Food and Drug Administration
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
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Food and Drug Administration Employees
Employee
Years
Job
Industry
Elaine Vining Elaine Vining's Food and Drug Administration Experience February 2011 - January 2015
Job Strategic Planning Consultant at the Impact Center
Industry Professional Training & Coaching
Experience
Impact Center March 2015 - Present
Food and Drug Administration February 2011 - January 2015
Drinker, Biddle and Reath, LLP January 2009 - January 2011
Elizabeth Glaser Pediatric AIDS Foundation November 2006 - June 2007
American Academy of Pediatrics January 1995 - February 2005
U.S. Department of Education March 1993 - January 1995
Clinton/Gore Presidential Transition November 1992 - February 1993
The Catholic University of America January 1987 - October 1992
U.S. House of Representatives Committee on the Budget December 1980 - January 1987
Skills
Federal Government..., Public Policy, Legislative Relations, Legislation, Policy Analysis, Government, Policy, Health Policy, Nonprofits, Politics, Program Management, FDA, Pharmaceutical Law, Healthcare Consulting, Grants, Public Affairs, Coalitions, Public Speaking, Community Outreach, Grassroots Organizing, Leadership, Public Health, Political Campaigns, Strategic Planning, Research, Strategic Communications, Program Development, Fundraising, Federal Government, Healthcare, Proposal Writing, Grant Writing, Strategy, Management
Education
Mount Saint Mary's College 1976 — 1980
Bachelor's Degree, History, Cum Laude
Mount Saint Mary's University
Bachelor of Arts (BA), Political Science and History
Impact Center March 2015 - Present
Food and Drug Administration February 2011 - January 2015
Drinker, Biddle and Reath, LLP January 2009 - January 2011
Elizabeth Glaser Pediatric AIDS Foundation November 2006 - June 2007
American Academy of Pediatrics January 1995 - February 2005
U.S. Department of Education March 1993 - January 1995
Clinton/Gore Presidential Transition November 1992 - February 1993
The Catholic University of America January 1987 - October 1992
U.S. House of Representatives Committee on the Budget December 1980 - January 1987
Skills
Federal Government..., Public Policy, Legislative Relations, Legislation, Policy Analysis, Government, Policy, Health Policy, Nonprofits, Politics, Program Management, FDA, Pharmaceutical Law, Healthcare Consulting, Grants, Public Affairs, Coalitions, Public Speaking, Community Outreach, Grassroots Organizing, Leadership, Public Health, Political Campaigns, Strategic Planning, Research, Strategic Communications, Program Development, Fundraising, Federal Government, Healthcare, Proposal Writing, Grant Writing, Strategy, Management
Education
Mount Saint Mary's College 1976 — 1980
Bachelor's Degree, History, Cum Laude
Mount Saint Mary's University
Bachelor of Arts (BA), Political Science and History
Daniel Eyassu Daniel Eyassu's Food and Drug Administration Experience August 2007 - August 2010
Job Safety and Sanitation Manager at Fuchs North America
Industry Food & Beverages
Experience
Fuchs North America December 2013 - Present
Tulkoff Food Products, Inc. January 2013 - February 2014
Dean Foods November 2010 - February 2013
Food and Drug Administration August 2007 - August 2010
Skills
Dairy, Food, Food Industry, Food Processing, Food Safety, Food Science, HACCP, Ingredients, Management, Program Management, Quality Assurance, Quality Auditing, Research, Analysis
Education
George Mason University 2013 — 2015
Graduate Certificate in Food Security, Foods, Nutrition, and Wellness Studies, General
Radford University 2002 — 2007
BS, Biology
Fuchs North America December 2013 - Present
Tulkoff Food Products, Inc. January 2013 - February 2014
Dean Foods November 2010 - February 2013
Food and Drug Administration August 2007 - August 2010
Skills
Dairy, Food, Food Industry, Food Processing, Food Safety, Food Science, HACCP, Ingredients, Management, Program Management, Quality Assurance, Quality Auditing, Research, Analysis
Education
George Mason University 2013 — 2015
Graduate Certificate in Food Security, Foods, Nutrition, and Wellness Studies, General
Radford University 2002 — 2007
BS, Biology
Hannah Meisel Hannah Meisel's Food and Drug Administration Experience November 2014 - Present
Job Regulatory and Science Team Intern at FDA
Industry Health, Wellness and Fitness
Experience
Food and Drug Administration November 2014 - Present
University of Maryland Health Center August 2014 - May 2015
House Calls, LLC May 2012 - November 2014
The Studio of Colour and Design May 2012 - January 2014
Skills
Public Speaking, Health Education, Community Outreach, Social Media, Program Development, Data Entry, Case Management, Nutrition, Office Administration, Organization, Coaching, Academic Writing, Administration, Customer Service, Adolescents
Education
University of Maryland College Park 2013 — 2015
Bachelor of Science (BS), Community Health
Montgomery College 2012 — 2013
Associate of Arts (AA), General Studies, Maintained 3.7 GPA; Dean's List
Food and Drug Administration November 2014 - Present
University of Maryland Health Center August 2014 - May 2015
House Calls, LLC May 2012 - November 2014
The Studio of Colour and Design May 2012 - January 2014
Skills
Public Speaking, Health Education, Community Outreach, Social Media, Program Development, Data Entry, Case Management, Nutrition, Office Administration, Organization, Coaching, Academic Writing, Administration, Customer Service, Adolescents
Education
University of Maryland College Park 2013 — 2015
Bachelor of Science (BS), Community Health
Montgomery College 2012 — 2013
Associate of Arts (AA), General Studies, Maintained 3.7 GPA; Dean's List
Leah Christl Leah Christl's Food and Drug Administration Experience May 2010 - Present
Job Associate Director for Therapeutic Biologics, OND Therapeutic Biologics and Biosimilars Team, CDER/FDA
Industry Government Administration
Experience
Food and Drug Administration May 2010 - Present
Food and Drug Administration November 2005 - March 2011
Food and Drug Administration December 2004 - November 2008
Food and Drug Administration January 2003 - May 2006
University of South Carolina January 2001 - January 2003
Medical University of South Carolina August 1995 - January 2001
Skills
Public Speaking, Regulatory Affairs, Drug Development, FDA, Protein Chemistry, Regulatory Submissions, Clinical Research, Biotechnology, Biosimilars, Pharmaceutical Industry, Biologics, Clinical Trials, Analytical Chemistry, Analytical Biochemistry, Microbiology, Leadership, Team Building, Team Management, Negotiation, Program Facilitation, Toxicology, Biopharmaceuticals, Regulatory Requirements, Lifesciences, Infectious Diseases, GCP, Vaccines, Life Sciences
Education
Medical University of South Carolina 1995 — 2001
Ph.D., Environmental Molecular Microbiology
Rochester Institute of Technology 1991 — 1995
B.S., Biology
Food and Drug Administration May 2010 - Present
Food and Drug Administration November 2005 - March 2011
Food and Drug Administration December 2004 - November 2008
Food and Drug Administration January 2003 - May 2006
University of South Carolina January 2001 - January 2003
Medical University of South Carolina August 1995 - January 2001
Skills
Public Speaking, Regulatory Affairs, Drug Development, FDA, Protein Chemistry, Regulatory Submissions, Clinical Research, Biotechnology, Biosimilars, Pharmaceutical Industry, Biologics, Clinical Trials, Analytical Chemistry, Analytical Biochemistry, Microbiology, Leadership, Team Building, Team Management, Negotiation, Program Facilitation, Toxicology, Biopharmaceuticals, Regulatory Requirements, Lifesciences, Infectious Diseases, GCP, Vaccines, Life Sciences
Education
Medical University of South Carolina 1995 — 2001
Ph.D., Environmental Molecular Microbiology
Rochester Institute of Technology 1991 — 1995
B.S., Biology
Ilana Fogelman's Food and Drug Administration Experience 1993 - 1999
Job CoFounding Partner, Head of Regulatory Affairs at C2N Diagnostics, Inc.
Industry Biotechnology
Experience
C2N Diagnostics January 2010 - Present
LifeTech Development Partners, LP February 2008 - Present
LifeTech Research July 2003 - Present
Merrill Lynch then Citigroup April 2000 - March 2003
Food and Drug Administration 1993 - 1999
National Institutes of Health 1995 - 1998
State Health Secretariat, 1987 - 1988
Skills
Clinical Trials, Immunology, Business Strategy, Strategic Planning, Pharmaceuticals, Biotechnology, Life Sciences, Start-ups, Emerging Markets, International Business, Venture Capital, Product Development, Oncology, Technology Transfer, Regulatory Affairs, Market Analysis, Market Research, Competitive Analysis, Forecasting, Lifesciences, Infectious Diseases, Clinical Development, Pharmaceutical Industry, Due Diligence, Strategy, Competitive Intelligence, Monoclonal Antibodies, FDA, Clinical Research, Commercialization, Market Access, Cell, Drug Development, Medical Devices, Biopharmaceuticals, Vaccines, Pharmacovigilance, Regulatory Submissions, Cancer, IND, Corporate Development, Product Launch, Medicine
Education
Harvard Medical School 1991 — 1993
Post-Docotoral Research Fellowship, Immunology
Harvard School of Public Health 1991 — 1993
Post Doctoral Research Fellowship, HIV Clinical Trials
Harvard School of Public Health 1988 — 1989
MPH, post-doctoral fellowships, MPH degree
Universidade de São Paulo 1981 — 1986
MD, Medicine
C2N Diagnostics January 2010 - Present
LifeTech Development Partners, LP February 2008 - Present
LifeTech Research July 2003 - Present
Merrill Lynch then Citigroup April 2000 - March 2003
Food and Drug Administration 1993 - 1999
National Institutes of Health 1995 - 1998
State Health Secretariat, 1987 - 1988
Skills
Clinical Trials, Immunology, Business Strategy, Strategic Planning, Pharmaceuticals, Biotechnology, Life Sciences, Start-ups, Emerging Markets, International Business, Venture Capital, Product Development, Oncology, Technology Transfer, Regulatory Affairs, Market Analysis, Market Research, Competitive Analysis, Forecasting, Lifesciences, Infectious Diseases, Clinical Development, Pharmaceutical Industry, Due Diligence, Strategy, Competitive Intelligence, Monoclonal Antibodies, FDA, Clinical Research, Commercialization, Market Access, Cell, Drug Development, Medical Devices, Biopharmaceuticals, Vaccines, Pharmacovigilance, Regulatory Submissions, Cancer, IND, Corporate Development, Product Launch, Medicine
Education
Harvard Medical School 1991 — 1993
Post-Docotoral Research Fellowship, Immunology
Harvard School of Public Health 1991 — 1993
Post Doctoral Research Fellowship, HIV Clinical Trials
Harvard School of Public Health 1988 — 1989
MPH, post-doctoral fellowships, MPH degree
Universidade de São Paulo 1981 — 1986
MD, Medicine
Brandi Saddler Brandi Saddler's Food and Drug Administration Experience January 2008 - 2015
Job Acquisition Program Specialist at FDA
Industry Government Administration
Experience
FDA April 2015 - Present
Food and Drug Administration January 2008 - 2015
Education
University of Maryland University College 2014 — 2015
Master of Business Administration (M.B.A.)
University of Maryland University College 2007 — 2010
MS, Health Care Administration, Health/Health Care Administration/Management
Morgan State University 1999 — 2003
Community Health Education, Health and Physical Education/Fitness
FDA April 2015 - Present
Food and Drug Administration January 2008 - 2015
Education
University of Maryland University College 2014 — 2015
Master of Business Administration (M.B.A.)
University of Maryland University College 2007 — 2010
MS, Health Care Administration, Health/Health Care Administration/Management
Morgan State University 1999 — 2003
Community Health Education, Health and Physical Education/Fitness
Brenna Flannery's Food and Drug Administration Experience June 2015 - Present
Job Toxicologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration June 2015 - Present
FDA August 2014 - June 2015
UC Davis January 2013 - August 2014
Michigan State University August 2008 - December 2012
Central High School June 2006 - May 2008
Diagnostic Center for Population and Animal Health (Michigan State) September 2003 - October 2004
Skills
Toxicology, Laboratory, Science, Teaching, Animal Models, Higher Education, Neuroscience, Western Blotting
Education
Michigan State University 2008 — 2012
Ph.D, Food Science and Integrative Toxicology
Michigan State University 2002 — 2006
Bachelor of Science (B.S.), Human Nutrition
Food and Drug Administration June 2015 - Present
FDA August 2014 - June 2015
UC Davis January 2013 - August 2014
Michigan State University August 2008 - December 2012
Central High School June 2006 - May 2008
Diagnostic Center for Population and Animal Health (Michigan State) September 2003 - October 2004
Skills
Toxicology, Laboratory, Science, Teaching, Animal Models, Higher Education, Neuroscience, Western Blotting
Education
Michigan State University 2008 — 2012
Ph.D, Food Science and Integrative Toxicology
Michigan State University 2002 — 2006
Bachelor of Science (B.S.), Human Nutrition
Barbara Berney's Food and Drug Administration Experience February 2009 - Present
Job Graphic designer, editor
Industry Publishing
Experience
Food and Drug Administration February 2009 - Present
Vision Surgery Rehab Network, NFP 2004 - Present
Barbara Berney Design Consultants April 1986 - Present
Regional Design Center February 2013 - December 2014
Art on the Lawn Art Fair 2000 - 2013
University of Illinois College of Medicine at Rockford August 1990 - April 2009
Art Glass Menagerie Studio-Gallery 2004 - 2006
Skills
Public Speaking, Curating, Graphic Design, Illustration, Digital Fine Art, Art Direction, Creative Direction, Adobe Creative Suite, Proposal Writing, Copy Editing, Editing, Creative Services, Creativity, Creative Solutions, Visual Arts, Art Show Director, Jewelry Design, Handmade Jewelry, Fact-checking, Contemporary Art, Workshop Facilitation, Delivering Workshops, Arts Event Direction, Event Planning, Art, Editorial, Magazines, Publications, Nonprofits, Press Releases, Creative Writing, Newsletters, Public Relations, Fine Art, Research, Social Networking, Community Outreach, InDesign, Illustrator, Brand Development, Digital Art, Copywriting, Mac, Training, Facebook, Journalism, Blogging
Education
Indiana University Bloomington 1972 — 1979
BA, Russian history and language, journalism
Food and Drug Administration February 2009 - Present
Vision Surgery Rehab Network, NFP 2004 - Present
Barbara Berney Design Consultants April 1986 - Present
Regional Design Center February 2013 - December 2014
Art on the Lawn Art Fair 2000 - 2013
University of Illinois College of Medicine at Rockford August 1990 - April 2009
Art Glass Menagerie Studio-Gallery 2004 - 2006
Skills
Public Speaking, Curating, Graphic Design, Illustration, Digital Fine Art, Art Direction, Creative Direction, Adobe Creative Suite, Proposal Writing, Copy Editing, Editing, Creative Services, Creativity, Creative Solutions, Visual Arts, Art Show Director, Jewelry Design, Handmade Jewelry, Fact-checking, Contemporary Art, Workshop Facilitation, Delivering Workshops, Arts Event Direction, Event Planning, Art, Editorial, Magazines, Publications, Nonprofits, Press Releases, Creative Writing, Newsletters, Public Relations, Fine Art, Research, Social Networking, Community Outreach, InDesign, Illustrator, Brand Development, Digital Art, Copywriting, Mac, Training, Facebook, Journalism, Blogging
Education
Indiana University Bloomington 1972 — 1979
BA, Russian history and language, journalism
Kimberly Maxile Kimberly Maxile's Food and Drug Administration Experience May 2012 - August 2012
Job Research Associate, at Headway Workforce Solutions
Industry Biotechnology
Experience
Mississippi Valley State University January 2011 - December 2012
Food and Drug Administration May 2012 - August 2012
Mississippi Valley State University May 2011 - July 2011
Mississippi Valley State University May 2010 - July 2010
Skills
Bioinformatics, Data Mining, Genomics, DNA extraction, PCR, ClustalW, Data Analysis, Purification, Molecular Biology, Laboratory, Nucleic Acid Extraction, PCR Thermo Cycler, Agarose gel..., NCBI/NLM-PubChem and..., OECD QSAR Tool Box, Genescan, Gene/ORF Finder, BLAST and FASTA Search..., Computational Modeling, IMG-ACT (IMG Annotation..., Proteomics, Statistical R, Cheminformatics, UCSC genome browser and..., Molecular Sequence..., HTML, Risk Assessment, Toxicology
Education
Mississippi Valley State University 2011 — 2013
Master's degree, Bioinformatics
The Washington Center for Internships and Academic Seminars 2012 — 2012
Grambling State University
Bachelor's degree, Biology
Mississippi Valley State University January 2011 - December 2012
Food and Drug Administration May 2012 - August 2012
Mississippi Valley State University May 2011 - July 2011
Mississippi Valley State University May 2010 - July 2010
Skills
Bioinformatics, Data Mining, Genomics, DNA extraction, PCR, ClustalW, Data Analysis, Purification, Molecular Biology, Laboratory, Nucleic Acid Extraction, PCR Thermo Cycler, Agarose gel..., NCBI/NLM-PubChem and..., OECD QSAR Tool Box, Genescan, Gene/ORF Finder, BLAST and FASTA Search..., Computational Modeling, IMG-ACT (IMG Annotation..., Proteomics, Statistical R, Cheminformatics, UCSC genome browser and..., Molecular Sequence..., HTML, Risk Assessment, Toxicology
Education
Mississippi Valley State University 2011 — 2013
Master's degree, Bioinformatics
The Washington Center for Internships and Academic Seminars 2012 — 2012
Grambling State University
Bachelor's degree, Biology
Yuching Yang's Food and Drug Administration Experience November 2011 - 2013
Job Research Investigator at The Hamner Institutes
Industry Research
Experience
The Hamner Institutes for Health Sciences April 2013 - Present
The Hamner Institutes for Health Sciences November 2010 - March 2013
Food and Drug Administration November 2011 - 2013
The Hamner Institutes for Health Sciences November 2006 - October 2010
Skills
Pharmacokinetics, Pharmacodynamics, Computational Biology, Risk Assessment, Probabilistic Models, Uncertainty Analysis, Simulations, Matlab, Toxicology, In Vivo, ADME, Drug Metabolism, Drug Discovery
Education
UMDNJ-Rutgers University
National Taiwan University
The Hamner Institutes for Health Sciences April 2013 - Present
The Hamner Institutes for Health Sciences November 2010 - March 2013
Food and Drug Administration November 2011 - 2013
The Hamner Institutes for Health Sciences November 2006 - October 2010
Skills
Pharmacokinetics, Pharmacodynamics, Computational Biology, Risk Assessment, Probabilistic Models, Uncertainty Analysis, Simulations, Matlab, Toxicology, In Vivo, ADME, Drug Metabolism, Drug Discovery
Education
UMDNJ-Rutgers University
National Taiwan University
Eric Landis Eric Landis's Food and Drug Administration Experience October 2009 - Present
Job Regulatory Scientist (Aquaculture) at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration October 2009 - Present
NOAA Northwest Fisheries Science Center June 2007 - October 2009
University of Maryland / USGS Western Fisheries Research Center September 2002 - July 2007
Kent SeaTech 2000 - 2002
Skills
Aquaculture, Scientific Review, Experimental Design, Clinical Study Design, Fish Health, Regulatory Requirements, Regulatory Submissions, Infectious Diseases, Public Policy, Molecular Biology, Biotechnology, Public Speaking, Scientific Writing, Toxicology, Lifesciences
Education
University of Maryland Baltimore 2002 — 2006
Doctor of Philosophy (Ph.D.), Molecular Medicine
University of California, San Diego 1999 — 2001
Bachelor's degree, Molecular Biology
Florida Institute of Technology
Food and Drug Administration October 2009 - Present
NOAA Northwest Fisheries Science Center June 2007 - October 2009
University of Maryland / USGS Western Fisheries Research Center September 2002 - July 2007
Kent SeaTech 2000 - 2002
Skills
Aquaculture, Scientific Review, Experimental Design, Clinical Study Design, Fish Health, Regulatory Requirements, Regulatory Submissions, Infectious Diseases, Public Policy, Molecular Biology, Biotechnology, Public Speaking, Scientific Writing, Toxicology, Lifesciences
Education
University of Maryland Baltimore 2002 — 2006
Doctor of Philosophy (Ph.D.), Molecular Medicine
University of California, San Diego 1999 — 2001
Bachelor's degree, Molecular Biology
Florida Institute of Technology
Jamie Metz Jamie Metz's Food and Drug Administration Experience May 2005 - August 2010
Job
Industry Government Administration
Experience
Government October 2014 - Present
Government September 2010 - October 2014
Food and Drug Administration May 2005 - August 2010
Skills
Recruitments, Public Sector, Project Coordination, Human Resources, Communication, Team Facilitation, FDA, Federal Government, Change Management, Policy, Process Improvement, Program Management, Project Management, Government, Business Process..., Visio, Negotiation, Microsoft Excel, SharePoint, Technical Writing, Strategy, Employee Relations, Microsoft Office, Project Planning, Quality Assurance, Analysis, Social Networking
Education
Montgomery College
General Studies
Government October 2014 - Present
Government September 2010 - October 2014
Food and Drug Administration May 2005 - August 2010
Skills
Recruitments, Public Sector, Project Coordination, Human Resources, Communication, Team Facilitation, FDA, Federal Government, Change Management, Policy, Process Improvement, Program Management, Project Management, Government, Business Process..., Visio, Negotiation, Microsoft Excel, SharePoint, Technical Writing, Strategy, Employee Relations, Microsoft Office, Project Planning, Quality Assurance, Analysis, Social Networking
Education
Montgomery College
General Studies
G. Avery Wilson's Food and Drug Administration Experience August 2008 - Present
Job Program Analyst at Food and Drug Administration
Industry Government Administration
Experience
The Church International March 2014 - Present
Food and Drug Administration August 2008 - Present
Skills
Federal Government, Human Resources, Program Management, Training, Training Delivery, Strategic Planning, Data Analysis, Business Process..., Business Requirements, Policy Analysis, Motivational Speaking, Pastoral, Ministering, Nonprofits, Published Author, Preaching, Youth Ministry, Evangelism, Spiritual Direction, Coaching, Discipleship, Church Growth, Church Administration, Project Management, Praise & Worship, Musicians, Father, Event Planning, New Hire Orientations, New Hire Training, Onboarding, Exit Process, Government, Community Outreach, Customer Service, Social Media
Education
Middle Township High School 1992 — 1994
Montgomery College
The Church International March 2014 - Present
Food and Drug Administration August 2008 - Present
Skills
Federal Government, Human Resources, Program Management, Training, Training Delivery, Strategic Planning, Data Analysis, Business Process..., Business Requirements, Policy Analysis, Motivational Speaking, Pastoral, Ministering, Nonprofits, Published Author, Preaching, Youth Ministry, Evangelism, Spiritual Direction, Coaching, Discipleship, Church Growth, Church Administration, Project Management, Praise & Worship, Musicians, Father, Event Planning, New Hire Orientations, New Hire Training, Onboarding, Exit Process, Government, Community Outreach, Customer Service, Social Media
Education
Middle Township High School 1992 — 1994
Montgomery College
Jonathan McKnight Jonathan McKnight's Food and Drug Administration Experience March 2011 - Present
Job Regulatory Counsel, Food and Drug Administration
Industry Biotechnology
Experience
Food and Drug Administration March 2011 - Present
Plasma Protein Therapeutics Association December 2005 - March 2011
Covington & Burling August 2005 - December 2005
Skills
Policy, Legislative Relations, Public Policy, Government, Policy Analysis, Litigation, Health Policy, Legal Research, Research, Legal Writing
Education
Georgetown University Law Center 2002 — 2003
Law, Law
University of Denver - Sturm College of Law 2000 — 2003
J.D., Law
Wittenberg University 1992 — 1996
Bachelor of Arts (B.A.), Political Science and Government
Food and Drug Administration March 2011 - Present
Plasma Protein Therapeutics Association December 2005 - March 2011
Covington & Burling August 2005 - December 2005
Skills
Policy, Legislative Relations, Public Policy, Government, Policy Analysis, Litigation, Health Policy, Legal Research, Research, Legal Writing
Education
Georgetown University Law Center 2002 — 2003
Law, Law
University of Denver - Sturm College of Law 2000 — 2003
J.D., Law
Wittenberg University 1992 — 1996
Bachelor of Arts (B.A.), Political Science and Government
Martha (Mai) Nguyen Martha (Mai) Nguyen's Food and Drug Administration Experience 2005 - 2013
Job Director of Generic Drug Policy Development at Food and Drug Administration
Industry Public Policy
Experience
FDA 2014 - Present
Food and Drug Administration 2005 - 2013
Powell Goldstein LLP 2003 - 2005
Powell Goldstein LLP 2000 - 2003
Center for Law and Social Policy 1999 - 2000
Skills
Drug Development, Public Policy, Food & Drug Law, Legislation, Regulatory Analysis, Administrative Law, Regulatory Policy, Drug Safety, Policy Analysis, Legal Research, Legal Writing, Legislative Relations, Westlaw, Health Law, Regulations
Education
