NDA Partners LLC
Industry: Company
DescriptionFounded: 2003
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NDA Partners LLC Employees
Employee
Years
Job
Industry
Natalie DeWitt, PhD Natalie DeWitt, PhD's NDA Partners LLC Experience June 2015 - Present
Job Consultant at NDA Partners LLC
Industry Biotechnology
Experience
NDA Partners LLC June 2015 - Present
Accendo Science Editing March 2012 - Present
Stanford University School of Medicine June 2014 - April 2015
California Institute of Regenerative Medicine September 2011 - June 2014
Institut Pasteur Korea February 2010 - August 2011
Nature January 2001 - February 2010
Nature Biotechnology January 1999 - January 2001
Yale University January 1995 - December 1998
Princeton University September 1994 - August 1995
University of Wisconsin-Madison 1988 - 1994
Skills
Cell Biology, Molecular Biology, Developmental Biology, Stem Cells, Regenerative Medicine, Translational Research, Lifesciences, Drug Discovery, Biotechnology, Biochemistry, Cell Culture, Genetics, Scientific Writing, Scientific Editing, Scientific Publishing, Editing, Scientific Papers, Cell, Cancer, Oncology, Genomics, DNA, Science, Protein Chemistry, Laboratory, Neuroscience, Immunology, Life Sciences, Research
Education
University of Wisconsin-Madison 1988 — 1994
Doctor of Philosophy (PhD), Cell/Cellular and Molecular Biology
University of Maryland College Park 1982 — 1987
BS, Biochemistry
NDA Partners LLC June 2015 - Present
Accendo Science Editing March 2012 - Present
Stanford University School of Medicine June 2014 - April 2015
California Institute of Regenerative Medicine September 2011 - June 2014
Institut Pasteur Korea February 2010 - August 2011
Nature January 2001 - February 2010
Nature Biotechnology January 1999 - January 2001
Yale University January 1995 - December 1998
Princeton University September 1994 - August 1995
University of Wisconsin-Madison 1988 - 1994
Skills
Cell Biology, Molecular Biology, Developmental Biology, Stem Cells, Regenerative Medicine, Translational Research, Lifesciences, Drug Discovery, Biotechnology, Biochemistry, Cell Culture, Genetics, Scientific Writing, Scientific Editing, Scientific Publishing, Editing, Scientific Papers, Cell, Cancer, Oncology, Genomics, DNA, Science, Protein Chemistry, Laboratory, Neuroscience, Immunology, Life Sciences, Research
Education
University of Wisconsin-Madison 1988 — 1994
Doctor of Philosophy (PhD), Cell/Cellular and Molecular Biology
University of Maryland College Park 1982 — 1987
BS, Biochemistry
David R. Savello David R. Savello's NDA Partners LLC Experience March 2003 - Present
Job Consultant and Investment Advisor
Industry Pharmaceuticals
Experience
NDA Partners LLC March 2003 - Present
Pappas Ventures March 2000 - Present
XenoPort August 2006 - December 2014
California Institute of Regenerative Medicine 2011 - 2014
Cardinal Health Inc. 1999 - 2005
Nektar Therapeutics 1999 - 2005
GSK March 1985 - March 1997
Skills
Technology Transfer, Regulatory Affairs, Pharmaceutical Industry, Clinical Development, Clinical Trials, Drug Development, GMP, Clinical Operations, Drug Safety, FDA, CRO, Biopharmaceuticals, Regulatory Submissions, IND, GCP, Pharmaceutics, GLP, Sop, Pharmacovigilance, Vaccines, CTMS, Biotechnology, Pharmacology, Oncology, Drug Discovery
Education
University of Maryland School of Pharmacy
M.S. and Ph.D., Pharmaceutics
Massachusetts College of Pharmacy and Health Sciences
B. Sc. Pharmacy, Pharmacy
NDA Partners LLC March 2003 - Present
Pappas Ventures March 2000 - Present
XenoPort August 2006 - December 2014
California Institute of Regenerative Medicine 2011 - 2014
Cardinal Health Inc. 1999 - 2005
Nektar Therapeutics 1999 - 2005
GSK March 1985 - March 1997
Skills
