Carol D. Karp
Chief Regulatory Officer
Pharmaceutical Sciences
Prothena
Ireland
Biography
Ms. Karp has served as our Chief Regulatory Officer since 2016. Prior to joining Prothena, she was an independent regulatory consultant to biotechnology and pharmaceutical companies. From 2013 to 2014, she was Senior Vice President, Regulatory Affairs and Compliance at Esperion Therapeutics, and from 2010-2013 she held several positions at Janssen Alzheimer Immunotherapy, a Johnson & Johnson company, including Vice President, Head of Global Regulatory Affairs, Pharmacovigilence & Risk Management, where she led global regulatory affairs, regulatory operations and CMC regulatory for a portfolio of neurodegenerative disease product candidates. Ms. Karp was Senior Vice President, Regulatory Affairs, QA and Drug Safety at CV Therapeutics, which was acquired by Gilead Sciences, and has held senior regulatory and scientific affairs positions at PowderJect, VIVUS, Cygnus and Janssen Pharmaceutica. Ms. Karp is a member of the Board of Trustees for the University of Rochester, and an expert advisor and member of the selection and review committees for the Stanford University School of Medicine’s SPARK translational research program. Ms. Karp earned her BA in biology from the University of Rochester. Ms. Karp has served as our Chief Regulatory Officer since 2016. Prior to joining Prothena, she was an independent regulatory consultant to biotechnology and pharmaceutical companies. From 2013 to 2014, she was Senior Vice President, Regulatory Affairs and Compliance at Esperion Therapeutics, and from 2010-2013 she held several positions at Janssen Alzheimer Immunotherapy, a Johnson & Johnson company, including Vice President, Head of Global Regulatory Affairs, Pharmacovigilence & Risk Management, where she led global regulatory affairs, regulatory operations and CMC regulatory for a portfolio of neurodegenerative disease product candidates. Ms. Karp was Senior Vice President, Regulatory Affairs, QA and Drug Safety at CV Therapeutics, which was acquired by Gilead Sciences, and has held senior regulatory and scientific affairs positions at PowderJect, VIVUS, Cygnus and Janssen Pharmaceutica. Ms. Karp is a member of the Board of Trustees for the University of Rochester, and an expert advisor and member of the selection and review committees for the Stanford University School of Medicine’s SPARK translational research program. Ms. Karp earned her BA in biology from the University of Rochester.
Research Interest
biotechnology and pharmaceutical