Michael Causey, Editor and Publisher, eDataIntegrity Report
Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past ten-plus years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers.
His two biggest remaining goals in life are to find out when 21 CFR Part 11 will be revised, and to play drums in a rock band.
Kimberly K. Egan is a partner in the Washington, D.C. office of DLA Piper LLP and Co-Chair of the firm’s US Health Care Sector. She splits her practice between product liability litigation and regulatory counseling.
Kim represents clients before the Food & Drug Administration and the Consumer Product Safety Commission, among other federal agencies, and appears in the International Who’s Who of Life Sciences Lawyers as well as the International Who’s Who of Business Lawyers.
Julie Gunlock is a senior fellow at the Independent Women’s Forum. Before joining IWF, Gunlock served as a Professional Staff Member on the Senate Homeland Security and Governmental Affairs Committee and on the House Homeland Security Committee, and on the staff of Representative Chris Cox’s Leadership Office.
She has written about food regulations for the National Review Magazine, the Washington Times, and The Tampa Tribune, and is regular contributor to Townhall.com and National Review Online. She appears frequently on radio and television programs, such as Fox News and RT Television. Gunlock received her bachelor’s degree in political science from St. Mary’s College of Maryland in 1994.
Ken Miles, Principal
Ken Miles has 28 years experience as a senior FDA medical device investigator. Today, as an FDA consultant, he helps medical device companies navigate the regulatory passageways to maintain processes certification and guide them to device approval.
He assists the medical device industry in complying with FDA requirements. His expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).
His clients range from small start-up companies to global corporations with domestic and foreign manufacturing sites that produce a variety of medical device products including x-ray imaging and therapeutic systems, surgical instruments, catheters, in-vitro diagnostic (IVD) products.
Mark Mansour, Partner
Bryan Cave, LLP
Mark Mansour is head of the FDA practice at Bryan Cave LLP. He has practiced US and international drug and device law since 1991. Mark’s practice focuses upon domestic and international drug, device, food and consumer product regulation, as well as regulatory and public policy issues relating to the device, drug, biotechnology and nanotechnology industries.
He also assists clients in developing and implementing strategies for multinational, medium sized as well as start-up companies facing challenges with international regulatory policy and compliance requirements. He received his B.S. in International Politics from the Georgetown University School of Foreign Service, his M.A. in International Affairs and Public Policy from Harvard University, and his J.D. from Georgetown University.
Patrick Stone, President, TradeStone QA
Patrick Stone, M.S., left the FDA in March 2011 after 12 years as a Biosresearch monitor at the agency’s Austin, TX office. He’s now President of TradeStone QA. While with the FDA, Patrick conducted domestic and international inspections of clinical investigators for pre-approval of pharmaceutical drugs, Pharmaceutical drug manufacturing plants and domestic Institutional Review Board investigations. He was also integral in helping to promote minority hiring at the agency.
He’s worked closely with) CDER CBER CDRH and CVM . He’s also had a hand in issuing 13 warning letters, one NDA revocation, and “countless” 483’s. Follow Patrick on Twitter.
