US FDA

Industry: Federal agency

Description

The 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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US FDA Employees

Employee
Years
Job
Industry
Donna Gallien, MPH Donna Gallien, MPH Antioch, Tennessee Details
Donna Gallien, MPH's US FDA Experience 1990 - Present
Job Federal Investigator at U.S. FDA
Industry Pharmaceuticals
Experience
U.S. FDA   1990 - Present

Skills
Extensive Domestic and..., Compliance, Clinical Trials, Clinical Research, Plasma Processing, Procedure Development, Procedure Review, Quality Auditing, Internal Controls, International Relations, Communication Skills, Biologics, GCPs, GLPs, Medical Devices, Medical Research, Employee Training, Team Management, Cross-functional Team..., Interviewing Skills, Behavioral Interviewing, Policy

Education
John F. Kennedy

Tulane University School of Public Health
Master of Public Health (MPH)

Tulane University

Dillard University
Bachelor of Science (BS)

Shafiq Ahadi Shafiq Ahadi Greater St. Louis Area Details
Shafiq Ahadi's US FDA Experience October 2010 - Present
Job Investigator at US Food and Drug Administration
Industry Biotechnology
Experience
US FDA   October 2010 - Present
CDER, Center for Drug Evaluation and Research   May 2008 - September 2010

Skills
cGMP practices, Investigation, Pharmacueticals, APIs, API manufacturing, Quality by Design, DEA, Drug Delivery, Analytical Chemistry, HPLC, Chromatography, Regulatory Affairs, Sop, Biotechnology, FDA, SOP, Pharmaceutical Industry, Life Sciences, Customer Service, Data Analysis, Research, Microsoft Excel, Microsoft Office

Education
Washington University in St. Louis   2009 — 2011

Saint Louis University   2005 — 2009

Justina Molzon Justina Molzon Bethesda, Maryland Details
Justina Molzon's US FDA Experience August 1990 - November 2014
Job CAPT (retired) US Public Health Service
Industry Pharmaceuticals
Experience
Currently Available for New Initiatives   December 2014 - Present
TBD  December 2014 - Present
US FDA   August 1990 - November 2014

Skills
Public Health, Pharmaceutical Industry, Government, Regulatory Affairs, Healthcare, FDA, Clinical Trials, Research, Oncology, Lifesciences, Epidemiology, Community Outreach, Biotechnology, Regulatory Requirements, Validation, Public Speaking, Program Management, Clinical Research, Policy, Strategic Planning, Sop, Strategy, GMP, Public Policy, Medical Devices, Policy Analysis, Analytical Chemistry, Biostatistics, CAPA, Change Control, Clinical Development, Diabetes, Drug Development, Drug Discovery, GCP, IND, Infectious Diseases, Informatics, Life Sciences, Microbiology, Pharmacokinetics, Pharmacovigilance, Program Evaluation, Quality Assurance, Regulatory Submissions, SOP, Science, Vaccines, Toxicology

Education
Chicago-Kent College of Law, Illinois Institute of Technology   1981 — 1985
Doctor of Law (J.D.), Emphasis on legal writing

University of Rhode Island   1973 — 1976
Master of Science (MS), Pharmaceutical Sciences

University of Rhode Island   1968 — 1973
Bachelor of Science (BS), Pharmacy, honors and distinction

Tom Cebula Tom Cebula Baltimore, Maryland Area Details
Tom Cebula's US FDA Experience January 2001 - May 2010
Job Chief Scientific Officer at CosmosID
Industry Biotechnology
Experience
CosmosID®  2013 - Present
University of Maryland, College Park, MD   2012 - Present
Johns Hopkins University  2008 - Present
CosmosID  2010 - 2013
US FDA   January 2001 - May 2010
FDA  1994 - 2001
FDA  1987 - 1994
FDA  1978 - 1987

Skills
Bioinformatics, Molecular Microbiology, DNA Repair, DNA sequencing, Comparative Genomics, Epidemiology, Genetics, Molecular Biology, Microbiology, Biology, Laboratory, PCR, Lifesciences, Biochemistry, DNA, Life Sciences

Education
The Johns Hopkins University School of Medicine   1977 — 1978
JHU Fellow, Medical Microbiology

The Johns Hopkins University School of Medicine   1977 — 1978
JHU Fellow, Medical Microbiology

Johns Hopkins McCollum Pratt Institute, Baltimore, MD 21218   1974 — 1977
NCI Fellow, Cell Biology/Biochemistry

The Johns Hopkins University, Ph.D. 1974   1968 — 1974
Ph.D., Biology (Biochemical Genetics)

Wilkes University   1964 — 1968
B.S., Chemistry

Michelle Law, PhD Michelle Law, PhD United States Details
Michelle Law, PhD's US FDA Experience March 2007 - February 2011
Job Doctoral Level Scientist with FDA experience specializing in [microbial] quality of pharmaceuticals and medical devices.
Industry Research
Experience
Oxford Regulatory & Compliance   February 2013 - Present
Quest Diagnostics  May 2013 - May 2014
Kimberly-Clark Corporation, Global Medical Device & Consumer Product Safety   February 2011 - February 2013
US FDA   March 2007 - February 2011
University of Michigan Health System  October 2004 - September 2006

Skills
Product Safety, Medical Devices, FDA pre-market..., Quality Assurance, Microbiological Safety..., Compliance, Auditing, Kaizen Facilitation, Pharmaceutical Industry, Microbiology, FDA, ELISA, GLP, Molecular Biology, PCR, Kaizen, Validation, Sop, Laboratory, Assay Development, Immunology, Cell, Protein Chemistry, Flow Cytometry, SOP

Education
Howard University   1997 — 2004
PhD, microbiology

California State University-Fullerton   1994 — 1997
BA, Biology

Fredric Richman Fredric Richman Washington D.C. Metro Area Details
Fredric Richman's US FDA Experience August 2005 - November 2008
Job Principal Consultant, Compliance Achievers, LLC
Industry Pharmaceuticals
Experience
Compliance Achievers LLC   November 2008 - Present
U.S. FDA   August 2005 - November 2008
U.S. FDA   October 2003 - July 2005
U.S. FDA   December 1996 - September 2003
U.S. FDA   October 1992 - November 1996
U.S. FDA   January 1977 - September 1992
U.S. FDA   July 1972 - December 1976
Schwarz Services International, Ltd.   June 1970 - June 1972

Skills
FDA, CAPA, Regulatory Affairs, GMP, Regulatory Requirements, Regulatory Submissions, Pharmaceutical Industry, Sop, Quality System, Quality Assurance, V&V, Pharmaceutics, UV/Vis, Vaccines, Technology Transfer, Analytical Chemistry, Policy, Validation, Drug Development, Laboratory, Chromatography, HPLC, LIMS, Medical Devices, GCP, GLP, Biotechnology, IND, Quality Auditing, Computer System..., Change Control, Biopharmaceuticals, Lifesciences, CRO, GxP, Clinical Development, Design Control, 21 CFR Part 11, Pharmacovigilance, Drug Discovery, Clinical Trials, ISO 13485, Chemistry, Infectious Diseases, Regulations, R&D, Life Sciences

Education
St. John's University   1971 — 1975
M.S., Chemistry

Brooklyn College/Queens College of CUNY   1965 — 1970
B.A., Chemistry

Kara Lemons Harrison, RAC, RQAP-GCP Kara Lemons Harrison, RAC, RQAP-GCP Chattanooga, Tennessee Area Details
Kara Lemons Harrison, RAC, RQAP-GCP's US FDA Experience September 1989 - November 1999
Job Quality Research Consultants
Industry Research
Experience
Quality Research Consultants   December 2013 - Present
INC Research  April 2011 - December 2013
Quintiles  March 2009 - April 2011
Duke Clinical Research Institute  2004 - February 2009
Avera Pharmaceuticals  August 2003 - March 2004
Pfizer  May 2002 - August 2003
Various CROs   December 1999 - May 2002
Applied Logic Associates   1999 - 2001
US FDA   September 1989 - November 1999

Skills
GCP, FDA, Quality Assurance, 21 CFR Part 11, Sop, Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, GxP, Clinical Monitoring, Regulatory Submissions, ICH-GCP, CAPA, CRO, Clinical Development, Quality Auditing, CTMS, GLP, Clinical Research, Auditing, Quality System, Computer System..., Validation, EDC, Regulatory Requirements, Vaccines, Clinical Data Management, Pharmacovigilance, Biopharmaceuticals, Change Control, Protocol, Therapeutic Areas, Biotechnology, Drug Development, Team Building, Team Leadership, SOP

Education
Drexel University College of Medicine   2010 — 2014
MS, Clinical Research Organization and Managment

Stetson University   1985 — 1989
BS, biology

Robert Hummel Robert Hummel Washington D.C. Metro Area Details
Robert Hummel's US FDA Experience September 2005 - April 2008
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA  April 2008 - Present
US FDA   September 2005 - April 2008
Science Applications International  August 2001 - September 2005
Cambridge Consulting Corporation supporting USAMMDA   April 1998 - August 2001

Skills
Regulatory Affairs, FDA, Clinical Trials, Life Sciences, Medical Devices, Intermediate Japanese..., Pharmaceutical Industry, Lifesciences, Regulatory Submissions, IND, Healthcare, Regulatory Requirements, Validation, Pharmacovigilance, Biopharmaceuticals, Oncology, Analysis, Policy, Vaccines, Research, Public Health, Infectious Diseases, Pharmacology, Medicine, Quality Assurance, Immunology, Microbiology, Pharmaceutics, Laboratory, Biotechnology, Clinical Development, Drug Development, Government, Clinical Research, Cell Culture, R&D, Sop, Chemistry, Science, Molecular Biology, GLP, Drug Discovery, GCP, 21 CFR Part 11, In Vivo, CRO, Technology Transfer, SOP

Education
California Pacific University   2001 — 2005
DBA, Business Administration

Hood College   2003 — 2004
Graduate Certificate, (FDA) Regulatory Compliance, 3.3 Cum. GPA