Technology Transfer, Regulatory Affairs, Pharmaceutical Industry, Clinical Development, Clinical Trials, Drug Development, GMP, Clinical Operations, Drug Safety, FDA, CRO, Biopharmaceuticals, Regulatory Submissions, IND, GCP, Pharmaceutics, GLP, Sop, Pharmacovigilance, Vaccines, CTMS, Biotechnology, Pharmacology, Oncology, Drug Discovery
Education
University of Maryland School of Pharmacy
M.S. and Ph.D., Pharmaceutics
Massachusetts College of Pharmacy and Health Sciences
B. Sc. Pharmacy, Pharmacy
Bryan Buckles Bryan Buckles's NDA Partners LLC Experience August 2013 - December 2013
Job Experienced Program Analyst/Acquisition Specialist. Retired Marine seeking new opportunities
Industry
Experience
NDA Partners LLC August 2013 - December 2013
United Methodist Church June 2003 - June 2013
Bulldog Technical Services February 2002 - May 2006
United States Marine Corps May 1981 - September 2001
Skills
Pastoral Care, Preaching, Theology, Liturgy, Religion, Community Outreach, Biblical Studies, Discipleship, Religious Studies, Pastoral Counseling, Missions, Volunteer Management, Spiritual Direction, Gospel, Military, Church Administration, Leadership Development, Youth Ministry, Church Growth, Pastoral, Evangelism, Apologetics, Church Events, Grief Counseling, Bible, Pastors, Expository Preaching, Homiletics, Hermeneutics, Exegesis, Campus Ministry, Command, Defense, DoD, Government, Information Assurance, National Security, Security, Intelligence, Leadership, Program Management, Security Clearance
Education
Wesley Theological Seminary 2000 — 2007
MDiv., Theology and Religious Vocations, 3.8
Excelsior College 1983 — 1987
Bachelor of Arts (BA), Liberal Arts and Sciences/Liberal Studies, 3.3
NDA Partners LLC August 2013 - December 2013
United Methodist Church June 2003 - June 2013
Bulldog Technical Services February 2002 - May 2006
United States Marine Corps May 1981 - September 2001
Skills
Pastoral Care, Preaching, Theology, Liturgy, Religion, Community Outreach, Biblical Studies, Discipleship, Religious Studies, Pastoral Counseling, Missions, Volunteer Management, Spiritual Direction, Gospel, Military, Church Administration, Leadership Development, Youth Ministry, Church Growth, Pastoral, Evangelism, Apologetics, Church Events, Grief Counseling, Bible, Pastors, Expository Preaching, Homiletics, Hermeneutics, Exegesis, Campus Ministry, Command, Defense, DoD, Government, Information Assurance, National Security, Security, Intelligence, Leadership, Program Management, Security Clearance
Education
Wesley Theological Seminary 2000 — 2007
MDiv., Theology and Religious Vocations, 3.8
Excelsior College 1983 — 1987
Bachelor of Arts (BA), Liberal Arts and Sciences/Liberal Studies, 3.3
Mary Ellen Cosenza Mary Ellen Cosenza's NDA Partners LLC Experience February 2015 - Present
Job President MEC Regulatory & Toxicology Consulting LLC
Industry Biotechnology
Experience
NDA Partners LLC February 2015 - Present
MEC Regulatory & Toxicology Consulting LLC January 2015 - Present
Amgen October 2011 - January 2015
Amgen July 2009 - October 2011
Amgen August 1995 - August 2005
Wyeth September 1986 - July 1995
Lederle Laboratories, American Cyanamid Co 1987 - 1995
Revlon Health Care Group 1984 - 1986
Skills
Regulatory Affairs, Biotechnology, GLP, Life Sciences, Regulatory Submissions, Biopharmaceuticals, Toxicology, Drug Development, Emerging Markets, International..., FDA, Lifesciences, IND, Sop, Regulatory Requirements, Drug Discovery, GMP, Pharmaceutical Industry, Immunology, Oncology, In Vivo, Biomarkers, CRO, GCP, Clinical Development, Monoclonal Antibodies, Technology Transfer, Pharmacokinetics, Validation, Clinical Trials, Pharmacology, In Vitro, Infectious Diseases, 21 CFR Part 11, Pharmaceutics, Pharmacovigilance, Commercialization, Cancer, Protein Chemistry, Assay Development, eCTD, Vaccines, Medical Affairs, Immunoassays, Cell, Purification, Chromatography, LIMS, ELISA, Drug Delivery
Education
University of Southern California 2006 — 2008
M.S., Regulatory Science
Saint John's University 1989 — 1994
