Medical Device Link.

PUBLIC POLICY

Return to Article: Panel Discussion: Regulatory Issues for Combination Products

Bradley Merrill Thompson is a member in the healthcare and life sciences practice of Epstein Becker & Green PC (Washington, DC). 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 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.

 

William Andrew Heaton, MD, is vice president and chief medical officer for Chiron, a Novartis business, and is responsible for clinical affairs, scientific affairs, and regulatory affairs of the unit.

Heaton is an honors graduate in medicine from Trinity College, Dublin University (Ireland), and completed pathology training at the University of Cape Town (South Africa). Subsequently, he was appointed a research fellow in blood banking at the University of Washington (St. Louis).

 

Mark D. Kramer is vice president of regulatory affairs for medical devices at GE Healthcare. Previously, he held various roles at FDA’s Center for Devices and Radiological Health (CDRH), including serving as director of the Office of Combination Products (OCP) until 2007.

As OCP director, Kramer led the development of policies, procedures, and processes to facilitate the assignment, premarket review, and postmarket regulation of combination products. He has an MS in biomedical engineering from Rensselaer Polytechnic Institute.

 

Patrick F. Terry is an entrepreneur who has founded a series of innovative philanthropic, research, and commercial organizations based on the life sciences, applied technology, and social-network theory. In 2000, he and a group of prominent leaders in the fields of genomics, bioinformatics, and biotechnology founded Genomic Health, a pioneering genomic diagnostics company based in California.

Terry has also cofounded the Coalition for 21st Century Medicine, Personalized Medicine Coalition, PXE International, the Genetic Alliance BioBank, and the International Genetic Alliance.