Hood College   1995 — 1998
MBA, Business Administration

Penn State University   1980 — 1982
Bachelor of Science (BS), Pre-Medicine/Pre-Medical Studies

United States Air Force Academy   1976 — 1980
Did not Graduate, Managment, 2.43

Cedar Cliff High School, Camp Hill, PA, USA   1972 — 1975
High School Diploma, Academic Curriculum, 3.0 Cumulative GPA

Joga Gobburu Joga Gobburu Baltimore, Maryland Area Details
Joga Gobburu's US FDA Experience October 1998 - October 2011
Job Professor, Executive Director, Center for Translational Medicine, Schools of Pharmacy & Medicine, University of Maryland
Industry Pharmaceuticals
Experience
Schools of Pharmacy & Medicine, University of Maryland   October 2011 - Present
US FDA   October 1998 - October 2011
Georgetown University, Food and Drug Administration   October 1997 - April 1999
State University of New York at Buffalo  June 1996 - October 1997

Skills
Clinical Research, Pharmacokinetics, Clinical Trials, Research, Pharmacometrics, Pharmacodynamics, Regulatory Submissions, Analysis, Drug Development, Clinical Pharmacology, Training, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Immunology, Clinical Development, FDA, Pharmacology, Oncology, Drug Discovery, R, Biopharmaceuticals, Cell, Cell Culture, Lifesciences, Pharmaceutics, Infectious Diseases, Simulations, CRO, Science, GCP

Education
The Johns Hopkins University - Carey Business School   2007 — 2009
MBA, Business Administration

North Dakota State University   1992 — 1996
PhD, Pharmaceutical Sciences

Birla Institute of Technology and Science, Pilani   1986 — 1992
B Pharm, MSc, Pharmacy, Chemistry

Robert Meyer Robert Meyer Charlottesville, Virginia Details
Robert Meyer's US FDA Experience 1994 - 2007
Job Director, Virginia Center for Regulatory and Translational Science
Industry Higher Education
Experience
Cardiome Pharma Corp  September 2015 - Present
United States Pharmacopeia  July 2015 - Present
University of Virginia School of Medicine  2013 - Present
PhRMA  January 2012 - January 2013
Merck  November 2009 - January 2013
Merck  February 2008 - November 2009
FDA  2002 - 2007
MTOC/ATOC   1998 - 2007
U.S. FDA   1994 - 2007

Skills
Drug Development, regulatory strategy, regulatory policy, drug safety, Clinical Development, Drug Safety, Regulatory Submissions, Strategy, Regulatory Affairs, Medicine, Regulatory Policy, Clinical Trials, Pharmaceutical Industry, Vaccines, Regulatory Requirements, IND, Biomarkers, Translational Medicine, Regulations, Drug Delivery, Biotechnology, Biopharmaceuticals, Lifesciences, Outcomes Research, Clinical Research, FDA, Life Sciences, Oncology

Education
University of Vermont College of Medicine   1988 — 1991
Fellowship, Pulmonary and Critical Care Medicine, Pulmonary Disease Residency Program

The University of Connecticut School of Medicine   1984 — 1988
Residency/Chief Residency, Internal Medicine Residency Program

The University of Connecticut School of Medicine   1980 — 1984
MD, Medicine

Lehigh University   1976 — 1980
BS, Natural Science

Thompson Memorial School   1964 — 1972

Anthony Charity Anthony Charity Washington D.C. Metro Area Details
Anthony Charity's US FDA Experience November 1988 - September 2013
Job President at AAC FDA Consultants, LLC
Industry Government Administration
Experience
Tunnell Consulting, Inc.   October 2013 - January 2015
FDA  November 1990 - September 2013
US FDA   November 1988 - September 2013

Skills
FDA, Regulatory Affairs, Public Health, Regulatory Requirements, Federal Government, Regulations, Policy, Microbiology, Epidemiology, Environmental Health, Infectious Diseases, Health Communication, Government, Policy Analysis, Emergency Management, FDA GMP, SOP, CAPA, Change Control, Technology Transfer, GMP, Pharmaceutical Industry, GLP, Public Policy, Biotechnology

Education
Cheyney University of Pennsylvania   1974 — 1979
Bachelor's Degree, Chemistry

Ruth Herzog Ruth Herzog Washington D.C. Metro Area Details
Ruth Herzog's US FDA Experience September 2013 - Present
Job
Industry Government Administration
Experience
US FDA   September 2013 - Present
Cambrex Charles City  June 2013 - August 2013
Ricerca Biosciences  August 2007 - March 2012
Ferro Corporation  January 2004 - January 2007
Atofina Chemicals, Inc  January 1996 - January 2004
Hoechst Celanese Corporation  October 1991 - December 1996

Skills
GMP, Validation, Quality Assurance, Chemistry, Technology Transfer, Manufacturing, Organic Chemistry, Process Improvement, Quality Control, Laboratory, Management, Training, Budgets, Risk Assessment, Factory

Education
The Johns Hopkins University
Ph.D, Chemical Engineering

Bryn Mawr College
B. S, Physics

Armand Balboni Armand Balboni Waterford, Virginia Details
Armand Balboni's US FDA Experience August 2014 - August 2015
Job Partner/Director at Bloom Burton &Co.
Industry Financial Services
Experience
U.S. Army Medical Department - USAMMDA   August 2015 - Present
Bloom Burton &Co.   2008 - Present
U.S. FDA   August 2014 - August 2015
U.S. Army Medical Research Institute of Infectious Diseases   2011 - August 2014

Skills
FDA, Strategic Planning, Financial Modeling, Biotechnology, Lifesciences, Technology Transfer

Education
Mount Sinai School of Medicine of New York University

Brooklyn Law School

Skidmore College

Bill Doub Bill Doub Greater St. Louis Area Details
Bill Doub's US FDA Experience June 1982 - December 2014
Job Consultant
Industry Pharmaceuticals
Experience
Retired and enjoying time to pursue personal interests and family and consulting   December 2014 - Present
US FDA   June 1982 - December 2014
American Chemical Society  January 2010 - December 2010
American Chemical Society  January 2009 - December 2009
Bach Society of Saint Louis   July 1999 - June 2009
US FDA   June 1984 - January 2009
Saint Louis University  September 1978 - June 1984

Skills
Analytical Chemistry, R&D, Research, Characterization, FDA, Dissolution, HPLC, Validation, Chromatography, Pharmaceuticals, Technical Writing, Microsoft Office, Excel, Data Analysis, Analysis, Testing, UV-Vis, Science, SOP, Chemistry, Microscopy, In Vitro, Instrumentation, Pharmaceutics, Pharmaceutical Industry, Method Development, Mass Spectrometry, UV/Vis

Education
University of Wisconsin-Madison   1976 — 1977
Post Doctoral Research Assistant, Electroanalytical Chemistry

University of Kentucky   1975 — 1976
Post-Doctoral Research Associate, Electroanalytical Chemistry

University of California, Riverside   1972 — 1975
Ph. D., Analytical Chemistry

California State Polytechnic University-Pomona   1966 — 1968
B.S., Chemsitry

Upland High School   1960 — 1964

Upland High School   1960 — 1964

Kim Quaintance Kim Quaintance Washington D.C. Metro Area Details
Kim Quaintance's US FDA Experience 1996 - 2011
Job Head, US Regulatory Policy at Bayer
Industry Pharmaceuticals
Experience
Bayer  February 2014 - Present
Eisai  February 2011 - January 2014
U.S. FDA   1996 - 2011
Pfizer  January 1990 - June 1996

Skills
Regulatory Affairs, FDA, Regulatory Submissions, IND, Pharmaceutical Industry, Drug Development, Clinical Development, Clinical Trials, GCP, Regulatory Requirements, Drug Discovery, Biotechnology, Biopharmaceuticals, GLP, Toxicology, Technology Transfer, Pharmacovigilance, Vaccines, Sop, Lifesciences, CRO, eCTD, Pharmacology, Oncology, GMP, Validation, Pharmacokinetics, Pharmaceutics, 21 CFR Part 11, Infectious Diseases, NDA, CMC, Medical Writing, Immunology, Biologics, HPLC, Medicinal Chemistry, Biomarkers, In Vivo, In Vitro, Analytical Chemistry, Life Sciences, SOP

Education
University of Illinois at Urbana-Champaign   1986 — 1990
B.S., Biochemistry

Arthur J. Miller Arthur J. Miller Irvine, California Details
Arthur J. Miller's US FDA Experience 1998 - 2005
Job Principal Scientist at Exponent, Inc. Center for Chemical Regulation & Food Safety
Industry Food & Beverages
Experience
Exponent, Inc. - Health Sciences   August 2005 - Present
US FDA   1998 - 2005
FDA  1998 - 2005
USDA - Agricultural Research Service  1976 - 1998

Skills
Food Safety, Microbiology, FDA, Risk Assessment, Risk Management, Root Cause Analysis, Consulting, Food Microbiology, Food Science, HACCP, Regulatory Affairs, GMP, Science, USDA, Process Simulation, Process Improvement, Expert Reports, Expert Witness, Public Health, Dairy, Food, Food Industry, Food Processing, Epidemiology, Biotechnology, Toxicology

Education
Drexel University   1980 — 1984
Ph.D., Environmental Science (Food Science concentration)

Penn State University   1975 — 1977
M.S., Food Science

Kansas State University
B.S., Biology

John F. Kennedy High School, Plainview-Old Bethpage   1965 — 1968

David F Crockett David F Crockett Cincinnati Area Details
David F Crockett's US FDA Experience August 1992 - Present
Job Chemist at US FDA
Industry Government Administration
Experience
US FDA   August 1992 - Present

Skills
GC-MS, Analytical Chemistry, Wet Chemistry, Mass Spectrometry, Method Development, Gas Chromatography, Chromatography, Organic Chemistry, Spectroscopy, LIMS, Titration, GLP, Chemistry, LC-MS, Validation, HPLC

