FDA, Center for Drug Evaluation and Research

Description

The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. Parent agency: Food and Drug Administration

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FDA, Center for Drug Evaluation and Research Employees

Employee
Years
Job
Industry
Peter Taschenberger Peter Taschenberger Washington D.C. Metro Area Details
Peter Taschenberger's FDA, Center for Drug Evaluation and Research Experience August 2010 - July 2015
Job Senior Counsel at U.S. Department of Health and Human Services, Office of Inspector General
Industry Law Practice
Experience
U.S. Department of Health and Human Services, Office of Inspector General   July 2015 - Present
FDA, Center for Drug Evaluation and Research   August 2010 - July 2015
United States Attorney's Office  July 2011 - February 2012
U.S. Department of Health and Human Services   May 2009 - July 2010
FDA, Office of the Commissioner   May 2008 - August 2008
U.S. Department of Health and Human Services   May 2007 - August 2007
U.S. House of Representatives   May 2005 - August 2005

Skills
Health Law, Legal Research, Administrative Law, Legal Writing, Policy, Public Policy, Litigation, Trials, Policy Analysis, Research, Legislation, Criminal Law, Civil Rights, Motions, Public Health, Food & Drug Law, Pharmaceutical Industry, Drug Development, Clinical Trials, Pharmacovigilance, Human Subjects Research, Biologics, Government Relations, Compliance, Investigations, HIPAA, EHR

Education
Saint Louis University School of Public Health   2007 — 2010
MPH

Saint Louis University School of Law   2006 — 2010
JD

DePauw University   2002 — 2006
BA

Emily Talbert, MPH Emily Talbert, MPH Rockville, Maryland Details
Emily Talbert, MPH's FDA, Center for Drug Evaluation and Research Experience 2010 - 2011
Job Health Communications Specialist at FDA
Industry Government Administration
Experience
FDA Center for Tobacco Products  2011 - Present
FDA Center for Drug Evaluation and Research  2010 - 2011
FDA Office of the Commissioner   2010 - 2010
FDA Office of the Commissioner   2009 - 2010
Host Hotels & Resorts  2008 - 2009
Host Hotels & Resorts  2005 - 2008
Host Hotels & Resorts  2003 - 2005
Host Hotels & Resorts  2002 - 2003

Skills
Health Communication, Writing, Editing, Public Health, Communications Planning, Strategic Communications, Government, Health Literacy, Social Marketing, Graphic Design, Program Evaluation, Research, Adobe Creative Suite, Community Outreach, Event Planning, Media Relations, Policy Analysis, Grant Writing

Education
Emory University   2010 — 2013
Master of Public Health (M.P.H.), Prevention Science, 4.0

Montgomery College   2006 — 2008
Certificate, Graphic Design, 4.0

University of Maryland College Park   2001 — 2005
Bachelor of Arts (B.A.), English Language and Literature / Creative Writing, 4.0

Jonathan Sheffi Jonathan Sheffi Boston, Massachusetts Details
Jonathan Sheffi's FDA, Center for Drug Evaluation and Research Experience May 2009 - July 2009
Job VP, Customer & Business Development at Curoverse
Industry Biotechnology
Experience
Curoverse   2012 - Present
Commonwealth School  May 2014 - Present
Redline  2013 - Present
Rock Health  May 2012 - August 2012
Novartis Vaccines and Diagnostics  2011 - 2012
Harvard Business School  August 2009 - May 2011
Life Technologies  June 2010 - August 2010
FDA Center for Drug Evaluation and Research  May 2009 - July 2009
Amgen  2007 - 2009
Amgen  2006 - 2007

Skills
Cross-functional Team..., Sales Management, Data Analysis, Competitive Intelligence, Financial Modeling, Account Management, Market Analysis, Strategic Thinking, Strategic Planning, Marketing Strategy, Business Analysis, Strategy, Healthcare, Entrepreneurship, Leadership, Pharmaceutical Industry, Negotiation, Business Development, Start-ups, Management, Mergers & Acquisitions, CRM, Lifesciences, Biotechnology, Analysis, Product Management, Clinical Trials, Marketing, Cancer Genomics, Competitive Analysis, Life Sciences

