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Roundtable Participants 4379

September 1, 2007

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Roundtable Participants



Susan Alpert, PhD, MD, is senior vice president and chief quality and regulatory officer at Medtronic Inc. (Minneapolis), a position she has held since 2005. She is responsible for all Medtronic quality, regulatory, and clinical compliance efforts, including overseeing health policy and payment. Alpert joined Medtronic in July 2003 as vice president for regulatory affairs and compliance from C. R. Bard Inc., where she had been vice president of regulatory sciences.

Alpert is currently the chairman of the Regulatory Affairs Professionals Society (RAPS) and has served on the board of the Food and Drug Law Institute (FDLI), a forum for FDA and the legal, business, academic, and consumer communities to exchange perspectives on public policy, law, and regulation relating to products subject to FDA jurisdiction. She serves on the advisory board of the Medical Technology Leadership Forum (MTLF), an educational organization headquartered in Washington, DC, and focused on policy makers, the general public, and the media, regarding critical issues affecting the development and adoption of advanced medical technology. In addition, Alpert serves on the board of Women Business Leaders (WBL), an organization of women leaders in the healthcare sector.

Before joining Bard, Alpert served at FDA, where she held a variety of positions in the centers dealing with drugs, devices and radiological health, and foods, including six years as director of the Office of Device Evaluation. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

Alpert completed her undergraduate degree at Barnard College, Columbia University, and holds an MS and PhD in biomedical sciences from New York University. She received her MD from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center (New York City) and at Children's National Medical Center (Washington, DC).


Bradley Merrill Thompson is a member of the firm in the health care and life sciences practice in the firm's Washington, DC, office. There, he counsels medical device and drug companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. For trade associations, Thompson serves as counsel to AdvaMed for payment issues, as general counsel to the Combination Products Coalition and as counsel and secretary for the Indiana Medical Device Manufacturers Council.

Thompson has taught food and drug law as an adjunct professor at the Indiana University School of Law. He also serves as cochair of the food and drug law committee of the administrative law section of the American Bar Association, and as a member of the medical device committee of FDLI.

From 1994 to 1997, Thompson was an active advocate for the citizens' petition that pushed for FDA to adopt good guidance practices. In 1997, Congress codified the good guidance practice requirement in FDAMA, and FDA later implemented those practices through rule making.

Thompson earned a BA cum laude and an MBA degree from the University of Illinois, and received his JD cum laude from the University of Michigan Law School. He was included in “100 Notable People in the Medical Device Industry” (Medical Device & Diagnostic Industry, June 2004), and has been named a “SuperLawyer” in Indiana.

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