Education
Virginia Commonwealth University   1989 — 1991
BS, Chemistry

Longwood College   1987 — 1989

Kristi Muldoon Jacobs Kristi Muldoon Jacobs Washington D.C. Metro Area Details
Kristi Muldoon Jacobs's US FDA Experience November 2008 - April 2013
Job Regulatory toxicologist
Industry Public Safety
Experience
FDA  June 2013 - Present
US FDA   November 2008 - April 2013
National Cancer Institute  June 2006 - October 2008
American University  2007 - 2008
Trinity University  2004 - 2006
Novartis  1999 - 2002

Skills
Cell Biology, Epigenetics, Molecular Biology, RNA biology, SDS-PAGE, Lifesciences, Protein Chemistry, Cell, Genetics, Pharmacology, Genomics, Laboratory, In Vitro, Animal Models, Cell Culture, Biochemistry, Molecular Genetics, Science, In Vivo, Toxicology, Management, PCR, Regulatory Submissions, qPCR

Education
University of Medicine and Dentistry of New Jersey   1999 — 2004
PhD, Biomedical Sciences

Stockton University   1995 — 1998
BS, Biochemisty

Jerry Mulnick Jerry Mulnick Greater New York City Area Details
Jerry Mulnick's US FDA Experience 1963 - 2005
Job Membership Chairman at Staten Island Ballroom Dancers, Inc.
Industry Civic & Social Organization
Experience
Staten Island Ballroom Dancers, Inc.   February 2006 - Present
U.S. Food & Drug Administration   January 1963 - January 2005
U.S. FDA   1963 - 2005

Skills
Medical Devices, Training, GMP, Federal Government, Quality Assurance, Community Outreach, Quality System, Biotechnology, Statistics, Policy, Program Development, Microsoft Excel, Pharmaceutical Industry, Strategic Communications, Sop, Research, Validation, Cell Culture, Project Management, GCP, Regulatory Requirements, Public Relations, Epidemiology, Public Speaking, Public Policy, Infectious Diseases, Health Education, Emergency Management, Science, Risk Assessment, Public Health, Molecular Biology, V&V, Quality Auditing, Legal Research, Microsoft Office, Clinical Trials, FDA, Healthcare, Nonprofits, Data Analysis, Food Safety, Regulations, Regulatory Affairs, Lifesciences, Family Therapy, Government, Clinical Research, Microsoft Word, CAPA

Education
Delaware Valley College   1956 — 1961
B.S., Food Industry

Delaware Valley University   1956 — 1961
BS, Food Industry

Mouna Selvam Mouna Selvam Washington D.C. Metro Area Details
Mouna Selvam's US FDA Experience July 1990 - Present
Job Senior Scientst at US FDA
Industry Government Administration
Experience
US FDA   July 1990 - Present
Georgetown Lombardi Comprehensive Cancer Center  January 1984 - September 1988
NCI/NIH   January 1982 - January 1984

Skills
Prescription Drug..., FDA, Clinical Trials, Medicine, Cancer Research, Lifesciences, Biotechnology, Regulatory Affairs, Molecular Biology, Biochemistry, Cell Culture, Infectious Diseases, HPLC, PCR, Immunology, Toxicology, ELISA, Clinical Research, Analytical Chemistry, Chemistry, Technology Transfer, Pharmacology

Education
Madras University   1974 — 1980
Doctor of Philosophy (Ph.D.), Biochemistry

Teachers College of Madras University   1973 — 1974
Bachelor's Degree, Special Education and Teaching

Pachaiyappas College For Men   1969 — 1973
Bachelor's Degree, Chemistry Major

Rama Krishna Mission Residential High School [Gurukulam]   1966 — 1969
High School

Minnie Baylor-Henry Minnie Baylor-Henry Greater Boston Area Details
Minnie Baylor-Henry's US FDA Experience 1991 - 1999
Job President, BHenry & Associates
Industry Medical Devices
Experience
YourEncore  July 2015 - Present
B-Henry & Associates   March 2015 - Present
Johnson & Johnson  January 2011 - March 2015
Deloitte  October 2009 - November 2011
Johnson & Johnson-McNeil Consumer & Specialty Pharmaceuticals   September 2004 - September 2008
US FDA   1991 - 1999

Education
Howard University
Bachelor of Science (BS), Pharmacy

The Catholic University of America
Doctor of Law (JD)

Bhawana (Bavna) Saluja Bhawana (Bavna) Saluja Washington D.C. Metro Area Details
Bhawana (Bavna) Saluja's US FDA Experience 2010 - 2012
Job Chemist, FDA
Industry Pharmaceuticals
Experience
FDA  September 2010 - Present
US FDA   2010 - 2012
Virginia Commonwealth University  August 2006 - July 2010
Office of Technology Transfer at Virginia Commonwealth University   June 2009 - November 2009
Dr. Reddy's Laboratories   October 2005 - June 2006

Skills
Dry Powder Inhalers, Inhalation, Petitions, Regulatory Affairs, Bioequivalence, Pharmacodynamics, Drug Delivery, Cell Biology, Clinical Trials, Chemistry, Formulation, R&D, Technology Transfer, Patents, Molecular Biology, Clinical Development, GLP, Drug Development, Pharmacokinetics

Education
Virginia Commonwealth University   2006 — 2010
PhD, Pharmaceutics

Delhi University   2003 — 2005
Master of Science, Pharmaceutics

Delhi University   1999 — 2003
Bachelor of Science, Pharmacy

Holy Child School

Denicia Hernandez Denicia Hernandez Santa Fe, New Mexico Area Details
Denicia Hernandez's US FDA Experience January 2001 - December 2001
Job Medical Research Associate / Clinical Study Manager
Industry Pharmaceuticals
Experience
Contract - Boehringer-Ingelheim   September 2012 - Present
Quintiles  January 2011 - September 2012
ReSearch Pharmaceutical Services  January 2010 - January 2011
ReSearch Pharmaceutical Services  September 2007 - December 2009
ReSearch Pharmaceutical Services  November 2006 - September 2007
Premier Research Group  November 2005 - November 2006
NPS Pharmaceuticals  June 2003 - November 2005
U.S. FDA   January 2001 - December 2001
Tx Dept of Health   June 1998 - March 2001

Skills
GMP, GCPs, Medical Devices, FDA, Clinical Study Design, Clinical Research, CRO, EDC, Clinical Development, Lifesciences, Quality Assurance, CTMS, Clinical Operations, Auditing, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, GCP, Clinical Research...

Education
The University of Texas at Austin   1991 — 1996
BS, Biology

Snehal Samant Snehal Samant Orlando, Florida Details
Snehal Samant's US FDA Experience June 2015 - August 2015
Job Ph.D. candidate at the Center for Pharmacometrics and Systems Pharmacology, University of Florida
Industry Pharmaceuticals
Experience
Center for Pharmacometrics and Sytems Pharmacology, University of Florida   August 2012 - Present
University of Florida  August 2012 - Present
U.S. FDA   June 2015 - August 2015
Millennium Pharmaceuticals  June 2013 - August 2013
Massachusetts College of Pharmacy and Health Sciences  August 2009 - May 2012
MCPHS University  August 2009 - May 2012
IndUS Pharmaceuticals, Inc   May 2011 - November 2011
Elder Pharmaceuticals Ltd.   June 2008 - July 2008

Skills
PK/PD modeling, Pharmacokinetics, Pharmacometrics, Pharmacology, R, PBPK, Statistics, NONMEM, WinNonlin, Mathematical Modeling, C, C++

Education
University of Florida   2012 — 2016
Doctor of Philosophy (PhD), Pharmacometrics & Systems Pharmacology

Massachusetts College of Pharmacy and Health Sciences   2009 — 2012
Master of Science, Pharmacokinetics, Pharmacometrics

University of Mumbai   2005 — 2009
Bachelor of Pharmacy, Pharmacy

Chauhan Institue of Science   2003 — 2005
HSC, Science

Luis G Valerio Jr, Ph.D. Luis G Valerio Jr, Ph.D. Washington D.C. Metro Area Details
Luis G Valerio Jr, Ph.D.'s US FDA Experience 2003 - 2015
Job Scientific Director, FEMA, and Head of Toxicology and Translational Science at Verto Solutions
Industry Writing and Editing
Experience
Flavor and Extract Manufacturers Association (FEMA)   May 2015 - Present
Verto Solutions  April 2015 - Present
Toxicology and Applied Pharmacology (Elsevier)   March 2012 - Present
Regulatory Toxicology and Pharmacology (Elsevier)   March 2013 - Present
Expert Opinion on Drug Metabolism & Toxicology (Informa)   November 2011 - Present
Toxicology Mechanisms and Methods (Informa)   January 2008 - Present
US FDA   2003 - 2015
Mary Kay Holding Corporation, Global Research & Development   July 2000 - July 2003
Universitat Autònoma de Barcelona  February 1999 - March 2000
University of Colorado, Division of Gastroenterology   May 1998 - May 1999

Skills
Toxicology, Methods development, Computational Modeling, Pharmaceuticals, Food Safety, Chemical Safety, Risk Management, Risk Assessment, Pharmaceutical Sciences, Drug Safety, Nanotechnology, Pharmacology, Publishing, Biotechnology, Academic Publishing, Pharmaceutical Industry, Immunology, Lifesciences, Drug Discovery, Regulatory Affairs, Drug Development, Journals, Science, Biochemistry, Neuroscience, Molecular Biology, Oncology, Online Publishing, In Vitro, Chemistry, Genetics, Cell Biology, Proofreading, Bioinformatics, Cell Culture, Microbiology, Clinical Trials, In Vivo, Cancer, Clinical Development, Clinical Research, Publications, CRO, PCR, Medical Writing, Western Blotting, Cell, Pharmaceutics, Cancer Research, R&D

Education
University of Colorado Health Sciences Center   1992 — 1998
Ph.D., Pharmaceutical Science

University of Colorado at Boulder   1989 — 1992
B.A., Environmental, Population, and Organismic Biology

