WASHINGTON, D.C. (April 28, 2005) -- Biotechnology Industry Organization (BIO) President Jim Greenwood today announced a series of major personnel staff additions and appointments, which will be “a pivotal step” in making BIO a stronger, more effective advocate and voice for its 1,100 members before the White House, Congress and regulatory agencies.
“Biotechnology, one of the most strategic and transformational industries in the world, must be represented by the strongest advocacy operation we can assemble. Our members and BIO have accomplished much in the last decade by turning bench science into cutting-edge health care, agriculture and environmental products -- and much more is possible.
“Our health care companies are producing new therapies for a wide range of intractable diseases, our food and agriculture companies are designing crops for better nutrition and more effective agriculture, and our industrial companies are producing new ways to help clean the environment.
“BIO’s new team brings incredible strength to our organization,” said Greenwood. “Our new staff members have decades of experience on Capitol Hill, in the industry, the Food and Drug Administration and the Department of Health and Human Services, which are critical to the development of all sectors of our technology.
“These additional players, augmented with the fine staff at BIO now, will help BIO tackle a broad range of issues including capital formation, and regulatory and reimbursement issues that our members face.”
Greenwood made the following appointments:
· Scott Whitaker, most recently Chief of Staff of the Department of Health and Human Services (HHS), has joined BIO as Chief Operating Officer. In this position, Whitaker will have general responsibility for managing all areas of the organization.
· Amit K. Sachdev has joined BIO as Executive Vice President, Health. In this role, Sachdev will be responsible for managing BIO’s health care portfolio, including policy development and execution. Sachdev was previously Deputy Commissioner for Policy at the Food and Drug Administration (FDA).
· Brent A. Del Monte has joined BIO as Vice President, Federal Government Relations. Del Monte recently served as Senior Manager, Washington Council Ernst & Young. As Vice President, Federal Government Relations, Del Monte will have responsibility for setting BIO’s legislative and political agenda and strategy.
· William Charles Lucas has joined BIO as Vice President and General Counsel. In this capacity, Lucas will serve as BIO’s senior legal officer. Lucas has most recently served as the Senior Assistant General Counsel, Legal External Affairs Group, Pfizer Inc.
· Alan F. Eisenberg will be appointed Executive Vice President, Advocacy and Operations. Eisenberg will be responsible for coordinating BIO’s advocacy and communications to ensure a strong and consistent advocacy message from the organization. In addition, Eisenberg will be responsible for BIO’s Board operations, as well as lead BIO’s PAC. Eisenberg has served as interim Chief of Staff and Special Assistant to the President since October 2004.
Greenwood released the following background information on new members of the BIO team:
Amit K. Sachdev
Amit K. Sachdev most recently served as the Deputy Commissioner for Policy at the FDA. In this role, Sachdev was the principal advisor to the commissioner on all policy matters, regulations development and program planning. Prior to that, Sachdev served as Senior Associate Commissioner for Legislative Affairs where he was responsible for developing and implementing the FDA's legislative agenda. While at FDA, Sachdev directed development of guidance to facilitate expedited review of medicines for the treatment of HIV/AIDS to support the President’s Global AIDS Initiative. He was also on the Secretary’s Task Force on Prescription Drug Importation, and managed the agency's successful efforts to work with Congress to enact several new laws and reforms governing the regulation of drugs, biologics and medical devices, including legislation to improve biopreparedness and to provide additional resources and performance goals for review of medical devices and animal drugs, respectively.
Prior to his appointment at the FDA, Sachdev served on Capitol Hill handling issues related to bioterrorism, food safety and biotechnology, and environmental protection, while working as Majority Counsel for the Committee on Energy and Commerce of the U.S. House of Representatives. Before entering government service, Sachdev was an Associate at the law firm of Ropes and Gray, and previously served as Counsel for the Chemical Manufacturers Association, in Arlington, Va., beginning in 1993. He earned his JD at Emory University School of Law, in Atlanta, and his BS in Industrial Management at Carnegie Mellon University, in Pittsburgh.
