Alteon Inc.
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Alteon Inc. Employees
Employee
Years
Job
Industry
Michelle Struck Michelle Struck's Alteon Inc. Experience 1995 - 1997
Job Document Control Manager Alfa Wassermann
Industry Pharmaceuticals
Experience
Alfa Wassermann June 2013 - Present
ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - September 2011
The Phoenix 2000 - 2002
ALTEON, INC 1995 - 1997
Skills
Protocol, Cross-functional Team..., Clinical Trials, GCP, EDC, Sop, Biotechnology, Oncology, IND, Clinical Development, CTMS, Pharmaceutical Industry, Training, CRO, Lifesciences, Regulatory Submissions, FDA, Clinical Research, Drug Development
Education
Stevens Institute of Technology 2003 — 2009
Chemical Biology
Fairleigh Dickinson University 1990 — 1994
BS, Biology
Alfa Wassermann June 2013 - Present
ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - September 2011
The Phoenix 2000 - 2002
ALTEON, INC 1995 - 1997
Skills
Protocol, Cross-functional Team..., Clinical Trials, GCP, EDC, Sop, Biotechnology, Oncology, IND, Clinical Development, CTMS, Pharmaceutical Industry, Training, CRO, Lifesciences, Regulatory Submissions, FDA, Clinical Research, Drug Development
Education
Stevens Institute of Technology 2003 — 2009
Chemical Biology
Fairleigh Dickinson University 1990 — 1994
BS, Biology
Dean Murphy, RAC Dean Murphy, RAC's Alteon Inc. Experience October 2004 - February 2006
Job Accomplished Regulatory Affairs, Compliance and Quality Professional in Pharma/MedDev/Biotech Industry
Industry Pharmaceuticals
Experience
Consultant, Self Employed June 2015 - Present
Maetrics, LLC February 2013 - Present
Vistakon, division of Johnson and Johnson Vision Care, Inc. October 2009 - December 2012
Ligand Pharmaceuticals January 2009 - December 2009
Pharmacopeia, Inc. July 2007 - December 2008
Chugai Pharma USA, Ltd. March 2006 - July 2007
Alteon Inc. October 2004 - February 2006
Novartis September 2003 - October 2004
Novartis 1998 - 2003
Bausch & Lomb 1995 - 1996
Skills
Quality Control, Pharmaceutical Industry, FDA, Biotechnology, GCP, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Medical Devices, Clinical Development, Sop, Clinical Research, GMP, Validation, eCTD, GLP, IND, NDA, Drug Development, Quality System, GxP, Regulatory Requirements, Design Control, CMC, Regulatory Filings, Combination Products, Change Control, Electronic Submissions, Quality Assurance, Regulatory Documentation, ICH-GCP, Aseptic Processing, R&D, CRO, Commercialization, Pharmaceutics, CAPA, Biopharmaceuticals, V&V, 21 CFR Part 11, ISO 14971, ISO 13485, Computer System..., Laboratory, Technology Transfer, Chemistry, LIMS, PMA, Quality Management, Life Sciences
Education
Stockton University 1978 — 1980
BS, Biology
Burlington County College 1976 — 1978
Bachelor's degree, Biology/Biological Sciences, General
Consultant, Self Employed June 2015 - Present
Maetrics, LLC February 2013 - Present
Vistakon, division of Johnson and Johnson Vision Care, Inc. October 2009 - December 2012
Ligand Pharmaceuticals January 2009 - December 2009
Pharmacopeia, Inc. July 2007 - December 2008
Chugai Pharma USA, Ltd. March 2006 - July 2007
Alteon Inc. October 2004 - February 2006
Novartis September 2003 - October 2004
Novartis 1998 - 2003
Bausch & Lomb 1995 - 1996
Skills
Quality Control, Pharmaceutical Industry, FDA, Biotechnology, GCP, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Medical Devices, Clinical Development, Sop, Clinical Research, GMP, Validation, eCTD, GLP, IND, NDA, Drug Development, Quality System, GxP, Regulatory Requirements, Design Control, CMC, Regulatory Filings, Combination Products, Change Control, Electronic Submissions, Quality Assurance, Regulatory Documentation, ICH-GCP, Aseptic Processing, R&D, CRO, Commercialization, Pharmaceutics, CAPA, Biopharmaceuticals, V&V, 21 CFR Part 11, ISO 14971, ISO 13485, Computer System..., Laboratory, Technology Transfer, Chemistry, LIMS, PMA, Quality Management, Life Sciences
Education
Stockton University 1978 — 1980
BS, Biology
Burlington County College 1976 — 1978
Bachelor's degree, Biology/Biological Sciences, General
Lisa Higgins Lisa Higgins's Alteon Inc. Experience March 1998 - December 1999
Job Sr Learning & Development Specialist at Clarkston Consulting
Industry Professional Training & Coaching
Experience
AICPA December 2014 - July 2015
Logos Technologies, LLC August 2008 - October 2014
Catalent Pharma Solutions February 2006 - August 2008
Pfizer April 2004 - February 2006
Novartis August 2002 - April 2004
WYETH AYERST (AHP) February 2002 - July 2002
WYETH AYERST (AHP) December 2000 - January 2002
Wyeth January 2000 - December 2000
Alteon Inc. March 1998 - December 1999
Skills
