U.S. 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. Customer service: 1 (888) 463-6332 Emergency: 1 (866) 300-4374 Headquarters: Silver Spring, MD Jurisdiction: United States of America Founded: June 30, 1906 Founders: Theodore Roosevelt, Harvey Washington Wiley
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U.S. Food and Drug Administration Employees
Employee
Years
Job
Industry
Daya Ranamukhaarachchi Daya Ranamukhaarachchi's U.S. Food and Drug Administration Experience October 2011 - Present
Job Senior Advisor for Innovation at US Food and Drug Administration
Industry Medical Devices
Experience
US Food and Drug Administration October 2011 - Present
US Food and Drug Administration February 2010 - September 2011
US Food and Drug Administration October 2006 - February 2010
US Food and Drug Administration November 2001 - September 2006
Centers for Disease Control and Prevention November 1999 - November 2001
Skills
Medical Devices, Regulatory Affairs, Cross-functional Team..., Regulatory Submissions, Molecular Diagnostics, Strategic Partnerships, Entrepreneurial..., Nanotechnology, biocompatiblity, medical innovation, Research, Project Management, Social Media, Change Management, Clinical Trials, Biotechnology, Leadership, Public Health, ISO 13485, Public Speaking, Molecular Biology, Business Strategy, Genomics, Validation, Quality System, Entrepreneurship, HPLC, Clinical Development, Clinical Research, Program Management, Science, Biomedical Engineering, R&D, Lifesciences, FDA, Strategic Planning, Business Development, Policy, GMP, Pharmaceutical Industry, Regulatory Requirements
Education
University of Florida 1994 — 2000
Ph.D., Molecular Biology, Genetics
US Food and Drug Administration October 2011 - Present
US Food and Drug Administration February 2010 - September 2011
US Food and Drug Administration October 2006 - February 2010
US Food and Drug Administration November 2001 - September 2006
Centers for Disease Control and Prevention November 1999 - November 2001
Skills
Medical Devices, Regulatory Affairs, Cross-functional Team..., Regulatory Submissions, Molecular Diagnostics, Strategic Partnerships, Entrepreneurial..., Nanotechnology, biocompatiblity, medical innovation, Research, Project Management, Social Media, Change Management, Clinical Trials, Biotechnology, Leadership, Public Health, ISO 13485, Public Speaking, Molecular Biology, Business Strategy, Genomics, Validation, Quality System, Entrepreneurship, HPLC, Clinical Development, Clinical Research, Program Management, Science, Biomedical Engineering, R&D, Lifesciences, FDA, Strategic Planning, Business Development, Policy, GMP, Pharmaceutical Industry, Regulatory Requirements
Education
University of Florida 1994 — 2000
Ph.D., Molecular Biology, Genetics
Norman Marks Norman Marks's U.S. Food and Drug Administration Experience January 2000 - December 2014
Job former Medical Director/Advisor, MedWatch, experienced in medical product safety, surveillance, and risk communication
Industry Hospital & Health Care
Experience
Medical Product Safety, LLC January 2015 - Present
US Food and Drug Administration January 2000 - December 2014
U.S. Food and Drug Administration August 1998 - January 2000
Humana Group Health Plan Inc., Chicago March 1992 - November 1997
Lafayette Clinic Of Urology July 1977 - March 1992
Skills
Clinical Trials, Medicine, Healthcare, Clinical Research, Public Health, Clinical Development, Health Communication, Drug Safety, Medical Devices, dietary supplement and..., Medical Product Safety, Risk Management, Healthcare Management
Education
University of Michigan School of Public Health 1990 — 1992
Dr.P.H ('a.b.d', or 'all but dissertation'), Health Services Administration and Policy
University of Colorado Denver 1988 — 1990
Masters of Health Administration (M.H.A.), Medical Care Organization
University of Wisconsin-Madison 1967 — 1970
Doctor of Medicine (M.D.), UW School of Medicine and Public Health
University of Wisconsin-Madison 1963 — 1967
B. Medical Science
Medical Product Safety, LLC January 2015 - Present
US Food and Drug Administration January 2000 - December 2014
U.S. Food and Drug Administration August 1998 - January 2000
Humana Group Health Plan Inc., Chicago March 1992 - November 1997
Lafayette Clinic Of Urology July 1977 - March 1992
Skills
Clinical Trials, Medicine, Healthcare, Clinical Research, Public Health, Clinical Development, Health Communication, Drug Safety, Medical Devices, dietary supplement and..., Medical Product Safety, Risk Management, Healthcare Management
Education
University of Michigan School of Public Health 1990 — 1992
Dr.P.H ('a.b.d', or 'all but dissertation'), Health Services Administration and Policy
University of Colorado Denver 1988 — 1990
Masters of Health Administration (M.H.A.), Medical Care Organization
University of Wisconsin-Madison 1967 — 1970
Doctor of Medicine (M.D.), UW School of Medicine and Public Health
University of Wisconsin-Madison 1963 — 1967
B. Medical Science
Josephine Aimiuwu, PhD's U.S. Food and Drug Administration Experience 2009 - June 2013
Job Senior Technical Advisor at Management Sciences for Health
Industry Pharmaceuticals
Experience
Management Sciences for Health October 2014 - Present
Health Systems Strengthening
US Food and Drug Administration 2009 - June 2013
The Ohio State University 2005 - 2010
Skills
Pharmacokinetics, Clinical Trials, Clinical Development, Data Analysis, FDA, Drug Development, Pharmacology, Clinical Research, Science, Assay Development, Drug Discovery, Health sytstems..., Pharmacovigilance, Regulatory Affairs, Automated drug..., Global health, Public health
Education
The Ohio State University 2005 — 2010
Doctor of Philosophy (PhD), Pharmaceutics
The Ohio State University 2003 — 2005
Bachelor of Science, Pharmaceutical Sciences with Distinction and Honors
Management Sciences for Health October 2014 - Present
Health Systems Strengthening
US Food and Drug Administration 2009 - June 2013
The Ohio State University 2005 - 2010
Skills
Pharmacokinetics, Clinical Trials, Clinical Development, Data Analysis, FDA, Drug Development, Pharmacology, Clinical Research, Science, Assay Development, Drug Discovery, Health sytstems..., Pharmacovigilance, Regulatory Affairs, Automated drug..., Global health, Public health
Education
The Ohio State University 2005 — 2010
Doctor of Philosophy (PhD), Pharmaceutics
The Ohio State University 2003 — 2005
Bachelor of Science, Pharmaceutical Sciences with Distinction and Honors
Murad Melhem Murad Melhem's U.S. Food and Drug Administration Experience 2003 - 2003
Job Principal Scientist at Amgen
Industry Pharmaceuticals
Experience
Amgen December 2013 - Present
Institute for Clinical Pharmacodynamics February 2010 - December 2013
Eli Lilly & Company January 2008 - February 2010
Cognigen Corporation November 2004 - December 2008
US food and drug administration 2003 - 2003
Skills
Pharmacodynamics, Pharmacokinetics, Clinical Pharmacology, Oncology, Pharmacology, Translational Research, R&D, Pharmaceutical Research, R, Data Analysis, Modeling, Mathematical Modeling, Drug Development, Clinical Trials, Drug Metabolism, In Vivo, IND, Clinical Study Design, Biomarkers, Cancer, PK/PD, Translational Medicine, NONMEM, ADME
Education
University of Cincinnati 1999 — 2004
PhD, Pharmaceutical Sciences
Al-Jami'ah Al-Urdunia 1993 — 1998
BSc, Pharmacy
Amgen December 2013 - Present
Institute for Clinical Pharmacodynamics February 2010 - December 2013
Eli Lilly & Company January 2008 - February 2010
Cognigen Corporation November 2004 - December 2008
US food and drug administration 2003 - 2003
Skills
Pharmacodynamics, Pharmacokinetics, Clinical Pharmacology, Oncology, Pharmacology, Translational Research, R&D, Pharmaceutical Research, R, Data Analysis, Modeling, Mathematical Modeling, Drug Development, Clinical Trials, Drug Metabolism, In Vivo, IND, Clinical Study Design, Biomarkers, Cancer, PK/PD, Translational Medicine, NONMEM, ADME
Education
University of Cincinnati 1999 — 2004
PhD, Pharmaceutical Sciences
Al-Jami'ah Al-Urdunia 1993 — 1998
BSc, Pharmacy
Gerald L. Anderson's U.S. Food and Drug Administration Experience April 2005 - December 2009
Job President/Board Chair at Nathan L. Anderson Memorial Scholarship Foundation, Inc, and Owner/CEO of GRA Associates LLC
Industry Hospital & Health Care
Experience
Walden University 2013 - Present
GRA Associates LLC June 2010 - Present
Nathan L. Anderson Memorial Scholarship Foundation, Inc. June 2010 - Present
US Air Force Reserve October 1996 - October 2012
Washington Adventist University July 2010 - April 2011
US Food and Drug Administration April 2005 - December 2009
Federal Executive Institute 2007 - 2007
US Food and Drug Administration January 2001 - March 2005
US Food and Drug Administration April 1996 - December 2000
DHHS, Health Resources and Services Administration 1992 - 1996
Skills
Project Management..., Former Certified..., Planning, Strategic Planning, Administration, Military, Team Building, Operations Management, Program Management, Government, Defense, Problem Solving, Logistics, Government Liaison, Process Improvement, Teaching, Contract Management, Healthcare Management, Organizational..., Leadership Development, Leadership, Project Planning, Public Speaking, PowerPoint, Training, Nonprofits, Coaching, Organizational..., Healthcare, Management, Analysis, Business Planning, Security Clearance, DoD, Proposal Writing, Team Leadership, Change Management, Risk Management, Emergency Management, PMP, Project Management, Management Consulting, Budgets, Healthcare Information..., Staff Development, Military Operations, Medicare, Strategy, Executive Management, Cross-functional Team...