Georgetown University Law Center 2000 — 2003
JD, Law
University of Pennsylvania 1995 — 1999
BA with Honors Distinction, Sociology of Health and Medicine
Connelly School of the Holy Child
FDA 2014 - Present
Food and Drug Administration 2005 - 2013
Powell Goldstein LLP 2003 - 2005
Powell Goldstein LLP 2000 - 2003
Center for Law and Social Policy 1999 - 2000
Skills
Drug Development, Public Policy, Food & Drug Law, Legislation, Regulatory Analysis, Administrative Law, Regulatory Policy, Drug Safety, Policy Analysis, Legal Research, Legal Writing, Legislative Relations, Westlaw, Health Law, Regulations
Education
Georgetown University Law Center 2000 — 2003
JD, Law
University of Pennsylvania 1995 — 1999
BA with Honors Distinction, Sociology of Health and Medicine
Connelly School of the Holy Child
AUDREY VIGIL AUDREY VIGIL's Food and Drug Administration Experience
Job Branch Manager, Division of Human Resource & Development
Industry Government Administration
Experience
Food and Drug Administration
Skills
Program Management, Policy, Government, Risk Management, Management, Leadership, Strategic Planning, Team Building, Team Leadership, Coaching, Human Resources, Executive Management, Employee Relations, Staff Development, Management Consulting, Leadership Development, Organizational..., Training
Education
Metropolitan State University of Denver
Food and Drug Administration
Skills
Program Management, Policy, Government, Risk Management, Management, Leadership, Strategic Planning, Team Building, Team Leadership, Coaching, Human Resources, Executive Management, Employee Relations, Staff Development, Management Consulting, Leadership Development, Organizational..., Training
Education
Metropolitan State University of Denver
Constance Wilhelm-Miller Constance Wilhelm-Miller's Food and Drug Administration Experience 1979 - 2010
Job Director, CDRH Acquisitions & Grants Services Staff
Industry Legal Services
Experience
FDA February 2010 - Present
Food and Drug Administration 1979 - 2010
USAF July 1981 - July 1986
US Air Force Honor Guard January 1982 - January 1986
Skills
Facilities Management, Policy, Acquisitions, Grants, Management, Strategic Planning, Program Management, Proposal Writing, Government
Education
Georgetown University Law Center 2007 — 2011
Contract Law; Family Law
FDA February 2010 - Present
Food and Drug Administration 1979 - 2010
USAF July 1981 - July 1986
US Air Force Honor Guard January 1982 - January 1986
Skills
Facilities Management, Policy, Acquisitions, Grants, Management, Strategic Planning, Program Management, Proposal Writing, Government
Education
Georgetown University Law Center 2007 — 2011
Contract Law; Family Law
Tracey Rogers, PhD Tracey Rogers, PhD's Food and Drug Administration Experience 1996 - 1998
Job Quality Executive Partners
Industry Pharmaceuticals
Experience
Geode Pharmaceutical Consulting, LLC April 2013 - January 2014
Quality Executive Partners Inc. July 2013 - December 2013
Harris Teeter October 2010 - April 2013
Lung LLC a subsidiary of United Therapeutics July 2012 - October 2012
Otsuka America Pharmaceutical, Inc. July 2005 - July 2012
Guilford Pharmaceuticals 2000 - 2004
Howard University 1998 - 2000
Food and Drug Administration 1996 - 1998
Skills
Pharmaceuticals, FDA, Research, Microsoft Office, R&D, Project Management, Formulation Chemistry, Technical Transfers, Team Leadership, Pharmaceutical Industry, Clinical Research, Chemistry, Formulation, Pharmaceutics, GMP, Pharmacy, Aseptic Processing, CMC, Drug Development, Quality Assurance, Process Improvement, CAPA, Clinical Development, Technology Transfer, Sop, IND, GxP, Regulatory Affairs, Clinical Trials, SOP
Education
Purdue University 1990 — 1997
Doctor of Philosophy (PhD), Industrial and Physical Pharmacy
Howard University
BS, Pharmacy
Geode Pharmaceutical Consulting, LLC April 2013 - January 2014
Quality Executive Partners Inc. July 2013 - December 2013
Harris Teeter October 2010 - April 2013
Lung LLC a subsidiary of United Therapeutics July 2012 - October 2012
Otsuka America Pharmaceutical, Inc. July 2005 - July 2012
Guilford Pharmaceuticals 2000 - 2004
Howard University 1998 - 2000
Food and Drug Administration 1996 - 1998
Skills
Pharmaceuticals, FDA, Research, Microsoft Office, R&D, Project Management, Formulation Chemistry, Technical Transfers, Team Leadership, Pharmaceutical Industry, Clinical Research, Chemistry, Formulation, Pharmaceutics, GMP, Pharmacy, Aseptic Processing, CMC, Drug Development, Quality Assurance, Process Improvement, CAPA, Clinical Development, Technology Transfer, Sop, IND, GxP, Regulatory Affairs, Clinical Trials, SOP
Education
Purdue University 1990 — 1997
Doctor of Philosophy (PhD), Industrial and Physical Pharmacy
Howard University
BS, Pharmacy
Maggie Fu Maggie Fu's Food and Drug Administration Experience August 2011 - Present
Job Program Specialist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration August 2011 - Present
FDA June 2010 - July 2011
Skills
Mandarin, Microsoft Office, Administration, Database Administration, Website Management, Database Management, Data Analysis, Educational Outreach, Survey Development, Project Management, Social Networking, Management, Organization, Strategic Communications, Web-based Communication, Internal & External..., Policy, Policy Analysis, Public Health, Microsoft Excel, PowerPoint, Research, Leadership
Education
Georgetown University 2014 — 2016
Master's Degree, Biomedical Science Policy and Advocacy
University of Maryland College Park 2007 — 2011
Bachelor of Science (B.S.), Public Health
Connelly School of the Holy Child
Food and Drug Administration August 2011 - Present
FDA June 2010 - July 2011
Skills
Mandarin, Microsoft Office, Administration, Database Administration, Website Management, Database Management, Data Analysis, Educational Outreach, Survey Development, Project Management, Social Networking, Management, Organization, Strategic Communications, Web-based Communication, Internal & External..., Policy, Policy Analysis, Public Health, Microsoft Excel, PowerPoint, Research, Leadership
Education
Georgetown University 2014 — 2016
Master's Degree, Biomedical Science Policy and Advocacy
University of Maryland College Park 2007 — 2011
Bachelor of Science (B.S.), Public Health
Connelly School of the Holy Child
Jessica Samuels Jessica Samuels's Food and Drug Administration Experience October 2010 - December 2012
Job Senior Elearning Instructional Designer
Industry Writing and Editing
Experience
Henry M. Jackson Foundation February 2014 - Present
Jessica Samuels Career Services May 2009 - Present
FAA December 2012 - February 2014
Food and Drug Administration October 2010 - December 2012
Berkshire Associates Inc. May 2010 - October 2010
NAHB April 2008 - May 2010
Montgomery County Public Schools January 2006 - March 2008
Teacher/ Health Education Coordinator January 2006 - March 2008
Anne Arundel County Public Schools August 2005 - January 2006
George Mason University August 2004 - May 2005
Skills
Job task analysis, subject matter expert..., test analysis, project management, Technical Writing, Editing, Microsoft Office, Learning Management..., HTML, Captivate, Gap Analysis, Business Process..., Microsoft Visio, Visio, Analysis, Project Management, Leadership Development, Instructional Design
Education
Towson University 2014 — 2017
Doctor of Education (EdD), Instructional Technology, A
McDaniel College 2006 — 2007
MS, Education Administration/Curriculum & Instruction
George Mason University 2002 — 2005
B.S., Education
Old Dominion University
Henry M. Jackson Foundation February 2014 - Present
Jessica Samuels Career Services May 2009 - Present
FAA December 2012 - February 2014
Food and Drug Administration October 2010 - December 2012
Berkshire Associates Inc. May 2010 - October 2010
NAHB April 2008 - May 2010
Montgomery County Public Schools January 2006 - March 2008
Teacher/ Health Education Coordinator January 2006 - March 2008
Anne Arundel County Public Schools August 2005 - January 2006
George Mason University August 2004 - May 2005
Skills
Job task analysis, subject matter expert..., test analysis, project management, Technical Writing, Editing, Microsoft Office, Learning Management..., HTML, Captivate, Gap Analysis, Business Process..., Microsoft Visio, Visio, Analysis, Project Management, Leadership Development, Instructional Design
Education
Towson University 2014 — 2017
Doctor of Education (EdD), Instructional Technology, A
McDaniel College 2006 — 2007
MS, Education Administration/Curriculum & Instruction
George Mason University 2002 — 2005
B.S., Education
Old Dominion University
Ramon Merel Ramon Merel's Food and Drug Administration Experience March 1999 - Present
Job Information Technology Specialist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration March 1999 - Present
US Department of Health & Human Services March 1989 - Present
Skills
Network Administration, Computer Security, Software Development, TCP/IP, Network Security, CISSP, Information Security..., Security, Linux, Security+, Windows Server, System Administration, Unix, Information Security, Operating Systems, FISMA, Microsoft Office, Research, Social Media, Management, Teaching, Program Management, Firewalls
Education
Miami Dade College 1985 — 1988
Business Data Processing Computer Programmer, Computer Science
Miami Dade College 1985 — 1988
AA, Computer Science
Food and Drug Administration March 1999 - Present
US Department of Health & Human Services March 1989 - Present
Skills
Network Administration, Computer Security, Software Development, TCP/IP, Network Security, CISSP, Information Security..., Security, Linux, Security+, Windows Server, System Administration, Unix, Information Security, Operating Systems, FISMA, Microsoft Office, Research, Social Media, Management, Teaching, Program Management, Firewalls
Education
Miami Dade College 1985 — 1988
Business Data Processing Computer Programmer, Computer Science
Miami Dade College 1985 — 1988
AA, Computer Science
Elizabeth Kenyon Elizabeth Kenyon's Food and Drug Administration Experience June 2010 - August 2012
Job Laboratory Technician at National Institute of Neurological Disorders and Stroke (NINDS)
Industry Research
Experience
National Institute of Neurological Disorders and Stroke (NINDS) April 2014 - Present
Uniformed Services University of the Health Sciences December 2012 - April 2014
Food and Drug Administration June 2010 - August 2012
Michigan State University May 2008 - June 2010
Michigan State University 2008 - 2009
Skills
Gel Electrophoresis, PCR, Molecular Biology, DNA extraction, qPCR, Microbiology, RT-PCR, RNA isolation, Molecular Cloning, Western Blotting, Experimental Design, Cell Culture, Protein Purification, ELISA, Biochemistry, Genetics, Protein Expression, Fluorescence Microscopy, Microscopy, SDS-PAGE
Education
Michigan State University College of Veterinary Medicine 2012 — 2012
Doctor of Veterinary Medicine, Veterinary Medicine
Michigan State University 2010 — 2011
M.S., Food Safety
Michigan State University 2006 — 2010
B.S., Zoology
National Institute of Neurological Disorders and Stroke (NINDS) April 2014 - Present
Uniformed Services University of the Health Sciences December 2012 - April 2014
Food and Drug Administration June 2010 - August 2012
Michigan State University May 2008 - June 2010
Michigan State University 2008 - 2009
Skills
Gel Electrophoresis, PCR, Molecular Biology, DNA extraction, qPCR, Microbiology, RT-PCR, RNA isolation, Molecular Cloning, Western Blotting, Experimental Design, Cell Culture, Protein Purification, ELISA, Biochemistry, Genetics, Protein Expression, Fluorescence Microscopy, Microscopy, SDS-PAGE
Education
Michigan State University College of Veterinary Medicine 2012 — 2012
Doctor of Veterinary Medicine, Veterinary Medicine
Michigan State University 2010 — 2011
M.S., Food Safety
Michigan State University 2006 — 2010
B.S., Zoology
Devin Koontz Devin Koontz's Food and Drug Administration Experience May 1998 - August 2013
Job Public Affairs Director at USDA Food and Nutrition Service
Industry Public Relations and Communications
Experience
FDA August 2015 - Present
USDA Food and Nutrition Service August 2013 - August 2015
Food and Drug Administration May 1998 - August 2013
FDA April 1991 - May 1998
Denver Merchandise Mart June 1987 - October 1990
Skills
Media Relations, Community Relations, Mediation, Government Relations, Public Speaking, Public Relations, Event Planning, Crisis Communications, Corporate Communications, Community Outreach, Government Liaison, Government, Lobbying, Press Releases, Research, Strategic Communications, Public Affairs, Internal Communications, Public Policy, Communications Planning, Policy, Newsletters, Policy Analysis, Spokesperson, Strategic Partnerships, Nonprofits, Grant Writing, Community Development
Education
Metropolitan State College of Denver 1991 — 1998
Bachelor of Arts, Organizational Communications
AHS 1985 — 1987
FDA August 2015 - Present
USDA Food and Nutrition Service August 2013 - August 2015
Food and Drug Administration May 1998 - August 2013
FDA April 1991 - May 1998
Denver Merchandise Mart June 1987 - October 1990
Skills
Media Relations, Community Relations, Mediation, Government Relations, Public Speaking, Public Relations, Event Planning, Crisis Communications, Corporate Communications, Community Outreach, Government Liaison, Government, Lobbying, Press Releases, Research, Strategic Communications, Public Affairs, Internal Communications, Public Policy, Communications Planning, Policy, Newsletters, Policy Analysis, Spokesperson, Strategic Partnerships, Nonprofits, Grant Writing, Community Development
Education
Metropolitan State College of Denver 1991 — 1998
Bachelor of Arts, Organizational Communications
AHS 1985 — 1987
Ahmed Askar, MPH, PMP's Food and Drug Administration Experience September 2013 - Present
Job
Industry Public Safety
Experience
Food and Drug Administration September 2013 - Present
Skills
Emergency Management, Team Leadership, Team Management, Cultural Diversity, Project Coordination, Research Project..., GIS analysis, Disaster Preparedness, Non-profit Development, Leadership
Education
George Mason University 2015 — 2020
Doctor of Philosophy (Ph.D.)
Wright State University 2010 — 2012
Master of Public Health (MPH)
The Ohio State University 2003 — 2008
Bachelor of Science
Franklin Heights High School 2000 — 2003
High School
Food and Drug Administration September 2013 - Present
Skills
Emergency Management, Team Leadership, Team Management, Cultural Diversity, Project Coordination, Research Project..., GIS analysis, Disaster Preparedness, Non-profit Development, Leadership
Education
George Mason University 2015 — 2020
Doctor of Philosophy (Ph.D.)
Wright State University 2010 — 2012
Master of Public Health (MPH)
The Ohio State University 2003 — 2008
Bachelor of Science
Franklin Heights High School 2000 — 2003
High School
Lydia Dean-Reese, M.S., M.B.A. Lydia Dean-Reese, M.S., M.B.A.'s Food and Drug Administration Experience May 1992 - September 1997
Job Paralegal Case Manager
Industry Legal Services
Experience
Paralegal November 2010 - Present
Grants by Lydia 2011 - December 2011
McDermott Will and Emery March 2008 - November 2010
Fish & Richardson, P.C. February 2007 - March 2008
et al 2002 - 2007
Quality Time Early Learning Center 2001 - 2003
Akin Gump Strauss Hauer & Feld LLP July 1996 - May 2002
Food and Drug Administration May 1992 - September 1997
Skills
Litigation, Intellectual Property, Courts, Legal Writing, Legal Research, Strategic Planning, Civil Litigation, Westlaw, Mergers & Acquisitions, Research, Lexis, Litigation Management, PACER, System Administration, Complex Analysis, Writing, Microsoft Office, Administration, Team Building, Analysis, Problem Solving, Coaching, Documentation, Litigation Support, Management, Project Management, Training & Development
Education
University of Maryland University College 2013 — 2015
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Maryland University College 2009 — 2013
Master's degree, Marketing/Marketing Management, General
Montclair State University 1984 — 1988
BA, Business
Paralegal November 2010 - Present
Grants by Lydia 2011 - December 2011
McDermott Will and Emery March 2008 - November 2010
Fish & Richardson, P.C. February 2007 - March 2008
et al 2002 - 2007
Quality Time Early Learning Center 2001 - 2003
Akin Gump Strauss Hauer & Feld LLP July 1996 - May 2002
Food and Drug Administration May 1992 - September 1997
Skills
Litigation, Intellectual Property, Courts, Legal Writing, Legal Research, Strategic Planning, Civil Litigation, Westlaw, Mergers & Acquisitions, Research, Lexis, Litigation Management, PACER, System Administration, Complex Analysis, Writing, Microsoft Office, Administration, Team Building, Analysis, Problem Solving, Coaching, Documentation, Litigation Support, Management, Project Management, Training & Development
Education
University of Maryland University College 2013 — 2015
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Maryland University College 2009 — 2013
Master's degree, Marketing/Marketing Management, General
Montclair State University 1984 — 1988
BA, Business
Nate Dahl, PharmD's Food and Drug Administration Experience February 2011 - March 2011
Job Hematology/Oncology Clinical Pharmacist at Mayo Clinic
Industry Pharmaceuticals
Experience
Mayo Clinic July 2011 - Present
Salvation Army Good Samaritan Clinic July 2011 - Present
Mayo Clinic July 2011 - Present
Mayo Clinic March 2011 - May 2011
Food and Drug Administration February 2011 - March 2011
Novo Nordisk A/S January 2011 - February 2011
Roger Maris Cancer Center November 2010 - December 2010
Sanford Health September 2010 - October 2010
Southpointe Pharmacy August 2010 - September 2010
sanofi-aventis September 2005 - September 2008
Skills
Hematology, Oncology, Medication Safety, Drug Information, Diabetes, Pharmacists, Clinical Research, Pharmacy, Managed Care, Cardiology, Patient Safety, Clinical Pharmacy, Pharmaceutical Industry, Medication Therapy..., Pharmacology, Clinical Pharmacology
Education
Lake Erie College of Ostheopathic Medicine 2008 — 2011
Pharm.D.
University of Minnesota Duluth 2001 — 2005
BS, Biochemistry & Molecular Biology
Mayo Clinic July 2011 - Present
Salvation Army Good Samaritan Clinic July 2011 - Present
Mayo Clinic July 2011 - Present
Mayo Clinic March 2011 - May 2011
Food and Drug Administration February 2011 - March 2011
Novo Nordisk A/S January 2011 - February 2011
Roger Maris Cancer Center November 2010 - December 2010
Sanford Health September 2010 - October 2010
Southpointe Pharmacy August 2010 - September 2010
sanofi-aventis September 2005 - September 2008
Skills
Hematology, Oncology, Medication Safety, Drug Information, Diabetes, Pharmacists, Clinical Research, Pharmacy, Managed Care, Cardiology, Patient Safety, Clinical Pharmacy, Pharmaceutical Industry, Medication Therapy..., Pharmacology, Clinical Pharmacology
Education
Lake Erie College of Ostheopathic Medicine 2008 — 2011
Pharm.D.
University of Minnesota Duluth 2001 — 2005
BS, Biochemistry & Molecular Biology
Brian Monsell Brian Monsell's Food and Drug Administration Experience June 1980 - December 1980
Job Mathematical Statistician at U. S. Census Bureau
Industry Research
Experience
Time Series Research Staff March 2002 - Present
U. S. Census Bureau October 1982 - Present
US Department of Commerce, Census Bureau, Time Series Methods Staff October 1982 - Present
Lumina studio theater 2008 - Present
Florida State University January 1981 - June 1982
Food and Drug Administration June 1980 - December 1980
Skills
Statistics, Data Analysis, Teaching, Research, SAS, R, Statistical Modeling, Analysis, Public Speaking, Analytics, Editing, Microsoft Office, Time Series Analysis, Survey Design, Statistical Computing, Programming, Multivariate Analysis, Quantitative Research, Logistic Regression, Software Development, Linear Regression, Data Collection, Data Mining, SAS programming
Education
Florida State University 1981 — 1982
MS, Applied Statistics
University of Massachusetts, Amherst 1978 — 1980
BA, Mathematics
Tusculum College 1975 — 1977
Mathematics
Mattituck-Cutchogue High School 1971 — 1975
Time Series Research Staff March 2002 - Present
U. S. Census Bureau October 1982 - Present
US Department of Commerce, Census Bureau, Time Series Methods Staff October 1982 - Present
Lumina studio theater 2008 - Present
Florida State University January 1981 - June 1982
Food and Drug Administration June 1980 - December 1980
Skills
Statistics, Data Analysis, Teaching, Research, SAS, R, Statistical Modeling, Analysis, Public Speaking, Analytics, Editing, Microsoft Office, Time Series Analysis, Survey Design, Statistical Computing, Programming, Multivariate Analysis, Quantitative Research, Logistic Regression, Software Development, Linear Regression, Data Collection, Data Mining, SAS programming
Education
Florida State University 1981 — 1982
MS, Applied Statistics
University of Massachusetts, Amherst 1978 — 1980
BA, Mathematics
Tusculum College 1975 — 1977
Mathematics
Mattituck-Cutchogue High School 1971 — 1975
Jonathan Brumbach Jonathan Brumbach's Food and Drug Administration Experience 2004 - 2011
Job Graduate Student at University of Utah
Industry Pharmaceuticals
Experience
Utah-Inha Advanced Drug Delivery Systems May 2011 - Present
Brumbach, Jonathan June 2005 - January 2011
Food and Drug Administration 2004 - 2011
University of Utah 2005 - 2010
Skills
Research
Education
University of Utah 2005 — 2010
Ph.D., 2011Pharmaceutics and Pharmaceutical Chemistry
University of Utah School of Medicine 2005 — 2010
Ph.D., Pharmaceutical Chemistry
Lewis and Clark College 2000 — 2004
Bachelor of art, Biochemistry
Lewis and Clark College 2000 — 2004
2000, 2004Biochemistry
Utah-Inha Advanced Drug Delivery Systems May 2011 - Present
Brumbach, Jonathan June 2005 - January 2011
Food and Drug Administration 2004 - 2011
University of Utah 2005 - 2010
Skills
Research
Education
University of Utah 2005 — 2010
Ph.D., 2011Pharmaceutics and Pharmaceutical Chemistry
University of Utah School of Medicine 2005 — 2010
Ph.D., Pharmaceutical Chemistry
Lewis and Clark College 2000 — 2004
Bachelor of art, Biochemistry
Lewis and Clark College 2000 — 2004
2000, 2004Biochemistry
Michael Hendry Michael Hendry's Food and Drug Administration Experience May 1985 - July 1989
Job
Industry Government Administration
Experience
Division of HIV/AIDS Prevention/NCHHSTP/CDC December 2008 - December 2013
Wyeth Research October 2001 - May 2008
California Dept. of Health Services June 1989 - October 2001
Food and Drug Administration May 1985 - July 1989
Skills
Virology, Immunology, Public Health, Viruses, Infectious Diseases, Molecular Biology, Microbiology, Epidemiology, Vaccines, Cell Biology, Global Health, Life Sciences, Monoclonal Antibodies, Therapeutics, Biotechnology, Antibodies, International Health, Public Health Policy, Animal Models, Anti-infectives, In Vivo, Health, In Vitro, Prevention, Clinical Development, Biopharmaceuticals, Biostatistics, HIV/AIDS prevention, Health Research, Pharmaceuticals, Lifesciences, Therapists, Health Policy, Pharmaceutical Industry, Clinical Trials, Cell
Education
Harvard School of Public Health 1978 — 1981
D.Sc., Microbiology
Harvard School of Public Health 1976 — 1978
M.S., Microbiology
Division of HIV/AIDS Prevention/NCHHSTP/CDC December 2008 - December 2013
Wyeth Research October 2001 - May 2008
California Dept. of Health Services June 1989 - October 2001
Food and Drug Administration May 1985 - July 1989
Skills
Virology, Immunology, Public Health, Viruses, Infectious Diseases, Molecular Biology, Microbiology, Epidemiology, Vaccines, Cell Biology, Global Health, Life Sciences, Monoclonal Antibodies, Therapeutics, Biotechnology, Antibodies, International Health, Public Health Policy, Animal Models, Anti-infectives, In Vivo, Health, In Vitro, Prevention, Clinical Development, Biopharmaceuticals, Biostatistics, HIV/AIDS prevention, Health Research, Pharmaceuticals, Lifesciences, Therapists, Health Policy, Pharmaceutical Industry, Clinical Trials, Cell
Education
Harvard School of Public Health 1978 — 1981
D.Sc., Microbiology
Harvard School of Public Health 1976 — 1978
M.S., Microbiology
Jason Deck Jason Deck's Food and Drug Administration Experience January 2011 - December 2011
Job Patent Examiner at USPTO
Industry Chemicals
Experience
USPTO March 2012 - Present
Food and Drug Administration January 2011 - December 2011
NIH June 2007 - November 2010
University of Texas at Austin 2000 - 2007
Skills
Drug Design, HPLC, Spectroscopy, Organic Chemistry, Science, Purification, Chromatography, Characterization, Chemistry, Research, Organic Synthesis, NMR, Data Analysis, Medicinal Chemistry, Analytical Chemistry, Drug Discovery, LC-MS, Analysis, Technical Writing, Teaching, Microsoft Office, Organic Modeling, Biotechnology, Patents, IR, Biochemistry, Protein Chemistry
Education
The University of Texas at Austin 2000 — 2007
The University of New Mexico 1998 — 2000
MS, Organic Chemistry
Fort Lewis College 1994 — 1997
BS, Chemistry
USPTO March 2012 - Present
Food and Drug Administration January 2011 - December 2011
NIH June 2007 - November 2010
University of Texas at Austin 2000 - 2007
Skills
Drug Design, HPLC, Spectroscopy, Organic Chemistry, Science, Purification, Chromatography, Characterization, Chemistry, Research, Organic Synthesis, NMR, Data Analysis, Medicinal Chemistry, Analytical Chemistry, Drug Discovery, LC-MS, Analysis, Technical Writing, Teaching, Microsoft Office, Organic Modeling, Biotechnology, Patents, IR, Biochemistry, Protein Chemistry