Quality Assurance, Software Documentation, Training, Testing, Program Management, GMP, Lean Manufacturing, Onsite, Software, Quality System, Leadership, FDA, Analysis, Offsite Backup, Technical Writing, Sop, Manufacturing, Project Management, Pharmaceutical Industry, Management, Process Improvement, Start-ups, Excellent communication..., Experienced in..., Experienced in the..., Experienced in..., Experienced in Quality..., Certified Scrum Master..., SOP, Employee Training
Education
Scrum.org 2014 — 2014
Professional Scrum Master Certification
Wake Technical Community College 2010 — 2010
Intro to Programming and Logic Course
Long Island University, Southampton Campus 1992 — 1996
BA Marine Science/Biology, Marine Science
AICPA December 2014 - July 2015
Logos Technologies, LLC August 2008 - October 2014
Catalent Pharma Solutions February 2006 - August 2008
Pfizer April 2004 - February 2006
Novartis August 2002 - April 2004
WYETH AYERST (AHP) February 2002 - July 2002
WYETH AYERST (AHP) December 2000 - January 2002
Wyeth January 2000 - December 2000
Alteon Inc. March 1998 - December 1999
Skills
Quality Assurance, Software Documentation, Training, Testing, Program Management, GMP, Lean Manufacturing, Onsite, Software, Quality System, Leadership, FDA, Analysis, Offsite Backup, Technical Writing, Sop, Manufacturing, Project Management, Pharmaceutical Industry, Management, Process Improvement, Start-ups, Excellent communication..., Experienced in..., Experienced in the..., Experienced in..., Experienced in Quality..., Certified Scrum Master..., SOP, Employee Training
Education
Scrum.org 2014 — 2014
Professional Scrum Master Certification
Wake Technical Community College 2010 — 2010
Intro to Programming and Logic Course
Long Island University, Southampton Campus 1992 — 1996
BA Marine Science/Biology, Marine Science
Amie Walsh Amie Walsh's Alteon Inc. Experience 2000 - 2002
Job Senior Clinical Research Associate at Edwards Lifesciences
Industry Research
Experience
Edwards Lifesciences July 2015 - Present
Medlock Consulting, LLC. July 2010 - Present
PAREXEL January 2015 - July 2015
Novo Nordisk November 2013 - December 2014
Bard Peripheral Vascular January 2011 - November 2013
Arizona Heart Institute April 2005 - May 2010
PPD 2002 - 2004
Alteon Inc 2000 - 2002
Skills
Exceptional listener..., Proven..., Innovative..., Productive worker with..., Dependable, responsible..., Enthusiastic,..., Clinical Trials, Research, Clinical Research, CTMS, GCP, Healthcare, EDC, CRO, Clinical Development, Oncology, Lifesciences, Biotechnology, Regulatory Submissions, FDA, Medical Devices, Cardiology, Regulatory Affairs, Pharmaceutical Industry, SOP, Clinical Monitoring, Management, Medicine, Hospitals, ICH-GCP, Medical Education, Healthcare Management, Drug Development, Clinical Data Management, Diabetes, Neurology, Healthcare Information..., Validation, Strategic Planning, Medical Writing, GMP, Protocol, Life Sciences, Surgery, Therapeutic Areas, Quality Patient Care, Patient Advocacy, Team Leadership, Patient Safety, Direct Patient Care
Education
Arizona State University
Bachelor of Life Sciences and Biology, Biology
Edwards Lifesciences July 2015 - Present
Medlock Consulting, LLC. July 2010 - Present
PAREXEL January 2015 - July 2015
Novo Nordisk November 2013 - December 2014
Bard Peripheral Vascular January 2011 - November 2013
Arizona Heart Institute April 2005 - May 2010
PPD 2002 - 2004
Alteon Inc 2000 - 2002
Skills
Exceptional listener..., Proven..., Innovative..., Productive worker with..., Dependable, responsible..., Enthusiastic,..., Clinical Trials, Research, Clinical Research, CTMS, GCP, Healthcare, EDC, CRO, Clinical Development, Oncology, Lifesciences, Biotechnology, Regulatory Submissions, FDA, Medical Devices, Cardiology, Regulatory Affairs, Pharmaceutical Industry, SOP, Clinical Monitoring, Management, Medicine, Hospitals, ICH-GCP, Medical Education, Healthcare Management, Drug Development, Clinical Data Management, Diabetes, Neurology, Healthcare Information..., Validation, Strategic Planning, Medical Writing, GMP, Protocol, Life Sciences, Surgery, Therapeutic Areas, Quality Patient Care, Patient Advocacy, Team Leadership, Patient Safety, Direct Patient Care
Education
Arizona State University
Bachelor of Life Sciences and Biology, Biology
Donald Six Donald Six's Alteon Inc. Experience January 2002 - November 2002
Job
Industry Biotechnology
Experience
PPD October 2012 - Present
ESD 6 2011 - Present
PPD October 2013 - November 2014
PPD March 2010 - November 2012
PPD October 2007 - February 2010
Memory Pharmaceuticals August 2005 - October 2007
Memory Pharmaceuticals November 2002 - July 2006
Alteon, Inc January 2002 - November 2002
Taratec Development Corporation July 2000 - January 2002
