November 9 - 10, 2009 ~ Hyatt Regency Irvine ~ Orange County, CA


Tuesday, November 10
11:30 a.m. - Lunch
Noon - Panel Presentation


Most people agree that the healthcare system in the United States is in need of significant reform. Policy changes not only affect the individual, but have the ability to drastically change the way medical device companies do business. Here, you'll hear from leading experts actively engaged in policy and advocacy at the national level. Learn about the important decisions being made in the Obama administration what they will mean for the medical device industry across the US.

Speakers:

Christopher Cox, Partner, Bingham; Former Chairman of the SEC

Chris Cox is a partner at Bingham and a principal of Bingham Consulting Group. He also serves on the board of the National Endowment for Democracy in Washington, D.C.

He has been chairman of the U.S. Securities and Exchange Commission, chairman of the Homeland Security Committee in the U.S. House of Representatives, the fifth-ranking elected leader in the House, and a 17-year member of Congress from California. 

He began his Washington career as a White House counsel to President Ronald Reagan, after serving as a partner in the international law firm of Latham & Watkins in Los Angeles and Orange County. In addition, Chris has taught corporate and individual income tax at Harvard Business School.

While in Congress, Chris worked with CEOs and boards of directors of virtually every Orange County public company and business as well as the Los Angeles Chamber of Commerce to assist in job creation and growth. He also served as chairman of the Task Force on Capital Markets and chairman of the Task Force on Budget Process Reform.

As a member of the House, in addition to his role as chairman of the Committee on Homeland Security, Chris was chairman of the Select Committee on U.S. National Security and a senior member of the Energy and Commerce Committee and the Financial Services Committee. For 10 years he served as chairman of the House Policy Committee. In each of these capacities he was responsible for significant legislation, including the Internet Tax Freedom Act, the Securities Litigation Reform Act and the Support for Eastern European Democracy Act.

In 1977, he simultaneously received a Master in Business Administration degree from Harvard Business School and a Juris Doctor degree from Harvard Law School, where he was an editor of the Harvard Law Review. He graduated from the University of Southern California in 1973.


Scott Gottlieb, M.D., Resident Fellow, American Enterprise Institute; Former Deputy Commissioner for Medical and Scientific Affairs, US Food and Drug Administration

Scott Gottlieb, MD is currently a practicing physician and Resident Fellow at the American Enterprise Institute (AEI), a private, nonpartisan, not-for-profit institution dedicated to research and education on issues of government, economics and social welfare.


From 2005-2007, Dr. Gottlieb served as FDA Deputy Commissioner and before that, from 2003-2004, as a senior advisor to FDA Commissioner Mark McClellan and as the FDA’s Director of Medical Policy Development. He left FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a Senior Adviser to the Administrator of Medicare and Medicaid Services, where he supported the agency's policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies.


Dr. Gottlieb is the author of more than 300 articles that have appeared in leading medical journals as well as The Wall Street Journal, The York Times, USA Today and Forbes Magazine. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on the cable financial news channel CNBC.


Dr. Gottlieb completed his residency in internal medicine at the Mount Sinai Hospital and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Connecticut. Dr. Gottlieb practices medicine as an attending physician at Stamford Hospital in Connecticut where he is an internist on the hospital's inpatient medical wards.



Jeffrey J. Kimbell, President, Jeffrey J. Kimbell & Associates

Mr. Kimbell represents clients in the life sciences community seeking legislative remedies for their needs. Kimbell & Associates was founded in 1998 and has since grown to include five full-time lobbyists and/or policy experts in the field of medical devices, pharmaceuticals, biodefense and biotechnology. The firm has 17 hand-selected clients, all in the life sciences space.


Three years after establishing his firm, in January of 2001, Mr. Kimbell was named to President George W. Bush's Transition Team Advisory Committee for the U.S. Department of Health and Human Services (HHS). He was the only consultant to serve on the Committee.


Prior to Kimbell & Associates, Mr. Kimbell served as the first Executive Director of the Medical Device Manufacturers Association (MDMA) from 1994-1998. While at MDMA, he directed all Washington policy initiatives on behalf of MDMA's member companies. During his tenure, the association grew from 25 companies to 130, an increase that can be directly attributed to a number of legislative victories, including passage of a landmark bill to overhaul the product approval process at the U.S. Food and Drug Administration.


Prior to MDMA, Mr. Kimbell was a personal aide to former Senator Howard H. Baker, Jr. (R-TN) and former Secretary of State Lawrence S. Eagleburger in the Washington office of the Tennessee-based law firm Baker, Worthington, Crossley & Stansberry. While at Baker-Worthington, Mr. Kimbell tracked legislative activity for a host of Fortune 500 clients and helped coordinate events for U.S. Senate Majority Leader Bill Frist, MD (R-TN), U.S. Senator Lamar Alexander (R-TN) and former Senator Fred Thompson (R-TN).



Mark Leahey, President & CEO, MDMA

Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents research-driven medical technology companies. Mr. Leahey's responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies, worked to open access to the hospital marketplace by challenging the exclusionary and anti-competitive nature of certain large group purchasing organizations (GPOs), as well as ensure that medical device technologies are reimbursed adequately. Mr. Leahey currently sits on the Medical Devices Committee for the Food and Drug Law Institute (FDLI) and the Editorial Advisory Board of Medical Product Outsourcing. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business.