Education
The University of Texas at Austin 2000 — 2007
The University of New Mexico 1998 — 2000
MS, Organic Chemistry
Fort Lewis College 1994 — 1997
BS, Chemistry
Huong Huynh Reagan Huong Huynh Reagan's Food and Drug Administration Experience September 2010 - Present
Job Pharmacologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration September 2010 - Present
AWIS San Diego 2001 - Present
Bio4Front, Inc. March 2010 - August 2010
AWIS San Diego September 2006 - August 2010
San Diego Postdoctoral Training Consortium October 2006 - February 2010
Sanford-Burnham Medical Research Institute July 2004 - February 2010
National Postdoctoral Association 2003 - 2010
The Burnham Institute March 2001 - June 2004
Skills
Pharmacokinetics, Clinical Research, Biostatistics, Analytical Method..., Code of Federal..., Medical Research
Education
Loma Linda University
Ph.D., Pharmacology
University of California, Riverside
B.S., Biology
Food and Drug Administration September 2010 - Present
AWIS San Diego 2001 - Present
Bio4Front, Inc. March 2010 - August 2010
AWIS San Diego September 2006 - August 2010
San Diego Postdoctoral Training Consortium October 2006 - February 2010
Sanford-Burnham Medical Research Institute July 2004 - February 2010
National Postdoctoral Association 2003 - 2010
The Burnham Institute March 2001 - June 2004
Skills
Pharmacokinetics, Clinical Research, Biostatistics, Analytical Method..., Code of Federal..., Medical Research
Education
Loma Linda University
Ph.D., Pharmacology
University of California, Riverside
B.S., Biology
Vahan Simonyan's Food and Drug Administration Experience May 2011 - Present
Job Lead Scientist at Food And Drug Administration
Industry Research
Experience
Food And Drug Administration May 2011 - Present
Independent Consulting for Georgetown University, Penn State, Royal Bank of Canada May 2005 - April 2011
National Institutes of Health, NCBI 2001 - April 2011
University of Pittsburgh December 1989 - January 2001
Skills
Biotechnology, Computational Biology, Chemistry, Genomics, Bioinformatics, Java, Fortran, Science, Microsoft SQL Server, Software Development, MFC, Biochemistry, CGI, MySQL, Assay Development, Machine Learning, Algorithms, Distributed Systems, Protein Chemistry, Perl, Statistics, Proteomics, DNA, Physics, Programming, Data Mining, Spectroscopy
Education
Lomonosov Moscow State University (MSU) 1994 — 1997
PhD, Physics and Mathematics
Mars 1900 — 1901
Extrateresstrial, expolanetary genetics
Food And Drug Administration May 2011 - Present
Independent Consulting for Georgetown University, Penn State, Royal Bank of Canada May 2005 - April 2011
National Institutes of Health, NCBI 2001 - April 2011
University of Pittsburgh December 1989 - January 2001
Skills
Biotechnology, Computational Biology, Chemistry, Genomics, Bioinformatics, Java, Fortran, Science, Microsoft SQL Server, Software Development, MFC, Biochemistry, CGI, MySQL, Assay Development, Machine Learning, Algorithms, Distributed Systems, Protein Chemistry, Perl, Statistics, Proteomics, DNA, Physics, Programming, Data Mining, Spectroscopy
Education
Lomonosov Moscow State University (MSU) 1994 — 1997
PhD, Physics and Mathematics
Mars 1900 — 1901
Extrateresstrial, expolanetary genetics
Melissa Tassinari Melissa Tassinari's Food and Drug Administration Experience January 2011 - Present
Job Division of Pediatric and Maternal Health at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration January 2011 - Present
Food and Drug Administration May 2009 - January 2011
Pfizer May 1991 - April 2009
Pfizer Global Research & Development 1991 - 2009
U Mass Medical School 1989 - 1991
Skills
Toxicology, Regulatory Affairs, Drug Development, FDA, Regulatory Submissions, Pharmaceutical Industry, GLP, R&D, Drug Safety, Clinical Development, Clinical Trials, In Vivo, Regulatory Requirements, Biopharmaceuticals, Clinical Research, Life Sciences, Laboratory, Medicine, GCP, Pharmacovigilance
Education
Medical College of Wisconsin 1975 — 1978
PhD, Anatomy
Mount Holyoke College 1971 — 1975
AB, Biology
Food and Drug Administration January 2011 - Present
Food and Drug Administration May 2009 - January 2011
Pfizer May 1991 - April 2009
Pfizer Global Research & Development 1991 - 2009
U Mass Medical School 1989 - 1991
Skills
Toxicology, Regulatory Affairs, Drug Development, FDA, Regulatory Submissions, Pharmaceutical Industry, GLP, R&D, Drug Safety, Clinical Development, Clinical Trials, In Vivo, Regulatory Requirements, Biopharmaceuticals, Clinical Research, Life Sciences, Laboratory, Medicine, GCP, Pharmacovigilance
Education
Medical College of Wisconsin 1975 — 1978
PhD, Anatomy
Mount Holyoke College 1971 — 1975
AB, Biology
Mandi Yu Mandi Yu's Food and Drug Administration Experience 2008 - 2009
Job
Industry
Experience
National Cancer Institute (NCI) 2014 - Present
National Cancer Institute (NCI) 2009 - Present
Food and Drug Administration 2008 - 2009
Education
University of Michigan
Doctor of Philosophy (Ph.D.), Survey methodology
University of Nebraska-Lincoln
Master's Degree, Survey methodology
Nankai University
Bachelor's Degree
National Cancer Institute (NCI) 2014 - Present
National Cancer Institute (NCI) 2009 - Present
Food and Drug Administration 2008 - 2009
Education
University of Michigan
Doctor of Philosophy (Ph.D.), Survey methodology
University of Nebraska-Lincoln
Master's Degree, Survey methodology
Nankai University
Bachelor's Degree
Cynthia Hicks-Leeper Cynthia Hicks-Leeper's Food and Drug Administration Experience September 1999 - May 2000
Job Driver trainer at Baltimore City Public Schools
Industry Education Management
Experience
Baltimore City Public Schools April 2004 - Present
International Services Incorporated January 2001 - February 2002
Knowledge Begginings May 2000 - January 2001
Food and Drug Administration September 1999 - May 2000
Wackenhut October 1998 - September 1999
Skills
Training, Human Resources, Security Clearance, Security, Staff Development, Coaching, Public Speaking, Payroll, Hiring, Research, Police, Teaching, Classroom, Curriculum Design, Curriculum Development, Music, Backing Vocals, Lead Vocals, Singer-songwriter, Stage Performance
Education
Everest College-Phoenix 2008 — 2010
Associate of Arts and Sciences (A.A.S.), Business Administration and Management, General
Morgan State University 1977 — 1978
None, Music
Frederick Douglass High School 1969 — 1973
Diploma, Music
Baltimore City Public Schools April 2004 - Present
International Services Incorporated January 2001 - February 2002
Knowledge Begginings May 2000 - January 2001
Food and Drug Administration September 1999 - May 2000
Wackenhut October 1998 - September 1999
Skills
Training, Human Resources, Security Clearance, Security, Staff Development, Coaching, Public Speaking, Payroll, Hiring, Research, Police, Teaching, Classroom, Curriculum Design, Curriculum Development, Music, Backing Vocals, Lead Vocals, Singer-songwriter, Stage Performance
Education
Everest College-Phoenix 2008 — 2010
Associate of Arts and Sciences (A.A.S.), Business Administration and Management, General
Morgan State University 1977 — 1978
None, Music
Frederick Douglass High School 1969 — 1973
Diploma, Music
Lori Davis Lori Davis's Food and Drug Administration Experience November 2007 - January 2011
Job Account Director at Aquilent Technologies
Industry Information Services
Experience
Aquilent January 2015 - Present
Mackson Consulting April 2014 - January 2015
Aquilent 2015 - 2015
Genova Technologies February 2013 - April 2014
Health Care Management Solutions July 2012 - February 2013
2020 Company, LLC January 2011 - July 2012
Food and Drug Administration November 2007 - January 2011
Centers for Medicare & Medicaid Services 2007 - 2007
Centers for Medicare & Medicaid Services 2005 - 2007
Centers for Medicare & Medicaid Services 2004 - 2005
Education
Louisiana State University
MPA
University of South Carolina-Columbia
BS
Aquilent January 2015 - Present
Mackson Consulting April 2014 - January 2015
Aquilent 2015 - 2015
Genova Technologies February 2013 - April 2014
Health Care Management Solutions July 2012 - February 2013
2020 Company, LLC January 2011 - July 2012
Food and Drug Administration November 2007 - January 2011
Centers for Medicare & Medicaid Services 2007 - 2007
Centers for Medicare & Medicaid Services 2005 - 2007
Centers for Medicare & Medicaid Services 2004 - 2005
Education
Louisiana State University
MPA
University of South Carolina-Columbia
BS
Dan Keravich, RPh, MSc, MBA, RAC Dan Keravich, RPh, MSc, MBA, RAC's Food and Drug Administration Experience May 1999 - October 2003
Job Director, Reg Affairs Wellness & Director, Reg Policy
Industry Pharmaceuticals
Experience
GSK October 2003 - Present
Food and Drug Administration May 1999 - October 2003
Education
Regulatory Affairs Certification-US
Loyola University Maryland 1993 — 1996
MBA, International Business
Massachusetts College of Pharmacy and Health Sciences 1979 — 1981
MSc., Pharmacy
Northeastern University 1975 — 1979
BS, Pharmacy
ASHP Clinical Residency Program
Master of Science (MS), Pharmacy & Regulatory
GSK October 2003 - Present
Food and Drug Administration May 1999 - October 2003
Education
Regulatory Affairs Certification-US
Loyola University Maryland 1993 — 1996
MBA, International Business
Massachusetts College of Pharmacy and Health Sciences 1979 — 1981
MSc., Pharmacy
Northeastern University 1975 — 1979
BS, Pharmacy
ASHP Clinical Residency Program
Master of Science (MS), Pharmacy & Regulatory
Philip Michael Steele, Ph.D. Philip Michael Steele, Ph.D.'s Food and Drug Administration Experience December 2001 - March 2007
Job Director of Regulatory Compliance at Johnson & Johnson
Industry Biotechnology
Experience
Johnson & Johnson February 2014 - Present
Mentor Worldwide, LLC. a Johnson and Johnson Company January 2010 - Present
Mentor Worldwide, LLC. a Johnson and Johnson Company July 2008 - January 2010
Mentor Corporation March 2007 - April 2008
Food and Drug Administration December 2001 - March 2007
Skills
FDA, Medical Devices, GMP, Quality System, V&V, R&D, Design Control, Pharmaceutical Industry, Regulatory Affairs, Cross-functional Team..., Clinical Trials, GLP, Six Sigma, Product Development, Manufacturing, Clinical Research, GCP, Regulatory Requirements, Quality Management, Management, CAPA, Technology Transfer, Clinical Development, Validation, ISO 13485
Education
The University of Texas Health Science Center at Houston 1991 — 1998
Ph.D., Neuroscience
Indiana University Bloomington 1985 — 1990
Bachelor of Science, Psychology
Johnson & Johnson February 2014 - Present
Mentor Worldwide, LLC. a Johnson and Johnson Company January 2010 - Present
Mentor Worldwide, LLC. a Johnson and Johnson Company July 2008 - January 2010
Mentor Corporation March 2007 - April 2008
Food and Drug Administration December 2001 - March 2007
Skills
FDA, Medical Devices, GMP, Quality System, V&V, R&D, Design Control, Pharmaceutical Industry, Regulatory Affairs, Cross-functional Team..., Clinical Trials, GLP, Six Sigma, Product Development, Manufacturing, Clinical Research, GCP, Regulatory Requirements, Quality Management, Management, CAPA, Technology Transfer, Clinical Development, Validation, ISO 13485
Education
The University of Texas Health Science Center at Houston 1991 — 1998
Ph.D., Neuroscience
Indiana University Bloomington 1985 — 1990
Bachelor of Science, Psychology
Kim Morehouse Kim Morehouse's Food and Drug Administration Experience June 1987 - Present
Job Research Chemist at FDA
Industry Government Administration
Experience
Food and Drug Administration June 1987 - Present
Council on Ionizing Radiation Measurements and Standards 2010 - 2010
National Institute of Environmental Health Sciences April 1985 - May 1987
Skills
Chemistry, Analytical Chemistry, Spectroscopy, UV/Vis, GC-MS, Mass Spectrometry, HPLC, Science, Chromatography, EPR, Organic Chemistry, Biochemistry, Molecular Biology, FDA, Research, Life Sciences, R&D, Data Analysis, Validation, Gas Chromatography, GMP, Toxicology
Education
University of Notre Dame 1980 — 1985
Ph.D., Chemistry
Oakland University 1976 — 1979
M.S. and B.S., Chemistry
Macomb Community College 1974 — 1976
Associates, General Education
Utica High School 1971 — 1974
Food and Drug Administration June 1987 - Present
Council on Ionizing Radiation Measurements and Standards 2010 - 2010
National Institute of Environmental Health Sciences April 1985 - May 1987
Skills
Chemistry, Analytical Chemistry, Spectroscopy, UV/Vis, GC-MS, Mass Spectrometry, HPLC, Science, Chromatography, EPR, Organic Chemistry, Biochemistry, Molecular Biology, FDA, Research, Life Sciences, R&D, Data Analysis, Validation, Gas Chromatography, GMP, Toxicology
Education
University of Notre Dame 1980 — 1985
Ph.D., Chemistry
Oakland University 1976 — 1979
M.S. and B.S., Chemistry
Macomb Community College 1974 — 1976
Associates, General Education
Utica High School 1971 — 1974
David Danielian Holland David Danielian Holland's Food and Drug Administration Experience April 2010 - Present
Job Program Assistant at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration April 2010 - Present
Ameriprise Financial Services, Inc. 2009 - 2011
Ameriprise Financial Services, Inc. 2009 - 2011
Program Support Center October 2001 - April 2010
Skills
Outlook
Education
Montgomery College 1999 — 2009
AA, Computer Applications
Food and Drug Administration April 2010 - Present
Ameriprise Financial Services, Inc. 2009 - 2011
Ameriprise Financial Services, Inc. 2009 - 2011
Program Support Center October 2001 - April 2010
Skills
Outlook
Education
Montgomery College 1999 — 2009
AA, Computer Applications
Tamara Rosbury Tamara Rosbury's Food and Drug Administration Experience April 2010 - Present
Job Medical Device Specialist
Industry Government Relations
Experience
United States Public Health Service June 2010 - Present
Food and Drug Administration April 2010 - Present
Cardiovascular Medical Devices Industry January 2006 - March 2009
Education
Massachusetts Institute of Technology 2001 — 2006
Ph.D., Electrical Engineering and Computer Science
Massachusetts Institute of Technology 1998 — 2000
S.M., Electrical Engineering and Computer Science
Tennessee State University 1994 — 1998
B.S., Physics
United States Public Health Service June 2010 - Present
Food and Drug Administration April 2010 - Present
Cardiovascular Medical Devices Industry January 2006 - March 2009
Education
Massachusetts Institute of Technology 2001 — 2006
Ph.D., Electrical Engineering and Computer Science
Massachusetts Institute of Technology 1998 — 2000
S.M., Electrical Engineering and Computer Science
Tennessee State University 1994 — 1998
B.S., Physics
Thomas M. Conrad, PhD, MPH, BS(N), RN,C Thomas M. Conrad, PhD, MPH, BS(N), RN,C's Food and Drug Administration Experience December 1989 - October 1999
Job Retired, Pharmaceutical Develepment
Industry Hospital & Health Care
Experience
Retired, Pharmaceutical Develepment August 2011 - Present
NitroMed October 1999 - August 2001
Food and Drug Administration December 1989 - October 1999
Federal Bureau of Prisons February 1988 - December 1989
U.S. Immigration and Customs Enforcement (ICE) May 1984 - February 1988
Southeastern Idaho Community Health July 1983 - May 1984
US Navy November 1974 - May 1982
Skills
Nursing, Hospitals, Medicine, Home Care, Pediatrics, Regulatory Affairs, Community Health, Drug Safety, Pharmaceutics, Pharmacoepidemiology, Healthcare, Healthcare Management, Clinical Research, Healthcare Information..., Public Health, EMR, Health Policy, Infectious Diseases, Quality Improvement, Informatics, Clinical Trials, Patient Safety, Managed Care
Education
LaSalle University, PhD 1996 — 1998
PhD, Health Care Management, Summa Cum Laude
The Johns Hopkins University 1993 — 1996
MPH, Epidemiology
Idaho State University 1980 — 1983
BS, Nursing
Retired, Pharmaceutical Develepment August 2011 - Present
NitroMed October 1999 - August 2001
Food and Drug Administration December 1989 - October 1999
Federal Bureau of Prisons February 1988 - December 1989
U.S. Immigration and Customs Enforcement (ICE) May 1984 - February 1988
Southeastern Idaho Community Health July 1983 - May 1984
US Navy November 1974 - May 1982
Skills
Nursing, Hospitals, Medicine, Home Care, Pediatrics, Regulatory Affairs, Community Health, Drug Safety, Pharmaceutics, Pharmacoepidemiology, Healthcare, Healthcare Management, Clinical Research, Healthcare Information..., Public Health, EMR, Health Policy, Infectious Diseases, Quality Improvement, Informatics, Clinical Trials, Patient Safety, Managed Care
Education
LaSalle University, PhD 1996 — 1998
PhD, Health Care Management, Summa Cum Laude
The Johns Hopkins University 1993 — 1996
MPH, Epidemiology
Idaho State University 1980 — 1983
BS, Nursing
Amanda Pasternak Amanda Pasternak's Food and Drug Administration Experience September 2008 - Present
Job Consumer Safety Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration September 2008 - Present
Skills
Public Health, Regulatory Affairs, FDA, Regulations, Policy, Government, Federal Government, Environmental Health, Regulatory Requirements, Food Microbiology, Regulatory Submissions, Microbiology, IND, Infectious Diseases, Lifesciences, Emergency Management, Food Safety, Private Investigations
Education
Gannon University 2003 — 2007
Bachelor's of Science, Biology
Food and Drug Administration September 2008 - Present
Skills
Public Health, Regulatory Affairs, FDA, Regulations, Policy, Government, Federal Government, Environmental Health, Regulatory Requirements, Food Microbiology, Regulatory Submissions, Microbiology, IND, Infectious Diseases, Lifesciences, Emergency Management, Food Safety, Private Investigations
Education
Gannon University 2003 — 2007
Bachelor's of Science, Biology
Chao Wu Chao Wu's Food and Drug Administration Experience May 2009 - January 2010
Job Senior R&D Engineer at Hillcrest
Industry Electrical/Electronic Manufacturing
Experience
Hillcrest Labs July 2011 - Present
ATOP Intelligence March 2011 - May 2015
Garmin International April 2011 - June 2011
Maryland Aerospace February 2010 - March 2011
Food and Drug Administration May 2009 - January 2010
Skills
Matlab, Signal Processing, Python, Labview, Algorithms, C++/C, Android
Education
University of Maryland College Park
PhD, Electrical and Computer Engineering
National University of Singapore
M.E., Electrical and Computer Engineering
University of Science and Technology of China
Bachelor's degree, Department 10
Hillcrest Labs July 2011 - Present
ATOP Intelligence March 2011 - May 2015
Garmin International April 2011 - June 2011
Maryland Aerospace February 2010 - March 2011
Food and Drug Administration May 2009 - January 2010
Skills
Matlab, Signal Processing, Python, Labview, Algorithms, C++/C, Android
Education
University of Maryland College Park
PhD, Electrical and Computer Engineering
National University of Singapore
M.E., Electrical and Computer Engineering
University of Science and Technology of China
Bachelor's degree, Department 10
Jason Warfel Jason Warfel's Food and Drug Administration Experience April 2010 - August 2015
Job Method Technical Transfer Lead at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb August 2015 - Present
Food and Drug Administration April 2010 - August 2015
FDA July 2005 - April 2010
FDA December 2003 - July 2005
Skills
Neuroscience, Chemistry, Cell, Laboratory, Immunology, Animal Models, Microbiology, Cell Culture, Molecular Biology, Western Blotting, PCR, Biochemistry, Protein Expression, Cell Biology, Infectious Diseases
Education
Georgetown University 2005 — 2009
Ph.D., Immunology, Microbiology, 3.93 / 4.00
University of Kentucky 1998 — 2003
BS, Biology; BA, Chemistry, 3.80 / 4.00
duPont Manual High School 1994 — 1998
High School
Bristol-Myers Squibb August 2015 - Present
Food and Drug Administration April 2010 - August 2015
FDA July 2005 - April 2010
FDA December 2003 - July 2005
Skills
Neuroscience, Chemistry, Cell, Laboratory, Immunology, Animal Models, Microbiology, Cell Culture, Molecular Biology, Western Blotting, PCR, Biochemistry, Protein Expression, Cell Biology, Infectious Diseases
Education
Georgetown University 2005 — 2009
Ph.D., Immunology, Microbiology, 3.93 / 4.00
University of Kentucky 1998 — 2003
BS, Biology; BA, Chemistry, 3.80 / 4.00
duPont Manual High School 1994 — 1998
High School
Elizabeth French Siegel Elizabeth French Siegel's Food and Drug Administration Experience November 2001 - December 2005
Job Vice President, Business Development at Arsenal New York
Industry Marketing and Advertising
Experience
Arsenal New York October 2011 - Present
One Source Visual Marketing Solutions January 2008 - September 2011
Plum Magazine January 2006 - January 2008
Food and Drug Administration November 2001 - December 2005
Skills
Advertising, Social Media, Business Development, Creative Direction, Digital Marketing, Marketing, Integrated Marketing, Print Consulting, Brand Development, Digital Media, Digital Strategy, Direct Mail, Direct Marketing, Email Marketing, Marketing Communications, Online Advertising, Social Media Marketing
Education
James Madison University - College of Business 1996 — 2000
Bachelor of Business Administration (BBA), Marketing Management
Istituto Venezia, Venice, Italy 1998 — 1999
Arsenal New York October 2011 - Present
One Source Visual Marketing Solutions January 2008 - September 2011
Plum Magazine January 2006 - January 2008
Food and Drug Administration November 2001 - December 2005
Skills
Advertising, Social Media, Business Development, Creative Direction, Digital Marketing, Marketing, Integrated Marketing, Print Consulting, Brand Development, Digital Media, Digital Strategy, Direct Mail, Direct Marketing, Email Marketing, Marketing Communications, Online Advertising, Social Media Marketing
Education
James Madison University - College of Business 1996 — 2000
Bachelor of Business Administration (BBA), Marketing Management
Istituto Venezia, Venice, Italy 1998 — 1999
Brian Trent's Food and Drug Administration Experience September 2010 - April 2015
Job Associate Director for Management and Executive Officer, National Eye Institute, National Institutes of Health
Industry Executive Office
Experience
National Institutes of Health April 2015 - Present
Food and Drug Administration September 2010 - April 2015
Assistant Secretary for Preparedness and Response 2006 - 2010
Office of Global Health Affairs, HHS Office of the Secretary 2004 - 2006
Skills
Program Management, Leadership, Management, Business Process..., Budgets, Coaching, Personnel Management, Managerial Finance, Grants, Government, Policy
Education
George Mason University
Bachelor of Science (B.S.), Public Administration
George Mason University - School of Policy, Government, and International Affairs
Master of Public Administration (M.P.A.), Public and Nonprofit Finance
National Institutes of Health April 2015 - Present
Food and Drug Administration September 2010 - April 2015
Assistant Secretary for Preparedness and Response 2006 - 2010
Office of Global Health Affairs, HHS Office of the Secretary 2004 - 2006
Skills
Program Management, Leadership, Management, Business Process..., Budgets, Coaching, Personnel Management, Managerial Finance, Grants, Government, Policy
Education
George Mason University
Bachelor of Science (B.S.), Public Administration
George Mason University - School of Policy, Government, and International Affairs
Master of Public Administration (M.P.A.), Public and Nonprofit Finance
Tom Chen Tom Chen's Food and Drug Administration Experience June 2010 - August 2010
Job MBA Candidate @ MIT Sloan
Industry Management Consulting
Experience
Medallia June 2015 - August 2015
Deloitte Consulting LLP August 2011 - July 2014
JHU Biomedical Engineering May 2010 - May 2011
Food and Drug Administration June 2010 - August 2010
Cogent Systems May 2009 - August 2009
Skills
Data Analysis, Analytics, Java, Data Visualization, Product Management, Databases, Leadership, Matlab, Financial Modeling, SPARQL, Testing, Team Leadership, Medical Devices, Strategy, RDF, Team Building, Statistics, Graph Databases, Open Source, SEMOSS, Microsoft Excel, SOA, Data Analytics, Predictive Analytics, Data Mining, Data Modeling, Quantitative Analytics, Big Data Analytics, Big Data, Consulting
Education
Massachusetts Institute of Technology - Sloan School of Management 2014 — 2016
Master of Business Administration (M.B.A.)
The Johns Hopkins University 2007 — 2011
BS, Biomedical Engineering, Instrumentation and Sensors
Arcadia High School 2003 — 2007
Medallia June 2015 - August 2015
Deloitte Consulting LLP August 2011 - July 2014
JHU Biomedical Engineering May 2010 - May 2011
Food and Drug Administration June 2010 - August 2010
Cogent Systems May 2009 - August 2009
Skills
Data Analysis, Analytics, Java, Data Visualization, Product Management, Databases, Leadership, Matlab, Financial Modeling, SPARQL, Testing, Team Leadership, Medical Devices, Strategy, RDF, Team Building, Statistics, Graph Databases, Open Source, SEMOSS, Microsoft Excel, SOA, Data Analytics, Predictive Analytics, Data Mining, Data Modeling, Quantitative Analytics, Big Data Analytics, Big Data, Consulting
Education
Massachusetts Institute of Technology - Sloan School of Management 2014 — 2016
Master of Business Administration (M.B.A.)
