Clinical and regulatory specialist with experience advising big pharma and start-up biotechs

Karen has deep regulatory experience having provided regulatory oversight for the submission of 27 NDAs/MAAs/PMAs and over 100 INDs / IDEs. She has held executive positions in regulatory affairs, quality assurance, and clinical operations in large pharmaceutical companies (Pfizer, Roche, AstraZeneca, Abbott) and start up biotech companies (Ocera, Gensia, Ancile). Past president of the Drug Information Association.