2013 FDA On-site Agency Visit Program Bios

Posted Date: 
April 15, 2013

FDA Program Speaker Bios:

Dr. Jesse Goodman, FDA Chief Scientist

Jesse L. Goodman, M.D., M.P.H. is the Agency's Chief Scientist. In this capacity, he is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts, among which has been the FDA response to the H1N1 pandemic. The Office of the Chief Scientist works closely with FDA’s Centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives.  These initiatives include the Critical Path Initiative1, scientific professional development, scientific integrity, and the Medical Countermeasure Initiative2 (MCMi). MCMi works to enhance preparedness for terrorism and emerging infectious disease threats in support of the U.S. Government’s Public Health Emergency Medical Countermeasure Enterprise.

Dr. Goodman's first position with the FDA was as Senior Medical Adviser to the Commissioner in 1998. In that role, he initiated and co-chaired the U.S. Government-wide Task Force that issued the nation’s first Public Health Action Plan to Combat Antimicrobial Resistance. He joined FDA full-time in 2001 as Deputy Director of the Center for Biologics Evaluation and Research (CBER), becoming Director in 2003.

Among CBER’s major public health accomplishments under his leadership were:

  • the public-private partnership that enabled rapid development and implementation of West Nile Virus screening of the blood supply, thereby preventing thousands of infections;
  • the doubling of the number and capacity of U.S.-licensed influenza vaccine manufacturers;
  • the licensure of many new life-saving vaccines, including against meningitis and cervical cancer;
  • improvements in the supply of life-saving plasma products; and
  • the implementation of a risk-based approach to enhancing the safety of transplanted tissues.

A graduate of Harvard, Dr. Goodman received his M.D. from the Albert Einstein College of Medicine and completed his residency and fellowship training at the Hospital of the University of Pennsylvania and at UCLA, where he was also Chief Medical Resident. Prior to joining FDA, he was Professor of Medicine and Chief of Infectious Diseases at the University of Minnesota, where he directed its multi-hospital research, training and clinical infectious diseases program. His laboratory was the first to isolate and characterize Anaplasma phagocytophilum, the agent causing a new tick-borne disease, human granulocytic ehrlichiosis.

Dr. Goodman has authored numerous scientific papers and edited the book Tick Borne Diseases of Humans, published by ASM Press in 2005. He is a member of the American Society for Clinical Investigation and the Institute of Medicine of the National Academy of Sciences. Dr. Goodman is an active clinician and Adjunct Professor of Medicine at the University of Minnesota and is Staff Physician and Infectious Diseases Consultant at the National Naval and Walter Reed Army Medical Centers and the National Institutes of Health. He is Board Certified in Internal Medicine, Oncology and Infectious Diseases.

Brian Trent,MPA, FDA CTP Director of Management
Topic: Center for Tobacco Products (CTP) Overview

Brian Trent has served in the federal government for the past twelve years preceded by ten years in local government with a background in Management. Brian received his B.S. from George Mason University in Public Administration and then went on to receive his Master of Public Administration (MPA) from George Mason University’s School of Public Affairs. Brian is also a graduate of the Federal Executive Institute.

Brian worked in the local government as a Budget Analyst for the Fairfax County Government in Fairfax, Virginia for 6 years and then as a Budget Director for the City of Norwalk in Norwalk, Connecticut for 4 years.

Brian then started his federal career as a Senior Program Analyst for the Department of Health and Human Services Office of the Assistant Secretary for Financial Resources. He then moved to the Office of Global Health Affairs as the Executive Officer.  From 2006 to 2010, Brian served as the Chief Operating Officer for the Assistant Secretary for Preparedness and Response.  Since 2010, Brian has worked in the Food Drug Administration’s Center for Tobacco Products where he is currently the Associate Director for Management and the Executive Officer.

Brian is an active member of the Government Finance Officers Association.

 

Walter Harris, FDA Chief Operating Officer

Mr. Harris brings to FDA more than 20 years of leadership and management experience from the private sector and in the federal government. He has managed at the executive levels in the areas of public health operations, healthcare operations, information technology (IT), and has led organizational development for large and small organizations.

Mr. Harris served 6 years in the Unites States Air Force and was selected to serve as a liaison to the Secretary of Defense, Honorable Casper Weinberger. Mr. Harris was also recalled to serve during Operation Desert Storm.

After an honorable discharge from the U.S. Air Force, Mr. Harris joined the Sodexho Marriott Corporation as a food service manager in the health care division. Sodexho Marriott has accounts with acute-care hospitals, nursing homes, and retirement communities across the United States. Over 15 years of service, he worked his way up through the health care ranks from food service manager to operations officer. During his tenure, he was also tasked with large-scale construction and technology programs that enabled healthcare organizations to successfully provide patients and customers with high quality health care products and services. He realized that the combination of healthcare operations, organizational developments, business management and information technology and was the right career path for him.