The Johns Hopkins University 2007 — 2011
BS, Biomedical Engineering, Instrumentation and Sensors
Arcadia High School 2003 — 2007
Madris Tomes, MBA Madris Tomes, MBA's Food and Drug Administration Experience April 2012 - April 2014
Job CEO at Device Events / Medical Device Postmarket Surveillance and UDI Expert
Industry Medical Devices
Experience
MBT Consulting, LLC July 2015 - Present
Avalere Health April 2014 - July 2015
Food and Drug Administration April 2012 - April 2014
Mackson Consulting June 2011 - March 2012
Booz Allen Hamilton January 2010 - June 2011
CGI Federal April 2008 - January 2010
Kaiser Permanente IT February 2005 - April 2008
NASW Insurance Trust January 2002 - December 2004
Medialink Worldwide, Inc January 2000 - March 2001
Kaplan Test Prep May 1997 - April 2000
Skills
UDI, Adverse Event Reporting, Business Process..., HL7, FDA, Healthcare Information..., EDI ANSI X12, Software Product..., UDI integration in..., Meaningful Use, Medicare Fraud Waste..., Unique Device..., GUDID, Business Intelligence, Sunshine Act, NPI, NoSQL, Strategy, IT Strategy, Medical Devices, Cross-Agency..., Risk Management, Knowledge Management, Fraud Detection, Business Process..., Business Development, Business Process, Program Management, Healthcare, CDRH, Analytics, Cloud Computing, Strategic Communications, Leadership, Health Policy, Strategic Partnerships, Requirements Gathering, Project Planning, Epic Systems, eHealth, Performance Management, Business Analysis, Management Consulting, Pharmacovigilance, HIPAA, Requirements Analysis, Public/private..., Project Management, Durable Medical..., SDLC
Education
American University 2000 — 2004
M.B.A, Information Technology
Penn State University, University 1994 — 1997
Bachelor of Science (B.S.), Marketing
Dallastown Area High School 1986 — 1990
Michigan State University
Public Policy Analysis
MBT Consulting, LLC July 2015 - Present
Avalere Health April 2014 - July 2015
Food and Drug Administration April 2012 - April 2014
Mackson Consulting June 2011 - March 2012
Booz Allen Hamilton January 2010 - June 2011
CGI Federal April 2008 - January 2010
Kaiser Permanente IT February 2005 - April 2008
NASW Insurance Trust January 2002 - December 2004
Medialink Worldwide, Inc January 2000 - March 2001
Kaplan Test Prep May 1997 - April 2000
Skills
UDI, Adverse Event Reporting, Business Process..., HL7, FDA, Healthcare Information..., EDI ANSI X12, Software Product..., UDI integration in..., Meaningful Use, Medicare Fraud Waste..., Unique Device..., GUDID, Business Intelligence, Sunshine Act, NPI, NoSQL, Strategy, IT Strategy, Medical Devices, Cross-Agency..., Risk Management, Knowledge Management, Fraud Detection, Business Process..., Business Development, Business Process, Program Management, Healthcare, CDRH, Analytics, Cloud Computing, Strategic Communications, Leadership, Health Policy, Strategic Partnerships, Requirements Gathering, Project Planning, Epic Systems, eHealth, Performance Management, Business Analysis, Management Consulting, Pharmacovigilance, HIPAA, Requirements Analysis, Public/private..., Project Management, Durable Medical..., SDLC
Education
American University 2000 — 2004
M.B.A, Information Technology
Penn State University, University 1994 — 1997
Bachelor of Science (B.S.), Marketing
Dallastown Area High School 1986 — 1990
Michigan State University
Public Policy Analysis
Ron A Miller, PhD Ron A Miller, PhD's Food and Drug Administration Experience February 2008 - Present
Job Regulatory Review Microbiologist at FDA's Center for Veterinary Medicine
Industry Veterinary
Experience
Food and Drug Administration February 2008 - Present
Food and Drug Adminstration May 2001 - February 2008
Skills
Microbiology, Life Sciences, ELISA, FDA, Laboratory, Vaccines, SOP, Biotechnology, Molecular Biology, In Vitro, In Vivo
Education
University of Maryland College Park 2005 — 2007
PhD
Louisiana State University 1998 — 2001
MS
University of North Carolina at Wilmington 1994 — 1998
BS
Food and Drug Administration February 2008 - Present
Food and Drug Adminstration May 2001 - February 2008
Skills
Microbiology, Life Sciences, ELISA, FDA, Laboratory, Vaccines, SOP, Biotechnology, Molecular Biology, In Vitro, In Vivo
Education
University of Maryland College Park 2005 — 2007
PhD
Louisiana State University 1998 — 2001
MS
University of North Carolina at Wilmington 1994 — 1998
BS
Shelton Stribling, MPH Shelton Stribling, MPH's Food and Drug Administration Experience August 2014 - Present
Job Consumer Safety Officer at U.S. Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration August 2014 - Present
Centers for Disease Control and Prevention March 2001 - July 2014
Centers for Disease Control and Prevention March 2001 - July 2014
Morehouse School of Medicine-Preventive Research Center June 2012 - January 2013
Skills
Cancer, Prevention, Epidemiology, Vaccines, Research, Community Outreach, Grant Writing, Molecular Biology, Biostatistics, Global Health, Public Health, Health Equity, Literature Reviews, International Health, Program Development
Education
Morehouse School of Medicine 2011 — 2013
Master of Public Health (MPH), Epidemiology
Jackson State University 1990 — 1994
Bachelor of Science (BS), Biology
Food and Drug Administration August 2014 - Present
Centers for Disease Control and Prevention March 2001 - July 2014
Centers for Disease Control and Prevention March 2001 - July 2014
Morehouse School of Medicine-Preventive Research Center June 2012 - January 2013
Skills
Cancer, Prevention, Epidemiology, Vaccines, Research, Community Outreach, Grant Writing, Molecular Biology, Biostatistics, Global Health, Public Health, Health Equity, Literature Reviews, International Health, Program Development
Education
Morehouse School of Medicine 2011 — 2013
Master of Public Health (MPH), Epidemiology
Jackson State University 1990 — 1994
Bachelor of Science (BS), Biology
Anthony Durkin Anthony Durkin's Food and Drug Administration Experience June 1997 - January 1998
Job Associate Professor
Industry Research
Experience
Beckman Laser Institute July 2010 - Present
Laser Microbeam and Medical Program April 2008 - Present
UC Irvine August 2003 - July 2010
Candela Corp. January 1998 - January 2001
Food and Drug Administration June 1997 - January 1998
Electro-Optics Branch/CDRH/FDA June 1995 - June 1997
University of Texas at Austin 1990 - 1995
University of North Texas January 1990 - August 1990
Center for Applied Quantum Electronics 1987 - 1989
Skills
Fluorescence..., Near infrared..., tissue optics, Competitive Intelligence, Grant Writing, Optics, Dermatology, Burns, Reconstructive Surgery, Medical Lasers, Fluorescence, Characterization, Biomedical Engineering, Spectroscopy, Medical Devices, Clinical Research, Digital Imaging, Signal Processing, Medical Imaging, Physics, Biotechnology, Sensors, Image Processing, Monte Carlo Simulation, Photonics, Experimentation, Image Analysis, Microscopy, In Vivo
Education
The University of Texas at Austin 1990 — 1995
PhD
University of North Texas 1987 — 1990
MS
Lamar University 1985 — 1986
Lamar University 1981 — 1985
BS
Beckman Laser Institute July 2010 - Present
Laser Microbeam and Medical Program April 2008 - Present
UC Irvine August 2003 - July 2010
Candela Corp. January 1998 - January 2001
Food and Drug Administration June 1997 - January 1998
Electro-Optics Branch/CDRH/FDA June 1995 - June 1997
University of Texas at Austin 1990 - 1995
University of North Texas January 1990 - August 1990
Center for Applied Quantum Electronics 1987 - 1989
Skills
Fluorescence..., Near infrared..., tissue optics, Competitive Intelligence, Grant Writing, Optics, Dermatology, Burns, Reconstructive Surgery, Medical Lasers, Fluorescence, Characterization, Biomedical Engineering, Spectroscopy, Medical Devices, Clinical Research, Digital Imaging, Signal Processing, Medical Imaging, Physics, Biotechnology, Sensors, Image Processing, Monte Carlo Simulation, Photonics, Experimentation, Image Analysis, Microscopy, In Vivo
Education
The University of Texas at Austin 1990 — 1995
PhD
University of North Texas 1987 — 1990
MS
Lamar University 1985 — 1986
Lamar University 1981 — 1985
BS
Caitlin Fahey's Food and Drug Administration Experience June 2012 - September 2012
Job Imaging Product Management Intern at Motorola
Industry
Experience
Motorola May 2015 - August 2015
Jamba Juice May 2013 - April 2015
Village of Libertyville May 2012 - August 2014
Food and Drug Administration June 2012 - September 2012
Skills
Customer Service, Public Speaking, CPR and AED Certified, First Aid, Microsoft Office, Product Management, Teamwork, Event Planning
Education
Indiana University - Kelley School of Business 2014 — 2018
Marketing Major, Freshman
Motorola May 2015 - August 2015
Jamba Juice May 2013 - April 2015
Village of Libertyville May 2012 - August 2014
Food and Drug Administration June 2012 - September 2012
Skills
Customer Service, Public Speaking, CPR and AED Certified, First Aid, Microsoft Office, Product Management, Teamwork, Event Planning
Education
Indiana University - Kelley School of Business 2014 — 2018
Marketing Major, Freshman
Nishant K. Mishra's Food and Drug Administration Experience June 2015 - Present
Job M.D., Ph.D.; Major Interest: Vascular Neurology.
Industry Research
Experience
Food and Drug Administration June 2015 - Present
European Stroke Organization May 2012 - Present
Medicine/Neurology/Stroke Journals September 2006 - Present
Stanford University May 2012 - August 2014
The University of Glasgow September 2008 - April 2012
The University of Texas Health Science Center at Houston January 2011 - April 2011
Karolinska University Hospital December 2009 - December 2009
University of Lausanne July 2006 - June 2008
Lilavati Hospital and Kirtilal Mehtra Medical Research Trust August 2005 - January 2006
Lilavati Hospital and Kirtilal Mehta Research Trust February 2005 - July 2005
Skills
Neurology, Stroke, Medicine, Clinical Research, Medical Education, Medical Research, Epidemiology, Public Health, Clinical Trials, Medical Writing, Scientific Writing, Medical Terminology, Medical Devices, Research, Radiology, Data Analysis, Statistics, Teaching, Treatment, Patient Safety, Biostatistics, Science, Neuroscience, Life Sciences, Health Policy, Healthcare, Internal Medicine, Hospitals
Education
Stanford University 2012 — 2014
Postdoctoral Fellowship, Cerebrovascular disorders
The University of Glasgow 2008 — 2012
PhD Medicine and Therapeutics, Stroke Medicine
University of Lausanne 2006 — 2008
Clinical Fellowship, Clinical Neurology: Stroke and Behavioral Disorders
Maharashtra University of Health Sciences 1999 — 2005
Bachelor of Medicine, Bachelor of Surgery (MD), Medicine
Kendriya Vidyalaya 1986 — 1998
All India Secondary School Examination, Central Board of Secondary Education., High School/Secondary Diplomas and Certificates
Food and Drug Administration June 2015 - Present
European Stroke Organization May 2012 - Present
Medicine/Neurology/Stroke Journals September 2006 - Present
Stanford University May 2012 - August 2014
The University of Glasgow September 2008 - April 2012
The University of Texas Health Science Center at Houston January 2011 - April 2011
Karolinska University Hospital December 2009 - December 2009
University of Lausanne July 2006 - June 2008
Lilavati Hospital and Kirtilal Mehtra Medical Research Trust August 2005 - January 2006
Lilavati Hospital and Kirtilal Mehta Research Trust February 2005 - July 2005
Skills
Neurology, Stroke, Medicine, Clinical Research, Medical Education, Medical Research, Epidemiology, Public Health, Clinical Trials, Medical Writing, Scientific Writing, Medical Terminology, Medical Devices, Research, Radiology, Data Analysis, Statistics, Teaching, Treatment, Patient Safety, Biostatistics, Science, Neuroscience, Life Sciences, Health Policy, Healthcare, Internal Medicine, Hospitals
Education
Stanford University 2012 — 2014
Postdoctoral Fellowship, Cerebrovascular disorders
The University of Glasgow 2008 — 2012
PhD Medicine and Therapeutics, Stroke Medicine
University of Lausanne 2006 — 2008
Clinical Fellowship, Clinical Neurology: Stroke and Behavioral Disorders
Maharashtra University of Health Sciences 1999 — 2005
Bachelor of Medicine, Bachelor of Surgery (MD), Medicine
Kendriya Vidyalaya 1986 — 1998
All India Secondary School Examination, Central Board of Secondary Education., High School/Secondary Diplomas and Certificates
Francisco H. Sánchez's Food and Drug Administration Experience September 2006 - January 2009
Job Senior Engineer at PJM Interconnection
Industry Utilities
Experience
PJM Interconnection August 2015 - Present
PJM Interconnection January 2009 - August 2015
FOOD AND DRUG ADMINISTRATION September 2006 - January 2009
TECO Energy January 2008 - April 2008
Florida International University January 2005 - September 2006
NASA June 2005 - August 2005
Skills
PowerPoint, Microsoft Word, Outlook, Power Systems, Software, Electrical Engineering, Energy, Engineering, Renewable Energy, PSS/E, Diversity & Inclusion, Transient Stability, Matlab, Program Management, Simulations, Analysis, Wind, Electronics
Education
Worcester Polytechnic Institute 2012 — 2013
Penn State University 2009 — 2011
Master, Business Administration
Florida International University 2004 — 2008
Bachelor of Science, Electrical Engineering
PJM Interconnection August 2015 - Present
PJM Interconnection January 2009 - August 2015
FOOD AND DRUG ADMINISTRATION September 2006 - January 2009
TECO Energy January 2008 - April 2008
Florida International University January 2005 - September 2006
NASA June 2005 - August 2005
Skills
PowerPoint, Microsoft Word, Outlook, Power Systems, Software, Electrical Engineering, Energy, Engineering, Renewable Energy, PSS/E, Diversity & Inclusion, Transient Stability, Matlab, Program Management, Simulations, Analysis, Wind, Electronics
Education
Worcester Polytechnic Institute 2012 — 2013
Penn State University 2009 — 2011
Master, Business Administration
Florida International University 2004 — 2008
Bachelor of Science, Electrical Engineering
Jason Bolen Jason Bolen's Food and Drug Administration Experience July 2015 - Present
Job Student TraineeAdministration at Food and Drug Administration
Industry Education Management
Experience
Food and Drug Administration July 2015 - Present
New England Institute of Art November 2014 - June 2015
Kuztown University Housing, Residence Life and Dining Services August 2013 - May 2014
Kutztown University August 2013 - May 2014
Kutztown University January 2012 - May 2013
Ocean State Job Lot May 2012 - August 2012
Kutztown University October 2011 - January 2012
Skills
Leadership, Fundraising, Teamwork, Time Management, Customer Service, Training, Community Development, Community Outreach, Organizational..., Administration, Timely Decision Making, Recruiting, Communication, Compromise Agreements, Listening to customers, Helping Others Succeed, Process Scheduler, Student Affairs
Education
Kutztown University 2010 — 2014
Bachelor of Arts, Political Science, 3.17
Kutztown University of Pennsylvania 2010 — 2014
Bachelor of Arts (BA), Political Science
Douglas High School 2006 — 2010
Graduate
Food and Drug Administration July 2015 - Present
New England Institute of Art November 2014 - June 2015
Kuztown University Housing, Residence Life and Dining Services August 2013 - May 2014
Kutztown University August 2013 - May 2014
Kutztown University January 2012 - May 2013
Ocean State Job Lot May 2012 - August 2012
Kutztown University October 2011 - January 2012
Skills
Leadership, Fundraising, Teamwork, Time Management, Customer Service, Training, Community Development, Community Outreach, Organizational..., Administration, Timely Decision Making, Recruiting, Communication, Compromise Agreements, Listening to customers, Helping Others Succeed, Process Scheduler, Student Affairs
Education
Kutztown University 2010 — 2014
Bachelor of Arts, Political Science, 3.17
Kutztown University of Pennsylvania 2010 — 2014
Bachelor of Arts (BA), Political Science
Douglas High School 2006 — 2010
Graduate
K. Scott Phillips's Food and Drug Administration Experience September 2009 - Present
Job Research Scientist at The US FDA
Industry Government Administration
Experience
Food and Drug Administration September 2009 - Present
University of North Carolina at Chapel Hill September 2007 - September 2009
UC Irvine August 2006 - September 2007
University of California, Riverside July 2000 - June 2006
Skills
Biochemistry, Western Blotting, Mass Spectrometry, Contact Lens Material..., Medical Device Biofilm..., Medical Device..., HPLC, Lifesciences, LC-MS, UV/Vis, Biomedical Engineering, Spectroscopy, Analytical Chemistry, Microscopy, Molecular Biology, Life Sciences, Cell Culture, Chemistry, Research
Education
University of California, Riverside 2000 — 2006
PhD, Analytical Chemistry
Furman University 1996 — 2000
BS, Chemistry
Food and Drug Administration September 2009 - Present
University of North Carolina at Chapel Hill September 2007 - September 2009
UC Irvine August 2006 - September 2007
University of California, Riverside July 2000 - June 2006
Skills
Biochemistry, Western Blotting, Mass Spectrometry, Contact Lens Material..., Medical Device Biofilm..., Medical Device..., HPLC, Lifesciences, LC-MS, UV/Vis, Biomedical Engineering, Spectroscopy, Analytical Chemistry, Microscopy, Molecular Biology, Life Sciences, Cell Culture, Chemistry, Research
Education
University of California, Riverside 2000 — 2006
PhD, Analytical Chemistry
Furman University 1996 — 2000
BS, Chemistry
John Wallingford's Food and Drug Administration Experience January 1987 - January 1997
Job Principal at Nutrispectives
Industry Pharmaceuticals
Experience
Nutrispectives July 2011 - Present
Pfizer Nutrition October 2009 - July 2011
Wyeth Nutrition March 2002 - October 2009
Wyeth Nutrition January 1997 - January 2002
Food and Drug Administration January 1987 - January 1997
NIH NEI 1984 - 1986
Skills
Nutrition, Life Sciences, Policy, R&D, Product Development, Clinical Research, Quality Assurance, Lifesciences, Regulatory Affairs, Biotechnology, Public Speaking, Regulatory Submissions, Program Management, Science, Leadership, Research, Marketing, Food, GMP, Ingredients, Sop, Clinical Trials, Chemistry, Strategy, Analytical Chemistry, FDA, Management, Drug Discovery, Pharmaceutical Industry, GLP
Education
University of California, Davis 1976 — 1978
M.S., Nutrition
University of Washington 1972 — 1975
B.A, Chemistry
Massachusetts Institute of Technology
Post; Ph.D, doctoral; Metabolism and Human Nutrition
Nutrispectives July 2011 - Present
Pfizer Nutrition October 2009 - July 2011
Wyeth Nutrition March 2002 - October 2009
Wyeth Nutrition January 1997 - January 2002
Food and Drug Administration January 1987 - January 1997
NIH NEI 1984 - 1986
Skills
Nutrition, Life Sciences, Policy, R&D, Product Development, Clinical Research, Quality Assurance, Lifesciences, Regulatory Affairs, Biotechnology, Public Speaking, Regulatory Submissions, Program Management, Science, Leadership, Research, Marketing, Food, GMP, Ingredients, Sop, Clinical Trials, Chemistry, Strategy, Analytical Chemistry, FDA, Management, Drug Discovery, Pharmaceutical Industry, GLP
Education
University of California, Davis 1976 — 1978
M.S., Nutrition
University of Washington 1972 — 1975
B.A, Chemistry
Massachusetts Institute of Technology
Post; Ph.D, doctoral; Metabolism and Human Nutrition
Patricia Stephenson Patricia Stephenson's Food and Drug Administration Experience January 1981 - Present
Job Consumer Safety Officer/Microbiologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration January 1981 - Present
Skills
PMA, Gene Therapy, Compliance, Project Planning, Research Project..., project manger, Virology, Validation, Environmental Monitoring, Tissue Culture, Clinical Study Design, Toxicology, Sop, Microbiology, Regulations, Analysis, Nonprofits, Project Management, Manufacturing, Cell Culture, In Vitro, Protein Chemistry, Public Health, Government, In Vivo, qPCR, GLP, Food Microbiology, Epidemiology, Health Communication, Training, Program Management, Policy, Organizational..., Community Outreach, Environmental Health, Infectious Diseases, ELISA, Program Evaluation, Research, Regulatory Submissions, Western Blotting, Biomaterials, RNA isolation, Regulatory Requirements, Immunology, Public Speaking, GMP, IRB, Vaccines
Education
Howard University 1976 — 1981
B.S., Microbiology
University of Maryland University College
Public Health
Food and Drug Administration January 1981 - Present
Skills
PMA, Gene Therapy, Compliance, Project Planning, Research Project..., project manger, Virology, Validation, Environmental Monitoring, Tissue Culture, Clinical Study Design, Toxicology, Sop, Microbiology, Regulations, Analysis, Nonprofits, Project Management, Manufacturing, Cell Culture, In Vitro, Protein Chemistry, Public Health, Government, In Vivo, qPCR, GLP, Food Microbiology, Epidemiology, Health Communication, Training, Program Management, Policy, Organizational..., Community Outreach, Environmental Health, Infectious Diseases, ELISA, Program Evaluation, Research, Regulatory Submissions, Western Blotting, Biomaterials, RNA isolation, Regulatory Requirements, Immunology, Public Speaking, GMP, IRB, Vaccines
Education
Howard University 1976 — 1981
B.S., Microbiology
University of Maryland University College
Public Health
Deb Kleinfeld Deb Kleinfeld's Food and Drug Administration Experience 1991 - 2007
Job Kleinfeld Consulting, LLC
Industry Government Administration
Experience
Kleinfeld Consulting, LLC 2008 - Present
US Food & Drug Administration 1991 - 2007
food and Drug Administration 1991 - 2007
Skills
GTP, GMP, GCP, Compliance, Quality Auditing, Quality Management, Quality Assurance, Regulatory Requirements, Regulatory Affairs, Corrective Actions, Training, FDA, Quality System, Sop, CAPA, Quality Control, Risk Assessment, 21 CFR Part 11, Regulations, Validation, Change Control, Clinical Trials, GLP, Biotechnology, ISO 13485, Regulatory Submissions, SOP
Education
Loretto Heights University 1979 — 1983
BS, Nursing
University of Phoenix
MBA, Business Administration
Kleinfeld Consulting, LLC 2008 - Present
US Food & Drug Administration 1991 - 2007
food and Drug Administration 1991 - 2007
Skills
GTP, GMP, GCP, Compliance, Quality Auditing, Quality Management, Quality Assurance, Regulatory Requirements, Regulatory Affairs, Corrective Actions, Training, FDA, Quality System, Sop, CAPA, Quality Control, Risk Assessment, 21 CFR Part 11, Regulations, Validation, Change Control, Clinical Trials, GLP, Biotechnology, ISO 13485, Regulatory Submissions, SOP
Education
Loretto Heights University 1979 — 1983
BS, Nursing
University of Phoenix
MBA, Business Administration
Matthew Pearlman Matthew Pearlman's Food and Drug Administration Experience June 2011 - August 2011
Job Direct Sales Representative at Comcast Cable
Industry Information Technology and Services
Experience
Comcast Cable April 2014 - Present
PCMG March 2013 - December 2013
Destination Israel August 2011 - January 2012
Food and Drug Administration June 2011 - August 2011
Montgomery County Public Schools January 2007 - June 2011
Skills
Collaborative Problem..., Problem Solving, Customer Service, Customer Satisfaction, Team-oriented, Customer Engagement, Teamwork, Sales, career in sales, Time Management, Public Speaking, Networking, Analysis, Leadership, Training, Microsoft Excel, Management, Account Management, Salesforce.com
Education
McDaniel College 2008 — 2011
Master of Science (M.S.), Curriculum and Instruction, 3.67
Frostburg State University 2003 — 2006
2006 Bachelor of Science, Elementary Education, 3.1
Comcast Cable April 2014 - Present
PCMG March 2013 - December 2013
Destination Israel August 2011 - January 2012
Food and Drug Administration June 2011 - August 2011
Montgomery County Public Schools January 2007 - June 2011
Skills
Collaborative Problem..., Problem Solving, Customer Service, Customer Satisfaction, Team-oriented, Customer Engagement, Teamwork, Sales, career in sales, Time Management, Public Speaking, Networking, Analysis, Leadership, Training, Microsoft Excel, Management, Account Management, Salesforce.com
Education
McDaniel College 2008 — 2011
Master of Science (M.S.), Curriculum and Instruction, 3.67
Frostburg State University 2003 — 2006
2006 Bachelor of Science, Elementary Education, 3.1
Julia McCarthy Julia McCarthy's Food and Drug Administration Experience September 2014 - December 2014
Job Ford Foundation Public Interest Legal Fellow at Natural Resources Defense Council
Industry Legal Services
Experience
Natural Resources Defense Council September 2015 - Present
New York University Law School August 2012 - May 2015
Food and Drug Administration September 2014 - December 2014
Natural Resources Defense Council June 2014 - August 2014
U.S. PIRG May 2013 - August 2013
National Sustainable Agriculture Coalition January 2012 - May 2012
ReNEW Schools Charter Management Organization July 2010 - June 2011
Woodmere Elementary School August 2008 - August 2010
Skills
Community Outreach, Policy Analysis, Non-profits, Public Speaking, Education Policy, Grant Writing, Nonprofits, Public Policy
Education
NYU School of Law 2013 — 2015
J.D. Candidate, Root-Tilden-Kern Public Interest Scholar
Georgetown University 2004 — 2008
Bachelor's Degree, History
Natural Resources Defense Council September 2015 - Present
New York University Law School August 2012 - May 2015
Food and Drug Administration September 2014 - December 2014
Natural Resources Defense Council June 2014 - August 2014
U.S. PIRG May 2013 - August 2013
National Sustainable Agriculture Coalition January 2012 - May 2012
ReNEW Schools Charter Management Organization July 2010 - June 2011
Woodmere Elementary School August 2008 - August 2010
Skills
Community Outreach, Policy Analysis, Non-profits, Public Speaking, Education Policy, Grant Writing, Nonprofits, Public Policy
Education
NYU School of Law 2013 — 2015
J.D. Candidate, Root-Tilden-Kern Public Interest Scholar
Georgetown University 2004 — 2008
Bachelor's Degree, History
Akua Gyau Akua Gyau's Food and Drug Administration Experience September 2010 - Present
Job Regulations Analyst at Food and Drug Administration
Industry Government Relations
Experience
Food and Drug Administration September 2010 - Present
Uniformed Services University of the Health Science January 2010 - August 2010
Skills
Health Policy, Public Health, Policy Analysis, Program Evaluation, Policy, Grant Writing, Collegebound, Mentoring, Youth Mentoring, Data Analysis, Nonprofits, Public Policy, Government, Program Development, Federal Government, Research, Community Outreach, Management, Microsoft Office, Public Speaking
Education
The George Washington University School of Medicine and Health Sciences 2015 — 2017
Master’s Degree, Health Care Quality
Kent State University 2005 — 2009
B.S., Health Care Administration
Springbrook High School 2001 — 2005
Food and Drug Administration September 2010 - Present
Uniformed Services University of the Health Science January 2010 - August 2010
Skills
Health Policy, Public Health, Policy Analysis, Program Evaluation, Policy, Grant Writing, Collegebound, Mentoring, Youth Mentoring, Data Analysis, Nonprofits, Public Policy, Government, Program Development, Federal Government, Research, Community Outreach, Management, Microsoft Office, Public Speaking
Education
The George Washington University School of Medicine and Health Sciences 2015 — 2017
Master’s Degree, Health Care Quality
Kent State University 2005 — 2009
B.S., Health Care Administration
Springbrook High School 2001 — 2005