Patrick Stone Patrick Stone Austin, Texas Area Details
Patrick Stone's US FDA Experience August 1998 - March 2011
Job Biotechnology & Pharmaceutical QA BIMO / GMP http://tradestoneqa.com/
Industry Pharmaceuticals
Experience
TradeStone QA LLC   April 2011 - Present
Xlibris Publishing   May 2011 - Present
US FDA   August 1998 - March 2011
Dallas District   January 2001 - January 2009
DPT Laboratories  February 1998 - August 1998
Stanbio Laboratory  1996 - 1998

Skills
Computer System..., Software Validation, GXP, Regulatory Affairs, Regulatory Documentation, Drug Development, Marketing Strategy, Social Media, Quality Assurance, IRB, Clinical Research, Gene Therapy, ICH-GCP, Staff Training, GCP, FDA GMP, FDA, QbD, Quality Auditing, GMP, Clinical Development, GxP, CAPA, Clinical Trials, Pharmaceutical Industry, Quality by Design, CTMS, Biotechnology, 21 CFR Part 11, Validation, Vaccines, GLP, IND, CRO, Oncology, Testing

Education
The University of Texas at San Antonio   1996 — 1998
MS, Biotechnology

St. Anthony High School Seminary   1986 — 1990

HDO

Florence Kaltovich Florence Kaltovich Washington D.C. Metro Area Details
Florence Kaltovich's US FDA Experience 1990 - 1997
Job Senior Program Manager, Regulatory Affairs (C) at NIH/NIAID/Vaccine Research Center
Industry Biotechnology
Experience
NIH/NIAID/Vaccine Research Center   December 2011 - Present
Rockville, MD  December 2008 - December 2011
PATH Malaria Vaccine Initiative  January 2009 - November 2011
Summit Drug Development Services   April 2008 - December 2008
SAIC  October 1997 - April 2008
PAREXEL  February 1997 - September 1997
US FDA   1990 - 1997

Skills
Quality Assurance, Regulatory Affairs, Vaccines, Biotechnology, FDA, Program Management, Technology Transfer, V&V, Regulatory Submissions, Strategy, R&D, Validation, Management, Clinical Development, Sop, Drug Development, Pharmaceutical Industry, GMP, Quality Auditing, Lifesciences, CAPA, Biopharmaceuticals, Quality System, GLP, Medical Devices, Manufacturing, Clinical Trials, Molecular Biology, Clinical Research, Drug Discovery

Education
The Johns Hopkins University   1987 — 1990
MHS, Environmental/Radiation Health

Drexel University   1983 — 1985
MS, Radiation Health

Stockton University   1977 — 1981
BS, chemistry

Deborah Sholtes Deborah Sholtes Washington D.C. Metro Area Details
Deborah Sholtes's US FDA Experience August 2008 - December 2009
Job
Industry Government Administration
Experience
FDA Center for Tobacco Products  March 2010 - Present
US FDA   August 2008 - December 2009
U.S. FDA   November 2007 - August 2008
US Food and Drug Administration  September 2006 - November 2007
US FDA/Office of the Chief Information Officer   March 1999 - August 2006
TRW  1992 - 2002
BDM  1992 - 1997

Skills
FDA, Epidemiology, Government, Program Management, Federal Government, Data Analysis, Policy, Project Management, Strategic Planning, Process Improvement, Change Management, Policy Analysis, Enterprise Architecture, Business Analysis, Public Policy, Requirements Analysis, Risk Management, Research, Management Consulting, Governance, Business Process..., Analysis, Technical Writing, Strategic Communications, Proposal Writing, Program Evaluation, PMP, Project Portfolio..., Strategy, Government Contracting, DoD, Public Health, PMO, Integration, Leadership, International Relations, SDLC, Information Assurance

Education
Partnership for Public Service - EIG   2013 — 2014

Harvard University Kennedy School of Government   2009 — 2009
Senior Executive Fellows

Washington University in St. Louis   1987 — 1989
M.S. Engineering and Public Policy

Beloit College   1982 — 1987
B.S. Environmental Geology

Partnership for Public Service - EIG

James Warn James Warn Elmira, New York Area Details
James Warn's US FDA Experience 1965 - 1999
Job Independent Government Administration Professional
Industry Government Administration
Experience
US FDA   1965 - 1999
US FDA   1965 - 1999

Education
University of Colorado Boulder   1962 — 1965

Mark Powley Mark Powley Washington D.C. Metro Area Details
Mark Powley's US FDA Experience May 2009 - Present
Job Pharmacolgy/Toxicology Reviewer at U.S. FDA
Industry Pharmaceuticals
Experience
U.S. FDA   May 2009 - Present
Merck  December 2006 - May 2009
Merck  November 2004 - December 2006
University of North Carolina at Chapel Hill  2001 - 2004

Skills
In Vivo, Toxicology, Pharmacokinetics, GLP, Pharmacology, In Vitro, Molecular Biology, Cell Culture, HPLC, Mass Spectrometry, Lifesciences, Biotechnology, Drug Discovery, Assay Development, Regulatory Affairs, Protein Purification, Purification, Animal Models, Sop, PCR, Cancer, Pharmaceutical Industry, Drug Development, Vaccines, Western Blotting, Laboratory, Oncology, Immunology, CRO, LC-MS, Regulatory Submissions, Cell, Cell Biology, ELISA, Validation, Microbiology, Analytical Chemistry, R&D, Chromatography, Infectious Diseases, Biochemistry, Tissue Culture, IND, FDA, GMP, Biopharmaceuticals, Chemistry

Education
Purdue University   1999 — 2001
Ph.D., Toxicology

Purdue University   1996 — 1999
M.S., Industrial Hygiene

Wright State University   1991 — 1996
B.S, Environmental Health

Corinne Rubin Corinne Rubin Greater New York City Area Details
Corinne Rubin's US FDA Experience May 2012 - May 2012
Job Freelance Conference Interpreter & Translator French & Spanish > English
Industry Translation and Localization
Experience
United Nations  January 2002 - Present
US-FDA  May 2012 - May 2012
WIPO  2002 - 2012
World Health Organization  2003 - 2007
International Federation of Red Cross and Red Crescent Societies  July 2004 - July 2006
Permanent Mission of the Republic of Korea to the United Nations  2001 - 2002

Skills
Translation, Intercultural..., Localization, Foreign Languages, Trados, Language Services, French, Multilingual, Interpreting, Proofreading, International Relations, Editing, Conference Interpreting, English, Human Rights, International..., Simultaneous..., Technical Translation, Legal Translation

Education
Universidad Internacional Menéndez Pelayo   2007 — 2007
summer intensive course, economics, finance, politics, literature

Middlebury Institute of International Studies at Monterey   1997 — 2000
MA, Translation (French & Spanish --> English)

University of Geneva   1998 — 1999
(exchange student), Conference Interpretation (French & Spanish --> English)

Bradford College, Bradford, MA   1994 — 1996
BA, Humanities

Franklin College of Switzerland   1993 — 1994
(year abroad), International Relations

Northeastern University   1992 — 1993
International Business

Daniel Geffin Daniel Geffin Washington D.C. Metro Area Details
Daniel Geffin's US FDA Experience Food TechnologistFDA2000 - Present
Job Regulatory Analyst at US FDA
Industry Food Production
Experience
US FDA   Food TechnologistFDA2000 - Present

Skills
Science, Regulatory Affairs, Food Processing, Food Microbiology, HACCP, Food Safety, GMP, FDA, Food Technology, Food Manufacturing, Food Science, Food Industry, Validation, Food, Quality Assurance, Microbiology, Process Improvement, Sanitation, Sop, Regulations

Education
University of Massachusetts, Amherst   1996 — 2000
BS, Food Science

Emory University School of Law   1986 — 1989

Adam Wasserman Adam Wasserman Cambridge, Massachusetts Details
Adam Wasserman's US FDA Experience 2003 - 2006
Job Associate Director Regulatory Affairs at Biogen Idec
Industry Pharmaceuticals
Experience
Biogen Idec  October 2014 - Present
Food & Drug Administration, Center for Drug Evaluation & Research   2006 - Present
US FDA   2003 - 2006
Memorial Sloan-Kettering Cancer Center  2001 - 2003

Skills
Neuroscience, Pharmacology, Lifesciences, Drug Development, Clinical Development, In Vivo, Drug Discovery, Animal Models, Clinical Trials, Toxicology, Regulatory Submissions, Regulatory Affairs, IND, FDA

Education
Georgetown University School of Medicine
Ph.D., Pharmacology

University of Wisconsin-Madison   1988 — 1991
Bachelor of Science (B.S.), Psychology

Bill Yee Bill Yee Northbrook, Illinois Details
Bill Yee's US FDA Experience 1996 - 1998
Job Food Safety Manager at Walgreens
Industry Retail
Experience
Walgreens  June 2015 - Present
Target Corp  May 2001 - May 2015
Genuardi's Family Markets  January 1998 - May 2001
US FDA   1996 - 1998
US FDA   1989 - 1996
Swatara Township  1987 - 1989

Skills
Food Industry, Product Development, Supply Chain, Food, Loss Prevention, Training, Food Safety, Inventory Management, HACCP, Leadership Development, Store Management, Income Statement, Retail, Inventory Control, Process Improvement, Quality Management, Team Building, Profit, Customer Service, Purchasing, Public Speaking, Merchandising, Quality Assurance, Outlook, Food Service, Strategic Planning, Big Box, Auditing, Customer Satisfaction, Leadership, Management, PowerPoint, Shrinkage, Microsoft Excel, Team Leadership, Operations Management, Project Planning, Grocery, Budgets, Forecasting, Project Management, Store Operations, GMP, Sales, Cross-functional Team..., Driving Results, Data Analysis, Sales Management, Microsoft Office, Quality System

Education
University of Michigan
B.S., Microbiology

University of Oklahoma Health Sciences Center
MPH, Health Administration

Susannah K. O'Donnell Susannah K. O'Donnell Baltimore, Maryland Area Details
Susannah K. O'Donnell's US FDA Experience September 2008 - Present
Job Regulatory Review Officer at FDA
Industry Research
Experience
US FDA   September 2008 - Present
US FDA   July 2006 - September 2008
US FDA   April 2001 - July 2006

