FDA/CDER Company
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. Parent agency: Food and Drug Administration
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FDA/CDER Employees
Proteus Digital Health, Inc December 2014 - Present
Greater maryland discussion group (GMDG) January 2014 - February 2015
J. AOAC (Association of Official Analytical Chemists) Intl. April 2013 - December 2014
TreMonti April 2011 - December 2014
Advanced BioNutrition: Fluid bed, Spray drying, Lyophilization, & Encapsulation June 2013 - July 2014
FDA/CDER January 2012 - June 2013
Pfizer Consumer Healthcare October 2009 - April 2011
Technical and Management Consultants (now 3DDD Market Research) February 2009 - December 2009
ICON Development Solutions June 2008 - June 2009
University of Maryland School of Pharmacy 2003 - 2008
Skills
NIR Spectroscopy, CMC Writing, Quality by Design (QbD), DSC/TGA, HPLC-Analytical Method..., Tablet/Capsule..., Extrusion-spheronization, Coating: Fluid Bed, Intellectual Property, ISO 9000, Pharmaceutics, Drug Delivery, Formulation, HPLC, Statistics, Quality Control, Regulations, Project Management, FDA, Iso 9000, NIR spectroscopy, Technology Transfer, V&V, Regulatory Affairs, Pharmaceutical Industry, GMP, Chemistry, R&D, FTIR, Change Control, CAPA, Analytical Chemistry, Clinical Trials, IND, Quality Assurance, Regulatory Submissions, Regulatory Requirements, Commercialization, Drug Development, Drug Discovery, Characterization, Chromatography, CRO, Microbiology, Quality by Design, Spectroscopy, GLP, Laboratory
Education
University of Maryland Baltimore 2003 — 2008
PhD, Pharmaceutical Science
FDA March 2014 - Present
FDA/OC March 2013 - March 2014
National Consortium for the Study of Terrorism and Responses to Terrorism (START) August 2013 - December 2013
FDA/CDER October 2011 - March 2013
DCMA June 2011 - October 2011
Maryland General Assembly January 2011 - April 2011
Office of Congressman Roscoe Bartlett September 2010 - December 2010
Office of Congressman Aaron Schock May 2010 - August 2010
Skills
Grassroots Organizing, Government, Office Management, Public Policy, Policy Analysis, Budgets, Management, Research, Policy, International Relations, Nonprofits, Public Speaking, PowerPoint, Microsoft Office
Education
University of Maryland University College 2011 — 2014
Master's Degree, Homeland Security Management
McDaniel College 2007 — 2010
Bachelors of Art, Political Science and International Studies
CERT
CERT
FDA/CDER October 2010 - Present
Georgetown University October 2006 - June 2010
Skills
primary cell culture, stable transfection..., cell proliferation assay, Apoptosis assay, Molecular cloning, Single cell RT-PCR, multicolor fluorescence, reporter gene assay, Immunohistochemistry, Immunofluorescence, protein purification, Western Blotting, Immunoprecipitation, kinase assay, calcium influx assay, confocal microscopy, Electron Microscopy, virus production..., Thin-layer..., Cell Culture, Confocal Microscopy, Molecular Cloning
Education
University of Miami Leonard M. Miller School of Medicine 2001 — 2006
PhD, Molecular and cellular Phamacology
Shanghai Institute of Cell Biology, Chinese Academy of Sciences 1995 — 1998
Master's degree, Cell Biology
Eastern China University of Science & Technology 1991 — 1995
Bachelor of Science (B.S.), Biochemistry
FDA/ Office of International Programs September 2012 - Present
FDA/CBER/OCBQ/DMPQ 2006 - September 2012
FDA/CBER 2004 - 2006
FDA/CDER 2003 - 2003
Skills
FDA, Lifesciences, Regulatory Submissions, Biotechnology, Vaccines, Chemistry, Regulatory Affairs, Government, GMP, Policy, Protein Chemistry, Public Health, Federal Government, Infectious Diseases, Biopharmaceuticals, Quality Assurance
Education
The Catholic University of America
Ph.D., Chemistry
Tunghai University 1973 — 1977
B.S., Biology
FDA/CDER August 2014 - Present
USAID/OHR January 2013 - August 2014
National Institutes of Health March 2009 - January 2013
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Public Speaking, Event Planning, Time Management, Training, Government, Team Building, Leadership, Strategic Planning
Education
Columbia College
Bachelor of Arts (B.A.), Business Administration and Management, General
Florida Community College at Jacksonville
Associate of Science (AS), Industrial Management Technology
FDA/OGD January 2015 - Present
FDA/CDER April 2013 - January 2015
Auckland University of Technology March 2011 - March 2013
Auckland UniServices Limited March 2011 - March 2013
University of Auckland September 2007 - March 2013
CSL March 2011 - April 2012
Nova Eco-Tech June 2009 - April 2012
GTR Design Solutions January 2009 - August 2010
University of Auckland September 2007 - December 2009
Genesis Research & Development January 2007 - July 2007
Skills
