Senior Communications Manager
Wiley Rein’s James Czaban and Sonali Gunawardhana to Speak at Barclays’ Global Healthcare Conference in Miami, March 12-14, 2013
James N. Czaban, chair of Wiley Rein’s Food & Drug Law Practice, and Sonali P. Gunawardhana, former U.S. Food and Drug Administration (FDA) regulatory counsel and now of counsel in the firm’s FDA Practice Group, will speak at Barclays' Global Healthcare Conference, one of the industry's most prominent gatherings. The three-day conference will be held March 12-14, 2013 in Miami, Fla. This regularly well-attended event showcases firms and companies from a broad range of sectors including biotechnology, global pharmaceuticals and specialty pharmaceuticals, medical supplies and devices, health care facilities, managed care, health care distribution and technology. Key personnel from more than 175 firms are expected to give presentations.
Mr. Czaban’s presentation—which directly precedes the March 12 keynote address by former Florida governor Jeb Bush—is titled "Views from an FDA Regulatory Perspective: Key Issues Facing the Drug Industry." Ms. Gunawardhana will lead a "fireside chat," also on March 12, focusing primarily on FDA enforcement from a medical device perspective. On March 13, Mr. Czaban and Ms. Gunawardhana will co-present at a breakfast session.
Mr. Czaban has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and health care related companies. He counsels clients on complex regulatory strategies and compliance matters, and represents them in administrative and judicial enforcement actions and other proceedings involving the FDA, Federal Trade Commission, Drug Enforcement Administration, Department of Justice and other federal and state agencies.
Ms. Gunawardhana has nearly 10 years' experience at the FDA and served in key roles at the Center Devices and Radiological Health (CDRH). At CDRH, she coordinated the review and approval of Guidance documents, exercised supervisory review of all proposed Warning Letters, Untitled Letters, and AIP enforcement actions against medical device sponsors, clinical investigators, good clinical laboratories and Institutional Review Boards, and initiated enforcement recommendations with respect to advertising and promotional practices for marketed and investigational devices. She also served on special duty assignments at the Center for Drug Evaluation and Research, including in the Office of Compliance and the Office of Medical Policy.
Wiley Rein's Food & Drug Law Practice dates to the founding of the firm in 1983 and its attorneys have decades of experience advising FDA-regulated companies on a variety of legal and regulatory challenges in the pharmaceutical, biotechnology, medical device, food and dietary supplement industries. Wiley Rein partners have held high-ranking positions in government and the team includes such luminaries as Bert W. Rein—who was named both a Washington “Visionary” and a “Leading Lawyer in Food and Drug Law” by The National Law Journal—and Mr. Czaban, who has been recognized as a leading Food & Drug lawyer on such local, national and international lists as Chambers USA, PLC Which lawyer?, Washingtonian and Best Lawyers.