Education
University of Maryland University College
MGA, Health Care Management
University of Maryland University College
Bachelor of Science (B.S.), Information Technology
University of Maryland University College
Bachelor of Arts (B.A.), Business Administration, Management and Operations
Walden University
Walden University 2013 - Present
GRA Associates LLC June 2010 - Present
Nathan L. Anderson Memorial Scholarship Foundation, Inc. June 2010 - Present
US Air Force Reserve October 1996 - October 2012
Washington Adventist University July 2010 - April 2011
US Food and Drug Administration April 2005 - December 2009
Federal Executive Institute 2007 - 2007
US Food and Drug Administration January 2001 - March 2005
US Food and Drug Administration April 1996 - December 2000
DHHS, Health Resources and Services Administration 1992 - 1996
Skills
Project Management..., Former Certified..., Planning, Strategic Planning, Administration, Military, Team Building, Operations Management, Program Management, Government, Defense, Problem Solving, Logistics, Government Liaison, Process Improvement, Teaching, Contract Management, Healthcare Management, Organizational..., Leadership Development, Leadership, Project Planning, Public Speaking, PowerPoint, Training, Nonprofits, Coaching, Organizational..., Healthcare, Management, Analysis, Business Planning, Security Clearance, DoD, Proposal Writing, Team Leadership, Change Management, Risk Management, Emergency Management, PMP, Project Management, Management Consulting, Budgets, Healthcare Information..., Staff Development, Military Operations, Medicare, Strategy, Executive Management, Cross-functional Team...
Education
University of Maryland University College
MGA, Health Care Management
University of Maryland University College
Bachelor of Science (B.S.), Information Technology
University of Maryland University College
Bachelor of Arts (B.A.), Business Administration, Management and Operations
Walden University
Dr. Jethro Ekuta Dr. Jethro Ekuta's U.S. Food and Drug Administration Experience 1996 - 1998
Job Vice President and Head of Regulatory Affairs, North America at Johnson & Johnson Consumer Inc.
Industry Pharmaceuticals
Experience
Johnson & Johnson Consumer Inc. July 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2011 - July 2015
Genzyme April 2010 - September 2011
Bristol-Myers Squibb March 2007 - April 2010
Wyeth Pharmaceuticals July 2005 - March 2007
Pfizer Global Research & Development July 2001 - July 2005
Procter & Gamble Pharmaceuticals September 1998 - July 2001
US Food and Drug Administration 1996 - 1998
Meharry Medical College 1995 - 1996
Skills
Regulatory Affairs, Clinical Development, Regulatory Submissions, IND, Pharmacovigilance, FDA, Clinical Trials, Oncology, Pharmaceutical Industry, GCP, Drug Development, Clinical Pharmacology, 21 CFR Part 11, Drug Discovery, Medical Affairs, Epidemiology, Medical Writing, Drug Safety, Lifesciences, Pharmacology, Biopharmaceuticals, Biotechnology, Vaccines, CRO, Therapeutic Areas, CTMS, Toxicology, Biologics, Pharmaceutics, GLP, Immunology, Regulatory Requirements, Translational Medicine, Sop, Technology Transfer, SOP, Life Sciences
Education
ABU
DVM
University of Mississippi
Ph.D., Pharmacology and Toxicology
Johnson & Johnson Consumer Inc. July 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2011 - July 2015
Genzyme April 2010 - September 2011
Bristol-Myers Squibb March 2007 - April 2010
Wyeth Pharmaceuticals July 2005 - March 2007
Pfizer Global Research & Development July 2001 - July 2005
Procter & Gamble Pharmaceuticals September 1998 - July 2001
US Food and Drug Administration 1996 - 1998
Meharry Medical College 1995 - 1996
Skills
Regulatory Affairs, Clinical Development, Regulatory Submissions, IND, Pharmacovigilance, FDA, Clinical Trials, Oncology, Pharmaceutical Industry, GCP, Drug Development, Clinical Pharmacology, 21 CFR Part 11, Drug Discovery, Medical Affairs, Epidemiology, Medical Writing, Drug Safety, Lifesciences, Pharmacology, Biopharmaceuticals, Biotechnology, Vaccines, CRO, Therapeutic Areas, CTMS, Toxicology, Biologics, Pharmaceutics, GLP, Immunology, Regulatory Requirements, Translational Medicine, Sop, Technology Transfer, SOP, Life Sciences
Education
ABU
DVM
University of Mississippi
Ph.D., Pharmacology and Toxicology
Olugbenga O. Obasanjo Olugbenga O. Obasanjo's U.S. Food and Drug Administration Experience August 2009 - March 2011
Job District Health Director at Georgia Department of Public Health
Industry Health, Wellness and Fitness
Experience
Georgia Department of Public Health September 2013 - Present
Prince William County, Commonwealth of Virginia May 2011 - December 2012
University of Maryland School of Public Health July 2010 - December 2011
US Food and Drug Administration August 2009 - March 2011
Health AIDS Support Services June 2004 - July 2009
Wavecrest 2004 - 2007
Harvard School of Public Health January 2002 - December 2002
UTMB June 2001 - January 2002
The Alumni Advisory Council of the Johns Hopkins University January 1999 - January 2002
Johns Hopkins University Bloomberg School of Public Health Alumni Association January 1999 - January 2002
Skills
Epidemiology, Public Health, Infectious Diseases, Prevention, Health, Healthcare IT, Healthcare, Global Health, Research, Health Promotion, Healthcare Information..., Grant Writing
Education
The Johns Hopkins University - Carey Business School 2010 — 2013
MBA, Medical Services Management
The Johns Hopkins University 1996 — 1999
PhD, Epidemiology
The Johns Hopkins University 1995 — 1996
MPH, Epidemiology
University of Ibadan 1987 — 1994
MBBS, Medicine and Surgery
Kings College Lagos 1982 — 1988
Georgia Department of Public Health September 2013 - Present
Prince William County, Commonwealth of Virginia May 2011 - December 2012
University of Maryland School of Public Health July 2010 - December 2011
US Food and Drug Administration August 2009 - March 2011
Health AIDS Support Services June 2004 - July 2009
Wavecrest 2004 - 2007
Harvard School of Public Health January 2002 - December 2002
UTMB June 2001 - January 2002
The Alumni Advisory Council of the Johns Hopkins University January 1999 - January 2002
Johns Hopkins University Bloomberg School of Public Health Alumni Association January 1999 - January 2002
Skills
Epidemiology, Public Health, Infectious Diseases, Prevention, Health, Healthcare IT, Healthcare, Global Health, Research, Health Promotion, Healthcare Information..., Grant Writing
Education
The Johns Hopkins University - Carey Business School 2010 — 2013
MBA, Medical Services Management
The Johns Hopkins University 1996 — 1999
PhD, Epidemiology
The Johns Hopkins University 1995 — 1996
MPH, Epidemiology
University of Ibadan 1987 — 1994
MBBS, Medicine and Surgery
Kings College Lagos 1982 — 1988
Steve Musser Steve Musser's U.S. Food and Drug Administration Experience March 2013 - Present
Job Deputy Center Director Scientific Operations
Industry Food & Beverages
Experience
US Food and Drug Administration March 2013 - Present
Education
University of Maryland Baltimore 1985 — 1989
Ph.D., Medicinal Chemistry
US Food and Drug Administration March 2013 - Present
Education
University of Maryland Baltimore 1985 — 1989
Ph.D., Medicinal Chemistry
Abraham Hartzema Abraham Hartzema's U.S. Food and Drug Administration Experience September 2007 - September 2008
Job Professor at University of Florida
Industry Higher Education
Experience
University of Florida January 2000 - Present
US Food and Drug Administration September 2007 - September 2008
Skills
Outcomes Research, Clinical Trials, Epidemiology, Clinical Research, Biostatistics, Clinical Development, Pharmacovigilance, Pharmaceutical Industry, GCP, Pharmacology, Clinical Pharmacology, Lifesciences, Neuroscience, Life Sciences, Medical Writing
Education
University of Minnesota-Twin Cities 1978 — 1981
PhD, Social and Administrative Pharmacy
University of Florida January 2000 - Present
US Food and Drug Administration September 2007 - September 2008
Skills
Outcomes Research, Clinical Trials, Epidemiology, Clinical Research, Biostatistics, Clinical Development, Pharmacovigilance, Pharmaceutical Industry, GCP, Pharmacology, Clinical Pharmacology, Lifesciences, Neuroscience, Life Sciences, Medical Writing
