Karsten Roth | Director Clinical Operations
Cinfa Biotech

Karsten Roth, Director Clinical Operations, Cinfa Biotech

Karsten Roth leads the clinical development and pharmacovigilance teams at Mundipharma-Biologics, former Cinfa Biotech. He is responsible for the development and implementation of preclinical, clinical and post-approval clinical activities and oversees the pharmacovigilance activities at Mundipharma-Biologics. He led the preclinical and clinical development activities for the Biosimilar peg-filgrastim Pelmeg® from initial planning until EC approval in Nov. 2018.
Karsten has over 22 years of experience in the pharmaceutical industry, having held various international executive positions with a strong focus on clinical development and medical affairs across several therapeutic areas. In his former positions, he contributed to several Biosimilar marketing authorization submissions for the US and EU, presentations at FDA, PMDA and EMA meetings, and was setting up and leading global advisory boards. 
Karsten holds a PhD in biochemistry, a postgraduate degree in pharmaceutical medicine and a master’s in project management from the George Washington University

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There are two parts to the Festival of Biologics: the five world-class international conferences covering Antibodies, Immunotherapy, BioSimilars, Clinical Trials, and High Potency APIs; and an exhibition featuring the most exciting technology and solutions for pharma and biotech. There is a registration fee to attend the conferences. To visit the exhibition is free.


Conference 29 - 31 October • Exhibition & Seminars 29 - 31 October 

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