Chad Schmear Chad Schmear's Food and Drug Administration Experience November 1996 - June 2003
Job Global Manager, Audit Analytics and Qualification at GE Healthcare
Industry Biotechnology
Experience
GE Healthcare September 2011 - Present
GE Healthcare January 2014 - June 2014
GE Healthcare January 2009 - August 2011
GE Healthcare July 2007 - December 2008
Baxter Healthcare January 2005 - July 2007
Abbott Laboratories June 2003 - December 2004
Food and Drug Administration November 1996 - June 2003
Skills
Medical Devices, Quality System, Validation, FDA, Auditing, Healthcare, Quality Assurance, Design Control, Quality Control, ISO 13485, CAPA, Quality Auditing, Manufacturing, Pharmaceutical Industry, Engineering, V&V, Leadership
Education
Marquette University 1991 — 1996
BS, Biomedical Engineering
GE Healthcare September 2011 - Present
GE Healthcare January 2014 - June 2014
GE Healthcare January 2009 - August 2011
GE Healthcare July 2007 - December 2008
Baxter Healthcare January 2005 - July 2007
Abbott Laboratories June 2003 - December 2004
Food and Drug Administration November 1996 - June 2003
Skills
Medical Devices, Quality System, Validation, FDA, Auditing, Healthcare, Quality Assurance, Design Control, Quality Control, ISO 13485, CAPA, Quality Auditing, Manufacturing, Pharmaceutical Industry, Engineering, V&V, Leadership
Education
Marquette University 1991 — 1996
BS, Biomedical Engineering
Maxine McClain Maxine McClain's Food and Drug Administration Experience January 1997 - January 1998
Job
Industry Biotechnology
Experience
Fluidigm Corporation March 2014 - Present
University of North Carolina at Chapel Hill June 2013 - March 2014
Seahorse Bioscience May 2012 - June 2013
Axion Biosystems July 2009 - May 2012
Georgia Institute of Technology May 2002 - March 2010
Oak Ridge National Laboratory January 2000 - January 2002
The Catholic University of America January 1998 - January 2000
Food and Drug Administration January 1997 - January 1998
Walter Reed Army Institute of Research January 1995 - January 1997
Skills
Culture and harvest of..., Extracellular..., Immunohistochemistry, Basic molecular..., Electrophoretic &..., HPLC, Electrochemical..., Scanning electron..., Surface energy analysis..., Two-photon and standard..., Cyclic-strain fatigue..., Determining Young’s..., Metallization (CVD,..., PDMS micromolding and..., Photolithography and..., Micropatterning..., Surface optimization..., AutoCad, IgorPro, Matlab, Minitab, Solidworks, MS Project, DNA, Impedance Spectroscopy, Fluorescence, Confocal Microscopy, PCR, ELISA, Fundraising, Assay Development, Cell
Education
Georgia Institute of Technology
Doctorate of Philosophy
The Catholic University of America 1998 — 2000
Masters
The Catholic University of America 1994 — 1998
Bachelors
Fluidigm Corporation March 2014 - Present
University of North Carolina at Chapel Hill June 2013 - March 2014
Seahorse Bioscience May 2012 - June 2013
Axion Biosystems July 2009 - May 2012
Georgia Institute of Technology May 2002 - March 2010
Oak Ridge National Laboratory January 2000 - January 2002
The Catholic University of America January 1998 - January 2000
Food and Drug Administration January 1997 - January 1998
Walter Reed Army Institute of Research January 1995 - January 1997
Skills
Culture and harvest of..., Extracellular..., Immunohistochemistry, Basic molecular..., Electrophoretic &..., HPLC, Electrochemical..., Scanning electron..., Surface energy analysis..., Two-photon and standard..., Cyclic-strain fatigue..., Determining Young’s..., Metallization (CVD,..., PDMS micromolding and..., Photolithography and..., Micropatterning..., Surface optimization..., AutoCad, IgorPro, Matlab, Minitab, Solidworks, MS Project, DNA, Impedance Spectroscopy, Fluorescence, Confocal Microscopy, PCR, ELISA, Fundraising, Assay Development, Cell
Education
Georgia Institute of Technology
Doctorate of Philosophy
The Catholic University of America 1998 — 2000
Masters
The Catholic University of America 1994 — 1998
Bachelors
Diana McCue Diana McCue's Food and Drug Administration Experience January 1999 - Present
Job Management Analyst
Industry Government Administration
Experience
FDA April 2010 - Present
Food And Drug Administration January 1999 - Present
FDA October 2009 - April 2010
Department of Health and Human Services January 1989 - January 1998
Skills
Analysis, Training, Public Health, Government, Policy Analysis, Servers, Medical Devices, Program Evaluation, Social Media, Operating Systems, Databases, FDA, Policy, GCP, Public Policy, System Administration, Leadership, Program Management, Health Policy, Infectious Diseases, Proposal Writing, Regulations, Management
Education
Montgomery College 1989 — 1991
Art History to Pre Medical Technology
FDA April 2010 - Present
Food And Drug Administration January 1999 - Present
FDA October 2009 - April 2010
Department of Health and Human Services January 1989 - January 1998
Skills
Analysis, Training, Public Health, Government, Policy Analysis, Servers, Medical Devices, Program Evaluation, Social Media, Operating Systems, Databases, FDA, Policy, GCP, Public Policy, System Administration, Leadership, Program Management, Health Policy, Infectious Diseases, Proposal Writing, Regulations, Management
Education
Montgomery College 1989 — 1991
Art History to Pre Medical Technology
Gail Becker Gail Becker's Food and Drug Administration Experience October 2002 - Present
Job Program Analyst/Project Manager/Customer Relations Manager at U. S. Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration October 2002 - Present
National Institutes of Health October 1996 - October 2002
GSA October 1992 - September 1996
National Park Service September 1988 - July 1992
National Park Service September 1984 - September 1988
National Park Service December 1981 - September 1984
National Park Service April 1980 - December 1981
Skills
Physical Security, Risk Assessment, Public Relations, Security, Enforcement, Project Management, Training, Parks, Government, Policy, Grant Writing, Community Outreach, Public Policy, Military, Research, Policy Analysis, Program Development, Grants, Program Evaluation, Federal Government, Government Contracting, Environmental Issues, Analysis, Proposal Writing, Program Management, Project Planning, Data Analysis, Governance
Education
HACC, Central Pennsylvania's Community College 1992 — 1992
Human Relations in Business
Everett Community College 1986 — 1986
Law Enforcement for Seasonal Park Rangers
Penn State University 1975 — 1979
Bachelor of Science, Recreation and Parks - Outdoor Interpretive Services
Food and Drug Administration October 2002 - Present
National Institutes of Health October 1996 - October 2002
GSA October 1992 - September 1996
National Park Service September 1988 - July 1992
National Park Service September 1984 - September 1988
National Park Service December 1981 - September 1984
National Park Service April 1980 - December 1981
Skills
Physical Security, Risk Assessment, Public Relations, Security, Enforcement, Project Management, Training, Parks, Government, Policy, Grant Writing, Community Outreach, Public Policy, Military, Research, Policy Analysis, Program Development, Grants, Program Evaluation, Federal Government, Government Contracting, Environmental Issues, Analysis, Proposal Writing, Program Management, Project Planning, Data Analysis, Governance
Education
HACC, Central Pennsylvania's Community College 1992 — 1992
Human Relations in Business
Everett Community College 1986 — 1986
Law Enforcement for Seasonal Park Rangers
Penn State University 1975 — 1979
Bachelor of Science, Recreation and Parks - Outdoor Interpretive Services
Mervyn F. Silverman Mervyn F. Silverman's Food and Drug Administration Experience September 1970 - September 1972
Job President of Mervyn F. Silverman & Associates
Industry Hospital & Health Care
Experience
Mervyn F Silverman & Associates January 1985 - Present
American Foundation for AIDS Research January 1986 - May 1996
The Robert Wood Johnson Foundation February 1986 - February 1992
Academy for Educational Development January 1990 - January 1992
KPIX TV, San Francisco, California January 1979 - December 1985
City and County of San Francisco May 1977 - January 1985
Planned Parenthood of Kansas and Mid-Missouri May 1976 - May 1977
Wichita Sedgewick County Department of Community Health September 1972 - May 1977
Modern Medicine Publications May 1970 - May 1975
Food and Drug Administration September 1970 - September 1972
Skills
Public Health, Healthcare, Medicine, Non-profits, Program Management, Research, Fundraising, Prevention, Public Policy, Nonprofits, Program Development, Public Speaking, HIV prevention, Media Relations, Program Evaluation, Leadership, Community Health, Grant Writing, Health Policy, Community Development, Epidemiology, Capacity Building, Health Education, Infectious Diseases, Community Outreach, Health Promotion, Policy Analysis, Clinical Research
Education
Stanford University 1981 — 1981
Executive Program in Organizational Management
Harvard T.H. Chan School of Public Health 1968 — 1969
MPH, Public Administration & International Health
Tulane University School of Medicine 1960 — 1964
MD
Washington and Lee University 1956 — 1960
BS-cum laude, Pre-Med
Mervyn F Silverman & Associates January 1985 - Present
American Foundation for AIDS Research January 1986 - May 1996
The Robert Wood Johnson Foundation February 1986 - February 1992
Academy for Educational Development January 1990 - January 1992
KPIX TV, San Francisco, California January 1979 - December 1985
City and County of San Francisco May 1977 - January 1985
Planned Parenthood of Kansas and Mid-Missouri May 1976 - May 1977
Wichita Sedgewick County Department of Community Health September 1972 - May 1977
Modern Medicine Publications May 1970 - May 1975
Food and Drug Administration September 1970 - September 1972
Skills
Public Health, Healthcare, Medicine, Non-profits, Program Management, Research, Fundraising, Prevention, Public Policy, Nonprofits, Program Development, Public Speaking, HIV prevention, Media Relations, Program Evaluation, Leadership, Community Health, Grant Writing, Health Policy, Community Development, Epidemiology, Capacity Building, Health Education, Infectious Diseases, Community Outreach, Health Promotion, Policy Analysis, Clinical Research
Education
Stanford University 1981 — 1981
Executive Program in Organizational Management
Harvard T.H. Chan School of Public Health 1968 — 1969
MPH, Public Administration & International Health
Tulane University School of Medicine 1960 — 1964
MD
Washington and Lee University 1956 — 1960
BS-cum laude, Pre-Med
Paul T. Kim Paul T. Kim's Food and Drug Administration Experience 1992 - 1994
Job Partner, Foley Hoag LLP
Industry Biotechnology
Experience
Foley Hoag LLP 2003 - Present
Senator Edward M. Kennedy 2001 - 2003
Congressman Henry A. Waxman 1997 - 2001
American Foundation for AIDS Research 1996 - 1997
Senate Special Committee on Aging 1994 - 1996
Food and Drug Administration 1992 - 1994
Ciba-Geigy Pharmaceuticals 1990 - 1992
Skills
Government Relations, Biotechnology, Legislative, FDA, Pharmaceuticals, Medical Devices, Legislation, Government Affairs, Policy, Policy Analysis, Public Health, Healthcare, Legal Research, Life Sciences, Medicare, Regulatory Affairs, Public Policy, Federal Regulations, Legislative Relations, Health Law, Lifesciences, Intellectual Property, Government, Pharmaceutical Industry, Health Policy, Coalitions, Patents, Licensing, Legal Writing, Administrative Law
Education
Georgetown University Law Center 1994 — 1998
JD
Harvard University Kennedy School of Government 1988 — 1990
MPP
Harvard University 1984 — 1988
AB, History and Science
Foley Hoag LLP 2003 - Present
Senator Edward M. Kennedy 2001 - 2003
Congressman Henry A. Waxman 1997 - 2001
American Foundation for AIDS Research 1996 - 1997
Senate Special Committee on Aging 1994 - 1996
Food and Drug Administration 1992 - 1994
Ciba-Geigy Pharmaceuticals 1990 - 1992
Skills
Government Relations, Biotechnology, Legislative, FDA, Pharmaceuticals, Medical Devices, Legislation, Government Affairs, Policy, Policy Analysis, Public Health, Healthcare, Legal Research, Life Sciences, Medicare, Regulatory Affairs, Public Policy, Federal Regulations, Legislative Relations, Health Law, Lifesciences, Intellectual Property, Government, Pharmaceutical Industry, Health Policy, Coalitions, Patents, Licensing, Legal Writing, Administrative Law
Education
Georgetown University Law Center 1994 — 1998
JD
Harvard University Kennedy School of Government 1988 — 1990
MPP
Harvard University 1984 — 1988
AB, History and Science
Rikin Mehta's Food and Drug Administration Experience 2011 - 2012
Job Healthcare and Medical Products Regulatory Executive
Industry Pharmaceuticals
Experience
DC Department of Health (DOH) January 2014 - Present
Rutgers University, School of Health Related Professions December 2011 - Present
FDA April 2012 - January 2014
Food and Drug Administration 2011 - 2012
FDA 2010 - 2011
FDA 2008 - 2010
Robert Wood Johnson University Hospital 2002 - 2008
Rite Aid Pharmacy 2001 - 2002
Skills
Policy, Healthcare, Public Health, Infectious Diseases, Managed Care, Pharmacology, Hospitals, Informatics, FDA, Pharmaceutical Industry, Pharmacy, Pharmacists, Clinical Pharmacy, Pharmacy Benefit..., Clinical Pharmacology, Regulatory Affairs, Pharmaceutics, Drug Development, Health Law, Global Health, Policy Analysis, Health Policy
Education
Georgetown University Law Center 2009 — 2011
LLM
Rutgers University School of Law - Newark
JD
University of Arkansas for Medical Sciences
Pharm.D
Rutgers University-New Brunswick
B.S.
Graduate Institute of International and Development Studies
Master of Laws (LL.M.)
DC Department of Health (DOH) January 2014 - Present
Rutgers University, School of Health Related Professions December 2011 - Present
FDA April 2012 - January 2014
Food and Drug Administration 2011 - 2012
FDA 2010 - 2011
FDA 2008 - 2010
Robert Wood Johnson University Hospital 2002 - 2008
Rite Aid Pharmacy 2001 - 2002
Skills
Policy, Healthcare, Public Health, Infectious Diseases, Managed Care, Pharmacology, Hospitals, Informatics, FDA, Pharmaceutical Industry, Pharmacy, Pharmacists, Clinical Pharmacy, Pharmacy Benefit..., Clinical Pharmacology, Regulatory Affairs, Pharmaceutics, Drug Development, Health Law, Global Health, Policy Analysis, Health Policy
Education
Georgetown University Law Center 2009 — 2011
LLM
Rutgers University School of Law - Newark
JD
University of Arkansas for Medical Sciences
Pharm.D
Rutgers University-New Brunswick
B.S.
Graduate Institute of International and Development Studies
Master of Laws (LL.M.)
Crystal Spinks, Ph.D. Crystal Spinks, Ph.D.'s Food and Drug Administration Experience June 2006 - January 2010
Job Senior Regulatory Affairs Associate, CMC at Glenmark Pharmaceuticals Inc., USA
Industry Pharmaceuticals
Experience
Glenmark Pharmaceuticals Inc., USA June 2015 - Present
Glenmark Pharmaceuticals Inc., USA December 2011 - Present
Howard University August 2005 - May 2011
Howard University 2005 - 2011
Food and Drug Administration June 2006 - January 2010
Food and Drug Administration May 2006 - January 2010
Howard University January 2009 - May 2009
Howard University August 2008 - December 2008
Howard University January 2008 - May 2008
Howard University August 2007 - December 2007
Skills
Analysis, HPLC, Chemistry, Chromatography, IR, FTIR, Formulation, GLP, GMP, Laboratory, Lifesciences, Pharmaceutical Industry, Pharmaceutics, Pharmacokinetics, Regulatory Affairs, Sop, Research, FDA, Drug Discovery, Clinical Trials, Cell Culture, Biotechnology
Education
Howard University 2007 — 2011
Doctoral, Pharmaceutical Sciences
North Carolina A & T State University 1999 — 2004
5/2004 B.S, Chemical Engineering
Glenmark Pharmaceuticals Inc., USA June 2015 - Present
Glenmark Pharmaceuticals Inc., USA December 2011 - Present
Howard University August 2005 - May 2011
Howard University 2005 - 2011
Food and Drug Administration June 2006 - January 2010
Food and Drug Administration May 2006 - January 2010
Howard University January 2009 - May 2009
Howard University August 2008 - December 2008
Howard University January 2008 - May 2008
Howard University August 2007 - December 2007
Skills
Analysis, HPLC, Chemistry, Chromatography, IR, FTIR, Formulation, GLP, GMP, Laboratory, Lifesciences, Pharmaceutical Industry, Pharmaceutics, Pharmacokinetics, Regulatory Affairs, Sop, Research, FDA, Drug Discovery, Clinical Trials, Cell Culture, Biotechnology
Education
Howard University 2007 — 2011
Doctoral, Pharmaceutical Sciences
North Carolina A & T State University 1999 — 2004
5/2004 B.S, Chemical Engineering
Richard Lowenthal's Food and Drug Administration Experience April 1988 - July 1993
Job
Industry Biotechnology
Experience
MTG Biotherapeutics, Inc. October 2014 - Present
Momotaro-Gene February 2008 - Present
Pacific-Link Regulatory Consulting November 2007 - Present
Cadence Pharmaceuticals November 2004 - October 2007
Maxim Pharmaceuticals October 2002 - November 2004
AnGes Inc. April 2001 - October 2002
Janssen Research Foundation (J&J) March 1995 - April 2001
Somerset Pharmaceuticals Inc July 1993 - March 1995
Food and Drug Administration April 1988 - July 1993
Skills
Regulatory, Biotechnology, Pharmaceuticals, Biopharmaceuticals, Oncology, FDA, R&D, Strategic Planning, Strategy Development, Infectious Diseases, Regulatory Submissions, Cross-functional Team..., Start-ups, Business Strategy, Product Development, Clinical Development, Regulatory Affairs, Life Sciences, Pharmaceutical Industry, Drug Development, Clinical Trials, GMP, GCP
Education
University of San Diego 2004 — 2006
MSEL
Massachusetts Institute of Technology 1987 — 1988
MS
Florida State University 1984 — 1987
MS
MTG Biotherapeutics, Inc. October 2014 - Present
Momotaro-Gene February 2008 - Present
Pacific-Link Regulatory Consulting November 2007 - Present
Cadence Pharmaceuticals November 2004 - October 2007
Maxim Pharmaceuticals October 2002 - November 2004
AnGes Inc. April 2001 - October 2002
Janssen Research Foundation (J&J) March 1995 - April 2001
Somerset Pharmaceuticals Inc July 1993 - March 1995
Food and Drug Administration April 1988 - July 1993
Skills
Regulatory, Biotechnology, Pharmaceuticals, Biopharmaceuticals, Oncology, FDA, R&D, Strategic Planning, Strategy Development, Infectious Diseases, Regulatory Submissions, Cross-functional Team..., Start-ups, Business Strategy, Product Development, Clinical Development, Regulatory Affairs, Life Sciences, Pharmaceutical Industry, Drug Development, Clinical Trials, GMP, GCP
Education
University of San Diego 2004 — 2006
MSEL
Massachusetts Institute of Technology 1987 — 1988
MS
Florida State University 1984 — 1987
MS
Renu Lal's Food and Drug Administration Experience May 2010 - Present
Job Drug Information Officer at Food and Drug Administration
Industry Pharmaceuticals
Experience
Food and Drug Administration May 2010 - Present
Genentech July 2007 - August 2009
Food and Drug Administration October 2002 - May 2007
Saint Elizabeths Hospital July 2001 - September 2002
Eckerd June 2000 - June 2001
Skills
Regulatory Affairs, Cross-functional Team..., Regulatory Submissions, Clinical Research, Pharmacy, FDA
Education
Medical University of South Carolina 1998 — 2000
Pharm.D., Pharmacy
University of Connecticut 1993 — 1998
B.S., Pharmacy
Food and Drug Administration May 2010 - Present
Genentech July 2007 - August 2009
Food and Drug Administration October 2002 - May 2007
Saint Elizabeths Hospital July 2001 - September 2002
Eckerd June 2000 - June 2001
Skills
Regulatory Affairs, Cross-functional Team..., Regulatory Submissions, Clinical Research, Pharmacy, FDA
Education
Medical University of South Carolina 1998 — 2000
Pharm.D., Pharmacy
University of Connecticut 1993 — 1998
B.S., Pharmacy
David Hilfiker's Food and Drug Administration Experience August 1997 - November 2005
Job Director at Johnson & Johnson
Industry Consumer Goods
Experience
Johnson & Johnson 2005 - Present
Food and Drug Administration August 1997 - November 2005
Education
University of Maryland College Park 1995 — 1997
MS, Biochemistry
Lafayette College 1990 — 1994
Johnson & Johnson 2005 - Present
Food and Drug Administration August 1997 - November 2005
Education
University of Maryland College Park 1995 — 1997
MS, Biochemistry
Lafayette College 1990 — 1994
Stephanie Magill's Food and Drug Administration Experience January 2003 - June 2012
Job Director of Public Affairs at Centers for Medicare & Medicaid Services
Industry Government Administration
Experience
Centers for Medicare & Medicaid Services January 2009 - Present
Food and Drug Administration January 2003 - June 2012
HHS, HRSA 2001 - 2003
Skills
Strategic Communications, Public Affairs, Government, Public Policy, Public Speaking, Policy Analysis, Policy, Program Management, Community Outreach, Research
Education
University of Utah 1999 — 2001
MS, Nutrition
Gonzaga University 1995 — 1999
BS, Biology
Centers for Medicare & Medicaid Services January 2009 - Present
Food and Drug Administration January 2003 - June 2012
HHS, HRSA 2001 - 2003
Skills
Strategic Communications, Public Affairs, Government, Public Policy, Public Speaking, Policy Analysis, Policy, Program Management, Community Outreach, Research
Education
University of Utah 1999 — 2001
MS, Nutrition
Gonzaga University 1995 — 1999
BS, Biology
Ajmal Hussain's Food and Drug Administration Experience 2010 - Present
Job Budget Officer, Medical Countermeasure Presidential Initiative (MCMi) at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 2010 - Present
Food and Drug Administration (FDA) December 2009 - Present
Veterans Health Administration 2008 - May 2010
U.S. Department of Veterans Affairs 2007 - 2009
Georgia State University 2006 - 2008
Georgia Medical Care Foundation June 2006 - June 2007
UPS Supply Chain Solutions 2005 - 2006
UBG 2005 - 2006
Skills
Healthcare, Process Improvement, Budgets, Government, Business Development, Policy, Data Analysis
Education
Georgia State University - J. Mack Robinson College of Business 2004 — 2009
MBA, MHA, Healthcare administration
Emory University, Rollins School of Public Health 2002 — 2004
MPH, Health Policy and Management
Rutgers University-New Brunswick 1995 — 1999
B.Sc, Biological Sciences
Food and Drug Administration 2010 - Present
Food and Drug Administration (FDA) December 2009 - Present
Veterans Health Administration 2008 - May 2010
U.S. Department of Veterans Affairs 2007 - 2009
Georgia State University 2006 - 2008
Georgia Medical Care Foundation June 2006 - June 2007
UPS Supply Chain Solutions 2005 - 2006
UBG 2005 - 2006
Skills
Healthcare, Process Improvement, Budgets, Government, Business Development, Policy, Data Analysis
Education
Georgia State University - J. Mack Robinson College of Business 2004 — 2009
MBA, MHA, Healthcare administration
Emory University, Rollins School of Public Health 2002 — 2004
MPH, Health Policy and Management
Rutgers University-New Brunswick 1995 — 1999
B.Sc, Biological Sciences
Susan Abbondanzo's Food and Drug Administration Experience Chairman, Department of HematopathologyArmed Forces Institute of PathologyJuly 1990 - February 2005
Job Deputy Director, CBER,OBRR,DH at Food and Drug Administration
Industry Medical Practice
Experience
Food and Drug Administration Chairman, Department of HematopathologyArmed Forces Institute of PathologyJuly 1990 - February 2005
Education
Fordham University 1971 — 1975
Food and Drug Administration Chairman, Department of HematopathologyArmed Forces Institute of PathologyJuly 1990 - February 2005
Education
Fordham University 1971 — 1975
Fred Farmer's Food and Drug Administration Experience September 2002 - July 2006
Job Chief Information Officer at M3 Information, LLC
Industry Information Technology and Services
Experience
M-3 Information, LLC March 2013 - Present
Consultant September 2012 - Present
ITSolutions, LLC July 2006 - November 2012
Interactive Technology Solutions, LLC July 2006 - August 2012
Acentia July 2006 - August 2012
Food and Drug Administration September 2002 - July 2006
ResortQuest International May 1998 - October 2002
Resortquest International 1998 - 2002
Marriott Corporation 1986 - 1998
Marriott International 1986 - 1998
Skills
IT Management, IT Strategy, Strategic Planning, Project Management, Management Consulting, Process Improvement, Security, Business Intelligence, Integration, Business Analysis, Government, Change Management, Business Process..., Risk Management, Budgets
Education
La Salle University 1971 — 1975
BA, Mathematics
M-3 Information, LLC March 2013 - Present
Consultant September 2012 - Present
ITSolutions, LLC July 2006 - November 2012
Interactive Technology Solutions, LLC July 2006 - August 2012
Acentia July 2006 - August 2012
Food and Drug Administration September 2002 - July 2006
ResortQuest International May 1998 - October 2002
Resortquest International 1998 - 2002
Marriott Corporation 1986 - 1998
Marriott International 1986 - 1998
Skills
IT Management, IT Strategy, Strategic Planning, Project Management, Management Consulting, Process Improvement, Security, Business Intelligence, Integration, Business Analysis, Government, Change Management, Business Process..., Risk Management, Budgets
Education
La Salle University 1971 — 1975
BA, Mathematics
Bola Adeolu's Food and Drug Administration Experience October 2008 - Present
Job Senior Regulatory Project Manager, FDA
Industry Government Administration
Experience
Food and Drug Administration October 2008 - Present
Montgomery General Hospital March 2005 - October 2008
CVS Pharmacy May 1994 - March 2005
Skills
Regulatory Affairs, Clinical Research, Clinical Trials, Pharmaceutical Industry, Biotechnology, Healthcare, FDA, Public Health, Regulatory Submissions, Clinical Pharmacology, Lifesciences, Pharmacovigilance, Infectious Diseases, Pharmacology, Validation, GLP, Clinical Development, Sop
Education
The Johns Hopkins University 2004 — 2008
MS, Biotechnology (Regulatory Affairs concentration)
The Johns Hopkins University - Carey Business School 2004 — 2008
MS/MBA, Biotechnology/Business Administration
Howard University 1989 — 1994
BS, Pharmacy
University of Lagos 1981 — 1986
BS, Biochemistry
Food and Drug Administration October 2008 - Present
Montgomery General Hospital March 2005 - October 2008
CVS Pharmacy May 1994 - March 2005
Skills
Regulatory Affairs, Clinical Research, Clinical Trials, Pharmaceutical Industry, Biotechnology, Healthcare, FDA, Public Health, Regulatory Submissions, Clinical Pharmacology, Lifesciences, Pharmacovigilance, Infectious Diseases, Pharmacology, Validation, GLP, Clinical Development, Sop
Education
The Johns Hopkins University 2004 — 2008
MS, Biotechnology (Regulatory Affairs concentration)
The Johns Hopkins University - Carey Business School 2004 — 2008
MS/MBA, Biotechnology/Business Administration
Howard University 1989 — 1994
BS, Pharmacy
University of Lagos 1981 — 1986
BS, Biochemistry
Brad Swezey's Food and Drug Administration Experience September 2007 - September 2008
Job President of The GOAL People, Inc (DBA JustSmallBizMarketing)
Industry Marketing and Advertising
Experience
The GOAL People, Inc, August 2011 - Present
45th Space Wing 2008 - April 2013
BLilley Productions 2013 - 2013
BLilley Productions 2013 - 2013
US Air Force Space Command 1998 - January 2009
Food and Drug Administration September 2007 - September 2008
45th Space Wing November 2006 - August 2007
National Guard Bureau 2005 - 2007
89th Airlift Wing November 2003 - February 2005
USAF April 2001 - September 2002
Skills
