LMG Life Sciences | Page 151

LIFE CYCLE FIRMS SPONSORED BIOGRAPHIES MICHAEL F. CLAYTON MORGAN LEWIS 1111 Pennsylvania Ave., NW Washington, DC 20004-2541 Tel: [phone] Email: [email protected] Web: www.morganlewis.com MORGAN LEWIS 1111 Pennsylvania Ave., NW Washington, DC 20004-2541 Tel: [phone] Email: [email protected] Web: www.morganlewis.com M. ELIZABETH BIERMAN M. Elizabeth Bierman is a partner in Morgan Lewis’s FDA Practice. Ms. Bierman has more than 25 years of experience in representing domestic and international companies with respect to all FDA and state regulatory compliance and enforcement matters relating to the development, manufacturing, and marketing of medical devices, health information technology, pharmaceuticals, tissue products, combination products, medical foods, and infant formulas. Ms. Bierman has counseled medical device companies on all aspects of FDA regulation affecting their business and products. She has advised on jurisdictional issues and regulatory pathway strategies for FDA-regulated products; advised technology and device companies on the FDA regulatory status and emerging legal issues related to health information technology; assisted in preparing medical device product applications, requests for designation, and other regulatory submissions; conducted FDA regulatory due diligence; counseled on medical device labeling and promotional materials and activities; advised on medical device post-market compliance issues (Medical Device Reporting, recalls, Quality System Regulation, responses to 483s, and Warning Letters); and provided regulatory support in litigation involving medical device manufacturers. She also had counseled clients on state law issues related to the distribution of medical devices. Ms. Bierman has spoken and taught at medical device industry conferences on the fundamentals of medical device law, and has served on the faculty of FDA’s staff college for training new review staff. She also has written articles for domestic and international publications regarding medical device and pharmaceutical regulatory issues. Ms. Bierman received her JD from Catholic University of America, Columbus School of Law and her BA from the University of Virginia. Ms. Bierman is admitted to practice in the District of Columbia. Michael F. Clayton is the leader of Morgan Lewis’s international Trademark and Copyright Practice, resident in the Washington, DC office. Morgan Lewis is consistently ranked among the top US firms for trademark/copyright counseling and transactional work in Managing Intellectual Property’s “Annual World IP Survey,” and has ranked as top firm for litigation. Mr. Clayton and his team of nearly 30 professionals have represented some of the world’s leading corporations across various industries, including life sciences and healthcare. His practice is focused on intellectual property transactional and litigation representations in trademark, copyright, trade secret, false advertising, and unfair competition matters. Mr. Clayton was recently identified by World Trademark Review among the top 20 trademark practitioners in the United States and has been named one of the 15 “Leading Lawyers in Intellectual Property” in the Washington, DC region by American Lawyer Media’s Legal Times. He has also been recognized by his peers in An International Who’s Who of Trademark Lawyers since the inaugural 2002 edition; included in The Best Lawyers in America in Advertising Law and Intellectual Property Law (2007–2011); and noted as a “Top Lawyer” by Washingtonian Magazine. Mr. Clayton is currently a member of the International Trademark Association (INTA) Panel of Neutrals. He has served on the board of directors of the INTA and co-chaired the 2001 annual meeting of INTA. He also frequently lectures and writes on intellectual property topics. Although his growing international practice and his clients’ needs often keep Mr. Clayton on the road, he remains committed to his community. Mr. Clayton was the first-ever recipient of the Elizabeth D. and Richard A. Merrill endowment for the Lecturer in Law post at the University of Virginia. In that capacity, he was the first to teach “Principles and Practice: Regulation of the Competitive Process (Intellectual Property)” at the school. He serves, in a pro bono capacity, as general counsel to the Women in Military Service for America Memorial, which celebrated its 15th Anniversary in 2012. Mr. Clayton is a 1980 graduate of the University of Virginia School of Law, where he was a Dillard Fellow, and is a 1977 Phi Beta Kappa graduate of Wake Forest University. Mr. Clayton is admitted to practice in the District of Columbia and Virginia and before the US Supreme Court. 140 LMG LIFE SCIENCES 2013