Skills
FDA, Regulatory Affairs, Public Health, Life Sciences, Research, Infectious Diseases, Microbiology, Molecular Microbiology, Epidemiology

Education
Emory University   1999 — 2001
MPH, Epidemiology

Michigan State University   1992 — 1995
BS, Microbiology

Olusegun Ajayi Olusegun Ajayi Greater Los Angeles Area Details
Olusegun Ajayi's US FDA Experience July 2002 - Present
Job US FDA/ USN
Industry Government Administration
Experience
US FDA   July 2002 - Present
US Navy  September 1997 - Present

Skills
Military

Education
Defense Acquisition University
DAWIA level 1, Contracting and logistics

Obafemi Awolowo University
Bachelor of Science (BSc), Chemical Engineering

University of Lagos
Master of Business Administration (MBA), Business Administration and Management, General

Xiang(Sam) Zhu Xiang(Sam) Zhu Greater New York City Area Details
Xiang(Sam) Zhu's US FDA Experience March 2007 - April 2008
Job Senior chemist II at L'Oreal
Industry Cosmetics
Experience
L'Oreal  October 2010 - Present
Croda  April 2008 - December 2010
U.S. FDA   March 2007 - April 2008
MedImmune(AstraZeneca)   May 2006 - August 2006

Education
University of Maryland College Park   2005 — 2007
Ph.D, Physical Chemistry

Boston College   2002 — 2005
MS, Chemistry

University of Science and Technology of China   1994 — 1999
B.S, Polymer chemist

Andy Kish Andy Kish Washington D.C. Metro Area Details
Andy Kish's US FDA Experience September 2012 - Present
Job Director, Program Evaluation and Implementation Staff at U.S. FDA
Industry Public Policy
Experience
U.S. FDA   September 2012 - Present
U.S. FDA   September 2009 - August 2012
Maximus  September 2008 - September 2009
United States Institute of Peace  2003 - 2007

Skills
Program Management, Policy Analysis, Project Management, Public Policy, Program Evaluation, Data Analysis, Strategy, Government, Analysis, Strategic Planning

Education
Carnegie Mellon University   2007 — 2008

Virginia Commonwealth University   1997 — 2001
BA, Politicial Science

Harvard University, John F. Kennedy School of Government
Executive Education Certificate

Sumit Sen Sumit Sen Orange County, California Area Details
Sumit Sen's US FDA Experience August 1995 - Present
Job Chemist (Instrument Specialist) at US FDA
Industry Government Administration
Experience
US FDA   August 1995 - Present

Skills
GMP, Regulatory Affairs, Analytical Chemistry, FDA, Validation, CAPA, Analytical Equipment, HPLC, GC-FID, FTIR, UV-Vis-NIR, Instrumentation, Instrument Validation, ISO 17025, 21 CFR Part 11, Regulatory Requirements, GC-MS, Quality Assurance, Quality Management, Quality System, Quality Control, Quality Auditing, Medical Devices, Pharmaceutical Sciences, Food Safety, Nutraceuticals, Sop, A2LA Accreditation, Pharmaceutical..., 21 CFR Part 210 & Part..., 21 CFR Part 800 & Part..., 21 CFR Part 100 & Part..., 21 CFR Part 111, Gel Permeation..., Headspace Gas..., GPC, Chemistry, UV/Vis, Gas Chromatography, R&D, Chromatography, LC-MS, LIMS, Technology Transfer, V&V, Change Control, Wet Chemistry, Mass Spectrometry, Laboratory, Microbiology

Education
The University of Akron   1988 — 1994
MS & PhD, MS (Chemical Engineering) & PhD (Polymer Science)

Jadavpur University   1981 — 1985
B. Eng., Chemical Engineering

Christine Parmentier Christine Parmentier San Francisco Bay Area Details
Christine Parmentier's US FDA Experience InvestigatorUS Food and Drug Administration2000 - Present
Job Investigator at U.S. FDA
Industry Government Administration
Experience
U.S. FDA   InvestigatorUS Food and Drug Administration2000 - Present
U. S. FDA   1993 - 2000

Education
University of California, San Francisco   1969 — 1971

Amy Singer Amy Singer Greater New York City Area Details
Amy Singer's US FDA Experience October 1996 - September 2005
Job Manager Quality, Standards and Training at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb  August 2007 - Present
Bristol-Myers Squibb  October 2005 - August 2007
US FDA   October 1996 - September 2005

Skills
Sop, GMP, FDA, Regulatory Affairs, Pharmaceutical Industry, Validation, Clinical Development, Clinical Trials, GCP, Biotechnology, Change Control, Quality Assurance, Regulatory Submissions, SharePoint, SharePoint Designer, Document Review, Procedural Development, Document Management, CTMS, SOP

Education
Penn State University   1992 — 1996
Bachelor of Science (B.S.), Food Science

HHS   1988 — 1992

David Gartner David Gartner Washington D.C. Metro Area Details
David Gartner's US FDA Experience September 2002 - Present
Job Branch Chief at US FDA
Industry Information Services
Experience
US FDA   September 2002 - Present
KRA Corporation  1994 - 2002
Maxima Corporation  1987 - 1994

Skills
Regulatory Analysis, Public Health, Regulatory Affairs, Federal Government, Epidemiology, Government, Regulations, FDA, Program Evaluation, Policy Analysis, Public Policy, Policy, Program Management

Education
American University   1976 — 1979
Bachelor of Arts (B.A.), Comunication

Windham College   1974 — 1976
Political Science and Government

Daryl Kaufman Daryl Kaufman Washington D.C. Metro Area Details
Daryl Kaufman's US FDA Experience September 1988 - Present
Job Senior Scientific Reviewer/Biologist at US FDA
Industry Government Relations
Experience
US FDA   September 1988 - Present
U.S. Environmental Protection Agency   February 1980 - April 1987

Skills
Medical Devices, Research, Program Management, Lifesciences, Data Analysis, Molecular Biology, Neurology, Biotechnology, Clinical Development, Environmental Health, Government, Healthcare, Life Sciences, Project Management, Public Health, Regulatory Affairs, Science

Education
The George Washington University   1978 — 1980
M.A., Environmental Health

Temple University   1973 — 1977
B.A.

Ardsley High School

Jennifer Crews Jennifer Crews Greater Atlanta Area Details
Jennifer Crews's US FDA Experience May 2009 - Present
Job Biotechnology Professional
Industry Biotechnology
Experience
US FDA   May 2009 - Present
United States Federal Government  October 2008 - Present
Crews Irrigation   June 1998 - April 2008
University of Alabama  February 1997 - December 2002
Farms Technology Division   June 1995 - January 1997
Auburn University  July 1992 - June 1995

Education
Auburn University
Bachelors, Animal Sciences Pre-veterinary Medicine

Randolph County High School

Gopal Gopinath Gopal Gopinath Washington D.C. Metro Area Details
Gopal Gopinath's US FDA Experience 2009 - Present
Job Geneticist Genomics/Bioinformatics
Industry Research
Experience
US FDA   2009 - Present
Cold Spring Harbor Laboratory  July 2003 - 2009
Medical College of Wisconsin  2002 - 2003
Univ of California, Berkeley   July 1999 - December 2001
Brandeis University  August 1998 - June 1999

Skills
Molecular Biology, Life Sciences, Genetics, Biochemistry, Science, Research, Biotechnology, Cell Biology, Data Analysis, Genomics, Microbiology, Lifesciences, PCR, Bioinformatics, DNA, Protein Chemistry, Western Blotting, Cell, Computational Biology, Scientific Writing, Molecular Cloning, Bioinformatics genomics...

Education
Anna Univeristy, Chennai, India   1992 — 1998
PhD, Biotechnology

Stony Brook University   2008 — 2008
Fundamentals of Biosciences Industry

Bahru Habtemariam Bahru Habtemariam Washington D.C. Metro Area Details
Bahru Habtemariam's US FDA Experience September 2008 - Present
Job Clinical Pharmacology Reviewer at US FDA
Industry Pharmaceuticals
Experience
US FDA   September 2008 - Present
Novartis  July 2006 - July 2008
Novartis Pharma AG  2006 - 2008
Cognigen   July 2004 - July 2006

Skills
Pharmacokinetics, Clinical Pharmacology, Pharmacodynamics, Clinical Trials, Drug Development, PK/PD, Pharmacology

Education
University of Maryland Baltimore

Emilio Escobar Emilio Escobar Dallas, Texas Details
Emilio Escobar's US FDA Experience April 2002 - Present
Job Supervisory Investigator at US FDA
Industry Government Administration
Experience
US FDA   April 2002 - Present
DPT Laboratories  1996 - 2002

Education
The University of Texas at San Antonio   1990 — 1995
BS, Biology

Joseph Puleo Joseph Puleo Washington D.C. Metro Area Details
Joseph Puleo's US FDA Experience May 1990 - January 2009
Job Independent Consultant
Industry Medical Devices
Experience
None  January 2009 - Present
US FDA   May 1990 - January 2009
US Food and Drug Admin   July 1972 - January 2009
US FDA   1972 - 1990

Skills
Quality Systems, Medical Devices, FDA, Food

Education
City University of New York City College   1969 — 1972
BS, chemistry

Brooklyn College

Antonio Laurenza Antonio Laurenza Greater New York City Area Details
Antonio Laurenza's US FDA Experience December 1984 - July 1990
Job Executive Director at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research  February 2008 - Present
GlaxoSmithKline  July 1990 - February 2008
US FDA   December 1984 - July 1990

Skills
Psychiatry, Neurology, Clinical Development, Translational Medicine, Clinical Trials, Pharmaceutical Industry, Drug Development, Neuroscience

