Biography: Life Sciences

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Kim's work for pharmaceutical and biotechnology clients covers all aspects of new drug development around the world. Her experience includes preclinical and clinical trial development, clinical data review, data safety monitoring board and adjudication board issues, FDA and EMEA approval of new molecular entities or line extensions, drug labelling issues, promotional issues, HIPAA and other patient privacy issues, data disclosure obligations, study subject compensation issues, informed consent and payment to physician regulations, advisory committee and oral explanation preparations, and WHO policies. She also provides strategic advice to pharmaceutical companies on compliance with Good Clinical Practices and ICH guidelines and media strategy, as well as R&D matters generally. Ms Egan also handles complex litigation issues for pharmaceutical companies, with a particular focus on scientific and regulatory fact development, witness preparation, jury testing and expert strategy.

Area of specialisation: product liability/regulatory