Education
Harvard Business School   2009 — 2011
MBA

Massachusetts Institute of Technology   2003 — 2004
MEng

Massachusetts Institute of Technology   1999 — 2003
SB

Massachusetts Institute of Technology   1999 — 2003
SB

Commonwealth School   1995 — 1999

Park School   1989 — 1995

Lauren Majdosz Lauren Majdosz Washington D.C. Metro Area Details
Lauren Majdosz's FDA, Center for Drug Evaluation and Research Experience June 2015 - Present
Job Organizational Development Specialist at FDA, Center for Drug Evaluation and Research
Industry Management Consulting
Experience
FDA, Center for Drug Evaluation and Research   June 2015 - Present
Suntiva  January 2015 - June 2015
Suntiva  November 2013 - January 2015
Information Experts  March 2013 - November 2013
Booz Allen Hamilton  October 2011 - March 2013
Human Technology Inc.  October 2009 - October 2011
Apex Performance Strategies   January 2007 - November 2009
Presidential Campaign  August 2008 - December 2008
Independent Consultant  August 2005 - May 2007
Washington College  September 2004 - May 2005

Skills
Leadership Development, Executive Coaching, Instructional Design, MBTI, Organizational Needs..., Program Evaluation, Employee Training, Training Needs Analysis, Organizational..., 360 Feedback, Organizational..., Career Development, Job Analysis, Organizational Design, Organizational Learning, Talent Management, Executive Development, Emotional Intelligence, Organizational Behavior, Training, Change Management, Personnel Management, Human Resources, Coaching, Human Capital, Leadership, Workshop Facilitation, Culture Change, Program Management, Workforce Planning, Technology Needs...

Education
Alliant International University-San Diego Cornerstone Court   2005 — 2007
Masters, Industrial and Organizational Psychology

Washington College   2001 — 2005
BA, Clinical Counseling Psychology and Sociolgy

Brain-Based Coaching

Brain-Based Coaching

Kathy Hanson Kathy Hanson Washington D.C. Metro Area Details
Kathy Hanson's FDA, Center for Drug Evaluation and Research Experience April 2014 - Present
Job Director, Division of Learning and Organization Development
Industry Government Administration
Experience
FDA, Center for Drug Evaluation and Research   April 2014 - Present
National Park Service  April 2008 - April 2014
George Washington University  August 2011 - December 2011
U.S. Office of Personnel Management   2005 - 2008
Federal Mediation and Conciliation Service  March 2002 - October 2005
United States Department of Agriculture  September 2000 - March 2002

Skills
Leadership Development, Organization Development, Public Speaking, Government, Program Management, Teaching, Change Management, Organizational..., Workshop Facilitation, Instructional Design, Volunteer Management, Human Resources, Management Consulting, Training, Grants, Leadership, Customer Service, Team Building, Executive Coaching, Public Policy, 360 Feedback, Staff Development, Strategic Planning, Nonprofits, Program Evaluation, Policy Analysis, Conflict Resolution, Project Management, Organizational..., Program Development, Career Development, Grant Writing, Research, Succession Planning, Event Planning

Education
University of Southern California   1998 — 2000
Ed.D., Educational Leadership

Western Carolina University   1983 — 1984
MA Ed., Higher Education

St. Andrews Presbyterian College   1979 — 1983
BA, English Literature

Nancy Hayes Nancy Hayes Baltimore, Maryland Area Details
Nancy Hayes's FDA, Center for Drug Evaluation and Research Experience February 2013 - Present
Job Supervisory Regulatory Counsel at Food and Drug Administration; Director, Division of Regulatory Policy I
Industry Legal Services
Experience
FDA Center for Drug Evaluation and Research  February 2013 - Present
Food and Drug Administration  July 2009 - Present
U.S. Department of the Interior   February 1993 - January 2001
Steptoe & Johnson LLP  September 1985 - February 1993

Skills
Legal Writing, Litigation, Politics, Legal Research, Administrative Law, Intellectual Property, Health Law, Public Policy, Legislation, Legislative Relations, Policy Analysis, Policy

Education
College of Notre Dame of Maryland   2000 — 2002
N/A, Masters in Education

The Catholic University of America, Columbus School of Law   1981 — 1985
Juris Doctor, Law

