WASHINGTON – (Business Wire) Sidley Austin LLP announced today that Gail Javitt has joined the firm's Washington, D.C. office as a counsel in the FDA Regulatory practice. Ms. Javitt's practice will focus on FDA regulation of laboratory-developed tests and in vitro diagnostic medical devices; pharmacogenomics; genetic testing; the legal aspects of global clinical research; FDA regulation of human tissues and biological products; and drug-diagnostic co-development and other combination products issues.

Ms. Javitt joins the firm after seven years at the Genetics and Public Policy Center in Washington, D.C. In her most recent position as Lawand Policy Director at the Center, Ms. Javitt was responsible for developing policy options to guide the development and use of reproductive technologies and also led an initiative to improve oversight of genetic testing quality.

"Gail Javitt is a distinguished lawyer with an impressive academic pedigree and we are very lucky to have her join us," said Carter G. Phillips, managing partner of Sidley's Washington, D.C. office. "Her distinctive background both as an FDA regulatory lawyer and as an academic has exposed her intensively to some of the most complex questions facing the life sciences industry and those experiences will further enhance Sidley's capabilities and reputation as a leader in the FDA regulatory arena."

Ms. Javitt is a Research Scholar in the Berman Institute of Bioethics at Johns Hopkins University, and an Adjunct Professor at the Georgetown University LawCenter, where she has taught Genetics and Law. She has served as an adjunct professor of law at the University of Maryland School of Law, where she taught Food and Drug Law and Genetics and Law, and at the Johns Hopkins School of Public Health, where she co-taught Health Law and Regulation. Ms. Javitt was a Greenwall Fellow in Bioethics and Health Policy at Johns Hopkins and Georgetown Universities.

"Gail is internationally recognized for her thought leadership on some of the most cutting-edge and complex emerging regulatory issues facing FDA today," said Coleen Klasmeier, head of Sidley's FDA Regulatory practice. "Her background as a food and drug lawyer combined with her extensive experience in wrestling with these issues will be a tremendous asset to our clients and I am pleased to welcome her to the firm."

Ms. Javitt served as law clerk to the Honorable Gary L. Taylor, U.S. District Court, Central District of California, and has written on a variety of science regulatory and legal topics including direct-to-consumer marketing of genetic testing and FDA regulation of biotechnology. She is also an Editorial Advisory Committee Member of the Food and Drug Law Institute.

"Sidley is widely known as the destination for life science companies facing the toughest legal and regulatory problems," said Ms. Javitt. "I am looking forward to bringing my prior knowledge to the team and to joining so many experienced and talented colleagues, including Coleen, whom I have known since we started our legal careers together as associates."

Ms. Javitt holds a J.D.,cum laude, from Harvard Law School, a M.P.H. from Johns Hopkins University and a B.A.,magna cum laude,Phi Beta Kappa, from Columbia College.

Sidley has an internationally recognized food and drug practice, representing major pharmaceutical, biological, medical device and food clients all over the world on matters relating to the development, manufacture and marketing of products regulated by the Food and Drug Administration, the European Commission, the European Medicines Agency and other related government authorities.

Sidley Austin LLP is one of the world's largest full-service lawfirms, with approximately 1700 lawyers practicing in 16 U.S. and international cities, including Beijing, Brussels, Frankfurt, Geneva, Hong Kong, London, Shanghai, Singapore, Sydney and Tokyo. Every year since 2003, Sidley has been named toLegal Business' Global Elite, its designation for the 18 firms "that define the pinnacle of the legal profession." BTI, a Boston-based consulting and research firm, has named Sidley to their Client Service Hall of Fame as one of only two lawfirms to rank in the Client Service Top 10 for seven years in a row, and to the BTI Power Elite as one of only seven law firms demonstrating the best client relationships for the fourth consecutive year.