Public Affairs, Media Relations, Air Force, Military, Security Clearance, Crisis Communications, Crisis Management, DoD, Government, Speech Writing, Strategic Communications, International Relations, National Security, Interagency Coordination, Internal Communications, Communication Training, Policy, Emergency Management, SCI Clearance, Program Management, Defense, Information Assurance, Military Operations, Communications Planning, Public Speaking, Message Development, Spokesperson, Organizational..., Intelligence, Community Outreach, Leadership, Government Contracting, Top Secret, Federal Government, Public Relations, Military Affairs, Corporate Communications, Operational Planning, Military Experience, Intelligence Analysis, Homeland Security, Counterterrorism, Public Policy, Army, Military Training, Strategic Leadership, Policy Analysis, Command, NATO, Foreign Policy
Education
Georgetown University Law Center 1995 — 1998
Law
United States Air Force Academy 1988 — 1992
BS, Political Science
The GOAL People, Inc, August 2011 - Present
45th Space Wing 2008 - April 2013
BLilley Productions 2013 - 2013
BLilley Productions 2013 - 2013
US Air Force Space Command 1998 - January 2009
Food and Drug Administration September 2007 - September 2008
45th Space Wing November 2006 - August 2007
National Guard Bureau 2005 - 2007
89th Airlift Wing November 2003 - February 2005
USAF April 2001 - September 2002
Skills
Public Affairs, Media Relations, Air Force, Military, Security Clearance, Crisis Communications, Crisis Management, DoD, Government, Speech Writing, Strategic Communications, International Relations, National Security, Interagency Coordination, Internal Communications, Communication Training, Policy, Emergency Management, SCI Clearance, Program Management, Defense, Information Assurance, Military Operations, Communications Planning, Public Speaking, Message Development, Spokesperson, Organizational..., Intelligence, Community Outreach, Leadership, Government Contracting, Top Secret, Federal Government, Public Relations, Military Affairs, Corporate Communications, Operational Planning, Military Experience, Intelligence Analysis, Homeland Security, Counterterrorism, Public Policy, Army, Military Training, Strategic Leadership, Policy Analysis, Command, NATO, Foreign Policy
Education
Georgetown University Law Center 1995 — 1998
Law
United States Air Force Academy 1988 — 1992
BS, Political Science
Gorka Garcia-Malene's Food and Drug Administration Experience 2009 - Present
Job Consumer Safety Officer at the FDA
Industry Government Administration
Experience
Food and Drug Administration 2009 - Present
Education
The Johns Hopkins University 2007 — 2009
Masters, Biotechnology
Rutgers University School of Law - Newark 2000 — 2003
JD, Law
Lehigh University 1996 — 2000
B.S., Biochemistry
Eastside
Food and Drug Administration 2009 - Present
Education
The Johns Hopkins University 2007 — 2009
Masters, Biotechnology
Rutgers University School of Law - Newark 2000 — 2003
JD, Law
Lehigh University 1996 — 2000
B.S., Biochemistry
Eastside
Bruce Burlington's Food and Drug Administration Experience 1993 - 1999
Job Independant Consultant
Industry Pharmaceuticals
Experience
D.B. Burlington August 2010 - Present
AstraZeneca 2010 - Present
Wyeth 1999 - 2007
Wyeth Pharmaceuticals 1999 - 2007
FOOD AND DRUG ADMINISTRATION CDER 1993 - 1999
Food and Drug Administration 1993 - 1999
Skills
Drug Development, Medical Devices, Health Economics, Immunology, Pharmaceutical Industry, Biotechnology, Oncology, Pharmacovigilance, FDA, Regulatory Submissions, Clinical Development, Validation, Regulatory Affairs, Biopharmaceuticals, Internal Medicine, Infectious Diseases, GCP, Vaccines, Management, Strategy, Market Access, Technology Transfer, Quality Auditing, Drug Discovery, Clinical Research, R&D, Medical Writing, CTMS, GMP, Healthcare, Due Diligence, Sop, Analytical Chemistry, CRO, Neuroscience, IND, Clinical Trials, Lifesciences, Neurology, Pharmaceutics, Pharmacology, Auditing
Education
Louisiana State University School of Medicine in New Orleans 1972 — 1976
D.B. Burlington August 2010 - Present
AstraZeneca 2010 - Present
Wyeth 1999 - 2007
Wyeth Pharmaceuticals 1999 - 2007
FOOD AND DRUG ADMINISTRATION CDER 1993 - 1999
Food and Drug Administration 1993 - 1999
Skills
Drug Development, Medical Devices, Health Economics, Immunology, Pharmaceutical Industry, Biotechnology, Oncology, Pharmacovigilance, FDA, Regulatory Submissions, Clinical Development, Validation, Regulatory Affairs, Biopharmaceuticals, Internal Medicine, Infectious Diseases, GCP, Vaccines, Management, Strategy, Market Access, Technology Transfer, Quality Auditing, Drug Discovery, Clinical Research, R&D, Medical Writing, CTMS, GMP, Healthcare, Due Diligence, Sop, Analytical Chemistry, CRO, Neuroscience, IND, Clinical Trials, Lifesciences, Neurology, Pharmaceutics, Pharmacology, Auditing
Education
Louisiana State University School of Medicine in New Orleans 1972 — 1976
Sumit Sarkar's Food and Drug Administration Experience October 2008 - Present
Job Research Scientist, FDA
Industry Research
Experience
Food and Drug Administration October 2008 - Present
U.S. Food and Drug Administration 2008 - Present
Harvard Medical School 2007 - 2008
Indiana University March 2004 - December 2006
Tufts-New England Medical Center September 2000 - March 2004
Skills
In Vivo, Cell Culture, Molecular Biology, Cell Biology, Pharmacology, Animal Models, In Vitro, Clinical Trials, Drug Development, Oncology, IND, Clinical Research, Toxicology, Western Blotting, Assay Development, GLP, ELISA
Education
Nagpur University 1996 — 2000
Ph.D, Neurobiology
University of Calcutta 1993 — 1996
M.Sc, Zoology
Food and Drug Administration October 2008 - Present
U.S. Food and Drug Administration 2008 - Present
Harvard Medical School 2007 - 2008
Indiana University March 2004 - December 2006
Tufts-New England Medical Center September 2000 - March 2004
Skills
In Vivo, Cell Culture, Molecular Biology, Cell Biology, Pharmacology, Animal Models, In Vitro, Clinical Trials, Drug Development, Oncology, IND, Clinical Research, Toxicology, Western Blotting, Assay Development, GLP, ELISA
Education
Nagpur University 1996 — 2000
Ph.D, Neurobiology
University of Calcutta 1993 — 1996
M.Sc, Zoology
Bill Millar's Food and Drug Administration Experience November 2012 - Present
Job Compliance Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration November 2012 - Present
Food and Drug Administration October 2008 - November 2012
Abbott Vascular Devices June 2008 - October 2008
Novo Nordisk Delivery Technologies July 2006 - April 2008
Bayer HealthCare January 2004 - July 2006
BioMarin July 2001 - January 2004
Bayer HealthCare March 1995 - July 2001
Education
Holy Names University 1997 — 1999
MBA, Finance
University of Nevada-Reno 1989 — 1994
BS, Biochemistry
Boulder City High School, Nevada 1985 — 1989
Food and Drug Administration November 2012 - Present
Food and Drug Administration October 2008 - November 2012
Abbott Vascular Devices June 2008 - October 2008
Novo Nordisk Delivery Technologies July 2006 - April 2008
Bayer HealthCare January 2004 - July 2006
BioMarin July 2001 - January 2004
Bayer HealthCare March 1995 - July 2001
Education
Holy Names University 1997 — 1999
MBA, Finance
University of Nevada-Reno 1989 — 1994
BS, Biochemistry
Boulder City High School, Nevada 1985 — 1989
Cheng Cui's Food and Drug Administration Experience March 2014 - Present
Job Scientific reviewer at FDA
Industry Government Administration
Experience
Food and drug administration March 2014 - Present
University of Pittsburgh July 2013 - March 2014
University of Pittsburgh School of Medicine January 2011 - June 2013
University of Pittsburgh School of Medicine January 2010 - December 2010
National Insitute of Health January 2008 - December 2009
University of Kansas Medical Center (KUMC) January 2005 - December 2007
Skills
Cell Culture, Confocal Microscopy, Computational Biology, Bioinformatics, Microscopy, Molecular Biology, Western Blotting, PCR, Cell Biology, In Vivo, Image Analysis, Immunohistochemistry, Matlab, In Vitro, RT-PCR, Tissue Culture, Statistics, Immunofluorescence, Fluorescence Microscopy, Flow Cytometry
Education
Indiana University Bloomington 2002 — 2005
Doctor of Philosophy (PhD), Biophysics
University of Notre Dame 1998 — 2002
M.S., Physics
Jilin University 1993 — 1997
B.S., Physics
Food and drug administration March 2014 - Present
University of Pittsburgh July 2013 - March 2014
University of Pittsburgh School of Medicine January 2011 - June 2013
University of Pittsburgh School of Medicine January 2010 - December 2010
National Insitute of Health January 2008 - December 2009
University of Kansas Medical Center (KUMC) January 2005 - December 2007
Skills
Cell Culture, Confocal Microscopy, Computational Biology, Bioinformatics, Microscopy, Molecular Biology, Western Blotting, PCR, Cell Biology, In Vivo, Image Analysis, Immunohistochemistry, Matlab, In Vitro, RT-PCR, Tissue Culture, Statistics, Immunofluorescence, Fluorescence Microscopy, Flow Cytometry
Education
Indiana University Bloomington 2002 — 2005
Doctor of Philosophy (PhD), Biophysics
University of Notre Dame 1998 — 2002
M.S., Physics
Jilin University 1993 — 1997
B.S., Physics
Carmen Abrams's Food and Drug Administration Experience September 2010 - Present
Job Instructional Designer
Industry Public Safety
Experience
Food and Drug Administration September 2010 - Present
Diabetes Action August 2007 - April 2014
Danya International September 2009 - August 2010
Montgomery College April 2006 - May 2010
Montgomery County Public Schools August 1991 - June 2009
Skills
Education, Web Design, Photography, Instructional Design, E-learning, Curriculum Design, Captivate, E-Learning, Instructor-led Training, Training, Instructional Technology, Graphic Design, Teaching, Dreamweaver, Flash, Editing, Adult Education
Education
University of Maryland Baltimore County 2008 — 2011
M.A., Instructional Systems Development
Montgomery College 2006 — 2008
Web Design
Penn State University 1989 — 1992
M.A., French
University of Notre Dame 1986 — 1989
Colegio La Piedad
Food and Drug Administration September 2010 - Present
Diabetes Action August 2007 - April 2014
Danya International September 2009 - August 2010
Montgomery College April 2006 - May 2010
Montgomery County Public Schools August 1991 - June 2009
Skills
Education, Web Design, Photography, Instructional Design, E-learning, Curriculum Design, Captivate, E-Learning, Instructor-led Training, Training, Instructional Technology, Graphic Design, Teaching, Dreamweaver, Flash, Editing, Adult Education
Education
University of Maryland Baltimore County 2008 — 2011
M.A., Instructional Systems Development
Montgomery College 2006 — 2008
Web Design
Penn State University 1989 — 1992
M.A., French
University of Notre Dame 1986 — 1989
Colegio La Piedad
Eric Ruby's Food and Drug Administration Experience 1987 - 1995
Job Vice President, Regulatory Affairs at Presidio Pharmaceuticals
Industry Pharmaceuticals
Experience
Presidio Pharmaceuticals January 2010 - Present
Alnylam Pharmaceuticals 2008 - January 2010
Vertex Pharmaceuticals 2003 - 2008
Control Delivery Systems 2002 - 2003
Vertex Pharmaceuticals 1996 - 2002
Mallinckrodt Veterinary 1995 - 1996
Food and Drug Administration 1987 - 1995
Skills
Pharmaceuticals, Regulatory Affairs, Lifesciences, Biopharmaceuticals, Veterinary, Pharmaceutical Industry, Drug Development, IND, Technology Transfer, Quality System, Clinical Development, Drug Discovery, Biotechnology, Validation, Regulatory Submissions, CAPA, FDA, Change Control, GMP, Oncology, Sop, Medical Devices, CRO, Intellectual Property, Clinical Trials, GLP, 21 CFR Part 11, CMC, NDA, CMC Regulatory Affairs, eCTD, Vaccines, GCP, SOP, Life Sciences
Education
University of California, Berkeley 1984 — 1986
M.S., Organic Chemistry
Harvard University 1977 — 1981
B.A., Chemistry
Presidio Pharmaceuticals January 2010 - Present
Alnylam Pharmaceuticals 2008 - January 2010
Vertex Pharmaceuticals 2003 - 2008
Control Delivery Systems 2002 - 2003
Vertex Pharmaceuticals 1996 - 2002
Mallinckrodt Veterinary 1995 - 1996
Food and Drug Administration 1987 - 1995
Skills
Pharmaceuticals, Regulatory Affairs, Lifesciences, Biopharmaceuticals, Veterinary, Pharmaceutical Industry, Drug Development, IND, Technology Transfer, Quality System, Clinical Development, Drug Discovery, Biotechnology, Validation, Regulatory Submissions, CAPA, FDA, Change Control, GMP, Oncology, Sop, Medical Devices, CRO, Intellectual Property, Clinical Trials, GLP, 21 CFR Part 11, CMC, NDA, CMC Regulatory Affairs, eCTD, Vaccines, GCP, SOP, Life Sciences
Education
University of California, Berkeley 1984 — 1986
M.S., Organic Chemistry
Harvard University 1977 — 1981
B.A., Chemistry
Santhosh Pabba's Food and Drug Administration Experience Clinical Staff PharmacistRedmond Regional Medical CenterOctober 2005 - February 2008
Job Reviewing Scientist at Food and Drug Administration
Industry Pharmaceuticals
Experience
Food and Drug Administration Clinical Staff PharmacistRedmond Regional Medical CenterOctober 2005 - February 2008
Education
Northeastern University 2000 — 2005
PhD, Pharmaceutical Sciences
Kakatiya University 1998 — 2000
Masters, Pharmacology
Kakatiya University 1993 — 2000
pharmacy
Food and Drug Administration Clinical Staff PharmacistRedmond Regional Medical CenterOctober 2005 - February 2008
Education
Northeastern University 2000 — 2005
PhD, Pharmaceutical Sciences
Kakatiya University 1998 — 2000
Masters, Pharmacology
Kakatiya University 1993 — 2000
pharmacy
Janine Morris's Food and Drug Administration Experience January 2008 - December 2008
Job Deputy Director for Policy, Regulatory Science and Strategic Collaboration at FDA Office of Special Medical Programs
Industry Medical Devices
Experience
FDA - Office of Special Medical Programs January 2015 - Present
FDA February 2012 - July 2015
FDA/CDRH/ODE/DRGUD/ULDB August 2010 - January 2012
FDA January 2009 - July 2010
FDA January 2008 - December 2008
Food and Drug Administration January 2008 - December 2008
FDA May 2001 - December 2007
FDA July 1990 - May 2001
Skills
Medical Devices, FDA, Orthopedic, Radiology, Neurology, Urology, Management, Regulatory Affairs, Quality System, Lifesciences, GMP, Program Management, Biotechnology, Government, CAPA
Education
Luleå University of Technology 1984 — 1989
Liscentiate, Engineering
University of Maryland College Park 1982 — 1984
BSME, Mechanical Engineering
FDA - Office of Special Medical Programs January 2015 - Present
FDA February 2012 - July 2015
FDA/CDRH/ODE/DRGUD/ULDB August 2010 - January 2012
FDA January 2009 - July 2010
FDA January 2008 - December 2008
Food and Drug Administration January 2008 - December 2008
FDA May 2001 - December 2007
FDA July 1990 - May 2001
Skills
Medical Devices, FDA, Orthopedic, Radiology, Neurology, Urology, Management, Regulatory Affairs, Quality System, Lifesciences, GMP, Program Management, Biotechnology, Government, CAPA
Education
Luleå University of Technology 1984 — 1989
Liscentiate, Engineering
University of Maryland College Park 1982 — 1984
BSME, Mechanical Engineering
Neeraj Pai's Food and Drug Administration Experience September 2008 - July 2012
Job Counsel at Sidley Austin LLP
Industry Legal Services
Experience
Sidley Austin LLP July 2012 - Present
Food and Drug Administration September 2008 - July 2012
McKee Nelson August 2001 - September 2008
Gibson, Dunn & Crutcher LLP August 1999 - November 2000
Skills
Litigation, Legal Research, Legal Writing, Civil Litigation, Tax Law, Administrative Law, Criminal Law, Internal Investigations, Fraud, White Collar Criminal..., Legal Advice, Criminal Defense, Due Diligence, Government, Legal Assistance, Legal Compliance, Legal Issues, Lexis, Litigation Management, Trial Practice, Trials
Education
Harvard Law School 1996 — 1999
J.D.
Villanova University 1992 — 1996
Bachelor of Science (B.S.), Accounting
Henderson High School
Henderson High School
Sidley Austin LLP July 2012 - Present
Food and Drug Administration September 2008 - July 2012
McKee Nelson August 2001 - September 2008
Gibson, Dunn & Crutcher LLP August 1999 - November 2000
Skills
Litigation, Legal Research, Legal Writing, Civil Litigation, Tax Law, Administrative Law, Criminal Law, Internal Investigations, Fraud, White Collar Criminal..., Legal Advice, Criminal Defense, Due Diligence, Government, Legal Assistance, Legal Compliance, Legal Issues, Lexis, Litigation Management, Trial Practice, Trials
Education
Harvard Law School 1996 — 1999
J.D.
Villanova University 1992 — 1996
Bachelor of Science (B.S.), Accounting
Henderson High School
Henderson High School
Kathleen Reedy's Food and Drug Administration Experience September 1994 - March 2007
Job Health, Wellness and Fitness Professional
Industry Health, Wellness and Fitness
Experience
Food and Drug Administration September 1994 - March 2007
National Science Foundation Grant July 1995 - June 2004
Navy Medical Research Institute September 1986 - August 1994
YMCA September 1978 - June 1984
Skills
Organization, People Skills, Analysis, Customer Service, Community Outreach, Non-profits, Program Development, Problem Solving, Research, Training, Grant Writing, Coaching, Public Speaking, Health Education, Leadership, Fundraising, Event Planning, Team Building, Public Health, Volunteer Management, Communication, Management, Teaching, Team Leadership, Government, Leadership Development, Nonprofits
Education
University of Maryland University College 1988 — 1991
MS level, Health/Health Care Administration/Management
Marshall University 1978 — 1985
BS and MS, Exercise Physiology
Erie Community College
AAS, Dental Hygiene
Food and Drug Administration September 1994 - March 2007
National Science Foundation Grant July 1995 - June 2004
Navy Medical Research Institute September 1986 - August 1994
YMCA September 1978 - June 1984
Skills
Organization, People Skills, Analysis, Customer Service, Community Outreach, Non-profits, Program Development, Problem Solving, Research, Training, Grant Writing, Coaching, Public Speaking, Health Education, Leadership, Fundraising, Event Planning, Team Building, Public Health, Volunteer Management, Communication, Management, Teaching, Team Leadership, Government, Leadership Development, Nonprofits
Education
University of Maryland University College 1988 — 1991
MS level, Health/Health Care Administration/Management
Marshall University 1978 — 1985
BS and MS, Exercise Physiology
Erie Community College
AAS, Dental Hygiene
Tej Poonai's Food and Drug Administration Experience March 1987 - January 2000
Job Principal Consultant at Compliance and Validation Services
Industry Pharmaceuticals
Experience
Compliance and Validation Services January 2006 - Present
Schering Plough Corp January 2002 - December 2005
Taro Pharmaceuticals January 2001 - December 2002
Ivax Corporation February 2000 - January 2001
Food and Drug Administration March 1987 - January 2000
Education
Long Island University 1998 — 2000
Ph.D, Industrial Pharmacy and Pharmaceutics
Compliance and Validation Services January 2006 - Present
Schering Plough Corp January 2002 - December 2005
Taro Pharmaceuticals January 2001 - December 2002
Ivax Corporation February 2000 - January 2001
Food and Drug Administration March 1987 - January 2000
Education
Long Island University 1998 — 2000
Ph.D, Industrial Pharmacy and Pharmaceutics
Vikas Gill's Food and Drug Administration Experience October 2008 - Present
Job Microbiologist at Food and Drug Administration
Industry Research
Experience
Food and Drug Administration October 2008 - Present
Education
Kansas State University 2003 — 2004
Food and Drug Administration October 2008 - Present
Education
Kansas State University 2003 — 2004
John Metcalfe's Food and Drug Administration Experience April 2015 - Present
Job Quality Assessment Lead at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration April 2015 - Present
FDA/CDER/OPS 2010 - January 2015
Food and Drug Adm 2003 - 2010
Salem State College September 1992 - January 2003
Skills
Lifesciences, Regulatory Submissions, Microbiology, Regulatory Affairs, Validation, Biotechnology, GMP, Sop, Biopharmaceuticals, CAPA, GLP, FDA, Cell Culture, Pharmaceutical Industry
Education
University of Rhode Island 1984 — 1989
Ph.D., Microbiology
Merrimack College 1980 — 1984
BA, Biology
Food and Drug Administration April 2015 - Present
FDA/CDER/OPS 2010 - January 2015
Food and Drug Adm 2003 - 2010
Salem State College September 1992 - January 2003
Skills
Lifesciences, Regulatory Submissions, Microbiology, Regulatory Affairs, Validation, Biotechnology, GMP, Sop, Biopharmaceuticals, CAPA, GLP, FDA, Cell Culture, Pharmaceutical Industry
Education
University of Rhode Island 1984 — 1989
Ph.D., Microbiology
Merrimack College 1980 — 1984
BA, Biology
Anne Reid's Food and Drug Administration Experience August 1990 - Present
Job Deputy Regional Food and Drug Director
Industry Government Administration
Experience
Food and Drug Administration August 1990 - Present
US Food & Drug Administration 1990 - April 2010
Skills
Policy, Government, Microsoft Office, Public Speaking, Customer Service, FDA, Research, Leadership, Strategic Planning, Biotechnology, Pharmaceutical Industry, Quality Assurance, Event Planning, Fundraising, Social Media, PowerPoint, Microsoft Excel, Quality Auditing, Clinical Trials, Medical Devices, Regulatory Requirements, Policy Analysis, Regulatory Affairs, Business Development
Education
Mississippi State University 1984 — 1990
Food and Drug Administration August 1990 - Present
US Food & Drug Administration 1990 - April 2010
Skills
Policy, Government, Microsoft Office, Public Speaking, Customer Service, FDA, Research, Leadership, Strategic Planning, Biotechnology, Pharmaceutical Industry, Quality Assurance, Event Planning, Fundraising, Social Media, PowerPoint, Microsoft Excel, Quality Auditing, Clinical Trials, Medical Devices, Regulatory Requirements, Policy Analysis, Regulatory Affairs, Business Development
Education
Mississippi State University 1984 — 1990
Joe Pishoneri's Food and Drug Administration Experience April 2005 - July 2008
Job Contract Specialist at U.S. Department of Agriculture Food Safety Inspection Service
Industry Government Administration
Experience
U.S. Department of Agriculture Food Safety Inspection Service March 2013 - Present
Equal Employment Opportunity Commission January 2010 - March 2013
Rockville, MD July 2008 - January 2010
Food and Drug Administration April 2005 - July 2008
Education
University of Phoenix 2003 — 2005
Masters in Business Administration, Marketing
Frostburg State University 1994 — 1998
Mass Communication
U.S. Department of Agriculture Food Safety Inspection Service March 2013 - Present
Equal Employment Opportunity Commission January 2010 - March 2013
Rockville, MD July 2008 - January 2010
Food and Drug Administration April 2005 - July 2008
Education
University of Phoenix 2003 — 2005
Masters in Business Administration, Marketing
Frostburg State University 1994 — 1998
Mass Communication
Joanne Lipkind's Food and Drug Administration Experience January 2011 - Present
Job Committee Management Specialist
Industry Government Administration
Experience
Food and Drug Administration January 2011 - Present
Education
Johnson & Wales University 1998 — 2002
Food and Drug Administration January 2011 - Present
Education
Johnson & Wales University 1998 — 2002
Dave Boyer's Food and Drug Administration Experience 2006 - 2007
Job Principal at BGR Group
Industry Government Relations
Experience
BGR Group February 2011 - Present
PhRMA January 2009 - February 2011
The White House January 2007 - January 2009
Food and Drug Administration 2006 - 2007
Biotechnology Industry Organization 2005 - 2006
US Department of Health and Human Services 2005 - 2005
U.S. Department of Health and Human Services July 2003 - January 2004
The Richard Burr Committee 2004 - 2004
U.S. Department of Health and Human Services March 2001 - July 2003
Education
Georgetown University 1996 — 2000
BA, Government
FCDS
BGR Group February 2011 - Present
PhRMA January 2009 - February 2011
The White House January 2007 - January 2009
Food and Drug Administration 2006 - 2007
Biotechnology Industry Organization 2005 - 2006
US Department of Health and Human Services 2005 - 2005
U.S. Department of Health and Human Services July 2003 - January 2004
The Richard Burr Committee 2004 - 2004
U.S. Department of Health and Human Services March 2001 - July 2003
Education
Georgetown University 1996 — 2000
BA, Government
FCDS
Jaya Vaidyanathan's Food and Drug Administration Experience September 2003 - Present
Job Clinical Pharmacologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration September 2003 - Present
Education
Medical University of South Carolina 1998 — 2003
PhD, Pharamceutical Sciences
Nagpur University
B.Pharm & M.Pharm, Pharmaceutical Sciences
Food and Drug Administration September 2003 - Present
Education
Medical University of South Carolina 1998 — 2003
PhD, Pharamceutical Sciences
Nagpur University
B.Pharm & M.Pharm, Pharmaceutical Sciences
Ramadevi Raghunandan's Food and Drug Administration Experience April 2002 - December 2005
Job Senior Scientist at Cytimmune
Industry Biotechnology
Experience
Cytimmune ManagerNovavax2009 - 2012
Food and Drug Administration April 2002 - December 2005
Education
Indian Institute of Science 1986 — 1992
PhD, Biochemistry
Cytimmune ManagerNovavax2009 - 2012
Food and Drug Administration April 2002 - December 2005
Education
Indian Institute of Science 1986 — 1992
PhD, Biochemistry
Bingchen Du's Food and Drug Administration Experience October 2009 - Present
Job Scientist, VP for marketing at EGFIE
Industry Biotechnology
Experience
EGFIE LLC July 2015 - Present
Food and Drug Administration October 2009 - Present
Georgetown University August 2003 - August 2009
Georgetown University August 2003 - August 2007
Skills
Physical Chemistry, Nanoparticles, Electrochemistry, Chemistry, Characterization, Nanotechnology, Fuel Cells, Microscopy, NMR, Analytical Chemistry, Purification, Carbon Nanotubes, Spectroscopy, FTIR, Materials Science, UV/Vis
Education
Georgetown University 2003 — 2009
Ph.D, Analytical and physical chemistry
Chinese Academy of Sciences 2000 — 2003
M.S, Physical chemistry
Jilin University 1996 — 2000
B.S, Chemistry
EGFIE LLC July 2015 - Present
Food and Drug Administration October 2009 - Present
Georgetown University August 2003 - August 2009
Georgetown University August 2003 - August 2007
Skills
Physical Chemistry, Nanoparticles, Electrochemistry, Chemistry, Characterization, Nanotechnology, Fuel Cells, Microscopy, NMR, Analytical Chemistry, Purification, Carbon Nanotubes, Spectroscopy, FTIR, Materials Science, UV/Vis
Education
Georgetown University 2003 — 2009
Ph.D, Analytical and physical chemistry
Chinese Academy of Sciences 2000 — 2003
M.S, Physical chemistry
Jilin University 1996 — 2000
B.S, Chemistry
Patrick Ronan's Food and Drug Administration Experience January 2004 - January 2007
Job President at Greenleaf Health LLC
Industry Pharmaceuticals
Experience
Greenleaf Health LLC December 2007 - Present
Novartis January 2007 - January 2008
Food and Drug Administration January 2004 - January 2007
U.S. House of Representatives January 2002 - January 2004
Skills
Public Policy, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, Public Affairs, Commercialization, Drug Development, FDA, Technology Transfer, Policy Analysis, Policy, Oncology, Medical Devices, Strategy, Lifesciences, Life Sciences, Legislative Relations, Health Policy, Government
Education
Georgetown University Law Center
J.D.
