Kim Egan is a litigation and regulatory lawyer with a background in pharmaceutical and medical device litigation and advice, Consumer Product Safety Commission work, food safety counseling and litigation, and commercial and mass tort litigation. She is listed in the 2009 International Who's Who of Business Lawyers and the 2008 International Who's Who of Life Sciences Lawyers. She sits on 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.

Kim's Consumer Product Safety Commission work includes counseling to clients who import, distribute or manufacture products intended for use by US consumers. She advises on the intersection between CPSC, FTC and FDA regulation of particular products and counsels on the special consumer protection concerns related to Chinese suppliers. She has published on Chinese supply chain issues as they affects toys, food items, and pharmaceuticals and has conducted webinars for industry groups on the same topics.

Kim's food work has included risk management planning and strategic assessments related to obesity claims, litigation analyses in connection with an acquisition of a company manufacturing dietary supplements, advice on FDA's food additive and food contact regulations, advice on FDA's GRAS ("Generally Regarded as Safe") regulations, general advice on food safety issues, product recalls, and supply chain rationalization.

Kim's work for pharmaceutical and biotechnology clients work 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 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 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.

Kim's litigation matters have included a wide variety of complex commercial litigation, including mass tort and product liability matters in the food, pharmaceutical, asbestos, silica, and medical device industries, as well as insurance coverage litigation, trade secret and business tort litigation, and contract disputes. Ms. Egan focuses on scientific and regulatory fact development, witness preparation, jury testing and expert strategy.

Kim is Chairman of the Board of Friends Together for Sudan, an organization that helps women and girls in the Darfour region of Sudan achieve meaningful access to education. She also provides pro bono support to organizations engaged in life sciences research in the former Soviet Union and elsewhere in the developing world.

Admissions

• 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

Publications

• Co-author, "Made in China: Five Opportunities Created by the Recent Recalls," For the Defense, International Law section (March 2009)
• "Does FDA's 'Changes Being Effected' Final Rule Really Change Anything?," Member Briefings, American Health Lawyers Association
• Co-author, "The China Syndrome: Five Lessons to Learn from Recent Scandals Involving Chinese Products," richmondmagazineonline.com (December/January 2009)
• Co-author, "Genetically Modified Foods Raise New Legal Issues," The National Law Journal (June 25, 2001)

Seminars

• Co-leader, "The Impact on Emerging Growth Companies of Issues Affecting FDA Regulations and Compliance," Hot Topics in Regulatory Affairs Workshop, co-sponsored by DLA Piper and CONNECT, San Diego (June 23, 2009)
• Speaker, "Shoring up Weak Links in the Pharmaceutical Supply Chain," webinar, Marsh Risk Consulting and Pharmaceutical Manufacturing magazine (October 28, 2008)

Civic and Charitable

• Board Member, Safe Kids Worldwide
• Chairman of the Board, Friends Together for Sudan