Education
University of Minnesota-Twin Cities 1978 — 1981
PhD, Social and Administrative Pharmacy
Robin Crisp Robin Crisp's U.S. Food and Drug Administration Experience August 2002 - October 2014
Job Director Portfolio and Analysis Division at U.S. Department of Energy
Industry Government Administration
Experience
U.S. Department of Energy October 2014 - Present
US Food and Drug Administration August 2002 - October 2014
ESN Inc 2001 - 2002
Dominion Resources Services 1999 - 2001
Stanley Associates 1996 - 1999
Skills
COTR, Federal Government, DoD, PMP, Project Management, Government Contracting, FDA, Policy Analysis, Government, SDLC, Business Process..., Scrum, FISMA, CRM, Policy, PMO, Information Security..., Regulatory Affairs, Security Clearance, Program Management, Public Policy, Earned Value Management, Computer Security, Quality Assurance, Enterprise Architecture
Education
Bath University 1982 — 1986
BS, Biochemistry
Ryeish Green School 1978 — 1982
U.S. Department of Energy October 2014 - Present
US Food and Drug Administration August 2002 - October 2014
ESN Inc 2001 - 2002
Dominion Resources Services 1999 - 2001
Stanley Associates 1996 - 1999
Skills
COTR, Federal Government, DoD, PMP, Project Management, Government Contracting, FDA, Policy Analysis, Government, SDLC, Business Process..., Scrum, FISMA, CRM, Policy, PMO, Information Security..., Regulatory Affairs, Security Clearance, Program Management, Public Policy, Earned Value Management, Computer Security, Quality Assurance, Enterprise Architecture
Education
Bath University 1982 — 1986
BS, Biochemistry
Ryeish Green School 1978 — 1982
James L Weaver James L Weaver's U.S. Food and Drug Administration Experience August 1989 - Present
Job Immunotoxicologist at US Food and Drug Administration
Industry Research
Experience
US Food and Drug Administration August 1989 - Present
Skills
Lifesciences, Toxicology, Animal Models, In Vivo, Pharmacology, IND, Drug Development, Immunology, Cell Culture, Pharmacokinetics, Life Sciences, Pharmaceutical Industry, In Vitro, Clinical Development, Drug Discovery
Education
University of Louisville 1982 — 1987
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
University of Vermont 1975 — 1977
Master of Arts (M.A.), Zoology/Animal Biology
University of Vermont 1971 — 1975
Bachelor of Arts (B.A.), Zoology/Animal Biology
US Food and Drug Administration August 1989 - Present
Skills
Lifesciences, Toxicology, Animal Models, In Vivo, Pharmacology, IND, Drug Development, Immunology, Cell Culture, Pharmacokinetics, Life Sciences, Pharmaceutical Industry, In Vitro, Clinical Development, Drug Discovery
Education
University of Louisville 1982 — 1987
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
University of Vermont 1975 — 1977
Master of Arts (M.A.), Zoology/Animal Biology
University of Vermont 1971 — 1975
Bachelor of Arts (B.A.), Zoology/Animal Biology
Paul Vogel Paul Vogel's U.S. Food and Drug Administration Experience July 1991 - November 1993
Job Chairman of the Board, and Chief Executive Officer at Lachman Consultant Services Inc.
Industry Pharmaceuticals
Experience
Lachman Consultant Services Inc. July 2014 - Present
Lachman Consultant Services Inc. July 2011 - Present
Lachman Consultant Services Inc November 1993 - December 2007
U.S. Food and Drug Administration July 1991 - November 1993
US Food and Drug Administration 1993 - 1993
US Food and Drug Administration January 1991 - July 1991
U.S. Food and Drug Administration February 1988 - January 1991
US Food and Drug Administration August 1980 - February 1988
U.S. Food and Drug Administration (FDA) August 1972 - June 1976
Skills
Biotechnology, GxP, Quality System, Clinical Research, Medical Devices, Laboratory, Supplements, Change Control, Analytical Chemistry, CAPA, Start-ups, Aseptic Processing, CRO, Pharmacovigilance, Biopharmaceuticals, FDA, HPLC, ISO 13485, Testing, Chemistry, Validation, Quality Control, Computer System..., Regulatory Submissions, Regulatory Requirements, GLP, Oncology, Drug Delivery, Lifesciences, Vaccines, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, R&D, V&V, Microbiology, Quality Assurance, GMP, Technology Transfer, Commercialization, GCP, Drug Development, CTMS, Sop, Pharmaceutics, Quality Auditing, Program Management, Manufacturing, Drug Discovery, Clinical Development
Education
Towson University 1969 — 1972
BS, Biological Sciences
Lachman Consultant Services Inc. July 2014 - Present
Lachman Consultant Services Inc. July 2011 - Present
Lachman Consultant Services Inc November 1993 - December 2007
U.S. Food and Drug Administration July 1991 - November 1993
US Food and Drug Administration 1993 - 1993
US Food and Drug Administration January 1991 - July 1991
U.S. Food and Drug Administration February 1988 - January 1991
US Food and Drug Administration August 1980 - February 1988
U.S. Food and Drug Administration (FDA) August 1972 - June 1976
Skills
Biotechnology, GxP, Quality System, Clinical Research, Medical Devices, Laboratory, Supplements, Change Control, Analytical Chemistry, CAPA, Start-ups, Aseptic Processing, CRO, Pharmacovigilance, Biopharmaceuticals, FDA, HPLC, ISO 13485, Testing, Chemistry, Validation, Quality Control, Computer System..., Regulatory Submissions, Regulatory Requirements, GLP, Oncology, Drug Delivery, Lifesciences, Vaccines, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, R&D, V&V, Microbiology, Quality Assurance, GMP, Technology Transfer, Commercialization, GCP, Drug Development, CTMS, Sop, Pharmaceutics, Quality Auditing, Program Management, Manufacturing, Drug Discovery, Clinical Development
Education
Towson University 1969 — 1972
BS, Biological Sciences
Rydell Castille's U.S. Food and Drug Administration Experience December 2009 - Present
Job Global Health Specialist at U.S Food and Drug Administration
Industry
Experience
U.S Food and Drug Administration December 2009 - Present
Centers for Medicare and Medicaid Services May 2001 - December 2009
Skills
Regulatory Affairs, Microsoft Office, Active Directory, Healthcare Information..., Policy, Program Management, Public Policy, Training
Education
St. Thomas More High School
University of Louisiana at Lafayette
U.S Food and Drug Administration December 2009 - Present
Centers for Medicare and Medicaid Services May 2001 - December 2009
Skills
Regulatory Affairs, Microsoft Office, Active Directory, Healthcare Information..., Policy, Program Management, Public Policy, Training
Education
St. Thomas More High School
University of Louisiana at Lafayette
Mara Kreishman-Deitrick Mara Kreishman-Deitrick's U.S. Food and Drug Administration Experience August 2013 - Present
Job Experimental Therapeutics, WRAIR
Industry Military
Experience
Experimental Therapeutics Branch, Military Malaria Research Program, WRAIR September 2014 - Present
US Food and Drug Administration August 2013 - Present
US Army Medical Materiel Development Activity December 2008 - Present
Skills
Product Management, Cross-functional Team..., Product Development, Product Marketing, Program Management, Project Management, Product Lifecycle..., Team Leadership, Management, Competitive Analysis, Strategic Planning, Strategy, Telecommunications, Leadership, Drug Development, Clinical Trials, Government Contracting, Partnerships, Army, International Project..., Regulatory Strategy...
Education
Univeristy of Texas Southwestern Medical Center at Dallas
Doctor of Philosophy (PhD), Biological Chemistry
University of Cincinnati
Bachelor of Science (BS), Biochemistry
Experimental Therapeutics Branch, Military Malaria Research Program, WRAIR September 2014 - Present
US Food and Drug Administration August 2013 - Present
US Army Medical Materiel Development Activity December 2008 - Present
Skills
Product Management, Cross-functional Team..., Product Development, Product Marketing, Program Management, Project Management, Product Lifecycle..., Team Leadership, Management, Competitive Analysis, Strategic Planning, Strategy, Telecommunications, Leadership, Drug Development, Clinical Trials, Government Contracting, Partnerships, Army, International Project..., Regulatory Strategy...