University of Nevada-Reno
B.S., Chemistry
University of Pennsylvania - The Wharton School
MBA, Finance
Greenleaf Health LLC December 2007 - Present
Novartis January 2007 - January 2008
Food and Drug Administration January 2004 - January 2007
U.S. House of Representatives January 2002 - January 2004
Skills
Public Policy, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, Public Affairs, Commercialization, Drug Development, FDA, Technology Transfer, Policy Analysis, Policy, Oncology, Medical Devices, Strategy, Lifesciences, Life Sciences, Legislative Relations, Health Policy, Government
Education
Georgetown University Law Center
J.D.
University of Nevada-Reno
B.S., Chemistry
University of Pennsylvania - The Wharton School
MBA, Finance
Clint Curtis's Food and Drug Administration Experience June 2015 - Present
Job Health Communications Specialist, FDA
Industry Health, Wellness and Fitness
Experience
Food and Drug Administration June 2015 - Present
Indian Health Service June 2013 - June 2015
Indian Health Service (HHS) March 2012 - May 2013
FHI360 July 2011 - March 2012
AED June 2009 - June 2011
IFPRI June 2008 - December 2008
Rare 2006 - 2008
Skills
Public Health, Food Security, Nutrition, Climate Change, International..., Global Health, Program Evaluation, Capacity Building, Program Development, Policy Analysis, Community Development, Non-profits, Grant Writing, Grants, NGOs, International Health, Proposal Writing, Qualitative Research, Community Outreach, Health Communication, Public Policy, Community Health, Nonprofits
Education
The George Washington University 2007 — 2009
MPH, Global Health
James Madison University 2003 — 2007
Bachelor of Science (B.Sc.), Cultural Anthropology
Food and Drug Administration June 2015 - Present
Indian Health Service June 2013 - June 2015
Indian Health Service (HHS) March 2012 - May 2013
FHI360 July 2011 - March 2012
AED June 2009 - June 2011
IFPRI June 2008 - December 2008
Rare 2006 - 2008
Skills
Public Health, Food Security, Nutrition, Climate Change, International..., Global Health, Program Evaluation, Capacity Building, Program Development, Policy Analysis, Community Development, Non-profits, Grant Writing, Grants, NGOs, International Health, Proposal Writing, Qualitative Research, Community Outreach, Health Communication, Public Policy, Community Health, Nonprofits
Education
The George Washington University 2007 — 2009
MPH, Global Health
James Madison University 2003 — 2007
Bachelor of Science (B.Sc.), Cultural Anthropology
Nicholas DePetris's Food and Drug Administration Experience May 2007 - December 2007
Job Development Lead at Edelman
Industry Information Technology and Services
Experience
Edelman March 2015 - Present
Edelman March 2013 - Present
XBLA Fans August 2011 - Present
Steam Game Fans October 2012 - November 2013
Edelman August 2012 - March 2013
Xbox Kinect Fans January 2012 - October 2012
Edelman March 2010 - August 2012
Edelman March 2009 - March 2010
Grinnell College August 2005 - December 2008
Food and Drug Administration May 2007 - December 2007
Skills
SQL, WordPress, Troubleshooting, Editing, Social Media, PeopleSoft Security, PeopleSoft Workflow
Education
Grinnell College 2004 — 2008
BA, Computer Science
Edelman March 2015 - Present
Edelman March 2013 - Present
XBLA Fans August 2011 - Present
Steam Game Fans October 2012 - November 2013
Edelman August 2012 - March 2013
Xbox Kinect Fans January 2012 - October 2012
Edelman March 2010 - August 2012
Edelman March 2009 - March 2010
Grinnell College August 2005 - December 2008
Food and Drug Administration May 2007 - December 2007
Skills
SQL, WordPress, Troubleshooting, Editing, Social Media, PeopleSoft Security, PeopleSoft Workflow
Education
Grinnell College 2004 — 2008
BA, Computer Science
Eugene Sun's Food and Drug Administration Experience 2001 - 2007
Job Executive Vice President at Melinta Therapeutics
Industry Pharmaceuticals
Experience
Melinta Therapeutics April 2013 - Present
Abbott Laboratories April 2005 - August 2011
TAP Pharmaceuticals 2004 - 2008
Food and Drug Administration 2001 - 2007
Abbott Laboratories December 2000 - April 2005
Abbott Laboratories June 1997 - December 2000
Abbott Laboratories September 1994 - June 1997
University of California, San Francisco 1991 - 1994
Education
University of California, San Francisco (UCSF) 1985 — 1991
Internship, Residency, Fellowship
New York University School of Medicine 1981 — 1985
M.D., Medicine
Harvard University 1977 — 1981
B.A., Applied Mathematics
Melinta Therapeutics April 2013 - Present
Abbott Laboratories April 2005 - August 2011
TAP Pharmaceuticals 2004 - 2008
Food and Drug Administration 2001 - 2007
Abbott Laboratories December 2000 - April 2005
Abbott Laboratories June 1997 - December 2000
Abbott Laboratories September 1994 - June 1997
University of California, San Francisco 1991 - 1994
Education
University of California, San Francisco (UCSF) 1985 — 1991
Internship, Residency, Fellowship
New York University School of Medicine 1981 — 1985
M.D., Medicine
Harvard University 1977 — 1981
B.A., Applied Mathematics
Maria Lau's Food and Drug Administration Experience June 2010 - Present
Job Project Manager at Food and Drug Administration
Industry Real Estate
Experience
Food and Drug Administration June 2010 - Present
Skills
Project Management, Program Management, Project Planning, Strategic Planning
Education
Florida International University - College of Business 2007 — 2010
Bachelors, Marketing and International Business
University of Maryland College Park
Master's Degree, Public Policy Analysis
Food and Drug Administration June 2010 - Present
Skills
Project Management, Program Management, Project Planning, Strategic Planning
Education
Florida International University - College of Business 2007 — 2010
Bachelors, Marketing and International Business
University of Maryland College Park
Master's Degree, Public Policy Analysis
Kannan Balan's Food and Drug Administration Experience October 2009 - October 2011
Job Biologist
Industry Research
Experience
FDA October 2011 - Present
Food and Drug Administration October 2009 - October 2011
Case Western Reserve University January 2006 - September 2009
University of Miami July 2002 - May 2005
Brown University February 2001 - June 2002
Howard University – Newborn Screening Program January 1995 - December 2000
E.Merck (India) Ltd. August 1992 - October 1993
Education
Howard University 1994 — 2000
Ph.D., Cell and Molecular Biology
University of Mumbai 1990 — 1992
M.Sc., Biochemistry
University of Mumbai 1987 — 1990
B.Sc., Microbiology & Biochemistry
FDA October 2011 - Present
Food and Drug Administration October 2009 - October 2011
Case Western Reserve University January 2006 - September 2009
University of Miami July 2002 - May 2005
Brown University February 2001 - June 2002
Howard University – Newborn Screening Program January 1995 - December 2000
E.Merck (India) Ltd. August 1992 - October 1993
Education
Howard University 1994 — 2000
Ph.D., Cell and Molecular Biology
University of Mumbai 1990 — 1992
M.Sc., Biochemistry
University of Mumbai 1987 — 1990
B.Sc., Microbiology & Biochemistry
Sarah Rizk's Food and Drug Administration Experience January 2004 - December 2004
Job Senior Regulatory Engineer at Intuitive Surgical
Industry Medical Devices
Experience
Intuitive Surgical March 2014 - Present
Covidien November 2013 - March 2014
Covidien April 2010 - October 2013
Conmed Corporation April 2009 - June 2010
Smiths Medical June 2006 - March 2009
Food and Drug Administration January 2004 - December 2004
Skills
ISO 13485, Medical Devices, FDA, ISO 14971, Design Control, CE marking, Cross-functional Team..., Regulatory Affairs, Biomedical Engineering, V&V, CAPA, Product Development, R&D, Validation, Quality System
Education
Marquette University 2007 — 2011
Master's of Science, Healthcare Technologies Management
Marquette University 2003 — 2006
Bachelors of Science, Biomedical Engineering
Intuitive Surgical March 2014 - Present
Covidien November 2013 - March 2014
Covidien April 2010 - October 2013
Conmed Corporation April 2009 - June 2010
Smiths Medical June 2006 - March 2009
Food and Drug Administration January 2004 - December 2004
Skills
ISO 13485, Medical Devices, FDA, ISO 14971, Design Control, CE marking, Cross-functional Team..., Regulatory Affairs, Biomedical Engineering, V&V, CAPA, Product Development, R&D, Validation, Quality System
Education
Marquette University 2007 — 2011
Master's of Science, Healthcare Technologies Management
Marquette University 2003 — 2006
Bachelors of Science, Biomedical Engineering
Ann Gastinger's Food and Drug Administration Experience 1970 - 1973
Job Experienced Chemical Research Associate
Industry Chemicals
Experience
Lehigh Valley Health Network 2010 - Present
Air Products 1987 - 2009
Vale Chemical Company, Inc 1984 - 1985
Food and Drug Administration 1970 - 1973
Skills
Chemistry
Education
Marywood University 1966 — 1970
B.S., Chemistry
Lehigh University
20 credits, Graduate Level Study
Lehigh Valley Health Network 2010 - Present
Air Products 1987 - 2009
Vale Chemical Company, Inc 1984 - 1985
Food and Drug Administration 1970 - 1973
Skills
Chemistry
Education
Marywood University 1966 — 1970
B.S., Chemistry
Lehigh University
20 credits, Graduate Level Study
Wayne Seifert's Food and Drug Administration Experience December 2014 - Present
Job Consumer Safety Officer, BMAB at FDA/CDER/OMPQ
Industry Biotechnology
Experience
Food and Drug Administration December 2014 - Present
Emergent BioSolutions January 2014 - November 2014
Wellstat Management Company January 2004 - January 2014
Cambrex March 2001 - January 2004
Life Technologies April 1997 - March 2001
Fujisawa May 1986 - April 1997
Skills
GMP, Biotechnology, GLP, Validation, HPLC, FDA, Cell, Pharmaceutical Industry, Technology Transfer, Cleaning Validation, V&V, Quality Assurance, CAPA, Change Control, Aseptic Processing, 21 CFR Part 11, LIMS, Quality System, GAMP
Education
Erie Community College 1982 — 1986
Associate of Arts and Sciences (AAS), Chemical Technology/Technician, 3.8
University of Phoenix
Food and Drug Administration December 2014 - Present
Emergent BioSolutions January 2014 - November 2014
Wellstat Management Company January 2004 - January 2014
Cambrex March 2001 - January 2004
Life Technologies April 1997 - March 2001
Fujisawa May 1986 - April 1997
Skills
GMP, Biotechnology, GLP, Validation, HPLC, FDA, Cell, Pharmaceutical Industry, Technology Transfer, Cleaning Validation, V&V, Quality Assurance, CAPA, Change Control, Aseptic Processing, 21 CFR Part 11, LIMS, Quality System, GAMP
Education
Erie Community College 1982 — 1986
Associate of Arts and Sciences (AAS), Chemical Technology/Technician, 3.8
University of Phoenix
Dave Oswald's Food and Drug Administration Experience August 2010 - Present
Job Project Manager at Food and Drug Administration
Industry Information Technology and Services
Experience
Food and Drug Administration August 2010 - Present
IT consultant Self Employed May 2009 - August 2010
Highland Technology Services, Inc. September 2008 - April 2009
ARINC Engineering Services, LLC September 1998 - September 2007
ARINC Engineering Services 1998 - 2007
Skills
Program Management, Operations Management, Management, Leadership, Strategy, Business Development, Team Management, CMMI, PMP, Government, Government Contracting, Project Management, SDLC, Federal Government, Proposal Writing, Business Process..., Process Improvement, Integration, Analysis, Quality Assurance, Data Analysis, Policy, Software Documentation, Cross-functional Team..., Project Planning, Requirements Analysis, MS Project, Change Management, Project Portfolio..., PMO, IT Strategy, Governance, SharePoint, Risk Management, Enterprise Architecture, Security, Business Intelligence, Team Leadership, IT Management, Business Analysis, Visio, Technical Writing, Software Project..., FDA, ITIL, Requirements Gathering
Education
University of Maryland University College 2002 — 2008
MS, Computer Systems Management
Frostburg State University 1979 — 1981
MS, Fisheries Biology
St. Mary's College of Maryland 1975 — 1979
BS, Biology
Food and Drug Administration August 2010 - Present
IT consultant Self Employed May 2009 - August 2010
Highland Technology Services, Inc. September 2008 - April 2009
ARINC Engineering Services, LLC September 1998 - September 2007
ARINC Engineering Services 1998 - 2007
Skills
Program Management, Operations Management, Management, Leadership, Strategy, Business Development, Team Management, CMMI, PMP, Government, Government Contracting, Project Management, SDLC, Federal Government, Proposal Writing, Business Process..., Process Improvement, Integration, Analysis, Quality Assurance, Data Analysis, Policy, Software Documentation, Cross-functional Team..., Project Planning, Requirements Analysis, MS Project, Change Management, Project Portfolio..., PMO, IT Strategy, Governance, SharePoint, Risk Management, Enterprise Architecture, Security, Business Intelligence, Team Leadership, IT Management, Business Analysis, Visio, Technical Writing, Software Project..., FDA, ITIL, Requirements Gathering
Education
University of Maryland University College 2002 — 2008
MS, Computer Systems Management
Frostburg State University 1979 — 1981
MS, Fisheries Biology
St. Mary's College of Maryland 1975 — 1979
BS, Biology
Uduak Inokon's Food and Drug Administration Experience 2011 - August 2015
Job Director Regulatory Operations Officer at Food and Drug Administration
Industry Government Administration
Experience
FDA August 2015 - Present
Food and Drug Administration 2011 - August 2015
PDA/FDA Conference 2015 - 2015
Food and Drug Administration August 2002 - November 2011
Hospitals / Community Pharmacies November 1993 - July 2002
Skills
Regulatory Affairs, FDA, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, Clinical Pharmacology, Infectious Diseases, Pharmacokinetics, Pharmacists, GMP
Education
Massachusetts College of Pharmacy and Health Sciences 2006 — 2009
PharmD
Schiller's International University 1997 — 1999
MA, International Relations & Diplomacy
Howard University 1989 — 1993
BSPharm, Pharmaceutical Science
FDA August 2015 - Present
Food and Drug Administration 2011 - August 2015
PDA/FDA Conference 2015 - 2015
Food and Drug Administration August 2002 - November 2011
Hospitals / Community Pharmacies November 1993 - July 2002
Skills
Regulatory Affairs, FDA, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, Clinical Pharmacology, Infectious Diseases, Pharmacokinetics, Pharmacists, GMP
Education
Massachusetts College of Pharmacy and Health Sciences 2006 — 2009
PharmD
Schiller's International University 1997 — 1999
MA, International Relations & Diplomacy
Howard University 1989 — 1993
BSPharm, Pharmaceutical Science
Dikoe Makhene's Food and Drug Administration Experience December 2000 - March 2002
Job Medical Officer, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases
Industry Research
Experience
NIAID/NIH 2002 - Present
Food and Drug Administration December 2000 - March 2002
Food and Drug Administration December 1996 - December 2000
Center for Immunization Research, Johns Hopkins U School of Hygiene July 1992 - August 1995
Skills
Epidemiology, Pharmacoepidemiology, Clinical Trials, Biostatistics, Pharmacodynamics, Clinical Research, Medicine, Lifesciences, Infectious Diseases, Clinical Development, Pharmacokinetics, Regulatory Affairs
Education
Johns Hopkins School of Hygiene and Public Health 1995 — 1996
Master of Public Health (M.P.H.)
Meharry Medical College
Doctor of Medicine (MD)
University of Toronto-Erindale College
Bachelor of Science (B.Sc.)
NIAID/NIH 2002 - Present
Food and Drug Administration December 2000 - March 2002
Food and Drug Administration December 1996 - December 2000
Center for Immunization Research, Johns Hopkins U School of Hygiene July 1992 - August 1995
Skills
Epidemiology, Pharmacoepidemiology, Clinical Trials, Biostatistics, Pharmacodynamics, Clinical Research, Medicine, Lifesciences, Infectious Diseases, Clinical Development, Pharmacokinetics, Regulatory Affairs
Education
Johns Hopkins School of Hygiene and Public Health 1995 — 1996
Master of Public Health (M.P.H.)
Meharry Medical College
Doctor of Medicine (MD)
University of Toronto-Erindale College
Bachelor of Science (B.Sc.)
Troy Ashline's Food and Drug Administration Experience January 2000 - January 2002
Job Self Employed
Industry Alternative Dispute Resolution
Experience
Amnesty International May 2008 - September 2010
philanthropist.org September 2004 - September 2007
Institute of Psychiatry August 2002 - July 2004
Food and Drug Administration January 2000 - January 2002
Quad Graphics September 1991 - April 1999
United States Department of Commerce January 1990 - April 1991
Norstar Bank January 1987 - January 1989
Education
Hudson Valley Community College
State University of New York at Cortland
Communications
Adirondack Community College
AS Degree, Business Administration
Amnesty International May 2008 - September 2010
philanthropist.org September 2004 - September 2007
Institute of Psychiatry August 2002 - July 2004
Food and Drug Administration January 2000 - January 2002
Quad Graphics September 1991 - April 1999
United States Department of Commerce January 1990 - April 1991
Norstar Bank January 1987 - January 1989
Education
Hudson Valley Community College
State University of New York at Cortland
Communications
Adirondack Community College
AS Degree, Business Administration
Amitabh Adhikari's Food and Drug Administration Experience October 2010 - February 2012
Job Sr. Developer at Armedia
Industry Computer Software
Experience
Armedia April 2014 - Present
Insight Global October 2013 - April 2014
Armedia February 2012 - October 2013
Food and Drug Administration October 2010 - February 2012
Content Studios 2007 - 2010
Touchstone Consulting Group 2007 - 2010
Richmar 2006 - 2006
QinetiQ North America 2005 - 2006
BearingPoint 2004 - 2005
CACI 2004 - 2004
Skills
Enterprise Architecture, Solution Architecture, Requirements Analysis, SDLC, SOA, PMP, Business Analysis
Education
George Mason University 1997 — 2000
BS, Computer Science
DTEA Sr Secondary School - Lodhi Estate 1984 — 1989
Science
Dr. Radhakrishnan International School (Dorins)
Armedia April 2014 - Present
Insight Global October 2013 - April 2014
Armedia February 2012 - October 2013
Food and Drug Administration October 2010 - February 2012
Content Studios 2007 - 2010
Touchstone Consulting Group 2007 - 2010
Richmar 2006 - 2006
QinetiQ North America 2005 - 2006
BearingPoint 2004 - 2005
CACI 2004 - 2004
Skills
Enterprise Architecture, Solution Architecture, Requirements Analysis, SDLC, SOA, PMP, Business Analysis
Education
George Mason University 1997 — 2000
BS, Computer Science
DTEA Sr Secondary School - Lodhi Estate 1984 — 1989
Science
Dr. Radhakrishnan International School (Dorins)
Rachel Sherman's Food and Drug Administration Experience November 2009 - January 2014
Job Principal, Drug and Biological Drug Products at Greenleaf Health LLC
Industry Health, Wellness and Fitness
Experience
Greenleaf Health LLC May 2014 - Present
Food and Drug Administration November 2009 - January 2014
FDA November 2009 - January 2014
FDA 2008 - 2009
FDA 2005 - 2009
FDA 1998 - 2009
FDA 1998 - 2006
FDA 1993 - 1998
FDA 1989 - 1993
Skills
FDA, Professional Mentoring, Leadership, Leadership Development, Public Health, Federal Government, Drug Development, Regulatory Policy, Clinical Trials, Public Health..., Pharmaceutical Industry, Post Market Surveillance, Organizational..., Direct Patient Care, Quality by Design, Clinical Research, Regulatory Affairs, Medical Compliance, Biotechnology, Lifesciences
Education
Mount Sinai School of Medicine of New York University
Doctor of Medicine (M.D.)
The Johns Hopkins University
Master of Public Health (MPH)
Washington University in St. Louis
Bachelor's degree
Greenleaf Health LLC May 2014 - Present
Food and Drug Administration November 2009 - January 2014
FDA November 2009 - January 2014
FDA 2008 - 2009
FDA 2005 - 2009
FDA 1998 - 2009
FDA 1998 - 2006
FDA 1993 - 1998
FDA 1989 - 1993
Skills
FDA, Professional Mentoring, Leadership, Leadership Development, Public Health, Federal Government, Drug Development, Regulatory Policy, Clinical Trials, Public Health..., Pharmaceutical Industry, Post Market Surveillance, Organizational..., Direct Patient Care, Quality by Design, Clinical Research, Regulatory Affairs, Medical Compliance, Biotechnology, Lifesciences
Education
Mount Sinai School of Medicine of New York University
Doctor of Medicine (M.D.)
The Johns Hopkins University
Master of Public Health (MPH)
Washington University in St. Louis
Bachelor's degree
Ebenezer B Asafu-Adjaye's Food and Drug Administration Experience May 1991 - Present
Job Dr at Food and Drug Administration
Industry Research
Experience
Food and Drug Administration May 1991 - Present
Skills
Analytical Chemistry, HPLC, Chromatography, Biochemistry, Validation, Spectroscopy, Chemistry
Education
Virginia Commonwealth University 1982 — 1987
Ph. D., Analytical Chemistry
South Dakota State University 1979 — 1982
M. S., Analytical Chemistry & Biochemistry
Kwame Nkrumah' University of Science and Technology, Kumasi 1972 — 1976
B. Sc (Hons), Biochemistry
Aggrey Memorial Secondary School, Cape Coast, Ghana
Ghana Secondary/Technical School, Takoradi, Ghana
GhanamSecondary/Technical School, Takoradi, Ghana
Food and Drug Administration May 1991 - Present
Skills
Analytical Chemistry, HPLC, Chromatography, Biochemistry, Validation, Spectroscopy, Chemistry
Education
Virginia Commonwealth University 1982 — 1987
Ph. D., Analytical Chemistry
South Dakota State University 1979 — 1982
M. S., Analytical Chemistry & Biochemistry
Kwame Nkrumah' University of Science and Technology, Kumasi 1972 — 1976
B. Sc (Hons), Biochemistry
Aggrey Memorial Secondary School, Cape Coast, Ghana
Ghana Secondary/Technical School, Takoradi, Ghana
GhanamSecondary/Technical School, Takoradi, Ghana
Brian J. Adkins, M.D., M.B.A.'s Food and Drug Administration Experience December 2010 - July 2012
Job Adjunct Faculty at Montgomery College
Industry Hospital & Health Care
Experience
Montgomery College - Germantown January 2014 - Present
The Adkins Academy, LLC July 2010 - Present
CareFirst BlueCross BlueShield January 2013 - April 2014
Food And Drug Administration December 2010 - July 2012
National Medical Association February 2008 - December 2010
Arizona State University Biodesign Institute May 2006 - August 2006
Baylor College of Medicine May 2004 - August 2004
Baylor College of Medicine May 2003 - September 2003
Skills
Business Strategy, Strategy, Healthcare, Data Analysis, Public Speaking, Entrepreneurship, Teaching, Leadership, Project Management, Community Outreach, Higher Education, Strategic Planning, Medical Education, Microsoft Office, Microsoft Excel, PowerPoint, Medicine, Analysis, Microsoft Word, Business Planning, Research, Due Diligence, Motivated self-starter, Specialty Pharmaceutical, Management, Clinical Research, Healthcare Analytics, Accountable Care..., Pharmacy Benefit..., Patient Centered..., Healthcare Consulting, Biotechnology, Proposal Writing, Hospitals, Cross-functional Team..., Strategic Partnerships, Program Management
Education
Loyola University Maryland 2012 — 2013
Master of Business Administration (M.B.A.), Emerging Leaders M.B.A Program
Howard University College of Medicine 2005 — 2010
M.D., Medicine
Howard University 2001 — 2005
B.S., Molecular Biology
Montgomery College - Germantown January 2014 - Present
The Adkins Academy, LLC July 2010 - Present
CareFirst BlueCross BlueShield January 2013 - April 2014
Food And Drug Administration December 2010 - July 2012
National Medical Association February 2008 - December 2010
Arizona State University Biodesign Institute May 2006 - August 2006
Baylor College of Medicine May 2004 - August 2004
Baylor College of Medicine May 2003 - September 2003
Skills
Business Strategy, Strategy, Healthcare, Data Analysis, Public Speaking, Entrepreneurship, Teaching, Leadership, Project Management, Community Outreach, Higher Education, Strategic Planning, Medical Education, Microsoft Office, Microsoft Excel, PowerPoint, Medicine, Analysis, Microsoft Word, Business Planning, Research, Due Diligence, Motivated self-starter, Specialty Pharmaceutical, Management, Clinical Research, Healthcare Analytics, Accountable Care..., Pharmacy Benefit..., Patient Centered..., Healthcare Consulting, Biotechnology, Proposal Writing, Hospitals, Cross-functional Team..., Strategic Partnerships, Program Management
Education
Loyola University Maryland 2012 — 2013
Master of Business Administration (M.B.A.), Emerging Leaders M.B.A Program
Howard University College of Medicine 2005 — 2010
M.D., Medicine
Howard University 2001 — 2005
B.S., Molecular Biology
John Thorsky's Food and Drug Administration Experience January 2003 - February 2005
Job District Director at FDA (Retired)
Industry Government Administration
Experience
FDA February 2005 - September 2013
Food and Drug Administration January 2003 - February 2005
FDA March 2000 - January 2003
FDA September 1988 - March 2000
FDA September 1974 - September 1988
Skills
Sop, FDA, Pharmaceutical Industry, V&V, GMP, Biopharmaceuticals, Technology Transfer, Regulatory Requirements, Biotechnology, Lifesciences, Validation, CAPA, Regulatory Affairs, GLP, Toxicology, Regulatory Submissions, Vaccines, Quality Assurance, Medical Devices, IND, LIMS, Change Control, 21 CFR Part 11, Clinical Trials, Clinical Development, GCP, Microbiology, Analytical Chemistry, Chromatography, HPLC, Pharmaceutics, Aseptic Technique, Quality Auditing, Life Sciences, SOP
Education
Purdue University 1973 — 1974
Pharmacology & Toxicology
Indiana State University 1969 — 1973
Bachelor of Science (BS), Life Science (biology, chemistry)
FDA February 2005 - September 2013
Food and Drug Administration January 2003 - February 2005
FDA March 2000 - January 2003
FDA September 1988 - March 2000
FDA September 1974 - September 1988
Skills
Sop, FDA, Pharmaceutical Industry, V&V, GMP, Biopharmaceuticals, Technology Transfer, Regulatory Requirements, Biotechnology, Lifesciences, Validation, CAPA, Regulatory Affairs, GLP, Toxicology, Regulatory Submissions, Vaccines, Quality Assurance, Medical Devices, IND, LIMS, Change Control, 21 CFR Part 11, Clinical Trials, Clinical Development, GCP, Microbiology, Analytical Chemistry, Chromatography, HPLC, Pharmaceutics, Aseptic Technique, Quality Auditing, Life Sciences, SOP
Education
Purdue University 1973 — 1974
Pharmacology & Toxicology
Indiana State University 1969 — 1973
Bachelor of Science (BS), Life Science (biology, chemistry)
Kathryn Carbone's Food and Drug Administration Experience March 1996 - November 2007
Job Deputy Scientific Director at National Institutes of Health
Industry Research
Experience
National Institutes of Health November 2007 - Present
Food and Drug Administration March 1996 - November 2007
The Johns Hopkins School of Medicine July 1988 - March 1996
Skills
Immunology, Molecular Biology, Genetics, Cell Biology, Lifesciences
Education
The Johns Hopkins University School of Medicine 1986 — 1988
Fellowship, Infectious Diseases
The Johns Hopkins University School of Medicine 1983 — 1986
Residency, Internal Medicine
University of Wisconsin School of Medicine and Public Health 1979 — 1983
MD, Medicine, with Honors
Harvard University 1974 — 1979
AB, Biology, Magna cum Laude
National Institutes of Health November 2007 - Present
Food and Drug Administration March 1996 - November 2007
The Johns Hopkins School of Medicine July 1988 - March 1996
Skills
Immunology, Molecular Biology, Genetics, Cell Biology, Lifesciences
Education
The Johns Hopkins University School of Medicine 1986 — 1988
Fellowship, Infectious Diseases
The Johns Hopkins University School of Medicine 1983 — 1986
Residency, Internal Medicine
University of Wisconsin School of Medicine and Public Health 1979 — 1983
MD, Medicine, with Honors
Harvard University 1974 — 1979
AB, Biology, Magna cum Laude
Amy L. Steffey, DVM, MPH's Food and Drug Administration Experience 2008 - 2010
Job Epidemiologist Seeking New Opportunity in Research
Industry Research
Experience
MedImmune (AstraZeneca) 2010 - 2012
MedImmune (AstraZeneca) 2010 - 2010
Food and Drug Administration 2008 - 2010
Schering-Plough 2008 - 2008
Purdue Pharma 2007 - 2007
Pfizer 2006 - 2006
Education
University of Michigan
Master of Public Health (M.P.H.), Epidemiology
Michigan State University
Doctor of Veterinary Medicine (D.V.M.)
