Innovations in development for the biosimilar industry
Carsten Brockmeyer | Owner and Managing Director Brockmeyer Biopharma GmbH
Dr. Carsten Brockmeyer is the owner and Managing Director of Brockmeyer Biopharma GmbH (www.brockmeyer-biopharma.com), a consulting firm providing strategic and operational support for novel and biosimilar biopharmaceutical development. Dr. Brockmeyer is a pioneer in the development of biopharmaceutical and biosimilar medicinal products. He has guided the development of the first European biosimiliar Epoetin alfa medicine from cell line to launch. He is a cell biologist and immunologist by training, with a strong background in analytics, immunology, biotechnology and pharmaceutical sciences. He holds a doctoral degree from the Hannover Medical School. Dr. Brockmeyer began his industrial career as Scientific Group Leader for quality control of monoclonal antibodies at Baxter International, Biotech Division, where he later became Associated Science Director, responsible for development, manufacturing, and quality control of monoclonal antibodies and novel cell therapy products. From 1999 until 2008, Dr. Brockmeyer was General Manager of HEXAL Biotech Forschungs GmbH, which in 2005 became part of Novartis/Sandoz. Dr. Brockmeyer was supervising development, manufacturing, quality control and product release activities for the biosimilar epoetin alfa product. During his industrial career, he also served as Head Global Project Management, and acting Head Global Clinical Development at Sandoz Biopharmaceuticals.
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Appearances at this years' conference:
Pre-Conference Workshop, Tuesday 28 February 2012
@ 09.00
Workshop content:
Implementing the EU Biosimilars guidelines
Experiences with the EU biosimilar regulations and authorities
What are the hurdles in developing EU and global quality Biosimilars?
How to design successful development plans for EU Biosimilars and Biobetters?
What are the upcoming EU Biosimilars guidelines including the EU biosimilar monoclonal antibody guideline telling us?
How to develop a scientific advice strategy and a submission plan for successful EU Biosimilars and Biobetters approvals?
› Carsten Brockmeyer, Owner and Managing Director, Brockmeyer Biopharma GmbH