Education
Univeristy of Texas Southwestern Medical Center at Dallas
Doctor of Philosophy (PhD), Biological Chemistry
University of Cincinnati
Bachelor of Science (BS), Biochemistry
Nabila Parvez Nabila Parvez's U.S. Food and Drug Administration Experience June 2011 - December 2014
Job Coop Coordinator at Hackers / Founders
Industry Internet
Experience
Hackers / Founders July 2015 - Present
Hackers / Founders February 2015 - July 2015
Pan American Health Organization November 2014 - February 2015
US Food and Drug Administration June 2011 - December 2014
UC Berkeley Residence Hall Assembly (RHA) August 2013 - May 2014
Peer Health Exchange September 2011 - May 2014
Skills
Early-stage Startups, Project Management, Data Analysis, Streamlining..., Critical Thinking, Public Health, Policy Research, Field Work, Daily Operations..., Curriculum Innovation, Non-profit Leadership, Student Recruiting, Collaborative Problem..., Event Planning, Health Education, Microsoft Excel, Microsoft Word, Public Speaking, Microsoft Office, Leadership, Community Outreach, Teaching, PowerPoint, Social Media, Editing, Fundraising, Volunteer Management
Education
University of California, Berkeley 2010 — 2014
Bachelor of Science (B.S.), Public Health
Hackers / Founders July 2015 - Present
Hackers / Founders February 2015 - July 2015
Pan American Health Organization November 2014 - February 2015
US Food and Drug Administration June 2011 - December 2014
UC Berkeley Residence Hall Assembly (RHA) August 2013 - May 2014
Peer Health Exchange September 2011 - May 2014
Skills
Early-stage Startups, Project Management, Data Analysis, Streamlining..., Critical Thinking, Public Health, Policy Research, Field Work, Daily Operations..., Curriculum Innovation, Non-profit Leadership, Student Recruiting, Collaborative Problem..., Event Planning, Health Education, Microsoft Excel, Microsoft Word, Public Speaking, Microsoft Office, Leadership, Community Outreach, Teaching, PowerPoint, Social Media, Editing, Fundraising, Volunteer Management
Education
University of California, Berkeley 2010 — 2014
Bachelor of Science (B.S.), Public Health
Philip Coyne Philip Coyne's U.S. Food and Drug Administration Experience July 1991 - May 1998
Job Adjunct Professor, Global Health at University of Notre Dame
Industry Medical Practice
Experience
Uniformed Services University of the Health Sciences May 2014 - Present
University of Notre Dame May 2014 - Present
US Navy September 1997 - June 2014
US Public Health Service/NIH/NIAID November 2012 - May 2014
USUHS June 2008 - October 2012
National Institutes of Health November 2003 - July 2008
Medicines for Malaria Venture 2003 - 2008
Walter Reed Army Institute of Research, Silver Spring, Maryland 2001 - 2003
The World Bank May 1998 - April 2001
US Food and Drug Administration July 1991 - May 1998
Skills
Public Health, Clinical Research, Global Health, Clinical Trials, Malaria, Healthcare, Medicine, Clinical Development, Teaching, Medical Education, Medical Research, Internal Medicine, Healthcare Management, Biotechnology, Biostatistics, Health Policy, Program Evaluation, Drug Development, Policy, Virology, Microbiology, Prevention, Hospitals, GCP, Treatment
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1981 — 1985
MD, Medicine, Infectious Diseases
University of North Carolina at Chapel Hill 1979 — 1981
MSPH, Parasitology
University of Notre Dame 1972 — 1976
BS, Biology
Windsor High School 1969 — 1972
Uniformed Services University of the Health Sciences May 2014 - Present
University of Notre Dame May 2014 - Present
US Navy September 1997 - June 2014
US Public Health Service/NIH/NIAID November 2012 - May 2014
USUHS June 2008 - October 2012
National Institutes of Health November 2003 - July 2008
Medicines for Malaria Venture 2003 - 2008
Walter Reed Army Institute of Research, Silver Spring, Maryland 2001 - 2003
The World Bank May 1998 - April 2001
US Food and Drug Administration July 1991 - May 1998
Skills
Public Health, Clinical Research, Global Health, Clinical Trials, Malaria, Healthcare, Medicine, Clinical Development, Teaching, Medical Education, Medical Research, Internal Medicine, Healthcare Management, Biotechnology, Biostatistics, Health Policy, Program Evaluation, Drug Development, Policy, Virology, Microbiology, Prevention, Hospitals, GCP, Treatment
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1981 — 1985
MD, Medicine, Infectious Diseases
University of North Carolina at Chapel Hill 1979 — 1981
MSPH, Parasitology
University of Notre Dame 1972 — 1976
BS, Biology
Windsor High School 1969 — 1972
Anh Lac Anh Lac's U.S. Food and Drug Administration Experience March 2009 - Present
Job Consumer Safety OfficerInvestigator at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration March 2009 - Present
Walmart 2005 - 2009
Skills
Federal Law and..., regulatory inspections..., Food and Cosmetic..., Drug Manufacturing, Team Leadership, Microsoft Office, Report Writing, Clinical Research, Auditing, FDA, GMP, Policy, Research, Technical Writing, Government, Public Health, Data Analysis, Healthcare, Regulations
Education
The University of Texas at Arlington 2003 — 2007
Bachelor of Science (BS), Biology, General
US Food and Drug Administration March 2009 - Present
Walmart 2005 - 2009
Skills
Federal Law and..., regulatory inspections..., Food and Cosmetic..., Drug Manufacturing, Team Leadership, Microsoft Office, Report Writing, Clinical Research, Auditing, FDA, GMP, Policy, Research, Technical Writing, Government, Public Health, Data Analysis, Healthcare, Regulations
Education
The University of Texas at Arlington 2003 — 2007
Bachelor of Science (BS), Biology, General
Hui Wen Ng Hui Wen Ng's U.S. Food and Drug Administration Experience September 2013 - Present
Job Postdoctoral Research Fellow at FDA
Industry Government Administration
Experience
University of Arkansas for Medical Sciences August 2014 - Present
US Food and Drug Administration September 2013 - Present
University of Nottingham October 2009 - September 2013
Trustz Pharmacy November 2009 - August 2013
Pfizer January 2009 - July 2009
Alliance Boots July 2008 - January 2009
The Co-operative Group August 2007 - October 2007
Derby Hospitals NHS Foundation Trust July 2007 - July 2007
Skills
Computational Chemistry, Molecular Dynamics, Drug Design, Pharmacists, Principal Component..., Homology Modelling, Docking, GPCRs, Homology Modeling, Pharmacology, Protein Chemistry, Molecular Modeling, Pharmaceutics, Chemistry, Drug Discovery, Life Sciences, Medicinal Chemistry
Education
University of Arkansas for Medical Sciences 2014 — 2015
Graduate Certificate in Regulatory Sciences
MedDRA Training
Pharmacovigilance (Online Training)
Astra Nova UK
Regulatory Affairs 101 by American Association of Pharmaceutical Scientists
University of Nottingham 2009 — 2013
PhD
University of Nottingham 2004 — 2008
MPharm
Sunway College 2002 — 2004
Cambridge A Levels
University of Arkansas for Medical Sciences August 2014 - Present
US Food and Drug Administration September 2013 - Present
University of Nottingham October 2009 - September 2013
Trustz Pharmacy November 2009 - August 2013
Pfizer January 2009 - July 2009
Alliance Boots July 2008 - January 2009
The Co-operative Group August 2007 - October 2007
Derby Hospitals NHS Foundation Trust July 2007 - July 2007
Skills
Computational Chemistry, Molecular Dynamics, Drug Design, Pharmacists, Principal Component..., Homology Modelling, Docking, GPCRs, Homology Modeling, Pharmacology, Protein Chemistry, Molecular Modeling, Pharmaceutics, Chemistry, Drug Discovery, Life Sciences, Medicinal Chemistry
Education
University of Arkansas for Medical Sciences 2014 — 2015
Graduate Certificate in Regulatory Sciences
MedDRA Training
Pharmacovigilance (Online Training)
Astra Nova UK
Regulatory Affairs 101 by American Association of Pharmaceutical Scientists
University of Nottingham 2009 — 2013
PhD
University of Nottingham 2004 — 2008
MPharm
Sunway College 2002 — 2004
Cambridge A Levels
C. Brent Steinmiller C. Brent Steinmiller's U.S. Food and Drug Administration Experience December 2010 - Present
Job at US Food and Drug Administration
Industry Hospital & Health Care
Experience
US Food and Drug Administration December 2010 - Present
Skills
