methylation/demethylation. PLoS One. 2012;7(12): e52703.
Eloranta S, Lambert PC, Sjöberg J, Andersson TM, Björkholm M, Dickman PW. Temporal Trends in Mortality From Diseases of the Circulatory System After Treatment for Hodgkin Lymphoma: A Population-Based Cohort Study in Sweden (1973 to 2006). J Clin Oncol. 2013 Feb 25.
Patel C, Stenke L, Varma S, Lindberg ML, Björkholm M, Sjöberg J, Viktorsson K, Lewensohn R, Landgren O, Gottesman MM, Gillet JP. Multidrug resistance in relapsed acute myeloid leukemia: evidence of biological heterogeneity. Cancer. 2013 Aug 15;119(16):3076-83. doi: 10.1002/cncr.28098. Epub 2013 May 14
Björkholm M, Sjöberg J, Nygell UA, Porwit A, Björck E. Development of Hodgkin lymphoma in homozygotic triplets with constitutional deletion in MKL1. Blood. 2013 Jun 6;121(23):4807. doi: 10.1182/blood-2013-02-469031.
Hongya Han, Dawei Xu, Cheng Liu, Hans-Erik Claesson, Magnus Björkholm, and Jan Sjöberg. Interleukin-4-mediated 15-lipoxygenase-1 trans-activation requires UTX recruitment and H3K27me3 demethylation at the promoter in A549 cells. PLoS One. 2014 Jan 20;9(1):e85085. doi: 10.1371/journal.pone.0085085. eCollection 2014. Erratum in: PLoS One. 2014;9(2):e91499.
Kristinsson SY, Gao Y, Björkholm M, Lund SH, Sjöberg J, Caporaso N, Goldin LR, Landgren O. Hodgkin lymphoma risk following infectious and chronic inflammatory diseases: a large population-based case-control study from Sweden. Int J Hematol. 2015 Jun;101(6):563-8. doi: 10.1007/s12185-015-1772-6. Epub 2015 Mar 11
Holm G, Andersson M, Ekberg M, Fagrell B, Sjöberg J, Bottai M, Björkholm M. Setae from larvae of the northern processionary moth (Thaumetopoea pinivora, TP) stimulate proliferation of human blood lymphocytes in vitPLoS One. 2014 Dec 22;9(12):e113977. doi: 10.1371/journal.pone.0113977. eCollection 2014ro.
Hongya Han, Yongtao Xue-Franzén, Xinyan Miao, Edit Nagy, Nailin Li,Dawei Xu, Jan Sjöberg, Magnus Björkholm, Hans-Erik Claesson. Early growth response gene (EGR)-1 regulates leukotrieneD4-induced cytokine transcription in Hodgkin lymphoma cells. Accepted for publication in Prostaglandins and Other Lipid Mediators, doi: 10.1016/j.prostaglandins.2015.06.004
Hongya Han, Xiuming Liang, Monica Ekberg, Joanna S. Kritikou, Åsa Brunnström, Benjamin Pelcman, Maria Matl, Xinyan Miao, Margareta Andersson, Xiaotian Yuan, Frida Schain, Selina Parvin, Eva Melin, Jan Sjöberg, Dawei Xu, Lisa Westerberg, Magnus Björkholm, Hans-Erik Claesson. Human 15-lipoxygenase-1 is a regulator of dendritic-cell spreading and podosome formation. FASEB J. 2017 Feb;31(2):491-504. doi: 10.1096/fj.201600679RR. Epub 2016 Oct 17.
Reviews
Björkholm M, Svedmyr E, Sjöberg J. How we treat elderly patients with Hodgkin lymphoma. Curr Opin Oncol. 2011;23:421-8.
Péan E, Flores B, Hudson I, Sjöberg J, Dunder K, Salmonson T, Gisselbrecht C, Laane E, Pignatti F. The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human use. Oncologist. 2013;18(5):625-33. doi: 10.1634/theoncologist.2013-0020. Epub 2013 Apr 24
Stanel SC, Sjöberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017.
Tzogani K, van Hennik P, Walsh I, De Graeff P, Folin A, Sjöberg J, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F. EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma. Oncologist. 2018 May;23(5):631-636. doi: 10.1634/theoncologist.2017-0301. Epub 2017 Nov 30.
