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Management Team
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Experienced, Knowledgeable, Experts
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Ellen Morgan - CEO/President, co-founder
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Ms. Morgan has been in the industry since 1975, with over 20 years in
management and analysis of clinical research data. Ms. Morgan is a renowned
expert in data management, statistics, clinical information systems and
preparing submissions to the FDA.
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- Former Director of Data Management and Statistics for Gensia, Inc.
- Former Manager of Clinical Database Operations for Pfizer, Inc.
- Former Project Coordinator, Clinical Data Management for Sterling Drug.
- BS in Chemistry from Siena College
- MS in Management Engineering/Statistics from Rensselaer Polytechnic Institute
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Russell Holmes - Chairman/Executive Vice President, co-founder
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Russell Holmes has been in the industry since 1987, and is responsible for the Information
Technology and Business Operations departments. While concurrently serving as corporate Secretary,
he has shown the ability to handle diverse roles in technology, finance, corporate governance,
business development, and electronic regulatory submissions.
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- Former Manager of Project Information Resources for Gensia, Inc.
- Senior CANDA and Statistical Data Analyst for Pfizer, Inc.
- BS in Computer Science & Mathematics
- MBA from Sacred Heart University
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Stewart Bieler - Vice President, Clinical Operations & Project Management
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Mr. Bieler has been in the industry since 1989, primarily working in the
areas of clinical development, medical writing and regulatory submissions. Mr.
Bieler is well versed in the entire clinical development process.
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- Former Senior Manager, Regulatory Submissions for Dura Pharmaceuticals, Inc.
- Former Manager, Clinical Development for Gensia, Inc.
- BA in Economics from Stanford University
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Steve Preiss - Vice President, Corporate Regulatory & East Coast Business Operations
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Mr. Preiss has twenty-three years of industry experience, including ~20 years
in clinical research and development. Prior to joining Synteract, Mr. Preiss was
the Vice President of Clinical and Regulatory Affairs for UroSurge,
Inc. Mr. Preiss has B.S in Chemistry.
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- Former Vice President of Clinical and Regulatory Affairs for UroSurge, Inc.
- BS in Chemistry
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Marilyn Carlson - Vice President, Medical and Regulatory Affairs
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Dr. Marilyn R. Carlson has 15 years of industry experience in the development and
post-marketing support of drugs, biologics, and diagnostics. In 2004, she joined Synteract
as Vice President of Medical & Regulatory Affairs and is currently responsible for medical,
regulatory and safety services.
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- BA in anthropology/biology from Hunter College
- D.M.D. from Harvard
- Dental residency - Long Island Jewish-Hillside Medical Center
- M.D. from Case Western Reserve University, elected to Alpha Omega Alpha
- Internal medicine residency - Cleveland Clinic Foundation
- Regulatory Affairs Certification - Regulatory Affairs Professionals Society
- Clinical Research, Medical Affairs, Technical Brand Management - Procter & Gamble Healthcare and P&G Pharmaceuticals
- Vice President Clinical & Medical Affairs - XOMA
- Chief Medical Officer & Vice President - Ista Pharmaceuticals and Prometheus Laboratories
- Founder entreMeDica, Inc. - Consulting company providing Chief Medical Officer services to biotechnology and life-science companies
- U.S. Agent for non-U.S. companies seeking FDA approval
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Bob Hull - Director of Clinical Programming
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Mr. Hull has been working for Synteract since 1996. He has emphasized data analysis throughout his career.
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- Formerly worked for Harbor-UCLA Vaccine Research Center on a probabilistic matching algorithm.
- BS in Applied Mathematics from Biola University
- MS in Applied Mathematics from California State University Long Beach
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Elaine Kelley - Senior Director, Clinical Operations
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Ms. Kelley has been in the pharmaceutical and biotechnology industry since
1981. She has primarily worked in the area of clinical research and development
and has extensive experience in the design, monitoring and management of all
phases of clinical trials. She also has experience in medical writing for
regulatory submissions and scientific publications.
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- Formerly held management positions in a large pharmaceutical corporation and a biotechnology company.
- BS in Biological Science from the University of California, Irvine
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