Organon July 1991 - July 2000
Skills
Computer System..., 21 CFR Part 11, GCP, Document Management, EDC, Help Desk Support, Firewalls, Trial Management, Network Development, IT Management, Pharmaceutical Industry, Validation, Biotechnology, Data Management, Project Management, Program Management, Clinical Trials, Change Control, FDA, Lifesciences, Clinical Development, CTMS, Protocol, Clinical Research, Sop, Software Documentation, Neuroscience, Drug Discovery, LIMS, Outsourcing, Neurology, Line Management, Pharmaceutics, Start-ups, ICH-GCP
Education
New Jersey Institute of Technology 1993 — 1995
MS
California State University-East Bay 1985 — 1988
BS
Florida State University 1981 — 1985
PPD October 2012 - Present
ESD 6 2011 - Present
PPD October 2013 - November 2014
PPD March 2010 - November 2012
PPD October 2007 - February 2010
Memory Pharmaceuticals August 2005 - October 2007
Memory Pharmaceuticals November 2002 - July 2006
Alteon, Inc January 2002 - November 2002
Taratec Development Corporation July 2000 - January 2002
Organon July 1991 - July 2000
Skills
Computer System..., 21 CFR Part 11, GCP, Document Management, EDC, Help Desk Support, Firewalls, Trial Management, Network Development, IT Management, Pharmaceutical Industry, Validation, Biotechnology, Data Management, Project Management, Program Management, Clinical Trials, Change Control, FDA, Lifesciences, Clinical Development, CTMS, Protocol, Clinical Research, Sop, Software Documentation, Neuroscience, Drug Discovery, LIMS, Outsourcing, Neurology, Line Management, Pharmaceutics, Start-ups, ICH-GCP
Education
New Jersey Institute of Technology 1993 — 1995
MS
California State University-East Bay 1985 — 1988
BS
Florida State University 1981 — 1985
Elliot Katten's Alteon Inc. Experience 2002 - 2003
Job Supervisor of Organic Chemistry Lab,
Industry Pharmaceuticals
Experience
St John's University August 2007 - Present
Polarome International October 2004 - February 2007
Pfizer 2004 - 2004
Alteon Inc 2002 - 2003
Bristol Myers Squibb 1997 - 2002
Givaudan Corp January 1971 - September 1997
Skills
Large Scale Systems, kilo lab operations, Organometallic Chemistry, Organic Chemistry, Teaching, Chemistry, R&D, Flavors and Fragrances, HPLC, GC-MS, Chromatography, GMP, LC-MS, Laboratory, Analytical Chemistry, Organic Synthesis, NMR, Mass Spectrometry, Medicinal Chemistry, UV/Vis, IR
Education
University of Illinois at Chicago 1965 — 1970
MS,& BS, Organic Chemistry
Fordham University
St John's University August 2007 - Present
Polarome International October 2004 - February 2007
Pfizer 2004 - 2004
Alteon Inc 2002 - 2003
Bristol Myers Squibb 1997 - 2002
Givaudan Corp January 1971 - September 1997
Skills
Large Scale Systems, kilo lab operations, Organometallic Chemistry, Organic Chemistry, Teaching, Chemistry, R&D, Flavors and Fragrances, HPLC, GC-MS, Chromatography, GMP, LC-MS, Laboratory, Analytical Chemistry, Organic Synthesis, NMR, Mass Spectrometry, Medicinal Chemistry, UV/Vis, IR
Education
University of Illinois at Chicago 1965 — 1970
MS,& BS, Organic Chemistry
Fordham University
Homa Sadeghi's Alteon Inc. Experience 1992 - 1996
Job VP Research at PhaseBio
Industry Biotechnology
Experience
PhaseBio April 2008 - June 2010
BioRexis Pharmaceutical Corporation 2001 - 2006
Alteon Inc. 1992 - 1996
American Cyanamid 1989 - 1993
Skills
Immunology, Drug Discovery, Clinical Development, Pharmaceutical Industry, Lifesciences, Molecular Biology, Drug Development, Cell Culture, Technology Transfer, Dermatology, Biotechnology, Western Blotting, GMP, Protein Chemistry, Biochemistry, Vaccines, Biopharmaceuticals, Infectious Diseases, Oncology, High Throughput..., Life Sciences
Education
Saint Louis University School of Medicine 1982 — 1988
PhaseBio April 2008 - June 2010
BioRexis Pharmaceutical Corporation 2001 - 2006
Alteon Inc. 1992 - 1996
American Cyanamid 1989 - 1993
Skills
Immunology, Drug Discovery, Clinical Development, Pharmaceutical Industry, Lifesciences, Molecular Biology, Drug Development, Cell Culture, Technology Transfer, Dermatology, Biotechnology, Western Blotting, GMP, Protein Chemistry, Biochemistry, Vaccines, Biopharmaceuticals, Infectious Diseases, Oncology, High Throughput..., Life Sciences
Education
Saint Louis University School of Medicine 1982 — 1988
Joni Novak's Alteon Inc. Experience September 2004 - July 2005
Job Project Coordinator at Sutter Health
Industry Construction
Experience
Sutter Health October 2013 - Present
Home September 2010 - October 2013
Granite Construction, Inc. February 2007 - September 2010
Pitney Hardin LLP August 2005 - June 2006
Alteon Inc. September 2004 - July 2005
Shearman & Sterling LLP October 2003 - May 2004
Simmons & Simmons 2002 - 2003
