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Im Interesse der Patienten: Anforderungen an Qualität, Wirksamkeit und Sicherheit von Biopharmazeutika

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Studio 44
Plenary / Panel
German and English language

Vortragende

Director Government Affairs Europe, Amgen, Brussels
Ao. Professor, Zentrum für Biomolekulare Medizin und Pharmakologie, Institut für Pharmakologie, Medizinische Universität Wien
Head Development, Global Biopharmaceutical Operations, Sandoz GmbH, Kundl Abstract
Novartis and its subsidiary Sandoz apply the same high quality
standards to all products of its extensive pipeline of biopharmaceuticals,
no matter whether novel or follow-on. Building on more than 25 years of
experience in modern biotechnology and protein science, Sandoz has been
setting the standards in the development of biosimilars, with two major
products approved and marketed in the European Union and the United States
- the only two biosimilars marketed in any highly regulated market thus
far. This science-based approach is also reflected in the European Union's
recently issued laws and guidelines on biosimilars. Sandoz will provide
insights into the comprehensive development programs based
state-of-the-art pharmaceutical and clinical science ("Quality by Design")
that have passed the scrutiny of both, the European Medicines Agency
(EMEA) as well as the US Food and Drug Administration (FDA) - providing
patients with high quality, safe, and efficacious treatment alternatives.
Journalist Science, ORF - Österreichischer Rundfunk Radio Ö1, Vienna Chair

Thomas BOLS

Director Government Affairs Europe, Amgen, Brussels

 Thomas is Amgen's Director Government Affairs Europe and a member of the Amgen International Leadership Team. He joined Amgen in January 2003 from Fleishman-Hillard/GPC International, a worldwide government and public relations consulting firm, where he was Executive Director Health Care & Pharmaceuticals. Previously, he has been working for management consultancies, industry federations and the EU Institutions. Thomas is a member of EuropaBio's Healthcare Council and is Vice-Chariman of the EBE's public affairs committee. Furthermore he is the Chairman of both the EuropaBio's and EBE's Task Forces on Biosimilar Medicinal Products. Thomas studied Political Sciences at the University of Amsterdam and holds a postgraduate degree in European Law. A Dutch citizen, born in 1964, he is married and has 2 children.

Dr. Harald SITTE

Ao. Professor, Zentrum für Biomolekulare Medizin und Pharmakologie, Institut für Pharmakologie, Medizinische Universität Wien

 05/1995 Graduation as Dr. med. univ., Univ. of Vienna
1993-1994 Thesis, Institute of Pharmacology, University of Vienna, supervisor: E.A. Singer
 Since 1998 Assistant/Associate Professor at the Center for Biomol. Medicine and Pharmacology, Inst. Of Pharmacol.,
  Med. Univ. of Vienna, Prof. Dr. Michael Freissmuth
 12/2001 Habilitation
1995-1997 Research Associate, Institute for Biochemical Pharmacology, Univ. of Vienna, Prof. Dr. Oleh Hornykiewicz
  The Panum Institute, University of Copenhagen, Denmark
2002-2003 Guest Scientist ("Lektor") at the Laboratory of Neuropharmacology (Prof. Dr. Ulrik Gether), Dept. Pharmacology,

Dr. Jörg WINDISCH

Head Development, Global Biopharmaceutical Operations, Sandoz GmbH, Kundl

 Dr. Windisch manages the technical development of biopharmaceuticals globally for both, Novartis Pharma and Sandoz. This joint organization across multiple sites in Europe and in the US ensures the highest quality standards are applied to both, innovative biopharmaceuticals and biosimilars. During the last 11 years Dr. Windisch has held various roles of increasing responsibility in biotechnological development and manufacturing at Sandoz/Novartis, allowing him to contribute significantly to the development of the company's biosimilar and biopharmaceutical products as well as to the discussions with the EMEA and the FDA related thereto. Dr. Windisch has published and presented extensively in the field of biopharmaceuticals and holds multiple patents. He was educated in Europe and the US and holds a doctorate in biochemistry conferred sub auspiciis praesidentis.

Elisabeth J. NÖSTLINGER-JOCHUM

Journalist Science, ORF - Österreichischer Rundfunk Radio Ö1, Vienna

seit 1989 Wissenschaftsjournalistin, ORF