Education
Università degli Studi di Napoli 'Federico II'   1979 — 1984
MD

Università degli Studi di Napoli 'Federico II'   1974 — 1979
MD

Andrew Papas, PhD, MBA Andrew Papas, PhD, MBA Greater Boston Area Details
Andrew Papas, PhD, MBA's US FDA Experience 1978 - 1989
Job Vice President of Regulatory Affairs at NSF International, Global Health Sciences Division (Becker and Associates)
Industry Biotechnology
Experience
NSF International, Health Sciences, Pharma Biotech Consulting   July 2013 - Present
NSF International (formerly Becker & Associates Consulting, Inc)   November 2011 - July 2013
ANP Consulting, LLC   January 2011 - November 2011
Shire Human Genetic Therapies  2007 - December 2010
Wyeth  2001 - 2007
Sepracor  2000 - 2001
Polaroid  1989 - 2000
US FDA   1978 - 1989

Skills
Regulatory Affairs, Biotechnology, FDA GMP, Team Leadership, Global CMC Regulatory..., Drug Development, Combination Products, FDA, Pharmaceutical Industry, IND, Regulatory Submissions, Biopharmaceuticals, Clinical Development, GMP, HPLC, Protein Chemistry, CMC, Oncology, Pharmaceutics, Medical Devices, Clinical Research

Education
Boston University - School of Management   2000 — 2001
MBA, International Business & Team Dynamics

Boston University
BA, Chemistry

University of Massachusetts Lowell
PhD, Chemistry

Donnie Lowther Donnie Lowther Washington D.C. Metro Area Details
Donnie Lowther's US FDA Experience 1988 - Present
Job Producer, Director, Editor at Around Space Productions
Industry Government Administration
Experience
Around Space Productions   2001 - Present
U.S. FDA   1988 - Present
National Space Society  1985 - Present
St James United Methodist Church in Alexandria, VA   1980 - Present
U.S. Consumer Product Safety Commission   February 1975 - September 1988

Skills
Editing, Leadership, Government, Television, Social Media, Research, Technical Writing, Video Production, Policy, Producing, Microsoft Office, Event Management, T.V. Directing

Education
Fairmont State University   1970 — 1973
B.S., Biology

Robert Altobelli Robert Altobelli Springfield, Massachusetts Area Details
Robert Altobelli's US FDA Experience September 2001 - Present
Job Investigator at US FDA
Industry Government Relations
Experience
US FDA   September 2001 - Present
MA Div. of Food and Drugs   June 1992 - September 2001

Education
University of Massachusetts, Amherst   1988 — 1992
BS, Public Health

Suneela Prodduturi Suneela Prodduturi Ellicott City, Maryland Details
Suneela Prodduturi's US FDA Experience March 2005 - April 2009
Job Pharmaceutical Professional
Industry Pharmaceuticals
Experience
Food and Drug Adminstration  June 2014 - Present
Pharmaceutics International Inc., MD   January 2014 - May 2014
Steer Engineering Private Limited   February 2012 - December 2013
Aizant Drug Research Solutions Pvt. Ltd., Hyderabad   April 2009 - November 2012
US FDA   March 2005 - April 2009
University of Mississippi  July 2004 - March 2005
University of Mississippi  August 2000 - July 2004
University of Louisiana at Monroe  January 2000 - July 2000

Education
University of Southern California   2008 — 2009
Patient and Product Safety, Regulatory Science

University of Mississippi   2000 — 2004
Ph.D., Pharmaceutics, 4.0/4.0 GPA

Kakatiya University   1995 — 1999
Bachelors of Pharmacy, Pharmaceutical Sciences

shewit bezabeh shewit bezabeh Washington D.C. Metro Area Details
shewit bezabeh's US FDA Experience September 2000 - Present
Job Medical Epidemiologist at US FDA
Industry Hospital & Health Care
Experience
WHC  October 2001 - Present
US FDA   September 2000 - Present
MedStar Health  2000 - Present

Skills
Public Health, Epidemiology, Clinical Research, Medicine, Internal Medicine, Board Certified, Medical Research, Hospitals, Emergency Medicine, Prevention, Patient Safety, Clinical Trials, Global Health, International Health, Medical Education, Healthcare, Healthcare Management, EMR, Critical Care

Education
The Johns Hopkins University   1995 — 1996
MPH, Public Health

The Johns Hopkins University School of Medicine   1995 — 1996
MPH, Preventive Medicine

University of California, Irvine   1983 — 1990
Doctor of Medicine (MD), Interna Medicine

University of California, Irvine - College of Medicine   1983 — 1990
MD, Medicine

Jill Burkoff Jill Burkoff Washington D.C. Metro Area Details
Jill Burkoff's US FDA Experience 2008 - Present
Job Consumer Safety Officer at US FDA
Industry Biotechnology
Experience
US FDA   2008 - Present

Education
The George Washington University   1977 — 1979
B.S., Biology

Yaning Wang Yaning Wang Washington D.C. Metro Area Details
Yaning Wang's US FDA Experience 2003 - Present
Job Deputy Director
Industry Government Administration
Experience
US FDA   2003 - Present
University of Florida  1999 - 2003

Skills
Pharmacokinetics, Pharmacology, NONMEM, Pharmacodynamics, Clinical Pharmacology, Clinical Trials, Pharmaceutical Industry, Drug Development, Drug Discovery, Drug Metabolism, Infectious Diseases, Oncology, Clinical Development, Statistics, Disease model, R, SAS, Alzheimer's disease, Huntington's Disease, Parkinson's disease, Trial simulation, Bioequivalence, Biosimilars, Cardiovascular Safety..., Pharmacometrics, WinBUGS, Population..., Scaled bioequivalence, In Vivo, Therapeutic Areas, Science, In Vitro, Toxicology, Clinical Study Design, PK/PD, LC-MS, Biostatistics, WinNonlin, HPLC, Regulatory Submissions, GLP

Education
University of Florida   2001 — 2003
Master of Statistics, Statistics, 4.0

University of Florida   1999 — 2003
Ph.D., Pharmaceutics, 4.0

Beijing University of Physical Education   1996 — 1999
Master of Education in Biochemistry, Analytical Chemistry

Peking University   1992 — 1996
Bachelor, Pharmaceutics

Gregg Claycamp Gregg Claycamp Washington D.C. Metro Area Details
Gregg Claycamp's US FDA Experience January 2007 - November 2011
Job Senior Scientist for Risk Analysis and Decision Analysis at FDA CVM
Industry Government Administration
Experience
FDA  November 2011 - Present
US FDA   January 2007 - November 2011
FDA  2001 - 2011
University of Pittsburgh  1990 - 2001
University of Iowa College of Medicine  1985 - 1990
University of Kansas  1981 - July 1985

Skills
Decision Analysis, Risk Modeling, SAS, Monte Carlo Simulation, Decision Support, Risk Management, Statistics, Risk Analysis, Policy, Risk Assessment, FDA, Toxicology, Lifesciences, Regulatory Requirements, Drug Development, Clinical Trials, Biotechnology, Clinical Development, Regulatory Submissions, Biostatistics, GLP, Pharmaceutical Industry

Education
Northwestern University   1977 — 1982
PhD, Radiological Health Engineering

Northwestern University   1975 — 1977
MS, Radiological Health Engineering

Stanford University   1970 — 1974
BA, Human Biology

Derek (Yuanchao) Zhang Derek (Yuanchao) Zhang Washington D.C. Metro Area Details
Derek (Yuanchao) Zhang's US FDA Experience September 2002 - December 2008
Job President at Alavanda Regulatory and Drug Development Consulting, Inc.
Industry Pharmaceuticals
Experience
Frontage Laboratories, Inc  December 2008 - April 2013
U.S. FDA   September 2002 - December 2008
Pfizer  July 1998 - August 2002

Skills
Pharmaceutical Industry, Clinical Development, FDA, Clinical Trials, Regulatory Affairs, Global Drug Development, FDA IND Filing, Biologics and...

Education
University of California, San Francisco   1993 — 1998
Doctor of Philosophy (Ph.D.), Biopharmaceutical Sciences

University of Rochester   1992 — 1993
Master's Degree, Physical Chemistry

Fudan University   1984 — 1988
Bachelor of Science (BS), Chemistry

Consuelo Nausin Consuelo Nausin San Francisco Bay Area Details
Consuelo Nausin's US FDA Experience February 2003 - Present
Job Chemist at US FDA
Industry Government Administration
Experience
US FDA   February 2003 - Present

Skills
Analytical Chemistry, Elemental Analysis, ICP-MS, ICP-OES, XRF, Speciation, ISO 17025, Internal Auditing, Laboratory, FDA, UV/Vis, IR, Chemistry, LC-MS, Internal Audit, Mass Spectrometry, Wet Chemistry, Gas Chromatography, GC-MS, Chromatography, FTIR, HPLC

Education
Mills College
Bachelor of Arts (B.A.), Chemistry

Mills College
Bachelor's degree, Chemistry

Ekopimo Okon Ibia Ekopimo Okon Ibia Washington D.C. Metro Area Details
Ekopimo Okon Ibia's US FDA Experience 1998 - 2004
Job Director at Merck & Co., Inc.
Industry Pharmaceuticals
Experience
Merck & Co., Inc.   January 2015 - Present
Johns Hopkins University  2008 - Present
Drug Information Association  2006 - Present
Merck Research Laboratories  2004 - Present
Merck  2004 - Present
Merck & Co., Inc.   December 2004 - January 2015
US FDA   1998 - 2004

Skills
Pharmaceutical Industry, Clinical Research, Pediatrics, Medicine, Regulatory Affairs, FDA, Clinical Development, Infectious Diseases, Hospitals, Drug Development, Lifesciences, Policy, Biotechnology, Clinical Trials, Regulatory Submissions, Healthcare, Public Health, GCP, Cross-functional Team..., Pharmacovigilance, Medical Writing, Vaccines, Immunology, Oncology, Drug Discovery, CRO, Life Sciences