Skills
Budgets, Microsoft Office, Project Management, Customer Service, Contract Negotiation, Strategic Planning, Process Improvement, Forecasting, Social Media, Public Relations, Public Speaking, Marketing, Program Management, Event Management, Marketing Communications, Real Estate, Process Scheduler, Social Media Marketing, Construction, Marketing Strategy
Education
Oregon State University 1997 — 2001
Bachelor of Science (B.S.), Political Science
Sutter Health October 2013 - Present
Home September 2010 - October 2013
Granite Construction, Inc. February 2007 - September 2010
Pitney Hardin LLP August 2005 - June 2006
Alteon Inc. September 2004 - July 2005
Shearman & Sterling LLP October 2003 - May 2004
Simmons & Simmons 2002 - 2003
Skills
Budgets, Microsoft Office, Project Management, Customer Service, Contract Negotiation, Strategic Planning, Process Improvement, Forecasting, Social Media, Public Relations, Public Speaking, Marketing, Program Management, Event Management, Marketing Communications, Real Estate, Process Scheduler, Social Media Marketing, Construction, Marketing Strategy
Education
Oregon State University 1997 — 2001
Bachelor of Science (B.S.), Political Science
Adi Lampmann's Alteon Inc. Experience 2003 - 2005
Job Senior Manager, Global Regulatory Affairs at Eisai
Industry Pharmaceuticals
Experience
Eisai June 2015 - Present
Eisai Inc. July 2013 - June 2015
Eisai Product Creation Systems November 2006 - July 2013
Alteon Inc. 2003 - 2005
Skills
FDA, Clinical Trials, GCP, Pharmaceutical Industry
Education
California State University-Northridge 2000 — 2002
Bachelor's degree, Biology, General
Eisai June 2015 - Present
Eisai Inc. July 2013 - June 2015
Eisai Product Creation Systems November 2006 - July 2013
Alteon Inc. 2003 - 2005
Skills
FDA, Clinical Trials, GCP, Pharmaceutical Industry
Education
California State University-Northridge 2000 — 2002
Bachelor's degree, Biology, General
Kenneth Moch's Alteon Inc. Experience December 1998 - July 2006
Job President at Euclidian Life Science Advisors
Industry Biotechnology
Experience
Euclidian Life Science Advisors April 2014 - Present
Chimerix, Inc. April 2010 - April 2014
Chimerix, Inc. June 2009 - April 2010
Euclidean Life Science Advisors January 2008 - November 2009
Biomedical Enterprises Inc 2008 - 2009
ThinkEquity Partners 2006 - 2008
Alteon Inc December 1998 - July 2006
Alteon Inc. February 1995 - December 1998
Biocyte Corporation 1989 - 1995
The Liposome Company, Inc. 1982 - 1988
Skills
Analysis, Biopharmaceuticals, Biotechnology, Business Strategy, Clinical Development, Business Development, Clinical Research, Clinical Trials, Drug Development, Commercialization, Drug Discovery, FDA, Healthcare, Immunology, Leadership, Finance, Life Sciences, Lifesciences, Management, Medical Devices, Mergers, Pharmaceutical Industry, Oncology, Product Development, Regulatory Submissions, Start-ups, Strategic Planning, Strategy, Technology Transfer, Vaccines, Venture Capital, Mergers & Acquisitions
Education
Stanford University Graduate School of Business 1978 — 1980
MBA
Princeton University 1972 — 1976
AB, Biochemistry; Minor - Science in Human Affairs (Health Policy)
Rye Neck High School
Euclidian Life Science Advisors April 2014 - Present
Chimerix, Inc. April 2010 - April 2014
Chimerix, Inc. June 2009 - April 2010
Euclidean Life Science Advisors January 2008 - November 2009
Biomedical Enterprises Inc 2008 - 2009
ThinkEquity Partners 2006 - 2008
Alteon Inc December 1998 - July 2006
Alteon Inc. February 1995 - December 1998
Biocyte Corporation 1989 - 1995
The Liposome Company, Inc. 1982 - 1988
Skills
Analysis, Biopharmaceuticals, Biotechnology, Business Strategy, Clinical Development, Business Development, Clinical Research, Clinical Trials, Drug Development, Commercialization, Drug Discovery, FDA, Healthcare, Immunology, Leadership, Finance, Life Sciences, Lifesciences, Management, Medical Devices, Mergers, Pharmaceutical Industry, Oncology, Product Development, Regulatory Submissions, Start-ups, Strategic Planning, Strategy, Technology Transfer, Vaccines, Venture Capital, Mergers & Acquisitions
Education
Stanford University Graduate School of Business 1978 — 1980
MBA
Princeton University 1972 — 1976
AB, Biochemistry; Minor - Science in Human Affairs (Health Policy)
Rye Neck High School
Phyllis Adler's Alteon Inc. Experience May 1996 - July 2005
Job Assoc. Manager, Clinical Contracts
Industry Biotechnology
Experience
MannKind Corporation June 2011 - October 2014
MannKind Corporation May 2006 - June 2011
Asubio Pharmaceutical, Inc. August 2005 - May 2006
Alteon Inc May 1996 - July 2005
Skills
