LMG Life Sciences | Page 157

LIFE CYCLE FIRMS SPONSORED BIOGRAPHIES ERIC W. SITARCHUK MORGAN LEWIS 1701 Market St. Philadelphia, PA 19103-2921 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 KATHLEEN M. SANZO Kathleen M. Sanzo is a partner in and leader of Morgan Lewis’s FDA Practice. Ms. Sanzo’s practice focuses on all regulatory and compliance matters of the Food and Drug Administration relating to bulk and finished prescription and OTC drug and biologic manufacture, approval, promotion, marketing, and distribution; pre-clinical and clinical testing; drug and device promotional and labeling issues; food additive and dietary supplement matters; pharmaceutical and medical device enforcement matters before the Office of Inspector General of the Department of Health and Human Services; and regulatory and compliance matters of the Consumer Product Safety Commission and related state enforcement agencies. Ms. Sanzo is vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice. Following graduation from Duke University in 1979, Ms. Sanzo received her JD from Emory Law School in 1982, and her LLM from The George Washington University National Law Center in 1985, where she was selected as the Food and Drug Law Institute Fellow, and worked at the Office of General Counsel of the Food and Drug Administration. Ms. Sanzo is the author or co-author of numerous speeches and publications, including the following: “United States v. Franck’s Lab, Inc.,” in FDLI’s Top 20 Food and Drug Cases, 2011 & Cases to Watch, 2012 and “Alliance for Natural Health U.S. et al. v. Sebelius,” in FDLI’s Top 20 Food and Drug Cases, 2010 & Cases to Watch, 2011; “Prescription, Drug Promotions and Marketing,” in FDLI’s Food and Drug Law Regulation 2011, 2nd edition; the FDLI Monograph Series article “Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals: Perspectives on FDA Guidance, Lifecycle Management and Creating a New Scientific Discipline,” November 2010; Washington Legal Foundation article, “The Ever-Widening Legal Morass Around Off-Label Communication,” (Contemporary Legal Note Series Number 63), September 2009; “New Risks, New Plan – Drug safety concerns show need for sophisticated risk management,” Legal Times, Volume XXX, No 25; “Keys to Successful Interactions with Governing Bodies, Food and Drug Law Settlements and Negotiations,” (Aspatore Books), 2006. Selected speeches include: “FDA Watch” at the NCCN Academy for Excellence & Leadership in Oncology School of Pharmaceutical & Biotech Business in March 2011; “Regulatory and Legal Considerations on the Use of New Social Media – Twittering on Legal Trends” presented at the AdvaMed’s Advertising and Promotion of Medical Devices in an Age of DTC and Social Media marketing Program in March 2011; “Healthcare Reform – New Path for Biosimilars,” May 2010; “The Use of Social Media in Promotion of Medical Products,” presented at PLI’s Health Care Conference, April 2010; “Legal Issues Arising from REMS Programs,” presented at the ACI REMS Conference in New York, 2010. Ms. Sanzo is admitted to practice in the District of Columbia. Eric W. Sitarchuk is a partner in Morgan Lewis’s Litigation Practice and chair of the White-Collar Litigation and Government Investigations Practice. Mr. Sitarchuk focuses his practice on white-collar litigation and has more than 25 years of experience in this area. 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