Saint Anselm College
B.A., Political Science; Russian Studies

Stacey Welch, BS, MA, RAC Stacey Welch, BS, MA, RAC Greater New York City Area Details
Stacey Welch, BS, MA, RAC's FDA, Center for Drug Evaluation and Research Experience 2002 - 2004
Job Regulatory Affairs Professional
Industry Pharmaceuticals
Experience
Spring Hill College  2005 - 2009
FDA Center for Drug Evaluation and Research  2002 - 2004
Social & Scientific Systems  1999 - 2002
The Advisory Board Company, Health Care Advisory Board   1998 - 1999
University of Pittsburgh, Department of Molecular Genetics and Biochemistry   1995 - 1996
Cleveland Clinic, Department of Immunology   1992 - 1994

Skills
FDA, Lifesciences, Regulatory Affairs, Cancer, Cell, Clinical Trials, IND, Oncology, Biotechnology, Research

Education
University of Pittsburgh   1994 — 1998
MA, History & Philosophy of Science/Medical Ethics

Cornell University   1988 — 1992
BS, Genetics and Development

Walter Biswas Walter Biswas Silver Spring, Maryland Details
Walter Biswas's FDA, Center for Drug Evaluation and Research Experience December 2014 - Present
Job Budget Officer at FDA
Industry Government Administration
Experience
FDA, Center for Drug Evaluation and Research   December 2014 - Present
US Department of Health and Human Services, HHS University, Center for Instructional Technology   October 2010 - December 2014
Partnership for Public Service  January 2013 - December 2013
US Department of Health and Human Services, HHS University, Center for Curriculum Management   April 2009 - October 2010
Planning and Learning Technologies, PAL-Tech, Inc.   December 2007 - April 2009

Skills
Management, Policy, Policy Analysis, Public Policy, Government, Analysis, Research, Program Management, Data Analysis, Leadership, Writing, Financial Analysis, Budget Monitoring, Budget Process, Budget Management, Instructional Design, Project Management, Cross Functional Team..., Team Building, Business Analysis, Statistics

Education
The Catholic University of America   2001 — 2005
Bachelor of Arts (B.A.), History, Philosophy, Theology

University of Maryland University College   2013 — 2015
Master of Business Administration (MBA), Master of Science (MS)

Chris Melton Chris Melton Greater Los Angeles Area Details
Chris Melton's FDA, Center for Drug Evaluation and Research Experience November 2014 - Present
Job Health Communication Specialist at FDA
Industry Medical Devices
Experience
FDA - Center for Drug Evaluation and Research  November 2014 - Present
Acquisitional Medical Devices, LLC   January 2014 - December 2014
Olympus  May 2009 - May 2013
Cardinal Health  2003 - 2009
Ethicon, Inc.   2000 - 2003
Verizon Wireless  1998 - 2000

Skills
Disposables, Capital Equipment, Surgical Instruments, Medical Devices, Operating Room, Surgeons, Product Launch, Hospitals, Healthcare, Product Development, Sales Operations, Market Development, Product Marketing, Cross-functional Team..., Product Management, Competitive Analysis, Sales Management, Salesforce.com, Urology, Marketing Strategy, Orthopedic, Sales, Sales Process, Surgery, New Business Development, Training, Selling

Education
Austin College   1992 — 1996
Psychology, Biology, Spanish

Jefferson High School, Jefferson TX   1989 — 1992
High School Diploma, General Studies

Orhan Suleiman Orhan Suleiman Washington D.C. Metro Area Details
Orhan Suleiman's FDA, Center for Drug Evaluation and Research Experience April 2003 - November 2014
Job MS, PhD, FAAPM, FHPS
Industry Pharmaceuticals
Experience
Science24Seven   November 2014 - Present
FDA Center for Drug Evaluation and Research  April 2003 - November 2014
FDA's Office of Counter-terrorism   April 2002 - April 2003
FDA's Division of Mammography Quality and Radiation Programs   February 1993 - April 2002

Skills
Regulatory Affairs, Clinical Trials, FDA, Radiation, Clinical Development, Science, Lifesciences, Biotechnology, Pharmacoepidemiology, Toxicology, Clinical Research, Epidemiology, Analytical Chemistry, IND, Research, Chemistry, Medical Imaging, Drug Development, Biostatistics, Biomedical Engineering, Medical Devices, Radiology, Medicine, Radiation Safety, Cancer, Health Physics, Life Sciences, X-ray, Oncology