Clinical Trials, CRO, Clinical Research, Clinical Development, Pharmaceutical Industry, Contract Negotiation, Drug Development, CTMS, Vendor Management, GCP, FDA, 21 CFR Part 11, Budgets, Project Management, Clinical Operations, Biotechnology, Outsourcing Management, Forecasting, Outsourcing, Pharmaceuticals, Cross-functional Team..., Contract Management, Travel Management, Project Planning, EDC, Budgeting, Negotiating Contracts, Planning, Clinical, Life Sciences, Process Improvement, Meeting Planning, Clinical Trial Analysis, Accruals, Financial Management..., Financial Analysis
Education
Fashion Institute of Technology 1973 — 1975
AAA, Advertising & Design
MannKind Corporation June 2011 - October 2014
MannKind Corporation May 2006 - June 2011
Asubio Pharmaceutical, Inc. August 2005 - May 2006
Alteon Inc May 1996 - July 2005
Skills
Clinical Trials, CRO, Clinical Research, Clinical Development, Pharmaceutical Industry, Contract Negotiation, Drug Development, CTMS, Vendor Management, GCP, FDA, 21 CFR Part 11, Budgets, Project Management, Clinical Operations, Biotechnology, Outsourcing Management, Forecasting, Outsourcing, Pharmaceuticals, Cross-functional Team..., Contract Management, Travel Management, Project Planning, EDC, Budgeting, Negotiating Contracts, Planning, Clinical, Life Sciences, Process Improvement, Meeting Planning, Clinical Trial Analysis, Accruals, Financial Management..., Financial Analysis
Education
Fashion Institute of Technology 1973 — 1975
AAA, Advertising & Design
Judith Hedstrom's Alteon Inc. Experience January 2002 - January 2006
Job Biopharmaceutical executive leader and strategy consultant
Industry Biotechnology
Experience
Judith S. Hedstrom Consulting Inc. January 2006 - Present
Clifton Life Sciences May 2014 - November 2014
Alteon Inc. January 2002 - January 2006
McKinsey & Company January 1996 - January 2002
APACHE Medical Systems (acquired by Cerner) March 1993 - January 1996
The Wilkerson Group (later became Easton Associates, now Navigant Consulting Inc.) 1988 - 1993
Skills
Strategy, Biotechnology, Start-ups, Lifesciences, Mergers & Acquisitions, Business Development, Management Consulting, Market Research, Pharmaceutical Industry, Due Diligence, Medical Devices, Oncology, New Business Development, Clinical Development, Business Planning, Strategic Planning, Marketing Strategy, Venture Capital, Competitive Analysis, Market Analysis, Commercialization, Corporate Development, Clinical Trials, Valuation, Biopharmaceuticals, Technology Transfer, Competitive Intelligence, Product Development, Financial Modeling, Life Sciences, Pharmaceuticals, Management, Drug Discovery, Leadership, Technology Evaluation, Business Strategy, Healthcare, Strategy Development, Market Access; data..., R&D, Product Launch, Executive Management
Education
The University of Chicago - Booth School of Business 1983 — 1986
MBA, Finance, Marketing
The University of Chicago 1974 — 1978
BA, Chemistry
Dwight D. Eisenhower CHS 1970 — 1974
Diploma, Valedictorian
Judith S. Hedstrom Consulting Inc. January 2006 - Present
Clifton Life Sciences May 2014 - November 2014
Alteon Inc. January 2002 - January 2006
McKinsey & Company January 1996 - January 2002
APACHE Medical Systems (acquired by Cerner) March 1993 - January 1996
The Wilkerson Group (later became Easton Associates, now Navigant Consulting Inc.) 1988 - 1993
Skills
Strategy, Biotechnology, Start-ups, Lifesciences, Mergers & Acquisitions, Business Development, Management Consulting, Market Research, Pharmaceutical Industry, Due Diligence, Medical Devices, Oncology, New Business Development, Clinical Development, Business Planning, Strategic Planning, Marketing Strategy, Venture Capital, Competitive Analysis, Market Analysis, Commercialization, Corporate Development, Clinical Trials, Valuation, Biopharmaceuticals, Technology Transfer, Competitive Intelligence, Product Development, Financial Modeling, Life Sciences, Pharmaceuticals, Management, Drug Discovery, Leadership, Technology Evaluation, Business Strategy, Healthcare, Strategy Development, Market Access; data..., R&D, Product Launch, Executive Management
Education
The University of Chicago - Booth School of Business 1983 — 1986
MBA, Finance, Marketing
The University of Chicago 1974 — 1978
BA, Chemistry
Dwight D. Eisenhower CHS 1970 — 1974
Diploma, Valedictorian
R. Tim Ayers's Alteon Inc. Experience 2004 - 2006
Job Clinical Trial Head
Industry Pharmaceuticals
Experience
Novartis September 2011 - Present
Roche Pharmaceuticals 2007 - September 2011
Pfizer June 2006 - February 2007
Roche Pharmaceuticals 2005 - 2006
Alteon Inc. 2004 - 2006
Skills
CTMS, Clinical Development, Clinical Trials
Education
University of Medicine and Dentistry of New Jersey 2004 — 2006
M.S., Biomedical Sciences
Northeastern University 1997 — 2001