Ph.D., Pharmaceutical Science
City University of New York-Queens College
BS, Biology/ Chemistry
NDA Partners LLC February 2015 - Present
MEC Regulatory & Toxicology Consulting LLC January 2015 - Present
Amgen October 2011 - January 2015
Amgen July 2009 - October 2011
Amgen August 1995 - August 2005
Wyeth September 1986 - July 1995
Lederle Laboratories, American Cyanamid Co 1987 - 1995
Revlon Health Care Group 1984 - 1986
Skills
Regulatory Affairs, Biotechnology, GLP, Life Sciences, Regulatory Submissions, Biopharmaceuticals, Toxicology, Drug Development, Emerging Markets, International..., FDA, Lifesciences, IND, Sop, Regulatory Requirements, Drug Discovery, GMP, Pharmaceutical Industry, Immunology, Oncology, In Vivo, Biomarkers, CRO, GCP, Clinical Development, Monoclonal Antibodies, Technology Transfer, Pharmacokinetics, Validation, Clinical Trials, Pharmacology, In Vitro, Infectious Diseases, 21 CFR Part 11, Pharmaceutics, Pharmacovigilance, Commercialization, Cancer, Protein Chemistry, Assay Development, eCTD, Vaccines, Medical Affairs, Immunoassays, Cell, Purification, Chromatography, LIMS, ELISA, Drug Delivery
Education
University of Southern California 2006 — 2008
M.S., Regulatory Science
Saint John's University 1989 — 1994
Ph.D., Pharmaceutical Science
City University of New York-Queens College
BS, Biology/ Chemistry
Timothy Ulatowski Timothy Ulatowski's NDA Partners LLC Experience January 2011 - August 2012
Job CEO at Ulatowski Consulting LLC
Industry Medical Devices
Experience
Ulatowski Consulting LLC April 2014 - Present
Becker & Associates September 2011 - April 2014
NDA Partners LLC January 2011 - August 2012
FDA January 2003 - January 2011
FDA 1980 - 2003
Skills
FDA law and regulations..., Knowledge of FDA..., Hands on experience..., Expert in quality..., Expert witness reports..., Executive and staff...
Education
Georgetown University School of Medicine 1984 — 1987
MS, Physiology/Biomedical Engineering
Penn State University 1971 — 1974
BS, Microbiology
Ulatowski Consulting LLC April 2014 - Present
Becker & Associates September 2011 - April 2014
NDA Partners LLC January 2011 - August 2012
FDA January 2003 - January 2011
FDA 1980 - 2003
Skills
FDA law and regulations..., Knowledge of FDA..., Hands on experience..., Expert in quality..., Expert witness reports..., Executive and staff...
Education
Georgetown University School of Medicine 1984 — 1987
MS, Physiology/Biomedical Engineering
Penn State University 1971 — 1974
BS, Microbiology
David Feigal David Feigal's NDA Partners LLC Experience August 2010 - Present
Job at NDA Partners LLC
Industry Pharmaceuticals
Experience
NDA Partners LLC August 2010 - Present
Arizona State University 2005 - Present
Amgen 2008 - 2010
NDA Partners 2004 - 2009
Elan Pharmaceuticals 2006 - 2007
Center for Devices and Radiological Health, FDA 1999 - 2004
Center for Biologics Evaluation and Research, FDA 1997 - 1999
Center for Drug Evaluation and Research, FDA 1992 - 1997
UCSF Medical Center 1983 - 1989
Skills
FDA, Drug Discovery, Neuroscience, Research, Clinical Research, Clinical Trials, Molecular Biology, Regulatory Affairs, Biotechnology, Medical Devices, Lifesciences, Immunology, Infectious Diseases, Drug Development, Pharmaceutical Industry, Medicine, Oncology, Clinical Development, Statistics, Healthcare, Science, Teaching, Strategy, Policy, Pharmacology, Biochemistry, Cancer, Vaccines, Biostatistics, Technology Transfer, Sop, Public Health, Regulatory Submissions, GLP, Genomics, Laboratory, CRO, Genetics, Medical Writing
Education
University of California, Berkeley 1981 — 1983
MPH, Epidemilogy and Biostatistics
Stanford University School of Medicine 1971 — 1976
MD
University of Minnesota-Twin Cities 1967 — 1971
BA, Psychology
NDA Partners LLC August 2010 - Present
Arizona State University 2005 - Present
Amgen 2008 - 2010
NDA Partners 2004 - 2009