Food, Nutrition, Healthcare, Research, Data Analysis, PowerPoint, Microsoft Office, Quality Assurance, Microsoft Excel, HACCP, Policy, Training, Customer Service, Public Health, Management, Team Building, Health Communication, Strategic Planning, Environmental Health, Prevention, Health Education, Global Health, International Health, Health Promotion, Food Microbiology, Infectious Diseases, Community Health, Public Health Education, Health Equity, Public Health Emergency..., Health Policy
Education
University of Central Arkansas 2007 — 2009
Masters work towards degree, Dietetics
University of Central Arkansas 2003 — 2007
Bachelor of Science, Dietetics and Nutrition2007
US AIR FORCE TECHNICAL SCHOOL 2001 — 2001
hospitality
US Food and Drug Administration December 2010 - Present
Skills
Food, Nutrition, Healthcare, Research, Data Analysis, PowerPoint, Microsoft Office, Quality Assurance, Microsoft Excel, HACCP, Policy, Training, Customer Service, Public Health, Management, Team Building, Health Communication, Strategic Planning, Environmental Health, Prevention, Health Education, Global Health, International Health, Health Promotion, Food Microbiology, Infectious Diseases, Community Health, Public Health Education, Health Equity, Public Health Emergency..., Health Policy
Education
University of Central Arkansas 2007 — 2009
Masters work towards degree, Dietetics
University of Central Arkansas 2003 — 2007
Bachelor of Science, Dietetics and Nutrition2007
US AIR FORCE TECHNICAL SCHOOL 2001 — 2001
hospitality
Andrew Livermore Andrew Livermore's U.S. Food and Drug Administration Experience March 1986 - December 2001
Job Business Development Director at eGlobalTech
Industry Information Technology and Services
Experience
eGlobalTech July 2013 - Present
B3 Solutions July 2011 - July 2013
QinetiQ North America September 2008 - July 2011
USPTO June 2007 - September 2008
US Department of Homeland Security September 2006 - June 2007
US Department of Homeland Security March 2003 - September 2006
Immigration and Natralization Service December 2001 - March 2003
US Food and Drug Administration March 1986 - December 2001
FDA - CFSAN 1986 - 2001
Skills
Government, Federal Government, VMware, Information Assurance, Program Management, Government Contracting, DoD, Risk Assessment, Security Clearance, Enterprise Architecture, Proposal Writing, Analysis, Security, Information Security, Earned Value Management, Policy, Requirements Analysis, Competitive Analysis, Systems Engineering, Contract Management, Enterprise Software, Management, Military, Leadership, Business Development, Defense, Computer Security, Process Improvement, Training, Emergency Management, PMP, Project Management, CISSP, Integration, Strategy, IT Operations, Information Technology, Government Procurement, Networking, Vulnerability Assessment, Software Development, Executive Management, Strategic Planning, FAR, Management Consulting, Homeland Security, Intelligence Analysis, Business Process..., Mergers & Acquisitions, New Business Development
Education
University of Maryland College Park 1988 — 1991
Bachelor of Science (BS), Conputer Science
eGlobalTech July 2013 - Present
B3 Solutions July 2011 - July 2013
QinetiQ North America September 2008 - July 2011
USPTO June 2007 - September 2008
US Department of Homeland Security September 2006 - June 2007
US Department of Homeland Security March 2003 - September 2006
Immigration and Natralization Service December 2001 - March 2003
US Food and Drug Administration March 1986 - December 2001
FDA - CFSAN 1986 - 2001
Skills
Government, Federal Government, VMware, Information Assurance, Program Management, Government Contracting, DoD, Risk Assessment, Security Clearance, Enterprise Architecture, Proposal Writing, Analysis, Security, Information Security, Earned Value Management, Policy, Requirements Analysis, Competitive Analysis, Systems Engineering, Contract Management, Enterprise Software, Management, Military, Leadership, Business Development, Defense, Computer Security, Process Improvement, Training, Emergency Management, PMP, Project Management, CISSP, Integration, Strategy, IT Operations, Information Technology, Government Procurement, Networking, Vulnerability Assessment, Software Development, Executive Management, Strategic Planning, FAR, Management Consulting, Homeland Security, Intelligence Analysis, Business Process..., Mergers & Acquisitions, New Business Development
Education
University of Maryland College Park 1988 — 1991
Bachelor of Science (BS), Conputer Science
Ivan A. Ross Ivan A. Ross's U.S. Food and Drug Administration Experience May 1987 - March 2013
Job Biologist/Author
Industry Research
Experience
Home April 2013 - Present
US Food and Drug Administration May 1987 - March 2013
Springer Science+Business Media November 1998 - December 2005
Skills
Content Management, Books, Web Content, Publishing, Editing, International..., Health Education in..., Proposal Writing, Creative Writing, Technical Writing, Copy Editing, Research, Social Media, Public Relations, Blogging, Nonprofits, Proofreading, Publications, Program Development, Public Speaking, Writing
Education
Tuskegee University, Alabama, USA 1971 — 1973
International Agriculture
University of Maryland College Park 1981 — 1987
Animal Sciences, Biochemistry
Home April 2013 - Present
US Food and Drug Administration May 1987 - March 2013
Springer Science+Business Media November 1998 - December 2005
Skills
Content Management, Books, Web Content, Publishing, Editing, International..., Health Education in..., Proposal Writing, Creative Writing, Technical Writing, Copy Editing, Research, Social Media, Public Relations, Blogging, Nonprofits, Proofreading, Publications, Program Development, Public Speaking, Writing
Education
Tuskegee University, Alabama, USA 1971 — 1973
International Agriculture
University of Maryland College Park 1981 — 1987
Animal Sciences, Biochemistry
William Nychis William Nychis's U.S. Food and Drug Administration Experience July 1972 - December 2011
Job Senior Regulatory Advisor at FDAImports.com, LLC
Industry Import and Export
Experience
FDAImports.com, LLC January 2013 - Present
U.S Food and Drug Administration July 1972 - December 2011
Skills
Courts, Regulatory Affairs, International Relations, Government, Policy, Regulatory Submissions, GMP, Pharmaceutical Industry, Regulatory Requirements, Program Management, FDA, Regulations, Microsoft Office, Biotechnology, Civil Litigation, Sop, Quality Auditing
Education
University of Pittsburgh 1967 — 1972
B.S. in Chemistry and Microbiology, Graduate work in Chemistry, 3
University of Pittsburgh 1967 — 1972
Chemistry and Microbiology
FDAImports.com, LLC January 2013 - Present
U.S Food and Drug Administration July 1972 - December 2011
Skills
Courts, Regulatory Affairs, International Relations, Government, Policy, Regulatory Submissions, GMP, Pharmaceutical Industry, Regulatory Requirements, Program Management, FDA, Regulations, Microsoft Office, Biotechnology, Civil Litigation, Sop, Quality Auditing
Education
University of Pittsburgh 1967 — 1972
B.S. in Chemistry and Microbiology, Graduate work in Chemistry, 3
University of Pittsburgh 1967 — 1972
Chemistry and Microbiology
Jennifer Sharp's U.S. Food and Drug Administration Experience February 1991 - May 1996
Job
Industry Design
Experience
Public Broadcasting Service March 2012 - Present
NPR February 2008 - February 2012
Orbitz January 2005 - July 2007
Spring Group October 2001 - April 2002
Xplore November 1999 - June 2001
ZEFER November 1996 - November 1999
US Food and Drug Administration February 1991 - May 1996
Skills
Branding, Team Management, Art Direction, Interaction Design, Leadership, User Experience, Information Architecture, User Interface, Experience Design, Graphic Design, User Interface Design, User-centered Design, Wireframes, User Experience Design, User Research
Education
University of Michigan 1986 — 1990
BFA
Public Broadcasting Service March 2012 - Present
NPR February 2008 - February 2012
Orbitz January 2005 - July 2007
Spring Group October 2001 - April 2002
Xplore November 1999 - June 2001
ZEFER November 1996 - November 1999
US Food and Drug Administration February 1991 - May 1996
Skills
Branding, Team Management, Art Direction, Interaction Design, Leadership, User Experience, Information Architecture, User Interface, Experience Design, Graphic Design, User Interface Design, User-centered Design, Wireframes, User Experience Design, User Research
Education
University of Michigan 1986 — 1990
BFA
Anthony Watson's U.S. Food and Drug Administration Experience November 2009 - May 2013
Job Director, Regulatory Affairs, Combination Products, Biogen, Inc.