Novartis September 2011 - Present
Roche Pharmaceuticals 2007 - September 2011
Pfizer June 2006 - February 2007
Roche Pharmaceuticals 2005 - 2006
Alteon Inc. 2004 - 2006
Skills
CTMS, Clinical Development, Clinical Trials
Education
University of Medicine and Dentistry of New Jersey 2004 — 2006
M.S., Biomedical Sciences
Northeastern University 1997 — 2001
Carolyn Coutts's Alteon Inc. Experience 2004 - 2005
Job Lead Regional Site Manager at Forest Laboratories
Industry Research
Experience
Forest Laboratories 2009 - Present
Novo Nordisk 2007 - July 2009
Novo Nordisk 2007 - 2009
Schering Plough Research Institute 2005 - 2007
Nabi Biopharmaceuticals June 2005 - December 2005
Omnicare Clinical Research, Inc. January 1999 - January 2005
Alteon Inc. 2004 - 2005
Elan Pharmaceuticals, Inc. 2004 - 2005
Ortec International, Inc. 2000 - 2003
GenMab June 2002 - December 2002
Education
University of North Carolina at Chapel Hill 1985 — 1989
BSN, Nursing
Forest Laboratories 2009 - Present
Novo Nordisk 2007 - July 2009
Novo Nordisk 2007 - 2009
Schering Plough Research Institute 2005 - 2007
Nabi Biopharmaceuticals June 2005 - December 2005
Omnicare Clinical Research, Inc. January 1999 - January 2005
Alteon Inc. 2004 - 2005
Elan Pharmaceuticals, Inc. 2004 - 2005
Ortec International, Inc. 2000 - 2003
GenMab June 2002 - December 2002
Education
University of North Carolina at Chapel Hill 1985 — 1989
BSN, Nursing
Bing Cai's Alteon Inc. Experience 1995 - 1997
Job DIVISION DIRECTOR (ACTING) at FDA/CDER/OPQ
Industry Pharmaceuticals
Experience
FDA/CDER/OPQ January 2015 - Present
FDA April 2013 - December 2014
FDA September 1997 - April 2013
Alteon Inc 1995 - 1997
Pharm-Eco 1993 - 1994
Skills
Analytical Chemistry, Biopharmaceuticals, Chemistry, Chromatography, Drug Development, Drug Discovery, FDA, GLP, GMP, HPLC, IND, LC-MS, Medicinal Chemistry, Organic Chemistry, Organic Synthesis, Pharmaceutical Industry, Regulatory Affairs, SOP, Sop, Technology Transfer, Validation, Regulatory Submissions, UV/Vis
Education
New York University 1988 — 1993
Ph. D., CHEMISTRY
Fudan University 1982 — 1986
BS, CHEMISTRY
FDA/CDER/OPQ January 2015 - Present
FDA April 2013 - December 2014
FDA September 1997 - April 2013
Alteon Inc 1995 - 1997
Pharm-Eco 1993 - 1994
Skills
Analytical Chemistry, Biopharmaceuticals, Chemistry, Chromatography, Drug Development, Drug Discovery, FDA, GLP, GMP, HPLC, IND, LC-MS, Medicinal Chemistry, Organic Chemistry, Organic Synthesis, Pharmaceutical Industry, Regulatory Affairs, SOP, Sop, Technology Transfer, Validation, Regulatory Submissions, UV/Vis
Education
New York University 1988 — 1993
Ph. D., CHEMISTRY
Fudan University 1982 — 1986
BS, CHEMISTRY
Sarah Villamor-Arana's Alteon Inc. Experience March 2004 - August 2005
Job Global Systems Auditor at Bayer HealthCare
Industry Biotechnology
Experience
Bayer HealthCare August 2015 - Present
Novartis Pharmaceuticals Corporation November 2014 - August 2015
Novartis Consumer Health July 2008 - October 2014
Forest Laboratories August 2005 - July 2008
Alteon Inc. March 2004 - August 2005
Skills
Pharmacovigilance, Drug Safety, CAPA, SOP, Clinical Trials, FDA, GCP, Regulatory Submissions, IND, KPI Reports, Pharmaceutics
Education
Rutgers University-New Brunswick 1998 — 2003
Bachelors of Science, Nursing
Bayer HealthCare August 2015 - Present
Novartis Pharmaceuticals Corporation November 2014 - August 2015
Novartis Consumer Health July 2008 - October 2014
Forest Laboratories August 2005 - July 2008
Alteon Inc. March 2004 - August 2005
Skills
Pharmacovigilance, Drug Safety, CAPA, SOP, Clinical Trials, FDA, GCP, Regulatory Submissions, IND, KPI Reports, Pharmaceutics
Education
Rutgers University-New Brunswick 1998 — 2003
Bachelors of Science, Nursing
Sharada Truter, PhD's Alteon Inc. Experience 1994 - 1995
Job Worldwide Regulatory Affairs at Pfizer
Industry Pharmaceuticals
Experience
PFIZER 2009 - Present
WYETH PHARMACEUTICALS July 2005 - October 2009
CORNELL UNIVERSITY - WEILL MEDICAL SCHOOL 1997 - 2005
MOUNT SINAI SCHOOL OF MEDICINE, NY. 1995 - 1997
ALTEON, INC 1994 - 1995
MOUNT SINAI SCHOOL OF MEDICINE, NY. 1989 - 1994
SUNY-HEALTH SCIENCE CENTER, NY 1988 - 1989
Skills
Biotechnology, Molecular Biology
Education
University of Cape Town
Ph.D., Medical Biochemistry; Molecular and Cell Biology
PFIZER 2009 - Present
WYETH PHARMACEUTICALS July 2005 - October 2009
CORNELL UNIVERSITY - WEILL MEDICAL SCHOOL 1997 - 2005
MOUNT SINAI SCHOOL OF MEDICINE, NY. 1995 - 1997
ALTEON, INC 1994 - 1995
MOUNT SINAI SCHOOL OF MEDICINE, NY. 1989 - 1994
SUNY-HEALTH SCIENCE CENTER, NY 1988 - 1989
Skills
Biotechnology, Molecular Biology
Education
University of Cape Town
Ph.D., Medical Biochemistry; Molecular and Cell Biology