Elan Pharmaceuticals 2006 - 2007
Center for Devices and Radiological Health, FDA 1999 - 2004
Center for Biologics Evaluation and Research, FDA 1997 - 1999
Center for Drug Evaluation and Research, FDA 1992 - 1997
UCSF Medical Center 1983 - 1989
Skills
FDA, Drug Discovery, Neuroscience, Research, Clinical Research, Clinical Trials, Molecular Biology, Regulatory Affairs, Biotechnology, Medical Devices, Lifesciences, Immunology, Infectious Diseases, Drug Development, Pharmaceutical Industry, Medicine, Oncology, Clinical Development, Statistics, Healthcare, Science, Teaching, Strategy, Policy, Pharmacology, Biochemistry, Cancer, Vaccines, Biostatistics, Technology Transfer, Sop, Public Health, Regulatory Submissions, GLP, Genomics, Laboratory, CRO, Genetics, Medical Writing
Education
University of California, Berkeley 1981 — 1983
MPH, Epidemilogy and Biostatistics
Stanford University School of Medicine 1971 — 1976
MD
University of Minnesota-Twin Cities 1967 — 1971
BA, Psychology
Kimberly Trickett Kimberly Trickett's NDA Partners LLC Experience July 2015 - Present
Job Office Administrator at NDA Partners LLC
Industry Museums and Institutions
Experience
NDA Partners LLC July 2015 - Present
The Montpelier Foundation May 2012 - Present
The Montpelier Foundation April 2010 - May 2012
The Montpelier Foundation May 2007 - April 2010
James Madison University Archaeology Department March 2005 - May 2007
The Montpelier Foundation May 2005 - August 2005
Skills
Museums, Museum Collections, Archaeology, Cataloging, History, Archives, PastPerfect, American History, Digital Photography, FileMaker, Volunteer Management, Historical Archaeology, Research, Mac/PC proficient, Microsoft Office, Grant Writing, Fundraising, Anthropology, Museum Education
Education
University of Leicester 2010 — 2012
Master’s Degree, Museum Studies, Master of Arts with Merit
James Madison University 2003 — 2007
Bachelor’s Degree, Anthropology, Historical Archaeology
NDA Partners LLC July 2015 - Present
The Montpelier Foundation May 2012 - Present
The Montpelier Foundation April 2010 - May 2012
The Montpelier Foundation May 2007 - April 2010
James Madison University Archaeology Department March 2005 - May 2007
The Montpelier Foundation May 2005 - August 2005
Skills
Museums, Museum Collections, Archaeology, Cataloging, History, Archives, PastPerfect, American History, Digital Photography, FileMaker, Volunteer Management, Historical Archaeology, Research, Mac/PC proficient, Microsoft Office, Grant Writing, Fundraising, Anthropology, Museum Education
Education
University of Leicester 2010 — 2012
Master’s Degree, Museum Studies, Master of Arts with Merit
James Madison University 2003 — 2007
Bachelor’s Degree, Anthropology, Historical Archaeology
Carl Peck's NDA Partners LLC Experience 2003 - Present
Job Chairman at NDA Partners LLC
Industry Pharmaceuticals
Experience
UCSF Department of Bioengineering and Therapeutic Sciences 2004 - Present
NDA Partners LLC 2003 - Present
Georgetown University 1994 - 2004
CDER, FDA 1987 - 2003
FDA 1987 - 1993
Uniformed Services University of the Health Sciences 1980 - 1987
Skills
Medical Education, Drug Development, Pharmacology, Clinical Research, Clinical Trials, Neuroscience, Lifesciences, Pharmaceutical Industry, Biotechnology, Cancer
Education
University of Kansas School of Medicine 1964 — 1968
Doctor of Medicine (MD), Medicine
University of Kansas 1960 — 1963
Bachelor of Arts (BA), Mathematics, Chemistry
UCSF Department of Bioengineering and Therapeutic Sciences 2004 - Present
NDA Partners LLC 2003 - Present
Georgetown University 1994 - 2004
CDER, FDA 1987 - 2003
FDA 1987 - 1993
Uniformed Services University of the Health Sciences 1980 - 1987
Skills
Medical Education, Drug Development, Pharmacology, Clinical Research, Clinical Trials, Neuroscience, Lifesciences, Pharmaceutical Industry, Biotechnology, Cancer
Education