In November 2002, Mr. Harris continued his healthcare career; he joined the federal government as an Enterprise Systems Manager (ESM) for the Veterans Health Administration (VHA). As an ESM, he managed a health care portfolio of management and financial programs totaling more than $600 million. His primary focus was to facilitate the creation and execution of requirements for VHA business and clinical customers. Two years later, Mr. Harris was promoted to the Director of the Enterprise Systems Office. In that role he was responsible for providing direction to a team of senior level enterprise portfolio managers in the evaluation and resolving crosscutting issues that impacted the entire VHA organization. The team, consisting of physicians, nurses, business managers, financial managers, and health data managers, was primarily responsible for creating and executing requirements for more than 200,000 customers in VHA.

In April 2006, Mr. Harris was appointed to the senior executive service as the Deputy Chief Information Officer at the Department of Housing and Urban Development (HUD). In his role as Deputy Chief Information Officer, Mr. Harris was responsible for the day-to-day operation of the information technology organization that served the 10,000 members of HUD. He was also responsible for spearheading the modernization of HUD’s business and financial systems that serve thousands end-users. He directed the development and deployment of enterprise products that allowed HUD business users to rapidly develop tools to assist them in accomplishment of HUD strategic and business objectives. In 2007, Mr. Harris was appointed as Acting Chief Information Officer for HUD. During his tenure he guided the deployment of the National Housing Locator, which used geospatial technology to assist HUD in locating housing for citizens displaced due to natural or manmade disasters.

In February of 2008, Mr. Harris joined the Centers for Disease Control as the Chief Management Officer for the Coordinating Center for Health and Information Services (CCHIS). In his role, Mr. Harris was the executive responsible for the end to end operations, and worked in partnership with the academic, scientific, medical and public health professionals in CCHIS and across CDC. On 2010, Mr. Harris was appointed as the Deputy Director of the Office of Surveillance, Epidemiology and Laboratory Services (OSELS). In this role Mr. Harris was the executive in charge of operations and management. He also worked closely with the scientific and program executives and OSELS staff in the planning, development and stand-up of the OSELS organization. Mr. Harris also led the implementation of systems and programs that supported the mission of OSELS and CDC. Mr. Harris also played a lead role in the return and integration of human resources back to CDC.

Mr. Harris earned a Bachelor of Art degree in management and communication from Concordia University in Mequon, Wisconsin, and a Master of Business Administration degree from Regis University in Denver, Colorado.

James (Jay) Tyler, FDA Chief Financial Officer

Jay Tyler brings 25 years of federal financial management experience to FDA. As the CFO, Jay is responsible for all budget and financial operations, Office of Acquisition and Ethics. In addition to his role as CFO, Jay will also serve the agency’s Designated Financial Compliance Officer (DCO) and Designated Ethics Counselor (DEC).

Most recently, Jay was the Director of the Financial Management Office at the Centers for Disease Control and Prevention (CDC). At CDC, Jay was responsible for the comprehensive budgetary policy and financial operations program for CDC’s multi-billion dollar budget. While at CDC, Jay led efforts to obtain authority for CDC to establish its first Working Capital Fund to finance the provision of administrative services, led the implementation of CDC’s first position based management system that integrates staff and budget planning, and led the implementation of CDC’s multi-year budget forecasting system.

Prior to CDC, Jay was the Budget Director for the U.S. Census Bureau where he successfully led budget operations in support of the multi-billion dollar 2010 Census of Population and Housing. Prior to CDC and Census, Jay was the Deputy Budget Director for the U.S. Pension Benefit Guaranty Corporation. Jay has also held senior financial analysts positions at the U.S. Department of Transportation and the U.S. Treasury Department. Jay is a graduate of the Office of Personnel Management’s Federal Executive Institute, Leadership for a Democratic Society Program. Jay earned a B.S. in Business Administration from Morgan State University and is a Certified Government Financial Manager.

Ronald Rouse, FDA Director, Division of Acquisitions Program, Office of Acquisitions and Grants Services
Topic: Upcoming Procurement Opportunities at FDA

Ronald Rouse is the Director, Division of Acquisition Programs in the Office of Acquisitions and Grants Services.  He has over 25 years of varied acquisition experience in multiple Federal Agencies, including:  the DoD, the Department of Agriculture, the General Services Administration, and for the last three years in the the Department of Health and Human Services at the FDA.  He has held the positions of a Contract Specialist, Contracting Officer, Procurement Analyst, Acquisition Branch Chief and now a Division Director.  He has been a Montgomery County resident since 1986.