Charles E. Bell's Alteon Inc. Experience 1995 - 1996
Job Sr. Project Manager at Novo Nordisk
Industry Pharmaceuticals
Experience
Novo Nordisk March 2014 - Present
ReSearch Pharmaceutical Services July 2010 - March 2014
Dainippon Sumitomo Pharma America 2008 - 2009
Johnson & Johnson 2007 - 2008
Pfizer 2006 - 2007
Eisai Medical Reserch 2005 - 2006
sanofi-aventis 2002 - 2005
Pfizer 2000 - 2002
Hoffmann-La Roche 1996 - 2000
Alteon, Inc 1995 - 1996
Skills
CTMS, Clinical Development, CRO, GCP, Clinical Trials, Pharmacovigilance, Clinical Monitoring, Therapeutic Areas, Pharmaceutical Industry, EDC, Oncology, ICH-GCP, Medical Affairs, Regulatory Affairs, Biotechnology, 21 CFR Part 11, Neurology, Endocrinology, FDA, Sop, Regulatory Submissions, Clinical Data Management, Clinical Research, Infectious Diseases, Diabetes, Drug Development, Medical Writing, Protocol, Cardiology, Oracle Clinical, Hematology, Rheumatology, Gastroenterology, Phase I, Immunology, Validation, Dermatology, Regulatory Requirements, Data Management, Clinical Study Design, Computer System..., Medical Devices, Lifesciences, Pharmacology, Drug Discovery, GxP, Clinical Operations, Pharmaceutics, Vaccines, GMP
Education
Saint Joseph's University 2013 — 2016
Master of Business Administration (MBA), Pharmaceutical & Healthcare Marketing
Upsala College
Bachelor of Arts (B.A.), Psychology and Sociology
Novo Nordisk March 2014 - Present
ReSearch Pharmaceutical Services July 2010 - March 2014
Dainippon Sumitomo Pharma America 2008 - 2009
Johnson & Johnson 2007 - 2008
Pfizer 2006 - 2007
Eisai Medical Reserch 2005 - 2006
sanofi-aventis 2002 - 2005
Pfizer 2000 - 2002
Hoffmann-La Roche 1996 - 2000
Alteon, Inc 1995 - 1996
Skills
CTMS, Clinical Development, CRO, GCP, Clinical Trials, Pharmacovigilance, Clinical Monitoring, Therapeutic Areas, Pharmaceutical Industry, EDC, Oncology, ICH-GCP, Medical Affairs, Regulatory Affairs, Biotechnology, 21 CFR Part 11, Neurology, Endocrinology, FDA, Sop, Regulatory Submissions, Clinical Data Management, Clinical Research, Infectious Diseases, Diabetes, Drug Development, Medical Writing, Protocol, Cardiology, Oracle Clinical, Hematology, Rheumatology, Gastroenterology, Phase I, Immunology, Validation, Dermatology, Regulatory Requirements, Data Management, Clinical Study Design, Computer System..., Medical Devices, Lifesciences, Pharmacology, Drug Discovery, GxP, Clinical Operations, Pharmaceutics, Vaccines, GMP
Education
Saint Joseph's University 2013 — 2016
Master of Business Administration (MBA), Pharmaceutical & Healthcare Marketing
Upsala College
Bachelor of Arts (B.A.), Psychology and Sociology
Kamy Netram's Alteon Inc. Experience March 1993 - March 1996
Job President at All In One Construction LLC
Industry Construction
Experience
All In One Construction LLC April 2004 - Present
BOE August 1996 - August 2003
Alteon Inc March 1993 - March 1996
Hoffmann-La Roche March 1991 - March 1993
University of South Florida, Tampa December 1988 - January 1990
Memorial Sloane-Kettering Cancer Center July 1986 - September 1988
Skills
Strategic Planning, Contract Negotiation, Project Planning, Budgets, Contractors, Construction, Construction Management, Decks, Restoration, Residential Homes, Contract Management, Carpentry, Team Building, Fences
Education
City University of New York-Herbert H. Lehman College 1999 — 2000
MA, Science Education
Baruch College, City University of New York (CUNY) 1998 — 1999
MS, Supervision and Administration
Fordham University
BA Science, Natural Sciences
All In One Construction LLC April 2004 - Present
BOE August 1996 - August 2003
Alteon Inc March 1993 - March 1996
Hoffmann-La Roche March 1991 - March 1993
University of South Florida, Tampa December 1988 - January 1990
Memorial Sloane-Kettering Cancer Center July 1986 - September 1988
Skills
Strategic Planning, Contract Negotiation, Project Planning, Budgets, Contractors, Construction, Construction Management, Decks, Restoration, Residential Homes, Contract Management, Carpentry, Team Building, Fences
Education
City University of New York-Herbert H. Lehman College 1999 — 2000
MA, Science Education
Baruch College, City University of New York (CUNY) 1998 — 1999
MS, Supervision and Administration
Fordham University
BA Science, Natural Sciences
Michael Yamin's Alteon Inc. Experience 1987 - 1993
Job Intellectual Property Consultant
Industry Biotechnology
Experience
Angion Biomedica Corp. 2001 - Present
Pearl Cohen Zedek Latzer Baratz LLP 2006 - Present
Araim Pharmaceuticals, Inc. 2008 - November 2013
Warren Pharmaceuticals, Inc. 2004 - November 2013
Mojave Therapeutics 2001 - 2004
Klauber & Jackson 1998 - 2001
Picower Institute for Medical Research 1995 - 1997
Innapharma, Inc. 1994 - 1995
