David W. Mullis,
Jr., Ph.D.
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Dr. Mullis is president of Mullis & Associates,
Inc., a consulting company that he founded in 1999, that
provides regulatory affairs and clinical support services to medical
device
companies, pharmaceuticals companies and biotechnology
firms. He has 25 years of successful corporate management experience
in FDA
regulated industry directing US and international programs
in regulatory affairs, clinical studies, quality assurance and
marketing. From
1998-1999, Dr. Mullis served as Vice President, Global
Clinical Programs at London International, plc. From 1989-1998,
he worked
with C.R. Bard, Inc., a fortune 500 medical device company,
where he was Vice President of Regulatory Affairs, Clinical Research
and Quality Assurance for a major division and held various
corporate
positions including Regional Vice President of Corporate
Regulatory Affairs, Vice President of Corporate Regulatory Affairs
and Vice
President of Clinical Programs Support. Dr. Mullis worked
for Cardiac Pacemakers, Inc., a subsidiary of Eli Lilly, from 1981
to 1989,
directing regulatory affairs, clinical research and product
assurance functions. Dr. Mullis has established an outstanding
record for
obtaining FDA approval for novel products and technologies
in medical devices, in vitro diagnostics and biotechnology. He
has extensive
experience in planning and implementing Investigational
Device Studies, developing Investigational New Drug Studies and
filing
various submissions with FDA and international regulatory
agencies.
Prior to his industry experience, Dr. Mullis
served as the Executive Director of a physicians’ professional
standards review organization where he lead the firm from its start-up
phase to a successful business level from 1977-1981. From 1973-1985,
he held faculty positions at several universities including The
University of Tennessee and Radford University and served as adjunct
professor at other colleges and universities.
Dr. Mullis received his B.S. degree from Appalachian
State University in 1970, his Master of Science degree from The
University of Tennessee in 1971 and the Ph.D. from The University
of Tennessee in 1976. He is a member of the Regulatory Professional
Society, Georgia Biomedical Partnership and president of the Georgia
Walking Horse Exhibitors Association. |