Working Group Drug-Development and Healthcare

Members of the Department of Clinical Pharmacology are involved in national and international committees and advisory boards to transfer knowledge.

Delegation of experts to the European Medicines Agency – EMA

• Committe for Orphan Medicinal Products (COMP): Brigitte Schwarzer-Daum previously Bernd Jilma and Hans-Georg Eichler
   
• Committee for Advanced Therapies (CAT): Martin Brunner, previously Bernd Jilma
   
• Scientific Advice Working Party (SAWP): Brigitte Schwarzer-Daum, previously Bernd Jilma and Hans-Georg Eichler
   
• Additional EMA-Experts: Gerhard Garhöfer, Bernd Jilma, Michael Wolzt, Markus Zeitlinger

Committee on Reimbursement of Drugs of the Austrian Sick Funds and Social Security Association Institutions (Heilmittelevaluierungkommission – HEK)

Chair: Markus Müller, Vice-Chair: Brigitte Schwarzer-Daum
 

Scientific Committee of the Medicinal Products Advisory Council - Austrian Ministry of Health

Martin Brunner, Bernd Jilma, Gerhard Garhöfer, Markus Müller, Brigitte Schwarzer-Daum, Michael Wolzt, Markus Zeitlinger

Ethics Committee of the Medical University of Vienna

Chair: Martin Brunner

Members: Martin Bauer, Christa Firbas, Brigitte Litschauer, Brigitte Schwarzer-Daum

Key Publications

1. Hans-Georg Eichler, Francesco Pignatti, Brigitte Schwarzer-Daum, Ana Hidalgo-Simon, Irmgard Eichler, Peter Arlett, Anthony Humphreys, Spiros Vamvakas, Nikolai Brund and Guido Rasi: Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. CLINICAL PHARMACOLOGY & THERAPEUTICS 2020; First Published: 16 October 2020 https://doi.org/10.1002/cpt.2083
2.  Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F. Schwarzer-Daum B, Sepodes B, Vamvakas S, Rasi G: Are novel, non randomised analytic methods fit for decision-making? The need for prospective, controlled and transparent validation: CLINICAL PHARMACOLOGY & THERAPEUTICS 2019, doi:10.1002/cpt.1638
3. Rafael Dal-Ré, Cristina Avendaño-Solà, Brigitte Bloechl-Daum, Anthonius de Boer, Stefan Eriksson, Uwe Fuhr, Søren Holm, Stefan K James, Robert J Mentz, Emilio Perucca, Frits R Rosendaal professor Shaun Treweek: Low risk pragmatic trials do not always require participants' informed consent BRITISH MEDICAL JOURNAL 2019;364:l1092 doi: 10.1136/bmj.l1092 (Published 27 March 2019)
4. Hans-Georg Eichler, Brigitte Bloechl-Daum, Karl Broich, Paul Kyrle, Jillian Oderkirk , Guido Rasi, Rui Ivo, Ad Schuurman, Thomas Senderovitz, Luke Slawomirski, Martin Wenzl, and Valerie Paris [Paper #2018-0405CR]:"Data rich, information poor; can we use health records to create a learning healthcare system for pharmaceuticals?" CLINICAL PHARMACOLOGY & THERAPEUTICS. 2018 Sep 4. doi: 10.1002/cpt.1226
5. Hans-Georg Eichler, Lynn G Baird, Richard Barker, Brigitte Bloechl-Daum et al. From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients. CLINICAL PHARMACOLOGY & THERAPEUTICS Volume 97,3, 234–246, (2015) DOI: 10.1002/cpt.59 
6. Eichler HG*, Bloechl-Daum Brigitte*, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G. : The risks of risk aversion in drug regulation. Nat Rev Drug Discov. 2013 Dec;12(12):907-16.
    *Contributed equally to this work, corresponding author 
7. Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, Leufkens H, Rowland M, Schneider CK, Bloechl-Daum B*: Bridging the efficacy–effectiveness gap: a regulator’s perspective on addressing variability of drug response: NATURE REVIEWS  DRUG DISCOVERY Volume 10, July 2011, 495-506
   *Corresponding Author 
8.  The Committee for Orphan Medicinal Products and the European Medicines Agency Scientific Secretariat:  Outlook: European regulation on orphan medicinal products: 10 years of experience and future perspectives. European regulation on orphan medicinal products: 10 years of experience and future perspectives.: Westermark K, Holm BB, Söderholm M, Llinares-Garcia J, Rivière F, Aarum S, Butlen-Ducuing F, Tsigkos S, Wilk-Kachlicka A, N'Diamoi C, Borvendég J, Lyons D, Sepodes B, Bloechl-Daum B, et al. NATURE REVIEWS DRUG DISCOVERY 10, 341-349 (May 2011) | doi:10.1038/nrd3445
9. Eichler HG, Bloechl-Daum B*, Abadie E, Barnett D, König F, Pearson S: Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. NATURE REVIEWS DRUG DISCOVERY 9, (April 2010) 277-291

*Corresponding Author and Shared First Author