Education
The George Washington University   1998 — 2001
MPH

University of Nigeria   1974 — 1980
MBBS

Hope Waddell Training Institution, Calabar

Sandy Weininger Sandy Weininger Washington D.C. Metro Area Details
Sandy Weininger's US FDA Experience Electrical/Biomedical EngineerUS FDA1990 - Present
Job Senior Biomedical Engineer at US FDA
Industry Medical Devices
Experience
US FDA   Electrical/Biomedical EngineerUS FDA1990 - Present

Education
University of Pennsylvania   1983 — 1988
Ph.D., Bioengineering

Drexel University   1978 — 1983
BS/MS, EE/BiMed

Winston Moran Winston Moran Washington D.C. Metro Area Details
Winston Moran's US FDA Experience January 2001 - Present
Job Biologist at US FDA
Industry Research
Experience
US FDA   January 2001 - Present
Advanced Bioscience Laboratories  June 1994 - December 2000
United States Army  September 1984 - May 1994

Skills
Cell Culture, PCR, Microsoft Word, ELISA, Microbiology, Western Blotting, Cell Biology, qPCR, Biochemistry, Toxicology, IND, Molecular & Cellular..., Molecular Cloning, Microsoft Office, Flow Cytometry, Molecular Virology, GMP, GLP, Laboratory Technicians, Blood Bank

Education
The Johns Hopkins University   1997 — 2000
Master of Science (MS), Biotechnology

University of Maryland University College   1990 — 1997
Bachelor of Science (BS), Microbiology, General

Stephen Hadley Stephen Hadley Greater Seattle Area Details
Stephen Hadley's US FDA Experience June 1991 - October 1995
Job Senior Program Officer at Bill & Melinda Gates Foundation
Industry Biotechnology
Experience
Bill & Melinda Gates Foundation  September 2013 - Present
CMC ICOS Biologics  February 2008 - August 2013
ICOS Corporation  October 1995 - February 2008
US FDA   June 1991 - October 1995
NeoRx Corporation  April 1986 - April 1989

Education
University of Washington   1980 — 1986
PhD, Organic Chemistry/Natural Products Chemistry

University of Maine   1975 — 1979
BS, Chemistry

Sandra Kweder Sandra Kweder Washington D.C. Metro Area Details
Sandra Kweder's US FDA Experience April 2000 - Present
Job Deputy Director, Office of New Drugs at U.S. FDA
Industry Government Administration
Experience
U.S. FDA   April 2000 - Present
Center for Drug Evaluation and Research, FDA   1997 - 2000

Skills
Policy Analysis, Public Speaking, Community Outreach, Internal Medicine, Health Policy, Public Health, Program Management, Strategic Planning, Drug Development, Regulatory Affairs, Regulatory Science, Medical Teaching

Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM   1981 — 1984
Doctor of Medicine (M.D.)

University of North Carolina at Chapel Hill   1980 — 1981
Health Policy and Administration

University of Connecticut   1975 — 1979
Bachelor of Science (B.S.), Biology, General

Perry G. Wang Perry G. Wang Washington D.C. Metro Area Details
Perry G. Wang's US FDA Experience October 2008 - Present
Job Research Chemist at US FDA
Industry Government Administration
Experience
US FDA   October 2008 - Present
Teleflex Medical  March 2007 - October 2008
Abbott Laboratories  September 2000 - March 2007

Skills
LC-MS, HPLC, Analytical Chemistry, GC-MS, Chromatography, UV/Vis, Chemistry, Mass Spectrometry, GLP, Validation, Method Development, Lifesciences

Education
Oregon State University
Doctor of Philosophy (Ph.D.), Environmental Engineering

Ira Somerset Ira Somerset Miami/Fort Lauderdale Area Details
Ira Somerset's US FDA Experience 1968 - 2001
Job Boat Captain at Hyline Harbor Tours & Water Taxi
Industry Food Production
Experience
Hyline Harbor Tours   June 2013 - Present
Hyline Cruises   June 2013 - Present
Non-specific Company   August 2001 - June 2009
U.S. FDA   1968 - 2001

Skills
Team Building, Negotiation, Customer Service, Aquaculture, Strategic Planning, Public Speaking, Public Relations, Project Planning, Government, Microsoft Office, Project Management, Microsoft Excel, New Business Development, Research, Leadership, Budgets, Editing, Training, Management, Event Planning

Education
Tufts University   1966 — 1968
Master's Degree, Environmental Engineering

University of Massachusetts, Amherst   1961 — 1966
BSCE, Civil Engineering

Elena Mishina Elena Mishina Washington D.C. Metro Area Details
Elena Mishina's US FDA Experience 1999 - Present
Job Senior Pharmacologist at US FDA
Industry Government Administration
Experience
US FDA   1999 - Present
FDA  January 1996 - January 1999
University at Buffalo  1991 - 1995
Kursk Medical University   June 1986 - October 1991
Kursk Medical University   March 1984 - June 1986

Skills
Pharmacokinetics, Pharmacology, Biochemistry, Regulatory Affairs, Toxicology, Molecular Biology, Lifesciences, Cell Culture, In Vivo, ELISA, Drug Discovery, HPLC, Clinical Trials, Biotechnology, Drug Development, PCR, GLP, In Vitro, IND, Regulatory Requirements, NDA, Clinical Research, LC-MS, Clinical Development, Immunology, Mass Spectrometry, Assay Development, Analytical Chemistry, Protein Chemistry, Medicinal Chemistry, Chromatography, Regulatory Submissions, Biopharmaceuticals, Cell, Animal Models, FDA, Infectious Diseases, CRO, Life Sciences

Education
SUNY at Buffalo   1991 — 1993
Post-Doctoral, Pharmacokinetics/Pharmacodynamics

Lomonosov Moscow State University (MSU)
Doctor of Philosophy (PhD), Organic Chemistry

highschool

Changning Guo Changning Guo Greater St. Louis Area Details
Changning Guo's US FDA Experience September 2004 - Present
Job Chemist at US FDA
Industry Pharmaceuticals
Experience
US FDA   September 2004 - Present

Skills
Analytical Chemistry, Inhalation Aerosols, Particle Size, laser diffraction..., cascade impaction, dynamic laser light..., Chemistry, Spectroscopy, X-ray Powder..., Design of Experiment..., Chemometrics, flow imaging microscopy, Raman microscopy, Vibrational Circular..., IR, NIR, Fluorescence, UV-vis, Raman imaging microscopy, spray pattern and plume..., Phase-Doppler...

Education
Syracuse University   1999 — 2004
Ph. D., Analytical Chemistry

Institute of Chemistry, Chinese Academy of Science   1996 — 1999
Master of Science (M.S.), Physical Chemistry

Tsinghua University   1991 — 1996
Bachelor of Science (B.S.), Chemistry

mandy eisemann mandy eisemann Washington D.C. Metro Area Details
mandy eisemann's US FDA Experience August 1999 - Present
Job Public Affairs Specialist at US FDA
Industry Public Relations and Communications
Experience
US FDA   August 1999 - Present

Education
Towson University

Harold Bryan Harold Bryan United States Details
Harold Bryan's US FDA Experience April 1959 - January 1989
Job
Industry Law Enforcement
Experience
Colorado Springs, CO  Director Regulatory AffairsMedtronicMay 1994 - July 1995
US FDA   April 1959 - January 1989

Education
University of Missouri   1952 — 1957
B.S., Farm Management

University of Missouri-Columbia   1952 — 1957
B.S., Agriculture

Laurie Frazier Laurie Frazier Portland, Maine Area Details
Laurie Frazier's US FDA Experience 2001 - July 2012
Job Engineering and Regulatory Support
Industry Medical Devices
Experience
US FDA   2001 - July 2012
AVX Tantalum Corporation  August 1996 - January 2001
Pioneer Plastics  1992 - 1996
Northrop Corporation  January 1980 - August 1990
Arner-Stone Labs   1976 - 1979

Skills
Regulatory Affairs, FDA, Lifesciences, GMP, Medical Devices, R&D, Chemistry, CAPA, Research, Data Analysis, Public Speaking, Microsoft Office, Quality System, Healthcare, Grant Writing, Biotechnology, Quality Assurance, Drug Development, Process Improvement, Technology Transfer, Regulatory Requirements, Microbiology, IND, Product Development, Biochemistry, Clinical Trials, Regulatory Submissions, 21 CFR Part 11, Manufacturing, Pharmaceutical Industry, Design Control, Sop, Clinical Research, Validation, GLP, Microscopy, Clinical Development

Education
Iowa State University

Anne Pariser Anne Pariser Washington D.C. Metro Area Details
Anne Pariser's US FDA Experience 2000 - July 2006
Job Associate Director for Knowledge Management at FDA
Industry Government Administration
Experience
FDA  December 2014 - Present
FDA  February 2010 - December 2014
FDA  July 2006 - February 2010
US FDA   2000 - July 2006

Skills
Rare Diseases, Orphan Drugs, Regulatory Science, Regulatory Policy, Leadership, FDA, Clinical Research, Public Health, Medicine, Medical Education, Epidemiology, Clinical Development, Drug Development, Clinical Trials, Infectious Diseases, Regulatory Affairs, Immunology, Biotechnology, Life Sciences

Education
Georgetown University School of Medicine
Doctor of Medicine (MD)

Bates College
Bachelor of Science (B.Sc.), Chemistry

Richard Bags Howard Richard Bags Howard Baltimore, Maryland Area Details
Richard Bags Howard's US FDA Experience January 1972 - December 1972
Job Trumpet player, Band leader, retired builder
Industry Construction
Experience
Dixieland and New Orleans Jazz   January 1998 - Present
Richard L. Howard Construction Co.   1989 - April 2013
various member firms   September 1973 - March 1990
Old Time Dance Music   1973 - 1985
self  January 1973 - June 1973
US FDA   January 1972 - December 1972
Hospital Cost Analysis   1970 - 1971
Stuart L Warner   1969 - 1971
Westinghouse Electric Company  1968 - 1969
Koppers Co   1966 - 1967

Skills
Leadership, Management, Strategic Planning, Real Estate, Options, Team Building, Microsoft Office, Contract Negotiation, Customer Service, Social Media, Residential Homes, Music Production, Music, Public Speaking