University of Kansas School of Medicine 1964 — 1968
Doctor of Medicine (MD), Medicine
University of Kansas 1960 — 1963
Bachelor of Arts (BA), Mathematics, Chemistry
Charles Grudzinskas's NDA Partners LLC Experience June 2003 - Present
Job Consultant
Industry Pharmaceuticals
Experience
NDA Partners LLC June 2003 - Present
ACDRS (American Course in Drug Development and Regulatory Science) September 2007 - Present
Immunomic Therapeutics, Inc... September 2007 - Present
Cary Pharmaceuticals, Inc. September 1998 - Present
BRTRC June 2002 - Present
Center for Drug Development Science (CDDS), Georgetown University Medical Center March 1998 - October 2011
PERI (Pharmaceutical Education and Research Institute September 1988 - December 2010
National Institutes of Health September 2000 - April 2008
MdBio November 1998 - April 2006
Law firm 2006 - 2006
Skills
US Patent Agent 28,515, Preparation and..., FDA Animal Rule pathway, FDA REMS, Preparation and..., Development of..., Development of..., Development of pain..., Intellectual property..., Due diligence across..., FDA regulations, Drug development and..., Development of..., Drug development...
Education
University of Minnesota-Twin Cities 1966 — 1970
Doctor of Philosophy (PhD), Organic Chemistry
UCLA 1961 — 1966
BSc
NDA Partners LLC June 2003 - Present
ACDRS (American Course in Drug Development and Regulatory Science) September 2007 - Present
Immunomic Therapeutics, Inc... September 2007 - Present
Cary Pharmaceuticals, Inc. September 1998 - Present
BRTRC June 2002 - Present
Center for Drug Development Science (CDDS), Georgetown University Medical Center March 1998 - October 2011
PERI (Pharmaceutical Education and Research Institute September 1988 - December 2010
National Institutes of Health September 2000 - April 2008
MdBio November 1998 - April 2006
Law firm 2006 - 2006
Skills
US Patent Agent 28,515, Preparation and..., FDA Animal Rule pathway, FDA REMS, Preparation and..., Development of..., Development of..., Development of pain..., Intellectual property..., Due diligence across..., FDA regulations, Drug development and..., Development of..., Drug development...
Education
University of Minnesota-Twin Cities 1966 — 1970
Doctor of Philosophy (PhD), Organic Chemistry
UCLA 1961 — 1966
BSc
Theresa Ritter's NDA Partners LLC Experience April 2015 - Present
Job Office Manager
Industry Management Consulting
Experience
NDA Partners LLC April 2015 - Present
NDA Partners LLC July 2013 - Present
Madison County Board of Equalization 2013 - 2013
Charmed Photography 2004 - 2012
U.S. Department of the Army Libraries April 1999 - August 2001
U.S. Department of the Army, Provost Marshal Office January 1994 - October 1998
Skills
Administrative..., Accounting, Microsoft Excel, Auditing, Financial Analysis, Accounts Payable, Financial Accounting, Accounts Receivable, Tax, Microsoft Office, Bookkeeping, Microsoft Word, Account Reconciliation, Budgets, General Ledger, PowerPoint
Education
Columbia College 2010 — 2012
Bachelor of Arts, Business Administration (Accounting), GPA 4.0
Campbell University
Bachelor of Science, Psychology, Summa Cum Laude
NDA Partners LLC April 2015 - Present
NDA Partners LLC July 2013 - Present
Madison County Board of Equalization 2013 - 2013
Charmed Photography 2004 - 2012
U.S. Department of the Army Libraries April 1999 - August 2001
U.S. Department of the Army, Provost Marshal Office January 1994 - October 1998
Skills
Administrative..., Accounting, Microsoft Excel, Auditing, Financial Analysis, Accounts Payable, Financial Accounting, Accounts Receivable, Tax, Microsoft Office, Bookkeeping, Microsoft Word, Account Reconciliation, Budgets, General Ledger, PowerPoint
Education
Columbia College 2010 — 2012
Bachelor of Arts, Business Administration (Accounting), GPA 4.0
Campbell University
Bachelor of Science, Psychology, Summa Cum Laude
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