Industry Biotechnology
Experience
Biogen Idec, Inc. June 2013 - Present
US Food and Drug Administration November 2009 - May 2013
FDA March 2004 - November 2009
FDA June 1994 - March 2004
United States Navy May 1990 - March 1994
Skills
FDA, Medical Devices, Regulatory Affairs, Policy, Government, Biotechnology, Clinical Trials, Lifesciences, Pharmaceutical Industry, Program Management, Public Health, Regulatory Submissions, Clinical Research, Quality Assurance, Process Improvement, Cross-functional Team..., Data Analysis, Regulatory Requirements, Regulations, Navy, Biopharmaceuticals, Biomedical Engineering, Strategic Planning
Education
University of Maryland University College 2004 — 2005
MBA, Business
University of Maryland University College 1999 — 2004
MS, Management Information Systems
United States Naval Academy 1986 — 1990
BS, General Engineering
Biogen Idec, Inc. June 2013 - Present
US Food and Drug Administration November 2009 - May 2013
FDA March 2004 - November 2009
FDA June 1994 - March 2004
United States Navy May 1990 - March 1994
Skills
FDA, Medical Devices, Regulatory Affairs, Policy, Government, Biotechnology, Clinical Trials, Lifesciences, Pharmaceutical Industry, Program Management, Public Health, Regulatory Submissions, Clinical Research, Quality Assurance, Process Improvement, Cross-functional Team..., Data Analysis, Regulatory Requirements, Regulations, Navy, Biopharmaceuticals, Biomedical Engineering, Strategic Planning
Education
University of Maryland University College 2004 — 2005
MBA, Business
University of Maryland University College 1999 — 2004
MS, Management Information Systems
United States Naval Academy 1986 — 1990
BS, General Engineering
Howard Webley's U.S. Food and Drug Administration Experience August 2000 - October 2007
Job Consumer Safety Officer/Investigator at FDA
Industry Food Production
Experience
FDA October 2007 - Present
US Food and Drug Administration August 2000 - October 2007
Skills
Food Microbiology, Microbiology, Food Safety, Environmental Monitoring, GMP, Food Science, FDA, GLP, PCR, HACCP, Bacterial Culture, Regulatory Affairs, ELISA, Aseptic Technique
Education
University of Massachusetts, Amherst 1997 — 2000
Bachelor of Science (BS), Microbiology, General
FDA October 2007 - Present
US Food and Drug Administration August 2000 - October 2007
Skills
Food Microbiology, Microbiology, Food Safety, Environmental Monitoring, GMP, Food Science, FDA, GLP, PCR, HACCP, Bacterial Culture, Regulatory Affairs, ELISA, Aseptic Technique
Education
University of Massachusetts, Amherst 1997 — 2000
Bachelor of Science (BS), Microbiology, General
Wendy Johnecheck's U.S. Food and Drug Administration Experience May 2010 - Present
Job Consumer Safety Officer at US Food and Drug Administration
Industry Government Relations
Experience
US Food and Drug Administration May 2010 - Present
Education
Tufts University
Phd, Food Policy and Economics
US Food and Drug Administration May 2010 - Present
Education
Tufts University
Phd, Food Policy and Economics
Shirley Murphy's U.S. Food and Drug Administration Experience 2002 - 2007
Job Physician, Pharmaceutical consultant, and Ukulele player
Industry Medical Practice
Experience
UNM Health Sciences Center March 2011 - Present
self-employed 2008 - Present
University of New Mexico School of Medicine January 1998 - Present
Food and Drug Administration 2005 - 2007
US Food and Drug Administration 2002 - 2007
GSK 1998 - 2002
Education
University of Kansas Medical Center 1966 — 1970
UNM Health Sciences Center March 2011 - Present
self-employed 2008 - Present
University of New Mexico School of Medicine January 1998 - Present
Food and Drug Administration 2005 - 2007
US Food and Drug Administration 2002 - 2007
GSK 1998 - 2002
Education
University of Kansas Medical Center 1966 — 1970
Hang Xie's U.S. Food and Drug Administration Experience May 2011 - Present
Job Immunologist at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration May 2011 - Present
US Food and Drug Administration July 2006 - May 2011
NIDCD/NIH September 2005 - July 2006
Education
University of Arkansas 1998 — 2001
Ph.D., Immunology
University of Arkansas 1996 — 1998
M.S., Immunology
US Food and Drug Administration May 2011 - Present
US Food and Drug Administration July 2006 - May 2011
NIDCD/NIH September 2005 - July 2006
Education
University of Arkansas 1998 — 2001
Ph.D., Immunology
University of Arkansas 1996 — 1998
M.S., Immunology
Robert Shibuya's U.S. Food and Drug Administration Experience March 2011 - October 2011
Job Medical Director at Biogen Idec
Industry Government Administration
Experience
Biogen Idec July 2014 - Present
Cubist Pharmaceuticals September 2012 - July 2014
US Food & Drug Administration October 2011 - September 2012
US Food and Drug Administration March 2011 - October 2011
US Food & Drug Administration May 2008 - March 2011
US Food & Drug Administration October 2004 - May 2008
US Food & Drug Administration January 2002 - October 2004
US Food & Drug Administration September 2000 - January 2002
ISTA Pharmaceuticals April 1997 - May 2000
Metrika Laboratories June 1996 - April 1997
Skills
Clinical Development, Pain/Analgesia, Regulatory Affairs, Good Clinical Practice, REMS, Drug Safety, Pharmacokinetics, Infectious Diseases, FDA, CRO, Pharmacology, IND, Life Sciences, Protocol, Oncology, Clinical Trials, Drug Development, Clinical Research, Biotechnology
Education
Washington University in St. Louis School of Medicine 1988 — 1992
M.D.
University of California, Berkeley 1983 — 1987
AB, Physiology
Biogen Idec July 2014 - Present
Cubist Pharmaceuticals September 2012 - July 2014
US Food & Drug Administration October 2011 - September 2012
US Food and Drug Administration March 2011 - October 2011
US Food & Drug Administration May 2008 - March 2011
US Food & Drug Administration October 2004 - May 2008
US Food & Drug Administration January 2002 - October 2004
US Food & Drug Administration September 2000 - January 2002
ISTA Pharmaceuticals April 1997 - May 2000
Metrika Laboratories June 1996 - April 1997
Skills
Clinical Development, Pain/Analgesia, Regulatory Affairs, Good Clinical Practice, REMS, Drug Safety, Pharmacokinetics, Infectious Diseases, FDA, CRO, Pharmacology, IND, Life Sciences, Protocol, Oncology, Clinical Trials, Drug Development, Clinical Research, Biotechnology
Education
Washington University in St. Louis School of Medicine 1988 — 1992
M.D.
University of California, Berkeley 1983 — 1987
AB, Physiology
Noel Ellis's U.S. Food and Drug Administration Experience February 2009 - Present
Job Reviewer at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration February 2009 - Present
University of Pennsylvania Dept. of Chemistry 2004 - 2009
Education
University of Pennsylvania 2004 — 2009
PhD, Organic Synthesis/ methods development
University of California, Santa Barbara 1999 — 2003
B.S, Biochemistry
US Food and Drug Administration February 2009 - Present
University of Pennsylvania Dept. of Chemistry 2004 - 2009
Education
University of Pennsylvania 2004 — 2009
PhD, Organic Synthesis/ methods development
University of California, Santa Barbara 1999 — 2003
B.S, Biochemistry
Nora York's U.S. Food and Drug Administration Experience 1988 - 1993
Job VP, Global Regulatory Affairs at DJO, LLC
Industry Medical Devices
Experience
DJO, LLC Regulatory Affairs ManagerACON LaboratoriesSeptember 1999 - February 2001
MarDx Diagnostics 1993 - 1999
US Food and Drug Administration 1988 - 1993
Education
The University of Texas at Dallas
BS, Biology (Molecular)
DJO, LLC Regulatory Affairs ManagerACON LaboratoriesSeptember 1999 - February 2001
MarDx Diagnostics 1993 - 1999
US Food and Drug Administration 1988 - 1993
Education
The University of Texas at Dallas
BS, Biology (Molecular)
Fred Fry's U.S. Food and Drug Administration Experience January 1980 - Present
Job Chemist at US Food and Drug Administration
Industry Food & Beverages
Experience
US Food and Drug Administration January 1980 - Present
FDA 1980 - Present
Skills
Pattern Recognition, Analytical Chemistry, Chemistry, FDA, Science, Chromatography, UV/Vis, LC-MS, Organic Chemistry, HPLC, NMR, Mass Spectrometry, IR, Spectroscopy, Biochemistry, GC-MS
Education
University of Illinois at Urbana-Champaign 1967 — 1974
PhD, Chemistry
US Food and Drug Administration January 1980 - Present
FDA 1980 - Present
Skills
Pattern Recognition, Analytical Chemistry, Chemistry, FDA, Science, Chromatography, UV/Vis, LC-MS, Organic Chemistry, HPLC, NMR, Mass Spectrometry, IR, Spectroscopy, Biochemistry, GC-MS
Education
University of Illinois at Urbana-Champaign 1967 — 1974
PhD, Chemistry
James M. Engles, MS, MBA's U.S. Food and Drug Administration Experience January 2010 - January 2011
Job Senior Research Program Manager at Johns Hopkins University
Industry Research
Experience
Johns Hopkins University School of Medicine February 2011 - Present
US Food and Drug Administration January 2010 - January 2011
Johns Hopkins University December 1999 - January 2010
US Navy 1985 - 1991
US Navy 1985 - 1986
Skills
Molecular Biology, Biotechnology, Life Sciences, DNA, Genomics, Spectroscopy, Clinical Research, Cancer, Clinical Trials, Science, Research, Data Analysis, Oncology, Cell Culture, PCR, Grant Writing, Western Blotting, Technical Writing, ELISA, IRB, Gel Electrophoresis, Protein Purification, Teaching, Tissue Culture, Cell Biology, Genetics
Education
The Johns Hopkins University - Carey Business School 2005 — 2008
MBA, Business Administration
The Johns Hopkins University- Zanvyl-Krieger School of Arts and Sciences 2005 — 2008
MS, Biotechnology