Education
The Johns Hopkins University   1983 — 1989
Doctor of Philosophy (Ph.D.), Environmental Health Sciences (Medical Physics)

University of Florida   1966 — 1972
BS, MS, Zoology, Radiological Sciences

Aaron Weisbuch Aaron Weisbuch Washington D.C. Metro Area Details
Aaron Weisbuch's FDA, Center for Drug Evaluation and Research Experience January 2015 - Present
Job Regulatory Counsel at U.S. Food and Drug Administration, CDER
Industry Public Policy
Experience
FDA - Center for Drug Evaluation and Research  January 2015 - Present
FDA - Center for Tobacco Products  October 2011 - January 2015
Hunton & Williams LLP  July 2011 - October 2011
Compliance LP  December 2010 - July 2011

Education
American University Washington College of Law   2007 — 2010
JD, Law and Government

San Diego State University-California State University   2003 — 2007
BA, Political Science, Music

David Blaszczak David Blaszczak Washington D.C. Metro Area Details
David Blaszczak's FDA, Center for Drug Evaluation and Research Experience 1996 - 1997
Job Principal, Precipio Health Strategies
Industry Hospital & Health Care
Experience
Precipio Health Strategies   September 2014 - Present
ADVI Advisors   January 2013 - August 2014
Potomac Research Group  2009 - 2012
Washington Research Group   2005 - 2009
Centers for Medicare & Medicaid Services  2000 - 2005
Maryland Insurance Administration  1998 - 2000
State of Maryland Office of the Attorney General  1997 - 1998
FDA Center for Drug Evaluation and Research  1996 - 1997

Skills
Managed Care, Policy, Strategic Planning, Policy Analysis, Medicare, Public Policy, Health Policy, Healthcare, Healthcare Information..., Medicaid, Healthcare Consulting, Public Health

Education
Conwell Egan

Temple University

University of Maryland Baltimore County

Tom Garvey MD Tom Garvey MD Washington D.C. Metro Area Details
Tom Garvey MD's FDA, Center for Drug Evaluation and Research Experience 1976 - 1981
Job President at Garvey Associates, Inc.
Industry Medical Practice
Experience
Garvey Associates, Inc.   1981 - Present
FDA Center for Drug Evaluation and Research  1976 - 1981

Skills
Clinical Research, Healthcare, Medical Devices, Project Management, Clinical Trials, Strategic Planning, Data Analysis, Public Speaking, Research, Teaching, Biotechnology, Clinical Development, Infectious Diseases, Oncology, Lifesciences, GCP, Pharmaceutical Industry, Regulatory Affairs, Life Sciences, Diabetes, CTMS, Dermatology, Drug Development, Program Management, Medicine, Medical Education

Education
Harvard University   1959 — 1963

Kendra Biddick Kendra Biddick United States Details
Kendra Biddick's FDA, Center for Drug Evaluation and Research Experience 2004 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA  2004 - Present
FDA Center for Drug Evaluation and Research  2004 - Present
Celera Genomics  2002 - 2003

Skills
Fiber arts--felting and...

Education
Earlham College
Bachelor's degree, French Studies

The Johns Hopkins University
Master of Arts (MA), Molecular Genetics

University of Maryland College Park
Master's degree, Library and Information Science

Jed Costanza Jed Costanza Washington D.C. Metro Area Details
Jed Costanza's FDA, Center for Drug Evaluation and Research Experience May 2015 - Present
Job Chemist FDA Center for Drug Evaluation and Research
Industry Nanotechnology
Experience
FDA Center for Drug Evaluation and Research  May 2015 - Present
FDA Office of the Chief Scientist   November 2013 - May 2015
U.S. Environmental Protection Agency   July 2008 - November 2013
Georgia Institute of Technology  January 2005 - July 2008
Naval Facilities Engineering Command (NAVFAC)   January 1989 - July 2006

Skills
Environmental..., Nanotechnology, Science, Chemistry, Environmental Science

Education
Georgia Institute of Technology   2000 — 2005
Ph.D., Environmental Engineering

Iowa State University   1985 — 1988
B.S., Chemical Engineering