Steffen has been with NDA since 2013 and excels at advising companies on their development strategies to meet expectations of regulatory agencies around the world. He applies his skills to a broad range of therapeutic areas and has successfully helped numerous clients interact with regulatory agencies throughout the stages of development and during regulatory review.
Key Areas Of Expertise
- Extensive expertise in the inner workings of the EU regulatory systems
- Have attended more than 100 oral explanations at CHMP and help numerous clients prepare for this
- Clinical pharmacology and therapeutics
- A board-certified specialist in clinical pharmacology and therapeutics
- Clinical documentation requirements supporting European regulatory applications
- Have been EU rapporteur for at least 16 centralised authorised products
- Clinical development plan scientific strategy and design
- Advanced Therapies (cell and gene therapies and tissue engineering)
- Biosimilar development
- Pharmacogenomics, biomarkers and personalized medicine
- Respiratory medicine
- Professional presentation skills and extensive teaching experience
- Adjunct professor in pharmacology at University of Copenhagen
Steffen headed the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority and acted as Danish member of the Committee for Human Medicinal Products (CHMP) at the EMA. He was also a member of the Committee for Advanced Therapies (CAT), the Chairperson of the CHMP’s Respiratory Drafting Group and Co-Chair of the European Commission Working Group on Market Access of Biosimilars. Steffen is an MD with a PhD in pharmacology with more than 10 years of clinical experience in general internal medicine and respiratory medicine.
Tarp S, Eric Furst D, Boers M, Luta G, Bliddal H, Tarp U, Heller Asmussen K, Brock B, Dossing A, Schjødt Jørgensen T, Thirstrup S, Christensen R. Risk of serious adverse effects of biological and targeted drugs in patients with rheumatoid arthritis: a systematic review meta-analysis. Rheumatology (Oxford). 2017 Mar 1;56(3):417-425.
Hellfritzsch M, Rathe J, Stage TB, Thirstrup S, Grove EL, Damkier P, Pottegård A. Generic switching of warfarin and risk of excessive anticoagulation: a Danish nationwide cohort study. Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):336-43.
Bergmann L, Enzmann H, Thirstrup S, Schweim JK, Widera I, Zwierzina H. Access to innovative oncology medicines in Europe. Ann Oncol. 2016 Feb;27(2):353-6. doi: 10.1093/annonc/mdv547. Epub 2015 Nov 16.
Simões EA, DeVincenzo JP, Boeckh M, Bont L, Crowe JE Jr, Griffiths P, Hayden FG, Hodinka RL, Smyth RL, Spencer K, Thirstrup S, Walsh EE, Whitley RJ. Challenges and opportunities in developing respiratory syncytial virus therapeutics. J Infect Dis. 2015 Mar 15;211 Suppl 1(Suppl 1):S1-S20.
Dr Steffen Thirstrup