Southwestern HS
Towson University
BS, Biology
Johns Hopkins University School of Medicine February 2011 - Present
US Food and Drug Administration January 2010 - January 2011
Johns Hopkins University December 1999 - January 2010
US Navy 1985 - 1991
US Navy 1985 - 1986
Skills
Molecular Biology, Biotechnology, Life Sciences, DNA, Genomics, Spectroscopy, Clinical Research, Cancer, Clinical Trials, Science, Research, Data Analysis, Oncology, Cell Culture, PCR, Grant Writing, Western Blotting, Technical Writing, ELISA, IRB, Gel Electrophoresis, Protein Purification, Teaching, Tissue Culture, Cell Biology, Genetics
Education
The Johns Hopkins University - Carey Business School 2005 — 2008
MBA, Business Administration
The Johns Hopkins University- Zanvyl-Krieger School of Arts and Sciences 2005 — 2008
MS, Biotechnology
Southwestern HS
Towson University
BS, Biology
Sheila Callahan's U.S. Food and Drug Administration Experience December 2004 - April 2007
Job Division Chief, Information Sharing and Implementation Division, Department of Defense, Washington, DC Metro Area
Industry Government Administration
Experience
United States Department of Defense December 2010 - Present
US Department of Homeland Security, Intelligence and Analysis January 2009 - November 2011
Threat Analysis Center April 2007 - January 2009
US Food and Drug Administration December 2004 - April 2007
Joint Intelligence Task Force January 2004 - December 2004
United States Secret Service, Intelligence Division March 1980 - January 2004
Education
University of Maryland University College 2008 — 2010
Masters Certificate, Homeland Security Management
'Towson State University 1974 — 1976
BS, Education
The Johns Hopkins University
United States Department of Defense December 2010 - Present
US Department of Homeland Security, Intelligence and Analysis January 2009 - November 2011
Threat Analysis Center April 2007 - January 2009
US Food and Drug Administration December 2004 - April 2007
Joint Intelligence Task Force January 2004 - December 2004
United States Secret Service, Intelligence Division March 1980 - January 2004
Education
University of Maryland University College 2008 — 2010
Masters Certificate, Homeland Security Management
'Towson State University 1974 — 1976
BS, Education
The Johns Hopkins University
Ronald Foster's U.S. Food and Drug Administration Experience April 1997 - July 1998
Job Chemicals Professional
Industry Environmental Services
Experience
General Services Administration October 1998 - January 2005
US Food and Drug Administration April 1997 - July 1998
TapanAm Associates June 1996 - April 1997
Oread Laboratories October 1995 - June 1996
ManTech Environmental Technology, Inc. February 1970 - March 1995
U.S. Coast Guard April 1993 - December 1994
Allied-Signal Bendix Aerospace October 1985 - December 1990
US Coast Guard Reserve February 1986 - February 1990
US Coast Guard December 1982 - January 1985
US Coast Guard Reserve February 1980 - February 1983
Education
University of Missouri-Kansas City
MS, Chemistry
General Services Administration October 1998 - January 2005
US Food and Drug Administration April 1997 - July 1998
TapanAm Associates June 1996 - April 1997
Oread Laboratories October 1995 - June 1996
ManTech Environmental Technology, Inc. February 1970 - March 1995
U.S. Coast Guard April 1993 - December 1994
Allied-Signal Bendix Aerospace October 1985 - December 1990
US Coast Guard Reserve February 1986 - February 1990
US Coast Guard December 1982 - January 1985
US Coast Guard Reserve February 1980 - February 1983
Education
University of Missouri-Kansas City
MS, Chemistry
Norman W. Baylor's U.S. Food and Drug Administration Experience May 2005 - October 2011
Job President and CEO at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group October 2011 - Present
US Food and Drug Administration May 2005 - October 2011
US Food and Drug Administration January 2005 - May 2005
US Food and Drug Administration September 1994 - January 2005
US Food and Drug Administration January 1993 - September 1994
US Food and Drug Administration July 1991 - December 1992
Skills
Virology, vaccine clinical..., Infectious Diseases, FDA, global public health..., Regulatory Affairs, Regulatory Submissions, CMC for vaccines, Biotechnology, Clinical Trials, Vaccines, Public Health, Lifesciences, Biopharmaceuticals, Clinical Development, Drug Development, Microbiology, Technology Transfer, Immunology, Drug Discovery, GLP, Biochemistry, Assay Development, Life Sciences
Education
University of Kentucky 1979 — 1985
MS and PhD, Microbiology
University of Wisconsin-Madison 1974 — 1978
Bachelor of Science (BS), Medical Microbiology
West Side High School
West Side High School
Biologics Consulting Group October 2011 - Present
US Food and Drug Administration May 2005 - October 2011
US Food and Drug Administration January 2005 - May 2005
US Food and Drug Administration September 1994 - January 2005
US Food and Drug Administration January 1993 - September 1994
US Food and Drug Administration July 1991 - December 1992
Skills
Virology, vaccine clinical..., Infectious Diseases, FDA, global public health..., Regulatory Affairs, Regulatory Submissions, CMC for vaccines, Biotechnology, Clinical Trials, Vaccines, Public Health, Lifesciences, Biopharmaceuticals, Clinical Development, Drug Development, Microbiology, Technology Transfer, Immunology, Drug Discovery, GLP, Biochemistry, Assay Development, Life Sciences
Education
University of Kentucky 1979 — 1985
MS and PhD, Microbiology
University of Wisconsin-Madison 1974 — 1978
Bachelor of Science (BS), Medical Microbiology
West Side High School
West Side High School
Jackie Shaw's U.S. Food and Drug Administration Experience 1990 - 1994
Job Director, Clinical Operations at Prosoft Clinical
Industry Pharmaceuticals
Experience
Prosoft Clinical December 2012 - Present
PAREXEL April 2012 - December 2012
Auxilium Pharmaceuticals March 2011 - January 2012
Graceway Pharmaceuticals March 2009 - February 2011
Clinsys Clinical Research 1998 - 2009
Clinsys Clinical Research (formerly Target Research Associate) 1998 - 2009
Target Research Associates 1998 - 2009
IBRD Rostrum Global 1994 - 1998
US Food and Drug Administration 1990 - 1994
Skills
CTMS, CRO, EDC, Clinical Development, Clinical Trials, GCP, Oncology, Pharmaceutical Industry, Infectious Diseases, Clinical Monitoring, Clinical Research, Dermatology, Protocol, Clinical Data Management, ICH-GCP, Sop, Therapeutic Areas, Neurology, Cardiology, Lifesciences
Education
College 1984 — 1989
BS Biological Sciences, Biology
University of Pittsburgh 1984 — 1989
BS Biological Sciences, Biology
Prosoft Clinical December 2012 - Present
PAREXEL April 2012 - December 2012
Auxilium Pharmaceuticals March 2011 - January 2012
Graceway Pharmaceuticals March 2009 - February 2011
Clinsys Clinical Research 1998 - 2009
Clinsys Clinical Research (formerly Target Research Associate) 1998 - 2009
Target Research Associates 1998 - 2009
IBRD Rostrum Global 1994 - 1998
US Food and Drug Administration 1990 - 1994
Skills
CTMS, CRO, EDC, Clinical Development, Clinical Trials, GCP, Oncology, Pharmaceutical Industry, Infectious Diseases, Clinical Monitoring, Clinical Research, Dermatology, Protocol, Clinical Data Management, ICH-GCP, Sop, Therapeutic Areas, Neurology, Cardiology, Lifesciences
Education
College 1984 — 1989
BS Biological Sciences, Biology
University of Pittsburgh 1984 — 1989
BS Biological Sciences, Biology
Pamela Chamberlain, DVM, DABT, PhD's U.S. Food and Drug Administration Experience June 2011 - Present
Job Supervisory Veterinary Medical Officer at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration June 2011 - Present
Covance Laboratories 2009 - June 2011
Covance Laboratories 2004 - 2009
Covance Laboratories 2003 - 2004
US Food and Drug Administration 1989 - 2003
Skills
Toxicology, GLP, Drug Development, Animal Models, CRO, Lifesciences, FDA, Sop, Pharmaceutical Industry, IND, Pharmacokinetics, Pharmacology, Regulatory Affairs, In Vivo, Vaccines, Clinical Development, Animal Work, Drug Discovery, Veterinary
Education
Michigan State University College of Veterinary Medicine
DVM
University of Maryland Baltimore
PhD, Toxicology
US Food and Drug Administration June 2011 - Present
Covance Laboratories 2009 - June 2011
Covance Laboratories 2004 - 2009
Covance Laboratories 2003 - 2004
US Food and Drug Administration 1989 - 2003
Skills
Toxicology, GLP, Drug Development, Animal Models, CRO, Lifesciences, FDA, Sop, Pharmaceutical Industry, IND, Pharmacokinetics, Pharmacology, Regulatory Affairs, In Vivo, Vaccines, Clinical Development, Animal Work, Drug Discovery, Veterinary
Education
Michigan State University College of Veterinary Medicine
DVM
University of Maryland Baltimore
PhD, Toxicology
Majid Laassri, MS., Ph.D.'s U.S. Food and Drug Administration Experience January 2001 - Present
Job BiologistScientist at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration January 2001 - Present
Cancer Reserch Center 1995 - 1999
St Ptersburg PolyTechnic University 1993 - 1995
Skills
Lifesciences, Cell Culture, Molecular Biology, Protein Purification, Protein Chemistry, Genomics, Genetics, Cell Biology, qPCR, Biochemistry, DNA, PCR, In Vitro, DNA sequencing, Cell, ELISA, Bioinformatics, Western Blotting, RT-PCR, In Vivo, Assay Development, Cancer Research, DNA Sequencing, Life Sciences
Education
Moscow Cancer Research Centre 1995 — 1999
Ph.D., Biology (Oncology)
St-Ptersburg Polytechnic University 1993 — 1995
Master of Science (MS), Molecular Biology
Université Moulay Ismail Meknès 1987 — 1992