SAS, Medical Research, NONMEM, Clinical Development, Biomedical Engineering, Pharmacometrics, PRINCE2, PK/PD, Pharmacology, Science, Drug Delivery, Clinical Research, Drug Development, Bioinformatics, Immunohistochemistry, Epidemiology, Neuroscience, In Vivo, Clinical Pharmacology, Cell, Clinical Trials, Validation, PCR, Cancer, Animal Models, In Vitro, Biotechnology, Pharmaceutical Industry, Biochemistry, Lifesciences, Biostatistics, Medicine, Pharmaceutical Research, Molecular Biology, Drug Discovery, Oncology, Immunology, R&D, Genomics, Protein Chemistry, Regulatory Affairs, Cell Biology, Cell Culture, Commercialization, Microbiology, Technology Transfer, Infectious Diseases, Genetics, Project Management, Histology
Education
Yale University 2002 — 2004
Ph.D
Yale University 2002 — 2004
M.Phil
Cornell University 1999 — 2002
MSc
University of California, San Diego 2011 — 2012
Certificate
Uppsala University 2011 — 2011
Certificate
University of Auckland 2008 — 2008
Graduate class
University of Auckland 1996 — 1998
BE (1st hon)
University of Otago 1993 — 1995
BS
Epsom Girls Grammar School 1988 — 1993
FDA/CDER July 2008 - Present
FDA May 1996 - June 2008
Education
University of North Carolina at Chapel Hill 1985 — 1991
Pharm.D., pharmacy
Salamandra January 2003 - Present
FDA/CDER 1993 - 2002
Skills
FDA, IND, Regulatory Affairs, Clinical Development, Strategy, Microsoft Office, GMP, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Clinical Trials, Technology Transfer, Project Management
Education
American University 1982 — 1985
PhRMA December 2012 - Present
Smart EHR March 2010 - Present
CTD Consulting, LLC 2008 - Present
Boehringer Ingelheim Pharmaceuticals May 2009 - January 2010
FDA/CDER July 2002 - July 2008
Mount Sinai School of Medicine 1997 - 2002
Columbia University Medical Center 1996 - 1997
Skills
Clinical Trials, Medical Writing, Clinical Research, Pharmacovigilance, Clinical Development
Education
Brown Medical School 1988 — 1994
M.D.
Columbia University in the City of New York
Cornell University
B,A.
Stanford University Graduate School of Business
ABD
Yale University School of Medicine
Residency
FDA/CDER April 2008 - Present
Skills
Strategic Planning, Project Management, Microsoft Office, Analysis, Regulatory Affairs, Microsoft Excel, Policy Analysis, FDA, Research, Biotechnology, Regulatory Submissions, Microsoft Word
Education
The Johns Hopkins University 2005 — 2008
MS
FDA/CDER September 2015 - Present
Instrumentation Laboratory May 2011 - September 2015
University of Connecticut August 2009 - August 2011
Rogers Corporation March 2007 - May 2009
GE Silicones April 2004 - March 2007
Skills
Polymers, Process Simulation, Rheology, Formulation, Supercritical Fluids, Chemical Engineering, Design of Experiments, Polymer Science, Polymer Characterization, Chemistry, Materials Science, R&D
Education
University of Massachusetts, Amherst 1999 — 2004
PhD, chemical engineering
University of Pittsburgh 1997 — 1999
MS, chemical engineering
Università degli Studi di Trieste 1994 — 1997
laurea, ingegneria chimica
Addis Ababa University 1985 — 1990
BSc, Chemical Engineering
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
Eisai Medical Research 2006 - 2008
FDA/CDER 1995 - 2006
Skills
IND, Regulatory Submissions, NDA, Drug Development, Regulatory Affairs, Clinical Development
Education
Auburn University, School of Vet Medicine
PhD, Immunotoxicology, Clinical Pathology
National Taiwan University
DVM, Veterinary Medicine
FDA/CDER November 2012 - Present
Medimmune/AstraZeneca December 2011 - September 2012
HealthCore, Inc. July 2010 - November 2011
The Degge Group March 2007 - June 2010
National Foundation of Alternative Medicine August 2005 - February 2007
University of Maryland School of Public Health, College Park August 2000 - August 2005
Skills
Outcomes Research, Pharmacoepidemiology, Clinical Trials, Epidemiology, Biotechnology
Education
University of Maryland College Park 2000 — 2005
PhD, Public Health
Tianjin University of Chinese Medicine, Tianjin China 1992 — 1997
Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine
FDA/CDER January 2014 - Present
FDA/CDRH/OCD September 2013 - January 2014
FDA/CDER/OEP/DACCM January 2011 - September 2013
Skills
Government, Microsoft Office, Public Policy, Community Outreach, Policy, Research, Grant Writing, Public Health, Health Promotion, Prevention, Organizational..., Public Health Education, Literature Reviews, Health Communication, Public Administration, Data Analysis, Policy Analysis
Education
University of Maryland College Park 2012 — 2013
Bachelor of Science in Community Health
Montgomery College
BARDA May 2015 - Present
INC Research March 2007 - May 2015
FDA/CDER 1999 - 2007
Skills
CRO
Education
University of Texas Health Science 1981 — 1988
Doctor of Philosophy (Ph.D.), Toxicology
University of Notre Dame 1977 — 1981
Bachelors of Science, Microbiology