Mark A. Heller, Goodwin Procter LLP
Mark Heller serves as chair of Goodwin Procter’s FDA Group and is a member of the Life Sciences Practice. He focuses on the Food and Drug Administration's and Federal Trade Commission's laws and regulations, and in the FDA context, assists clients with strategy development, the premarket submission process, compliance issues, enforcement matters, development of legislation, and administrative and judicial appeals.

Mr. Heller has lectured widely on medical device law and participated in teaching courses on device regulation. He has authored a guide to medical device regulation and chapters in texts on crisis management and the regulation of biomaterials.

Prior to joining Goodwin Procter, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA's Chief Counsel's office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources. Before joining the FDA, Mr. Heller was with the Federal Trade Commission.

Mr. Heller is listed in Chambers USA: America’s Leading Lawyers for Business and The Best Lawyers in America. He earned a J.D. from the University of Wisconsin-Madison and a B.A. from the University of Wisconsin-Madison (with honors).

Stephanie Philbin, Goodwin Procter LLP
Stephanie Philbin is a counsel in Goodwin Procter’s FDA Group and a member of its Life Sciences Practice. She concentrates on Food and Drug Administration laws.

Ms. Philbin advises clients on regulatory and compliance issues including those related to the Quality System Regulation, Medical Device Reporting, recalls, product importing and exporting, product promotion, pre-market submissions and compliance. Ms. Philbin assists clients in responding to agency investigations and in filing comments with FDA to respond to various regulatory initiatives. She also reviews SEC filings of FDA-regulated companies and conducts due diligence of companies as part of mergers and acquisitions. Ms. Philbin also assists in litigation.

Ms. Philbin is a member of the D.C. Bar Association. She is on the advisory board of Bloomberg BNA’s Medical Devices Law & Industry Report and the editorial advisory board for the Food and Drug Law Institute's (FDLI) Update. She frequently lectures on food and drug law and has co-authored numerous articles. Ms. Philbin earned a J.D. from Georgetown University Law Center and a B.A. from the College of the Holy Cross (cum laude, Phi Beta Kappa).