Michigan State University
Bachelor of Science (B.S.), Animal Science
MedImmune (AstraZeneca) 2010 - 2012
MedImmune (AstraZeneca) 2010 - 2010
Food and Drug Administration 2008 - 2010
Schering-Plough 2008 - 2008
Purdue Pharma 2007 - 2007
Pfizer 2006 - 2006
Education
University of Michigan
Master of Public Health (M.P.H.), Epidemiology
Michigan State University
Doctor of Veterinary Medicine (D.V.M.)
Michigan State University
Bachelor of Science (B.S.), Animal Science
Amanda Baskin's Food and Drug Administration Experience April 2002 - April 2003
Job Manager Supply Chain at Nissan North America
Industry Automotive
Experience
Nissan North America June 2012 - Present
Nissan North America May 2011 - Present
Nissan North America July 2004 - Present
Nissan North America June 2010 - May 2011
NISSAN TRADING CORPERATION (NITCO) September 2003 - July 2004
FOOD AND DRUG ADMINISTRATION April 2002 - April 2003
Education
Middle Tennessee State University 1996 — 2001
BS, Agribusiness
Middle Tennessee State University
MBA
Nissan North America June 2012 - Present
Nissan North America May 2011 - Present
Nissan North America July 2004 - Present
Nissan North America June 2010 - May 2011
NISSAN TRADING CORPERATION (NITCO) September 2003 - July 2004
FOOD AND DRUG ADMINISTRATION April 2002 - April 2003
Education
Middle Tennessee State University 1996 — 2001
BS, Agribusiness
Middle Tennessee State University
MBA
Ana Cris Garcia's Food and Drug Administration Experience March 2011 - March 2012
Job Daniel Pharmacy/ Dade Moeller
Industry Research
Experience
Dade Moeller January 2013 - Present
Daniel Pharmacy January 2011 - Present
Food and Drug Administration March 2011 - March 2012
Skills
Marine Biology, Research, Science, Data Analysis, Public Health, Literature Reviews, Assay Development, ELISA, Lifesciences, Ecology, Environmental Awareness, Environmental Science, Chemistry, Scuba Diving, Underwater Photography, Molecular Biology, Government
Education
Louisiana State University 2007 — 2010
M.S., Oceanography and Coastal Sciences
University of South Alabama 2011 — 2011
Non-matriculating, Oceanography, Chemical and Physical
Dade Moeller January 2013 - Present
Daniel Pharmacy January 2011 - Present
Food and Drug Administration March 2011 - March 2012
Skills
Marine Biology, Research, Science, Data Analysis, Public Health, Literature Reviews, Assay Development, ELISA, Lifesciences, Ecology, Environmental Awareness, Environmental Science, Chemistry, Scuba Diving, Underwater Photography, Molecular Biology, Government
Education
Louisiana State University 2007 — 2010
M.S., Oceanography and Coastal Sciences
University of South Alabama 2011 — 2011
Non-matriculating, Oceanography, Chemical and Physical
Amy Malla's Food and Drug Administration Experience May 2008 - Present
Job Project Manager
Industry Biotechnology
Experience
Centers for Medicare and Medicaid Services December 2012 - Present
Food and Drug Administration May 2008 - Present
Ortho Clinical Diagnostics 1994 - 2003
US Army 1985 - 1988
US Army 1985 - 1988
Skills
Clinical Trials, FDA, Regulatory Submissions
Education
Michigan State University 1978 — 1983
BS, Medical Technology
Centers for Medicare and Medicaid Services December 2012 - Present
Food and Drug Administration May 2008 - Present
Ortho Clinical Diagnostics 1994 - 2003
US Army 1985 - 1988
US Army 1985 - 1988
Skills
Clinical Trials, FDA, Regulatory Submissions
Education
Michigan State University 1978 — 1983
BS, Medical Technology
Robert Hopkins's Food and Drug Administration Experience September 1996 - September 1999
Job Sr Director, Clinical Development US at Emergent BioSolutions
Industry Biotechnology
Experience
Emergent BioSolutions September 2004 - Present
Emergent BioSolutions September 2004 - January 2014
DynPort Vaccine Company LLC, A CSC Company September 2002 - August 2004
DynPort Vaccine Company LLC, A CSC Company September 2001 - September 2002
Merck September 1998 - September 2001
Food and Drug Administration September 1996 - September 1999
FDA July 1994 - September 1996
Skills
Biotechnology, Clinical Development, GLP, Medicine, FDA, Infectious Diseases, Clinical Research, Vaccines, GCP, Immunology, Drug Development, Biopharmaceuticals, Lifesciences, Clinical Trials, Internal Medicine, Pharmaceutical Industry
Education
University of Maryland School of Medicine 1992 — 1994
Residency, Internal Medicine, Fellowship, Infectious Disease and Geographic Medicine
University of Maryland School of Medicine 1989 — 1992
Internal Medicine Residency
Emory University School of Medicine 1988 — 1989
Internship, Internal Medicine
Tulane University School of Medicine 1984 — 1988
MD, MPH & TM, Medicine, Tropical Medicine
Emergent BioSolutions September 2004 - Present
Emergent BioSolutions September 2004 - January 2014
DynPort Vaccine Company LLC, A CSC Company September 2002 - August 2004
DynPort Vaccine Company LLC, A CSC Company September 2001 - September 2002
Merck September 1998 - September 2001
Food and Drug Administration September 1996 - September 1999
FDA July 1994 - September 1996
Skills
Biotechnology, Clinical Development, GLP, Medicine, FDA, Infectious Diseases, Clinical Research, Vaccines, GCP, Immunology, Drug Development, Biopharmaceuticals, Lifesciences, Clinical Trials, Internal Medicine, Pharmaceutical Industry
Education
University of Maryland School of Medicine 1992 — 1994
Residency, Internal Medicine, Fellowship, Infectious Disease and Geographic Medicine
University of Maryland School of Medicine 1989 — 1992
Internal Medicine Residency
Emory University School of Medicine 1988 — 1989
Internship, Internal Medicine
Tulane University School of Medicine 1984 — 1988
MD, MPH & TM, Medicine, Tropical Medicine
Brian Pendleton's Food and Drug Administration Experience Senior Policy AdvisorFDA2009 - Present
Job Senior Policy Advisor at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration Senior Policy AdvisorFDA2009 - Present
Skills
Regulatory Affairs, Government, Public Policy, Policy Analysis, Public Health, Legislation, Policy, Global Health
Education
Kent State University 1977 — 1982
BA, MA, Political Science
Food and Drug Administration Senior Policy AdvisorFDA2009 - Present
Skills
Regulatory Affairs, Government, Public Policy, Policy Analysis, Public Health, Legislation, Policy, Global Health
Education
Kent State University 1977 — 1982
BA, MA, Political Science
Sergey Arzhantsev's Food and Drug Administration Experience PostDocPenn State UniversityFebruary 2003 - January 2009
Job Chemist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration PostDocPenn State UniversityFebruary 2003 - January 2009
Institute for Molecular Science November 1998 - February 2003
Education
Lomonosov Moscow State University (MSU) 1993 — 1997
PHD, Physics, Laser Physics
Lomonosov Moscow State University (MSU) 1987 — 1993
MS, Physics
Food and Drug Administration PostDocPenn State UniversityFebruary 2003 - January 2009
Institute for Molecular Science November 1998 - February 2003
Education
Lomonosov Moscow State University (MSU) 1993 — 1997
PHD, Physics, Laser Physics
Lomonosov Moscow State University (MSU) 1987 — 1993
MS, Physics
Frank Vocci's Food and Drug Administration Experience September 1978 - July 1989
Job President at Friends Research Institute, Inc.
Industry Research
Experience
Friends Research Institute, Inc. January 2009 - Present
Friends Research Institute, Inc. January 2009 - Present
National Institute on Drug Abuse July 1989 - December 2008
Food and Drug Administration September 1978 - July 1989
Skills
Neuroscience, Public Health, Clinical Trials, Clinical Research, Pharmacology, Treatment, Psychotherapy, Prevention, Epidemiology, Healthcare, Medicine, Immunology, Lifesciences, Board Certified, FDA, Research, Drug Discovery, Oncology, Medical Writing, Group Therapy, Adolescents, Cancer, Health Education, Health Policy, Case Managment, Clinical Supervision, Therapists, Psychological Assessment, Drug Development, CBT, Program Development, Neurology, Case Management, Life Sciences, Program Management
Education
University of Maryland Baltimore 1971 — 1976
Doctor of Philosophy (Ph.D.), Pharmacology and Neuroscience
Loyola College in Maryland 1967 — 1971
Bachelor of Science (BSc), Biology, General
Friends Research Institute, Inc. January 2009 - Present
Friends Research Institute, Inc. January 2009 - Present
National Institute on Drug Abuse July 1989 - December 2008
Food and Drug Administration September 1978 - July 1989
Skills
Neuroscience, Public Health, Clinical Trials, Clinical Research, Pharmacology, Treatment, Psychotherapy, Prevention, Epidemiology, Healthcare, Medicine, Immunology, Lifesciences, Board Certified, FDA, Research, Drug Discovery, Oncology, Medical Writing, Group Therapy, Adolescents, Cancer, Health Education, Health Policy, Case Managment, Clinical Supervision, Therapists, Psychological Assessment, Drug Development, CBT, Program Development, Neurology, Case Management, Life Sciences, Program Management
Education
University of Maryland Baltimore 1971 — 1976
Doctor of Philosophy (Ph.D.), Pharmacology and Neuroscience
Loyola College in Maryland 1967 — 1971
Bachelor of Science (BSc), Biology, General
sam labinjo's Food and Drug Administration Experience
Job Investigator at Food and drug administration
Industry Government Administration
Experience
Food and drug administration
Skills
Public Policy, Policy, Government, Litigation, Public Speaking, Community Outreach, Executive Protection, Non-profits, Evidence, Civil Litigation, Health Law, Internal Investigations
Education
Loyola University New Orleans
Xavier University of Louisiana
Bachelor of Science (B.S.), Chemistry
Food and drug administration
Skills
Public Policy, Policy, Government, Litigation, Public Speaking, Community Outreach, Executive Protection, Non-profits, Evidence, Civil Litigation, Health Law, Internal Investigations
Education
Loyola University New Orleans
Xavier University of Louisiana
Bachelor of Science (B.S.), Chemistry
Karen Feibus, MD's Food and Drug Administration Experience October 2011 - January 2012
Job Medical Officer at the Food and Drug Administration/US Department of Health and Human Services
Industry Government Administration
Experience
Office of Generic Drugs, Food and Drug Administration, US Department of Health and Human Services October 2014 - Present
Women's Health Services, Department of Veterans Affairs January 2012 - September 2014
Food and Drug Administration October 2011 - January 2012
Office of New Drugs, Food and Drug Administration November 2006 - October 2011
U.S. Food and Drug Administration December 2003 - November 2006
Capital Women's Care December 1998 - December 2003
Skills
Public Health, Reproductive Health, Obstetrics and..., Drug Regulatory Science
Education
Georgetown University School of Medicine 1986 — 1990
MD, Medicine
Cornell University, College of Arts and Sciences 1982 — 1986
Bachelor of Arts (B.A.), Biology, Neurobiology and Behavior
Office of Generic Drugs, Food and Drug Administration, US Department of Health and Human Services October 2014 - Present
Women's Health Services, Department of Veterans Affairs January 2012 - September 2014
Food and Drug Administration October 2011 - January 2012
Office of New Drugs, Food and Drug Administration November 2006 - October 2011
U.S. Food and Drug Administration December 2003 - November 2006
Capital Women's Care December 1998 - December 2003
Skills
Public Health, Reproductive Health, Obstetrics and..., Drug Regulatory Science
Education
Georgetown University School of Medicine 1986 — 1990
MD, Medicine
Cornell University, College of Arts and Sciences 1982 — 1986
Bachelor of Arts (B.A.), Biology, Neurobiology and Behavior
Margaret Amankwa-Sakyi's Food and Drug Administration Experience August 2009 - August 2011
Job Biostatistician at Food and Drug Administration
Industry Research
Experience
FDA December 2012 - Present
Food and Drug Administration August 2009 - August 2011
U.S Department of Health and Human Services Food and Drug Administration (FDA) August 2009 - August 2011
University of Maryland, School of Public Health January 2009 - May 2009
Georgetown University, Department of Biostatistics May 2008 - August 2008
Washington Hospital, Department of Bioethics May 2008 - August 2008
Skills
SAS, Data Analysis, Statistics, Data Management, Biostatistics, Epidemiology, Analysis, Research, Public Health, Data Collection, FDA, Clinical Research, Qualitative Research, SPSS, Statistical Consulting, Microsoft Excel, Program Evaluation, Analytics
Education
University of Maryland College Park 2008 — 2010
MPH(Biostatistics), Public Health
Kwame Nkrumah' University of Science and Technology, Kumasi 1997 — 2001
Bsc Agriculture, Economics
FDA December 2012 - Present
Food and Drug Administration August 2009 - August 2011
U.S Department of Health and Human Services Food and Drug Administration (FDA) August 2009 - August 2011
University of Maryland, School of Public Health January 2009 - May 2009
Georgetown University, Department of Biostatistics May 2008 - August 2008
Washington Hospital, Department of Bioethics May 2008 - August 2008
Skills
SAS, Data Analysis, Statistics, Data Management, Biostatistics, Epidemiology, Analysis, Research, Public Health, Data Collection, FDA, Clinical Research, Qualitative Research, SPSS, Statistical Consulting, Microsoft Excel, Program Evaluation, Analytics
Education
University of Maryland College Park 2008 — 2010
MPH(Biostatistics), Public Health
Kwame Nkrumah' University of Science and Technology, Kumasi 1997 — 2001
Bsc Agriculture, Economics
Louis Grosso, Ph.D., DABT's Food and Drug Administration Experience 1970 - 1972
Job Consultant at Pharmaceutical Research & Development Corp.
Industry Pharmaceuticals
Experience
Pharmaceutical Research & Development Corp. 2000 - Present
Merial 1997 - 1999
Merck & Co., Inc. 1982 - 1997
Hoechst-Roussel Pharmaceuticals (Sanofi Aventis) 1976 - 1982
US Department of Agriculture 1975 - 1976
US Environmental Protection Agency 1972 - 1975
Food and Drug Administration 1970 - 1972
Skills
Pharmaceuticals, Toxicology, IND, FDA, Regulatory Affairs, Medical Devices, Animal Models, Study Design, Veterinary, Clinical Trials, Pharmaceutical Industry
Education
Thomas Jefferson University 1967 — 1970
Ph.D., Pharmacology
Villanova University 1965 — 1967
MS, Biology
La Salle University 1961 — 1965
BA, Biology
Pharmaceutical Research & Development Corp. 2000 - Present
Merial 1997 - 1999
Merck & Co., Inc. 1982 - 1997
Hoechst-Roussel Pharmaceuticals (Sanofi Aventis) 1976 - 1982
US Department of Agriculture 1975 - 1976
US Environmental Protection Agency 1972 - 1975
Food and Drug Administration 1970 - 1972
Skills
Pharmaceuticals, Toxicology, IND, FDA, Regulatory Affairs, Medical Devices, Animal Models, Study Design, Veterinary, Clinical Trials, Pharmaceutical Industry
Education
Thomas Jefferson University 1967 — 1970
Ph.D., Pharmacology
Villanova University 1965 — 1967
MS, Biology
La Salle University 1961 — 1965
BA, Biology
Yoon Song's Food and Drug Administration Experience September 1995 - Present
Job Packaging Scientist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration September 1995 - Present
Education
Rutgers, The State University of New Jersey-New Brunswick 1990 — 1995
M.S., Ph.D., Food Engineering and Packaging
Korea University 1985 — 1989
B.A., Food Engineering
Food and Drug Administration September 1995 - Present
Education
Rutgers, The State University of New Jersey-New Brunswick 1990 — 1995
M.S., Ph.D., Food Engineering and Packaging
Korea University 1985 — 1989
B.A., Food Engineering
Charles Raubicheck's Food and Drug Administration Experience 1971 - 1975
Job PARTNER at Frommer Lawrence & Haug LLP
Industry Law Practice
Experience
Frommer Lawrence & Haug LLP June 2000 - Present
New York University School of Law 1976 - 2006
Food and Drug Administration 1971 - 1975
Skills
Intellectual Property, Litigation, Client Counseling, Unfair Competition, Trademarks, Trademark Infringement, Commercial Litigation, Civil Litigation, Prosecution
Education
Georgetown University 1964 — 1971
A.B., J.D., Government, Law
Frommer Lawrence & Haug LLP June 2000 - Present
New York University School of Law 1976 - 2006
Food and Drug Administration 1971 - 1975
Skills
Intellectual Property, Litigation, Client Counseling, Unfair Competition, Trademarks, Trademark Infringement, Commercial Litigation, Civil Litigation, Prosecution
Education
Georgetown University 1964 — 1971
A.B., J.D., Government, Law
Frances Fahnbulleh's Food and Drug Administration Experience
Job Regulatory Health Project Manager at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration
Skills
Public Health, Microsoft Office, Event Planning
Education
High School
Howard University School of Pharmacy
Food and Drug Administration
Skills
Public Health, Microsoft Office, Event Planning
Education
High School
Howard University School of Pharmacy
Andrew Francis Jr.'s Food and Drug Administration Experience July 2010 - Present
Job Technical Lead at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration July 2010 - Present
Lockheed Martin December 2008 - July 2010
SAIC May 2005 - December 2008
Merck June 2004 - December 2004
Merck June 2003 - August 2003
Skills
SDLC, Program Management, Enterprise Architecture, SharePoint, Integration, Agile Methodologies, SQL, Analysis, Microsoft Office
Education
Florida Agricultural and Mechanical University 1998 — 2004
BS, Computer Info Systems
Palm Bay High School 1996 — 1998
Deland High School 1994 — 1996
Food and Drug Administration July 2010 - Present
Lockheed Martin December 2008 - July 2010
SAIC May 2005 - December 2008
Merck June 2004 - December 2004
Merck June 2003 - August 2003
Skills
SDLC, Program Management, Enterprise Architecture, SharePoint, Integration, Agile Methodologies, SQL, Analysis, Microsoft Office
Education
Florida Agricultural and Mechanical University 1998 — 2004
BS, Computer Info Systems
Palm Bay High School 1996 — 1998
Deland High School 1994 — 1996
Vikas Gill's Food and Drug Administration Experience October 2008 - Present
Job Microbiologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration October 2008 - Present
Triumph Foods LLC June 2005 - October 2008
US Army 2001 - 2002
Skills
Microbiology, Food Safety, Food Science, HACCP, Food Processing, GMP, Analytical Chemistry, Science, Sanitation, Quality Assurance, Food, Food Microbiology, Laboratory, FDA, Quality System, PCR
Education
Kansas State University 2002 — 2004
MS, Food Microbiology
Punjab Agricultural University
MS, Food Science & Technology
Food and Drug Administration October 2008 - Present
Triumph Foods LLC June 2005 - October 2008
US Army 2001 - 2002
Skills
Microbiology, Food Safety, Food Science, HACCP, Food Processing, GMP, Analytical Chemistry, Science, Sanitation, Quality Assurance, Food, Food Microbiology, Laboratory, FDA, Quality System, PCR
Education
Kansas State University 2002 — 2004
MS, Food Microbiology
Punjab Agricultural University
MS, Food Science & Technology
Rhondalyn Cox's Food and Drug Administration Experience January 2009 - Present
Job USPHS Officer
Industry Government Administration
Experience
Food and Drug Administration January 2009 - Present
US Public Health Service March 2001 - Present
U.S. Immigration and Customs Enforcement (ICE) March 2001 - June 2005
US Navy December 1997 - March 2001
Skills
Public Health, Government, Healthcare, Policy, Community Outreach, Clinical Research, Public Speaking, Federal Government, Teaching, Policy Analysis, Program Development, Program Evaluation
Education
Indian Hill and Indiana University, Bloomington
Indiana University Bloomington
Bachelor of Science, Health Administration
Indiana University Bloomington
Health, Physical, Education, & Recreation (HPER), Masters in Public Health
Food and Drug Administration January 2009 - Present
US Public Health Service March 2001 - Present
U.S. Immigration and Customs Enforcement (ICE) March 2001 - June 2005
US Navy December 1997 - March 2001
Skills
Public Health, Government, Healthcare, Policy, Community Outreach, Clinical Research, Public Speaking, Federal Government, Teaching, Policy Analysis, Program Development, Program Evaluation
Education
Indian Hill and Indiana University, Bloomington
Indiana University Bloomington
Bachelor of Science, Health Administration
Indiana University Bloomington
Health, Physical, Education, & Recreation (HPER), Masters in Public Health
Wei-Chen Chen's Food and Drug Administration Experience August 2014 - Present
Job ORISE Postdoctoral Fellow at FDA
Industry Pharmaceuticals
Experience
Food and Drug Administration August 2014 - Present
University of Tennessee September 2013 - July 2014
Oak Ridge National Laboratory August 2011 - August 2013
National Health Research Institutes January 2001 - August 2005
Skills
R, MPI, Statistics, Machine Learning, Statistical Computing, C, Parallel Computing, Bayesian statistics, Linux, Bioinformatics, LaTeX, Scientific Computing, Fortran, Phylogenetics, High Performance..., Data Mining, Statistical Modeling, Perl, Clustering, Time Series Analysis, Mathematical Modeling, PHP, MySQL, Population Genetics, Microarray Analysis, Markov Ch
Education
Iowa State University 2005 — 2011
Ph.D., Statistics
National Central University 1998 — 2000
Master's Degree, Statistics
National Central University 1994 — 1998
Bachelor's Degree, Mathematics
Food and Drug Administration August 2014 - Present
University of Tennessee September 2013 - July 2014
Oak Ridge National Laboratory August 2011 - August 2013
National Health Research Institutes January 2001 - August 2005
Skills
R, MPI, Statistics, Machine Learning, Statistical Computing, C, Parallel Computing, Bayesian statistics, Linux, Bioinformatics, LaTeX, Scientific Computing, Fortran, Phylogenetics, High Performance..., Data Mining, Statistical Modeling, Perl, Clustering, Time Series Analysis, Mathematical Modeling, PHP, MySQL, Population Genetics, Microarray Analysis, Markov Ch
Education
Iowa State University 2005 — 2011
Ph.D., Statistics
National Central University 1998 — 2000
Master's Degree, Statistics
National Central University 1994 — 1998
Bachelor's Degree, Mathematics
Bruce S. Schneider's Food and Drug Administration Experience 1997 - Present
Job Medical Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 1997 - Present
U.S. Food and Drug Administration 1997 - Present
Albert Einstein College of Medicine 1989 - 1997
Long Island Jewish Medical Center 1983 - 1997
Rockefeller University 1975 - 1983
Skills
Medicine, FDA, Epidemiology, Public Health, Global Health, International Health, Infectious Diseases, Health Services Research, Pharmacoepidemiology, Evidence-based Medicine, Clinical Research, Medical Research, Biostatistics, Community Health, Prevention, Internal Medicine, Health Policy, Preventive Medicine, Environmental Health, Health Communication
Education
Harvard Medical School 1964 — 1968
Doctor of Medicine (MD), Medicine
Harvard University 1960 — 1964
AB, Biology
Food and Drug Administration 1997 - Present
U.S. Food and Drug Administration 1997 - Present
Albert Einstein College of Medicine 1989 - 1997
Long Island Jewish Medical Center 1983 - 1997
Rockefeller University 1975 - 1983
Skills
Medicine, FDA, Epidemiology, Public Health, Global Health, International Health, Infectious Diseases, Health Services Research, Pharmacoepidemiology, Evidence-based Medicine, Clinical Research, Medical Research, Biostatistics, Community Health, Prevention, Internal Medicine, Health Policy, Preventive Medicine, Environmental Health, Health Communication
Education
Harvard Medical School 1964 — 1968
Doctor of Medicine (MD), Medicine
Harvard University 1960 — 1964
AB, Biology
David Moeny's Food and Drug Administration Experience September 2005 - November 2014
Job Deputy Director, Division of Epidemiology at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
Food and Drug Administration September 2005 - November 2014
South East Alaska Regional Health Consortium September 2001 - July 2005
Skills
Public Health, Clinical Research, Healthcare, Infectious Diseases, Epidemiology, Research
Education
Uniformed Services University of the Health Sciences 2008 — 2010
Master of Public Health (MPH), Epidemiology
Massachusetts College of Pharmacy and Health Sciences
Bachelor's degree, pharmacy
FDA November 2014 - Present
Food and Drug Administration September 2005 - November 2014
South East Alaska Regional Health Consortium September 2001 - July 2005
Skills
Public Health, Clinical Research, Healthcare, Infectious Diseases, Epidemiology, Research
Education
Uniformed Services University of the Health Sciences 2008 — 2010
Master of Public Health (MPH), Epidemiology
Massachusetts College of Pharmacy and Health Sciences
Bachelor's degree, pharmacy
Department of Veterans Affairs
US Census Bureau
U.S. Department of Veterans Affairs
FDA
US Securities and Exchange Commission
USAID
US Fish and Wildlife Service
TSA