Plenary Session
The New Congress: Implications for the Life Sciences Industry
Monday, February 12, 2007
8:00 AM
Astor Salon
A bipartisan panel of former Administration and Capitol Hill senior officials and a leading journalist will discuss the impact that the new Congress will have on the biotech industry. These experts will discuss the many complex issues Congress will address this year, including PDUFA, drug safety, Medicare changes, followon biologics, patent reform and more.
Moderators
- James C. Greenwood; President and CEO, Biotechnology Industry Organization (BIO)
Panelists
- Alex Azar; former Deputy Secretary, Department of Health and Human Services
- Nick Littlefield; Partner and Co-Chair, Government Strategies Group;, Foley Hoag LLP
- Steve Usdin; Washington Editor;, BioCentury Publications Inc.
- Thomas A. Scully, J.D.; Senior Counsel, General Partner, Alston & Bird LLP; Welsh, Carson, Anderson & Stowe
Who's Who
James C. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, DC, which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 US states and 31 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products. Mr. Greenwood represented Pennsylvania's Eighth District in the US House of Representatives from January 1993 through January 2005. As a leader on health care issues, he authored numerous bills signed into law including legislation to promote pediatric labeling for pharmaceuticals, reform medical device review and approval, and expand research and establish innovative programs to address traumatic brain injury. He was the prime sponsor of comprehensive legislation to reform the nation's medical malpractice system. From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee?s vast jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation's nuclear power plants, ports and infrastructure; and waste and fraud in federal government agencies. Prior to his election to Congress, Mr. Greenwood served six years in the Pennsylvania General Assembly (1980-86) and six years in the Pennsylvania Senate (1986?1993). He specialized in health, environment, and children?s issues. Mr. Greenwood graduated from Dickinson College in 1973 with a BA in Sociology. From 1977 until 1980, heworked as a caseworker with abused and neglected children at the Bucks County Children and Youth SocialService Agency. Mr. Greenwood resides in Upper Makefield, Pennsylvania with his wife and three children.
Until February 3, 2007, Alex Azar served as Deputy Secretary of Health and Human Services for the United States. In that role, he was the chief operating officer of the largest civilian department in the federal government, with a budget of $640 billion and more than 67,000 employees. Working closely with Secretary Mike Leavitt, Azar oversaw all operations, including Medicare, Medicaid, welfare, public health, medical research, the regulation of food and drugs, child and family services, disease prevention, Indian health, mental health services, and many other activities. He also led a number of initiatives at the Department, including the fight against human trafficking, implementing the President?s Management Agenda, combating bio-terrorism, public health emergency preparedness, and the development and approval of all HHS regulations. He helped lead key activities including the response to Hurricane Katrina and planning for a potential influenza pandemic. He worked to promote economic liberty, especially related to health care and health security, around the world. Azar was nominated by President Bush in April of 2005 and immediately began serving as Acting Deputy Secretary. He was unanimously confirmed by the Senate as Deputy Secretary on July 22, 2005. From 2001 to 2005, Azar served as General Counsel of HHS. In that role, he was chief advisor to the Secretary on all legal matters concerning the Department and supervised over 450 attorneys working on approximately 21,000 administrative and federal court litigation matters. Prior to joining HHS, Azar was a partner with the Washington law firm of Wiley, Rein.
Nick Littlefield, Partner and Co-Chair, Government Strategies Group, at Foley Hoag LLP, concentrates his practice in the areas of biotechnology, biomedical research and health care technology. He specializes in regulatory, administrative and legislative issues for large and small companies, non profit organizations and trade associations. Nick and his colleagues in the Foley Hoag Life Sciences Group work from offices in Boston and Washington. For nine years until 1998, Nick served as Staff Director and Chief Counsel for Massachusetts Senator Edward M.Kennedy on the United States Senate Health, Education, Labor and Pensions Committee, where he worked extensively on biomedical research, health policy, and life sciences regulatory and legislative initiatives. Previously, he taught at Harvard Law School and was an Assistant United States Attorney in the Southern District of New York. He is a graduate of Harvard College and the University of Pennsylvania Law School.
Steve Usdin has spent the past 15 years covering political and policy issues affecting the life sciences sector in Washington. As the original Washington Editor of BioCentury, Mr. Usdin covers the FDA, NIH, CMS and other executive agencies as well as the Congress and the courts. He also is the Senior Editor responsible for coverage of social issues involving biotechnology. Mr. Usdin?s reporting about biotechnology and biomedical policy have been cited in The Economist, The Wall Street Journal, the Washington Post, New Scientist and other publications. Mr. Usdin has traveled and reported extensively on the intersection of science, technology and policy, as well as on intelligence and national security issues, in Japan, Russia and the former Soviet Union, India, China and Western Europe. His book, Engineering Communism: How Two Americans Spied.
Thomas A. Scully, JD, is Senior Counsel in Alston & Bird?s Washington, D.C. office with his practice focusing on health care regulatory and legislative matters, as well as on advising clients on health policy and strategies for healthcare delivery. Prior to joining the firm, Mr. Scully was appointed by President George W. Bush and confirmed by the US Senate as the Administrator of the Centers for Medicare & Medicaid Services (CMS), where he served from 2001 to 2003. Formerly known as the Health Care Financing Administration, CMS is responsible for the management of Medicare, Medicaid, SCHIP, and other national healthcare initiatives. CMS controls more spending than any other federal agency?over $600 Billion for fiscal year 2004. At CMS Mr. Scully was noted for his instrumental role in passing Medicare reform and Medicare Rx legislation, as well as for changing the agency?s culture and making the vast agency more open and accountable to the public. Mr. Scully initiated the first public reporting and disclosure for comparative quality among hospitals,nursing homes, home health agencies and dialysis centers. Tom also initiated a broad public education campaign to improve seniors? awareness and utilization of their Medicare benefits. Before joining CMS, Tom served as President and CEO of the Federation of American Hospitals from January 1995 to May 2001. The Federation represents over 1700 privately owned and managed hospitals. Tom is also a former partner in the Washington, D.C. law firm of Patton Boggs, LLP, where his practice focused on regulatory and legislative work in health care. Before joining the law firm, Tom worked at the White House in the first Bush Administration as Deputy Assistant to the President and Counselor to the Director of the Office of Management and Budget (OMB) from 1992?93; and as Associate Director of OMB for Human Resources, Veterans and Labor from 1989?92. In 1988, Tom worked on the Bush for President campaign. He was an attorn