Teresa Lewis, Director, Office of Small & Disadvantaged Business Utilization, Department of Health and Human Services (HHS)

Teresa is a member of the Senior Executive Service. She assumed her duties as the Director, Office of Small and Disadvantaged Business Utilization (OSDBU), Department Health and Human Services, on November 6, 2011. Teresa is responsible for implementing and managing the Department’s small business program. She is responsible for ensuring that all small businesses have the “maximum practicable opportunity” to participate in providing goods and services to the Department of Health and Human Services.

As OSDBU Director at the Department of the Treasury, March 30, 2008 – November 5, 2011, Teresa ensured that small businesses were able to market their goods and services; and receive their fair share of contracting opportunities. Under Teresa’s leadership, Treasury met four of its five prime contracting goals in Fiscal Year 2010 and all of its prime contracting goals in Fiscal Year 2011, including goals for service-disabled veteran-owned small businesses and small businesses located in historically under-utilized business zones (HUBZone).

Prior to her assignment at the Treasury Department, Teresa served in several positions at the U.S. Small Business Administration (SBA), such as Director, Office of Management and Technical Assistance/8(a) Business Development Program; Assistant Administrator, Office of Federal Contract Assistance for Veteran Business Owners; Procurement Policy Analyst/Office of Policy Research, Office of Government Contracting; Area Director (East Coast)/HUBZone Empowerment Program Office and Senior Eligibility Specialist, Team Leader/Office of Small Disadvantaged Business Certification and Eligibility.

She joined SBA in June 1998, following six years of Government contracting experience as a contract specialist with the Department of the Air Force and the Department of Commerce.

Teresa is a retired Major of the United States Air Force. A native of High Point, NC, she received a Master of Arts Degree, with honors, in Procurement and Acquisition Management from Webster University, St Louis, MO and a Bachelor of Science Degree in Business Administration from the University of North Carolina at Greensboro.  Teresa is the recipient of the 2011 SBA Administrator’s Leadership Award.

Deanna Murphy, FDA, Director, Office of Facilities Engineering & Mission Support Services

Deanna Murphy serves as FDA’s Director for the Office of Facilities Engineering and Mission Support Services, Office of Management.  She is responsible for real property, facilities operations, space management, logistics management, community relations and quality of worklife.  Murphy takes a strategic approach to managing FDA facilities and providing critical mission support services.  She considers these functions to be an integral part of the Agency’s Mission.  Murphy’s goals are to establish and maintain a close link between FDA’s science and regulatory programs, and its corporate business and real property strategies.  Murphy also serves as FDA’s Chief Sustainability Officer.  In this capacity, she strives to integrate sustainability into the mindset and work practices of each employee and incorporate into every program activity across the agency.

Ms. Murphy previously served as Director for the Office of White Oak Services and prior to that, Director for the White Oak Consolidation Program.  As Office of White Oak Services Director, Ms. Murphy, in partnership with the General Services Administration and the FDA Centers, led the consolidation of nearly 9000 FDA employees to a unique state-of-the-art Campus and provides best-in-class logistics and facilities operations services.  Her goal was to create a highly productive environment for all employees and visitors – sharing resources and technology, fostering collaboration, and enhancing scientific performance across the Agency.  The FDA Campus serves as the Agency’s nucleus for establishing health standards for the country and an anchor for community and scientific partnerships.

Ms. Murphy came to FDA in 2007 from NASA where she advised the Deputy Administrator on institutional and mission support issues.  She led a review and prioritization of the Agency’s strategic institutional nvestments.   Prior to this, she served as the Deputy Director of the Facilities Engineering and Real Property Division at NASA Headquarters where she ensured that NASA had the specialized facilities available to meet NASA’s mission.  Murphy developed NASA’s Real Property Management Plan which set a visionary approach to managing the agency’s $21 billion assets around the world.  Through her leadership, NASA achieved a “green” rating under President’s Management Agenda program initiative for Federal Real Property Asset Management.  She also served as Executive Officer to the previous NASA Deputy Administrator and supported the NASA Administrator during the critical Presidential transition phase.

Murphy has nearly 30 years of facilities engineering, environmental and institutional management experience.  She established policy, managed planning, design, construction, start-up, and contract activities for NASA’s Construction of Facilities program, and led the Agency’s Pollution Prevention Program and Clean Water Act Team.

Ms. Murphy holds a Bachelor of Science degree in Civil Engineering and a Master of Science degree in Engineering Management, both from the University of Maryland.

 

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