A Case Study on the Intersection of Bioethics and Regulation Benjamin Zegarelli, JD, Associate in Health Care and Life Science Practice, New York office of Epstein Becker Green ABSTRACT Although legal analysis does not typically involve bioethical considerations, cutting edge healthcare products and services involve certain aspects of bioethics and other practical issues when petitioning FDA or other regulatory agencies. This brief case study illustrates how these considerations impact a regulatory attorney’s representation of clients in the healthcare technology space. BIOGRAPHY Mr. Zegarelli obtained a Master of Science in Organic Chemistry in 2008 from the California Institute of Technology and graduated from the School of Law, Yeshiva University (J.D.) in 2013.He has worked for various entities in the health care industry and was a research chemist in the Discovery Group of a major research-based pharmaceutical and health care company, where he developed synthetic routes to myriad antidepressant/anxiolytic drug candidates. Mr. Zegarelli also previously interned at the Medicare Rights Center's federal policy office in Washington. 2015 New York State Biotechnology Symposium • May 12 & 13, 2015 At Brookhaven National Laboratory, Upton, NY