Kim Egan is a pharmaceutical lawyer with a background in product liability and mass tort litigation, regulatory advice and R&D counseling. She is listed in the International Who’s Who of Life Sciences Lawyers for 2008.

Ms. Egan has extensive experience with all aspects of new drug development in the United States and around the world. Her experience includes Good Clinical Practices, 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 labeling 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 handles litigation issues for pharmaceutical companies as well, with a particular focus on scientific and regulatory fact development, witness preparation, jury testing and expert strategy.

She has also handled a wide variety of complex commercial litigation matters, among them non-pharmaceutical product liability matters, insurance coverage litigation, trade secret and business tort litigation, railroad rate disputes and contract disputes.

In 2008, Ms. Egan was named to the advisory board of Life Sciences Law & Industry Report, a publication for lawyers, business executives, directors of research and regulatory specialists practicing in health care-related life sciences fields.

REPRESENTATIVE MATTERS:

• Self-critical analysis of new drug applications and regulatory feedback;
• Data integrity investigations and FDA and EMEA inspection advice for pivotal Phase III trials;
• Risk management advice for marketed products and products in development;
• Ongoing advice for several pharmaceutical companies regarding compliance with emerging clinical trial registration requirements, including training internal R&D and regulatory personnel on Standard Operating Procedures;
• Analysis of legal requirements for pediatric informed consent worldwide, including Europe, Latin America and Asia;
• Analysis of payments to physicians requirements in Latin America;
• Ongoing advice to several pharmaceutical companies regarding potential liability for subjects injured during clinical trials;
• Advice regarding regulatory implications of research collaboration agreements with foreign governments and academic institutions;
• Advice regarding pricing implications of procurement agreements;
• Ongoing advice regarding all aspects of high-profile products for various clients, including ongoing clinical research, analyses and presentations of data, line extensions, media relations, disclosure requirements, and strategic business planning; and
• MDL and related state court litigation regarding Bextra and Celebrex for Pfizer Inc.

ZULASSUNGEN

• District of Columbia
• New York
• United States District Court for the District of Columbia
• United States District Court for the District of Maryland
• United States District Court for the Southern District of New York
• United States District Court for the Eastern District of New York
• United States Court of Appeals for the District of Columbia Circuit