Advisory Board Member

Dr Sif Ormarsdottir

Sif joined NDA in 2107 and is an expert in drug development in gastrointestinal and liver diseases and liver safety (drug-induced liver injury). Her knowledge and experience covers all stages of drug development, including forward and reverse translation of pre-clinical liver toxicity issues and liver safety biomarkers.

Key Areas Of Expertise
  • A clinical background in general medicine with a special interest and in-depth knowledge of internal medicine, gastroenterology, and hepatology
  • Detailed knowledge of the European approval system including the European Medicines Agency (EMA)
  • Design of clinical development plans
    • Scientific and strategic aspects
  • Routine pharmacovigilance, including RMP, PSUR/PBRER, DSUR preparation
  • Board-certified in Internal Medicine & in Gastroenterology and Hepatology
Before Joining The NDA Advisory Board

Sif was a CHMP and SAWP member. She coordinated the drafting of regulatory guidelines for drug development in various gastrointestinal diseases and was chair of the CHMP´s Gastroenterology drafting group. She was an Associate Director Physician/Liver Safety Expert at AstraZeneca, where she was also the Chair and clinical lead of the Hepatotoxicity Safety Knowledge Group,

Sif is a Specialist physician in gastroenterology and hepatology, with more than 10 years of clinical experience and a PhD in medicine.

Recent Publications

Ormarsdóttir, J-Y Reginster, E Abadie. European regulatoryperspectives for innovative therapies. Osteoporos Int 2008 Jun;19(6):725-31.

Goldhahn J, Scheele WH, Mitlak BH, Abadie E, Aspenberg P, Augat P, Brandi ML, Burlet N, Chines A, Delmas PD, Dupin-Roger I, Ethgen D, Hanson B, Hartl F, Kanis JA, Kewalramani R, Laslop A, Marsh D, Ormarsdottir S, Rizzoli R, Santora A, Schmidmaier G, Wagener M, Reginster JY. Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis. Bone 2008 Aug; 43(2):343-7.

Compston J, Reid DM, Boisdron J, Brandi ML, Burlet N, Cahall D, Delmas PD, Dere W, Devogelaer JP, Fitzpatrick LA, Flamion B, Goel N, Korte S, Laslop A, Mitlak B, Ormarsdottir S, Ringe J, Rizzoli R, Tsouderos Y, Van Staa T, Reginster JY; Group for the Respect of Ethics and Excellence in Science. Osteoporos Int 2008 Sep;19(9):1247-50.

M Johannsson, S Ormarsdóttir, S Ólafsson. Liver injury caused by Herbalife. Icelandic Medical Journal 2010 March; 96: 167-172.

Smolen JS, Boers M, Abadie EC, Breedveld FC, Emery P, Bardin T, Goel N, Ethgen DJ, Avouac BP, Dere WH, Durez P, Matucci-Cerinic M, Flamion B, Laslop A, Lekkerkerker FJ, Miossec P, Mitlak BH, Ormarsdóttir S, Paolozzi L, Rao R, Reiter S, Tsouderos Y, Reginster JY; Group for Respect of Ethics and Excellence in Science (GREES). Recommendations for an update of the current (2003) regulatory requirements for registration of drugs to be used in the treatment of rheumatoid arthritis. Curr Med Res Opin 2011 Feb; 27(2): 315-25.

Miossec P, Verweij CL, Klareskog L, Pitzalis C, Barton A, Lekkerkerker F, Reiter S, Laslop A, Breedveld F, Abadie E, Flamion B, Dere W, Mpofu S, Goel N, Ethgen D, Mitlak B, Ormarsdóttir S, Rao R, Tsouderos Y, Reginster JY; Group for Respect of Ethics and Excellence in Science (GREES). Biomarkers and personalized medicine in rheumatoid arthritis: A proposal for interactions between academia, industry and regulatory bodies. Ann Rheum Dis 2011 Oct; 70(10):1713-8.

Robles-Diaz M, Lucena MI, Kaplowitz N, Stephens C, Medina-Cáliz I, González-Jimenez A, Ulzurrun E, Gonzalez AF, Fernandez MC, Romero-Gómez M, Jimenez-Perez M, Bruguera M, Prieto M, Bessone F, Hernandez N, Arrese M, Andrade RJ; Spanish DILI Registry; SLatinDILI Network; Safer and Faster Evidence-based Translation Consortium. Use of Hy's law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury. Gastroenterology 2014 Jul; 147(1):109-118.

Regev A, Seeff LB, Merz M, Ormarsdottir S, Aithal GP, Gallivan J, Watkins PB. Causality Assessment for Suspected DILI During Clinical Phases of Drug Development. Drug Saf 2014 Nov; 37 Suppl 1: 47-56.

Rachel J. Church, Gerd A. Kullak-Ublick, Jiri Aubrecht, Herbert L. Bonkovsky, Naga Chalasani, Robert J. Fontana, Jens Goepfert, Frances Hackman, Nicholas M. P. King, Simon Kirby, Patrick Kirby, Sif Ormarsdottir, Shelli J. Schomaker, Francis Wolenski, Nadir Arber, Michael Merz, John-Michael Sauer, Raul J. Andrade, Florian van Bömmel, Thierry Poynard, Paul B. Watkins. Emerging liver safety biomarkers: an evaluation in healthy volunteers and patients with drug-induced liver injury. Hepatology 2019 Feb; 69 (2): 760-773

Dr Sif Ormarsdottir

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