Brent A. Del Monte
Brent A. Del Monte joins BIO after leaving Washington Council Ernst & Young, of Washington, D.C., where he served as Senior Manager. In this position, Del Monte advised health care clients on methods of achieving legislative and regulatory goals. Before that, Del Monte was Counsel for the Committee on Energy and Commerce of the U.S. House of Representatives, where he led negotiations resulting in the enactment of the Medical Device User Fee and Modernization Act, and was responsible for the committee’s reauthorization of the Prescription Drug User Fee Act. And while serving as Legislative Director for U.S. Rep. Tom Bliley (R-Va.), Del Monte handled Medicare, Medicaid and public health issues.
Del Monte earned his JD at the Georgetown University Law Center, of Washington DC, and his bachelor’s at the College of William and Mary, of Williamsburg, Va.
William Charles Lucas
William Charles Lucas most recently served as Senior Assistant General Counsel, Legal External Affairs Group, at Pfizer Inc., in New York. In this position he supported health care reform, as well as legal activities related to pricing and reimbursement globally, including the European Union and the U.S. Lucas provided legal support for Medicare reform issues, Medicaid litigation and importation at the federal, state and local levels.
Prior to that, Lucas was the Vice President and Associate General Counsel, North American Pharmaceuticals Operations/R&D with Pharmacia Corp., of Peapack, N.J. At Pharmacia, Lucas provided legal and regulatory advice on the manufacture, promotion, sales and marketing of prescription pharmaceuticals in the U.S., including GMPs, managed care contracting and pricing decisions, genomics initiatives and clinical trial agreements. Lucas was previously Assistant General Counsel of Compliance at AstraZeneca, of Wilmington, Del., dealing with antitrust, fraud and abuse and FDA regulations. Lucas also served as Vice President and General Counsel of Zeneca Pharmaceuticals, also of Wilmington. Lucas earned the rank of Captain in the U.S. Army and received his JD from the University of Virginia, of Charlottesville, Va., and his bachelor’s in history from Princeton University, in Princeton, N.J.
Scott Whitaker served as Chief of Staff of the Department of Health and Human Services (HHS) from June 2003 to February 7, 2005. In his capacity as Chief of Staff, Whitaker managed all the day-to-day operations of the department and led the department’s activities on all major policy and management issues and initiatives. In addition to coordinating HHS activities and issues, he served as the top liaison between the department and the White House on all policy, management and political matters.
Prior to becoming Chief of Staff, Whitaker was nominated by the President and confirmed by the Senate to serve as Assistant Secretary for Legislation, Department of Health and Human Services. In that capacity, Whitaker led all the legislative operations of the department and its agencies. During his time as Assistant Secretary, Whitaker managed the passage of a significant number of legislative victories for the Administration, including the Bioterrorism Preparedness Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and the Project BioShield Act of 2004. Prior to joining HHS, Whitaker served for 10 years on the staff of Senate Assistant Majority Leader Don Nickles (R-Okla.), and since 1997, as policy adviser.
Whitaker holds a master's degree from Johns Hopkins University and a bachelor's degree from Palm Beach Atlantic University.
Alan F. Eisenberg
Alan F. Eisenberg has been Special Assistant to the President of BIO since October 2004 and served as interim Chief of Staff. Before joining BIO, Eisenberg served on the congressional staff of Greenwood, most recently as Health and Economics Policy Advisor. In this role, Eisenberg was extensively involved in the enactment of numerous public laws including the Medical Device User Fee and Modernization Act (P.L. 107-250) and the Best Pharmaceuticals for Children Act (P.L. 107-109). He has also served as a key staff on the HEALTH Act (H.R. 5), which passed the House three times from 2002-2004 and reforms the laws that govern medical malpractice insurance.
Prior to that, Eisenberg served on the staff of the Senate Health, Education, Labor and Pensions Public Health Subcommittee as Health Policy Advisor and before that as Legislative Assistant for Rep. John Shadegg (R-Ariz.). Before coming to Washington, he served as a finance manager and as a research economist with Ford Motor Company in Dearborn, Mich.
Eisenberg holds a master’s in public policy from Harvard University, a master of science in finance from George Washington University, and a bachelor’s from Union College.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.