Education
The George Washington University   1970 — 1973
MBA, Marketing

University of Maryland College Park   1963 — 1968
Bachelor of Science (BS), Industrial Engineering

David Morse David Morse Washington D.C. Metro Area Details
David Morse's US FDA Experience 1990 - 2007
Job Vice President at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL  March 2007 - Present
US FDA   1990 - 2007
AFRRI   1986 - 1989

Skills
FDA, Clinical Development, Oncology, Regulatory Affairs, Drug Development, Regulatory Submissions, Clinical Research, GLP, Sop, Pharmaceutical Industry, CRO, IND, Pharmaceutics, Lifesciences, R&D, Neurology, Vaccines, Biotechnology, Clinical Trials, Protein Chemistry, Biologics

Education
Uniformed Services University of the Health Sciences   1979 — 1983
PhD, Neuroscience

Vincent Vilker Vincent Vilker Washington D.C. Metro Area Details
Vincent Vilker's US FDA Experience Chief, Biotechnolgy DivisionNational Institute of Standards and Technology2002 - 2005
Job Director, Office of Testing and Research at US FDA
Industry Research
Experience
US FDA   Chief, Biotechnolgy DivisionNational Institute of Standards and Technology2002 - 2005
UCLA  1975 - 1996

Education
Massachusetts Institute of Technology   1970 — 1975
PhD, Chemical Engineering

University of Wisconsin-Madison   1961 — 1967
BS, Chemical Engineering

Chunchang Fang Chunchang Fang Greater Los Angeles Area Details
Chunchang Fang's US FDA Experience January 2003 - September 2010
Job V. P. at CSPC Dophen Corp.
Industry Pharmaceuticals
Experience
CSPC Dophen Corp.   April 2012 - Present
CSPC Dophen Corp.   October 2010 - April 2012
US-FDA  January 2003 - September 2010
QO Chemical   1989 - 1994

Skills
Technology Transfer, Regulatory Affairs, FDA, GMP, Drug Development, Biotechnology, GLP, Pharmaceutical Industry, Validation, Chemistry, R&D, Regulatory Submissions, Analytical Chemistry

Education
The Ohio State University   1984 — 1989
Ph.D., Physical Chemistry

Selwyn Wilson Selwyn Wilson Silver Spring, Maryland Details
Selwyn Wilson's US FDA Experience December 2013 - Present
Job Scientific Researcher at USFDA
Industry Research
Experience
US-FDA  December 2013 - Present
US-FDA  January 2010 - March 2014
FDA  September 2008 - January 2010
Centers for Disease Control  November 2007 - September 2008
Anand Institute of Laboratory Medicine   February 2005 - October 2007
University of Madras  November 1998 - July 2005
ORCHID Pharmaceuticals   July 2003 - November 2004
New Drug Discovery & Research,RANBAXY Research Laboratories   April 2003 - July 2003
Madras Medical College & Research Institute   July 1997 - October 1998
Christian Medical College & Hospital   September 1996 - October 1997

Skills
Microbiology, Molecular Biology, Biology, Biotechnology, ELISA, HPLC, Cell Culture, GLP, Biochemistry, Lifesciences, Chromatography, Flow Cytometry, Technology Transfer, Analytical Chemistry, GMP, Vaccines, Western Blotting, Validation, Regulatory Affairs, Assay Development, PCR, RT-PCR, Microscopy, Sequencing, qPCR, DNA, Drug Discovery, SDS-PAGE, Genomics, Gel Electrophoresis, Infectious Diseases, RNA isolation, Fluorescence Microscopy

Education
University of Madras   1998 — 2005
Ph.D, Microbiology / Molecular Biology

University of Madras   1998 — 2005
Ph.D, Applied Microbiology

University of Madras   1998 — 2005
M.Sc, Applied Microbiology

University of Madras   1998 — 2005
B.Sc, Biological Sciences

Amy Babb Amy Babb United States Details
Amy Babb's US FDA Experience November 2012 - Present
Job Technical Writer/Editor at United States Food and Drug Administration
Industry
Experience
US FDA   November 2012 - Present
US Food and Drug Administration  March 2011 - Present
Toxicologic Pathology Associates   March 2010 - March 2011
Charles River Laboratories  August 1993 - December 2009

Skills
Toxicology, In Vivo, FDA, Lifesciences, Biotechnology, GLP, Pharmacology, Sop, Pharmaceutical Industry, IND, Regulatory Submissions, Regulatory Affairs, Animal Models, CRO, Life Sciences

Education
Arkansas State University   1989 — 1993
B.S., Zoology

Dr. Mouna P. Selvam Dr. Mouna P. Selvam Washington D.C. Metro Area Details
Dr. Mouna P. Selvam's US FDA Experience July 1990 - Present
Job Senior Scientist at US FDA
Industry Government Administration
Experience
U.S. FDA   July 1990 - Present
Pan Data Systems   October 1988 - May 1990
Lombardi Cancer Research Center, Georgetown UNIV   January 1984 - September 1988
Laboratory of Tumor Immunology and Biology   January 1982 - January 1984
theCouncil of Scientific and Industrial Research   September 1976 - January 1981

Skills
FDA, Biochemistry, Protein Chemistry, Cell Culture, HPLC, ELISA, Drug Discovery

Education
Microbial Enzymes   1976 — 1980
Ph.D, Biochemistry

University of Madras   1974 — 1976
M.S;, Biochemistry, General chemistry; Education, Physical chemistry; Chemistry; Physics and Biology

Madras University   1969 — 1974
B.S. & B.Education, Chemistry Major & Education, First Class

ed janik ed janik Enfield, Connecticut Details
ed janik's US FDA Experience September 1977 - April 2012
Job Independent medical device consultant
Industry Medical Devices
Experience
Orchid Orthopedic Solutions  September 2012 - Present
US government  March 2012 - Present
US FDA   September 1977 - April 2012

Skills
Government, Policy, Strategic Planning, Process Improvement, Investigation, Public Speaking, FDA, Organizational..., Regulatory Affairs, Human Resources, Private Investigations, Interrogation, Counterintelligence, Criminal Investigations, Enforcement

Education
University of Massachusetts, Amherst
Bachelor of Science (BSc), Public Health

James Kewley James Kewley Buffalo/Niagara, New York Area Details
James Kewley's US FDA Experience 1982 - 1988
Job Principal Consultant at PAREXEL International
Industry Government Administration
Experience
PAREXEL International  January 2013 - Present
USFDA  January 2009 - December 2012
NYK-DO Compliance Branch   January 1989 - December 2009
US FDA   1982 - 1988

Education
State University of New York College at Oneonta
Bachelor of Science (B.S.)

Diana Eastwood Diana Eastwood Raleigh-Durham, North Carolina Area Details
Diana Eastwood's US FDA Experience 1992 - 1994
Job Real Estate Broker at Fathom Realty
Industry Real Estate
Experience
Fathom Realty  September 2014 - Present
Berkshire Hathaway Home Services York Simpson Underwood Realty   October 2012 - August 2014
U.S. FDA   1992 - 1994
U.S. FDA   1990 - 1992

Skills
First Time Home Buyers, Relocation, Sellers, Real Estate, Buyers, Seniors, Buyer Representation, Listings, Single Family Homes, Condos, Short Sales, Foreclosures, New Home Sales, Luxury, Investment Properties

Education
Binghamton University   1985 — 1998
B.S., Chemistry

University of Rochester   1988 — 1990
M.S., Physical Chemistry

Jduke Jduke Jduke Jduke Provo, Utah Area Details
Jduke Jduke's US FDA Experience June 1967 - Present
Job Independent Retail Professional
Industry Retail
Experience
U.S. FDA   June 1967 - Present

Skills
Microsoft Word, Evaluating a companies..., Assisting AUSA's in the..., Team Leadership, Public Speaking, Event Planning, Leadership, Teamwork, Time Management, Research

Education
Brigham Young University   1957 — 1967
Bachelor's degree, Zoology/Animal Biology

Donald Reed Donald Reed Gainesville, Florida Area Details
Donald Reed's US FDA Experience March 1979 - February 1991
Job Independent Research Professional
Industry Research
Experience
retired  June 2000 - Present
independent  April 1991 - May 2000
US FDA   March 1979 - February 1991

Skills
Analytical Chemistry, Instrumental Analysis, Technical Writing, Chemistry

Education
Georgetown University   1965 — 1965
graduate work, chemistry

The Ohio State University   1949 — 1953
BS, Chemistry Education

AJ Sankoh AJ Sankoh Greater Boston Area Details
AJ Sankoh's US FDA Experience September 1991 - February 1999
Job Vice President at Synageva BioPharma Corp.
Industry Pharmaceuticals
Experience
Synageva BioPharma Corp.  September 2014 - Present
Vertex Pharmaceuticals  April 2007 - September 2014
Sanofi-Aventis  March 2001 - April 2007
US FDA   September 1991 - February 1999

Skills
Clinical Development, Clinical Trials, Biostatistics, Protocol Development, Regulatory Submissions, People and project..., Global submission..., Excellent research..., Drug Development, Protocol, Clinical Study Design, GCP, CRO, EDC, CTMS, Validation, Pharmacovigilance, Clinical Data Management, CDISC

Education
SUNY at Buffalo
Doctor of Philosophy (PhD), Statistics

University of Toledo
Master of Science (MS), Applied Mathematics

Charlie Clavet Charlie Clavet Lincoln, Rhode Island Details
Charlie Clavet's US FDA Experience 1991 - Present
Job Microbiologist at US Department of Health and Human Services
Industry Government Administration
Experience
US Department of Health and Human Services  1991 - Present
US FDA   1991 - Present

Education
University of Rhode Island
M.S., Microbiology

Marie Kinkade Marie Kinkade Alameda, California Details
Marie Kinkade's US FDA Experience January 1990 - December 2011
Job Government Relations Professional
Industry Government Relations
Experience
Self-employed  2012 - Present
U.S. FDA   January 1990 - December 2011

Education
University of San Francisco
MBA

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