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CRC
EXPERIENCE
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Barbara
S. Fant, Ph.D.
President and CEO |
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Barbara S. Fant,
Pharm.D. has over 18 years experience in pharmaceutical and medical
device research and development. CRC is an independent consulting
firm that provides clinical and regulatory support services to medical
device and pharmaceutical companies to bring investigational products to
market. CRC’s client base includes U.S. and international
companies with a focus on start-up and incubator companies developing
novel medical devices. CRC has successfully filed over 30 IDE’s,
pre-IDE’s, 510(k)’s, and PMA’s with the FDA in the past four
years. In addition to ophthalmics, therapeutic areas of expertise
include imaging technologies and orthopedics.
Dr. Fant is the
principle regulatory consultant and owner of CRC. Prior to
founding CRC, Dr. Fant spent several years directing and managing
anti-infective clinical trials and pharmacokinetic studies with a major
pharmaceutical company; established and directed a highly successful
Phase I/Phase II academic-based clinical pharmacology research center at
the University of Cincinnati; served as the vice chairperson and
associate administrator for an independent institutional review board;
and, was an assistant director for clinical research for a large
contract research organization.
Dr. Fant is recognized
as an expert in FDA regulations pertaining to medical devices with
extensive experience in developing ophthalmic medical devices. She
currently serves as the chairperson for the ANSI Z80.11 subcommittee,
which is working in conjunction with FDA to develop an approved ANSI
standard for laser systems for refractive surgery and which will also be
presented to ISO for consideration.
Located in Cincinnati, Ohio, Dr. Fant is the
founding member of the Integrated Center for Device Development, a
unique consortium of consultants with the capability to take unique
medical devices from the concept stage through regulatory approval,
manufacturing, and distribution. Dr. Fant also serves on the board
of directors for Medennium, Inc., Salpingo Medical, and several
charitable and philanthropic organizations in the Cincinnati, Ohio
community. She holds a B.S. in Pharmacy from Ohio Northern
University and a Doctor of Pharmacy degree from the University of
Cincinnati Medical Center.
contact e-mail: bsfant@crc-regulatory.com
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Lena
Sattler
Associate Regulatory Consultant |
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Lena
Sattler, B.S.M.E., has over seven years of experience in
providing laser engineering support services in the U.S., Central
America, and Europe. She is widely recognized for her expertise in corneal
topography and LASIK treatment algorithms and works extensively with her
U.S. and international colleagues in furthering LASIK technology and
techniques. Mrs. Sattler
joined CRC’s staff in 2001, bringing with her a core knowledge in
custom LASIK algorithms, database design, and clinical investigator and
regulatory experience. Mrs. Sattler holds a B.S. in Mechanical Engineering from SUNY
at Stony Brook, New York, and also serves on the ANSI Z80.11
subcommittee for the development of an ANSI standard for laser systems
for refractive surgery.
contact e-mail:
lesattler@crc-regulatory.com
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