Alteon Inc. 1987 - 1993
Education
The Rockefeller University
PhD
University of California, Davis
BS, Bacteriology
Angion Biomedica Corp. 2001 - Present
Pearl Cohen Zedek Latzer Baratz LLP 2006 - Present
Araim Pharmaceuticals, Inc. 2008 - November 2013
Warren Pharmaceuticals, Inc. 2004 - November 2013
Mojave Therapeutics 2001 - 2004
Klauber & Jackson 1998 - 2001
Picower Institute for Medical Research 1995 - 1997
Innapharma, Inc. 1994 - 1995
Alteon Inc. 1987 - 1993
Education
The Rockefeller University
PhD
University of California, Davis
BS, Bacteriology
Donna Giordano-Schmidt's Alteon Inc. Experience 1993 - 1999
Job Senior Research Scientist at Pfizer
Industry Pharmaceuticals
Experience
Pfizer (Formerly Wyeth) October 2009 - Present
Wyeth November 2000 - Present
Ortho Clinical Diagnostics June 1999 - October 2000
Alteon Inc 1993 - 1999
Skills
Bioanalysis, GLP, Assay Development, Immunoassays, Clinical Development, Validation, Drug Development, Antibodies, Biopharmaceuticals, Sop, Laboratory
Education
Fairleigh Dickinson University
MS, Biochemistry
Pfizer (Formerly Wyeth) October 2009 - Present
Wyeth November 2000 - Present
Ortho Clinical Diagnostics June 1999 - October 2000
Alteon Inc 1993 - 1999
Skills
Bioanalysis, GLP, Assay Development, Immunoassays, Clinical Development, Validation, Drug Development, Antibodies, Biopharmaceuticals, Sop, Laboratory
Education
Fairleigh Dickinson University
MS, Biochemistry
Lisa Nardi, MS, BS, CCRA's Alteon Inc. Experience January 2002 - June 2003
Job Lead, Clinical Trial Leader at Novartis; (Associate Director)
Industry Pharmaceuticals
Experience
Novartis Institutes for BioMedical Research (NIBR) November 2008 - Present
sanofi-aventis June 2003 - November 2008
sanofi 2003 - 2008
Alteon Inc January 2002 - June 2003
Eisai Inc December 1999 - January 2002
Purepac Pharmaceutical Company September 1997 - October 1999
Skills
Medical Writing, Budgeting, Outsource Management, Clinical Trial..., Contract Negotiation, Protocol Writing, Clinical Trials, Oncology, Microsoft Publisher, Microsoft Office 2007, Microsoft Excel, Oracle Clinical, CTMS, Microsoft Project, Resource Management, Global Clinical Trials, Strategic Relationship..., Clinical Monitoring, Data Management, PowerPoint, WDCS, CT4, Documentum, Budgets, Business Strategy, Clinical Development, SharePoint, Outsourcing, Clinical Operations, CRO, MS Project, Drug Development, Therapeutic Areas, Clinical Research, Pharmaceutical Industry, Protocol, EDC, Clinical Study Design, ICH-GCP, IND, Medical Affairs, Regulatory Submissions, Biomarkers, Phase I, GCP, Pharmacovigilance, Clinical Data Management, SOP, FDA, Biotechnology
Education
Walden University 2010 — 2012
Masters of Clinical Research, Clinical Research
University of Arizona 2001 — 2001
Certificate, Pharmacokinetics
Kemic Institute - Pharmacokinetics - Bioavailability and Bioequivalence 1998 — 1998
Certificate, Bioavailability & Bioequivalence
University of Maryland 1998 — 1998
Certificate, BA/BE ESD/EVA Training
UMDNJ 1995 — 1997
CLS Toxicology, Toxicology
University of Medicine and Dentistry of New Jersey 1995 — 1997
BS, Clinical Laboratory Science (Toxicology major)
Novartis Institutes for BioMedical Research (NIBR) November 2008 - Present
sanofi-aventis June 2003 - November 2008
sanofi 2003 - 2008
Alteon Inc January 2002 - June 2003
Eisai Inc December 1999 - January 2002
Purepac Pharmaceutical Company September 1997 - October 1999
Skills
Medical Writing, Budgeting, Outsource Management, Clinical Trial..., Contract Negotiation, Protocol Writing, Clinical Trials, Oncology, Microsoft Publisher, Microsoft Office 2007, Microsoft Excel, Oracle Clinical, CTMS, Microsoft Project, Resource Management, Global Clinical Trials, Strategic Relationship..., Clinical Monitoring, Data Management, PowerPoint, WDCS, CT4, Documentum, Budgets, Business Strategy, Clinical Development, SharePoint, Outsourcing, Clinical Operations, CRO, MS Project, Drug Development, Therapeutic Areas, Clinical Research, Pharmaceutical Industry, Protocol, EDC, Clinical Study Design, ICH-GCP, IND, Medical Affairs, Regulatory Submissions, Biomarkers, Phase I, GCP, Pharmacovigilance, Clinical Data Management, SOP, FDA, Biotechnology
Education
Walden University 2010 — 2012
Masters of Clinical Research, Clinical Research
University of Arizona 2001 — 2001
Certificate, Pharmacokinetics
Kemic Institute - Pharmacokinetics - Bioavailability and Bioequivalence 1998 — 1998
Certificate, Bioavailability & Bioequivalence
University of Maryland 1998 — 1998
Certificate, BA/BE ESD/EVA Training
UMDNJ 1995 — 1997
CLS Toxicology, Toxicology
University of Medicine and Dentistry of New Jersey 1995 — 1997
BS, Clinical Laboratory Science (Toxicology major)