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Dr. Jörg WINDISCH Head Development, Global Biopharmaceutical Operations, Sandoz GmbH, Kundl

CV

 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.

Publications

Invited (EMEA) plenary presentation at the "EMEA/DIA Joint Workshop on EMEA s New Guidelines for Development and Approval of Biosimilars", Paris, December 8-9, 2005."Considerations on a Scientific Concept for the Development and Approval of Similar Biological Medicinal Products"
Invited (FDA) plenary presentation at the "FDA Public Workshop: Scientific Considerations Related to Developing Follow-On Protein Products", Rockville, MD, February 14-16, 2005:
"The Value of State-of-the-Art Analytical Characterization in the Development and Evaluation of Follow-on Protein Products" http://www.fda.gov/cder/meeting/followOn/Windisch_final.ppt
Invited plenary presentation at the "Sixth Annual Biological Production Forum", Berlin, March 27-28, 2007: "Quality by Design in Biopharmaceuticals - First Smalls Steps From Theory To Practice" http://www.biologicalproduction.com

Awards

Würdigungspreis des Wissenschaftsministers
Prof.-Ernst-Brandl-Preis