Bachelor's degree, General Biology
US Food and Drug Administration January 2001 - Present
Cancer Reserch Center 1995 - 1999
St Ptersburg PolyTechnic University 1993 - 1995
Skills
Lifesciences, Cell Culture, Molecular Biology, Protein Purification, Protein Chemistry, Genomics, Genetics, Cell Biology, qPCR, Biochemistry, DNA, PCR, In Vitro, DNA sequencing, Cell, ELISA, Bioinformatics, Western Blotting, RT-PCR, In Vivo, Assay Development, Cancer Research, DNA Sequencing, Life Sciences
Education
Moscow Cancer Research Centre 1995 — 1999
Ph.D., Biology (Oncology)
St-Ptersburg Polytechnic University 1993 — 1995
Master of Science (MS), Molecular Biology
Université Moulay Ismail Meknès 1987 — 1992
Bachelor's degree, General Biology
Otha Easley's U.S. Food and Drug Administration Experience September 1983 - April 1992
Job Law Enforcement Consultant, Retired Deputy Special Agent in Charge, US Dept of Commerce
Industry Law Enforcement
Experience
US Dept of Commerce, NOAA, Office of Law Enforcement April 1992 - January 2014
US Food and Drug Administration September 1983 - April 1992
Skills
Strategic Planning, Research, Business Strategy, Project Management, Entrepreneurship, Public Policy, Nonprofits, Policy, Organizational..., Government, Strategic Communications, Leadership Development, Project Planning, Federal Law Enforcement, Policy Analysis, Community Outreach, Investigation, Criminal Investigations, Enforcement, Emergency Management, Criminal Justice
Education
University of New Orleans 1985 — 1986
Computer Programming
The University of Texas at El Paso 1978 — 1980
Bachelor's degree, Chemistry
Wentworth Military Academy 1976 — 1978
Associate of Arts (AA), Military and Strategic Leadership
US Dept of Commerce, NOAA, Office of Law Enforcement April 1992 - January 2014
US Food and Drug Administration September 1983 - April 1992
Skills
Strategic Planning, Research, Business Strategy, Project Management, Entrepreneurship, Public Policy, Nonprofits, Policy, Organizational..., Government, Strategic Communications, Leadership Development, Project Planning, Federal Law Enforcement, Policy Analysis, Community Outreach, Investigation, Criminal Investigations, Enforcement, Emergency Management, Criminal Justice
Education
University of New Orleans 1985 — 1986
Computer Programming
The University of Texas at El Paso 1978 — 1980
Bachelor's degree, Chemistry
Wentworth Military Academy 1976 — 1978
Associate of Arts (AA), Military and Strategic Leadership
Russell Zaban's U.S. Food and Drug Administration Experience 2001 - Present
Job Emergency Coordinator at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration 2001 - Present
Silliker Laboratories August 2000 - May 2001
Shuster Laboratories February 1988 - May 2000
Skills
Emergency Management, Government, Policy Analysis, Policy, Public Health, Program Management, Program Evaluation, Disaster Response, Homeland Security, Risk Assessment, Epidemiology, Program Development, Enforcement
Education
The University of Georgia 1985 — 1987
Bachelor of Science (B.S.), Microbiology
Young Harris College 1979 — 1981
Associate of Science (AS), Science
US Food and Drug Administration 2001 - Present
Silliker Laboratories August 2000 - May 2001
Shuster Laboratories February 1988 - May 2000
Skills
Emergency Management, Government, Policy Analysis, Policy, Public Health, Program Management, Program Evaluation, Disaster Response, Homeland Security, Risk Assessment, Epidemiology, Program Development, Enforcement
Education
The University of Georgia 1985 — 1987
Bachelor of Science (B.S.), Microbiology
Young Harris College 1979 — 1981
Associate of Science (AS), Science
Aloka Srinivasan's U.S. Food and Drug Administration Experience August 2003 - May 2012
Job Principal Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL June 2012 - Present
US-Food and Drug Administration August 2003 - May 2012
Skills
Regulatory Submissions, FDA, Regulatory Affairs, Generic Programming, Drug Development, CMC, Leadership, Chemistry, Sop, GLP, GMP, Clinical Development, Regulatory Requirements, Pharmaceutics, Pharmaceutical Industry, CMC development, SOP, Technology Transfer
Education
University of Missouri-Columbia 1987 — 1993
Ph.D., 4.0
PAREXEL June 2012 - Present
US-Food and Drug Administration August 2003 - May 2012
Skills
Regulatory Submissions, FDA, Regulatory Affairs, Generic Programming, Drug Development, CMC, Leadership, Chemistry, Sop, GLP, GMP, Clinical Development, Regulatory Requirements, Pharmaceutics, Pharmaceutical Industry, CMC development, SOP, Technology Transfer
Education
University of Missouri-Columbia 1987 — 1993
Ph.D., 4.0
Lu Cui's U.S. Food and Drug Administration Experience 1994 - 2001
Job Director, TA Head at AbbVie
Industry Pharmaceuticals
Experience
AbbVie 2013 - Present
Eisai Inc. 2007 - 2012
sanofi-aventis 2001 - 2007
US Food and Drug Administration 1994 - 2001
Skills
Drug Development, Pharmaceutical Industry, Clinical Trials, Statistics, Data analysis, Regulatory strategy, Regulatory Interactions, Staff Development
Education
University of Rochester
Doctor of Philosophy (PhD), Statistics
AbbVie 2013 - Present
Eisai Inc. 2007 - 2012
sanofi-aventis 2001 - 2007
US Food and Drug Administration 1994 - 2001
Skills
Drug Development, Pharmaceutical Industry, Clinical Trials, Statistics, Data analysis, Regulatory strategy, Regulatory Interactions, Staff Development
Education
University of Rochester
Doctor of Philosophy (PhD), Statistics
Stephine Keeton, Ph.D.'s U.S. Food and Drug Administration Experience June 2014 - Present
Job Team Leader at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration June 2014 - Present
PPD April 2014 - June 2014
PPD March 2011 - April 2014
FDA November 2009 - March 2011
FDA December 2005 - November 2009
Skills
Biostatistics, Protocol, Vaccines, Clinical Trials, SAS, Analysis, Clinical Research, Statistics, CRO, Research, Clinical Development, Data Analysis, SAS Programming, Pharmaceutical Industry
Education
University of Mississippi 2001 — 2006
Doctor of Philosophy (Ph.D.), Mathematics
University of Mississippi 1999 — 2001
Master of Science (M.S.), Mathematics
University of Alabama at Birmingham 1992 — 1996
Bachelor of Science (B.S.), Mathematics and Business Administration
US Food and Drug Administration June 2014 - Present
PPD April 2014 - June 2014
PPD March 2011 - April 2014
FDA November 2009 - March 2011
FDA December 2005 - November 2009
Skills
Biostatistics, Protocol, Vaccines, Clinical Trials, SAS, Analysis, Clinical Research, Statistics, CRO, Research, Clinical Development, Data Analysis, SAS Programming, Pharmaceutical Industry
Education
University of Mississippi 2001 — 2006
Doctor of Philosophy (Ph.D.), Mathematics
University of Mississippi 1999 — 2001
Master of Science (M.S.), Mathematics
University of Alabama at Birmingham 1992 — 1996
Bachelor of Science (B.S.), Mathematics and Business Administration
Donald Lech's U.S. Food and Drug Administration Experience May 2009 - Present
Job Chemist/Compliance Officer at FDA
Industry Government Administration
Experience
US Food and Drug Administration May 2009 - Present
US Food and Drug Administration May 2002 - April 2009
US Food and Drug Administration October 1995 - May 2002
US Food and Drug Administration May 1992 - September 1995
Hoffmann La-Roche January 1992 - May 1992
US Air Force November 1989 - September 1990
Clemson University August 1987 - November 1989
Organon, Inc. January 1986 - August 1987
Education
Oxford University 2011 — 2012
Postgraduate Certificate in Nanotechnology, Nanotechnology
Clemson University 1987 — 1989
Master's degree, Organic Chemistry
Tulane University 1981 — 1985
Bachelor's degree, Chemistry
US Food and Drug Administration May 2009 - Present
US Food and Drug Administration May 2002 - April 2009
US Food and Drug Administration October 1995 - May 2002
US Food and Drug Administration May 1992 - September 1995
Hoffmann La-Roche January 1992 - May 1992
US Air Force November 1989 - September 1990
Clemson University August 1987 - November 1989
Organon, Inc. January 1986 - August 1987
Education
Oxford University 2011 — 2012
Postgraduate Certificate in Nanotechnology, Nanotechnology
Clemson University 1987 — 1989
Master's degree, Organic Chemistry
Tulane University 1981 — 1985
Bachelor's degree, Chemistry
Andrea Weir's U.S. Food and Drug Administration Experience November 1993 - August 2005
Job Senior Consultant at ToxStrategies, Inc
Industry Pharmaceuticals
Experience
ToxStrategies, Inc. March 2015 - Present
Charles River Laboratories September 2005 - April 2013
US Food and Drug Administration November 1993 - August 2005
Skills
Toxicology, Drug Development, Pharmaceutical Industry, Pharmacology, Regulatory Toxicology, Pharmaceuticals, Biopharmaceuticals
Education
University of Mississippi Medical Center 1982 — 1987
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
University of Kentucky 1980 — 1982
Master’s Degree, Toxicology
University 0f Kentucky 1976 — 1980
Bachelor’s Degree, Plant Pathology
ToxStrategies, Inc. March 2015 - Present
Charles River Laboratories September 2005 - April 2013
US Food and Drug Administration November 1993 - August 2005
Skills
Toxicology, Drug Development, Pharmaceutical Industry, Pharmacology, Regulatory Toxicology, Pharmaceuticals, Biopharmaceuticals
Education
University of Mississippi Medical Center 1982 — 1987
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
University of Kentucky 1980 — 1982
Master’s Degree, Toxicology
University 0f Kentucky 1976 — 1980
Bachelor’s Degree, Plant Pathology
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