| Barbara S. Fant, Ph.D. President and CEO |
| Barbara Fant, Pharm. D, is the Principal Regulatory Consultant and President of CRC and has 25 years of experience in pharmaceutical and medical device research and development. 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 nationally and internationally recognized as an expert provider of FDA regulatory and clinical services for the development and approval of refractive, intraocular, and corneal ophthalmic medical devices and orthopedic medical devices. She has 15 years of experience in working with FDA in the management of LASIK clinical studies and excimer laser regulatory submissions for LASIK, corneal collagen cross-linking, artificial iris, and other refractive and corneal indications and is also the ophthalmic technical reviewer for one of the most highly respected notified bodies for CE mark certification in Europe.. Dr. Fant is an active member of the ANSI Z80.11 committee, which developed a new standard for refractive surgery lasers, serving as chair of the ANSI Z80.11 committee for 3 years and chair of its clinical subcommittee for 5 years. Dr. Fant is also active in the ANSI Z80 committees for phakic refractive lenses, toric IOL’s, and accommodating IOL’s.Dr. Fant is a frequent invited speaker at numerous national and international medical device and drug-device combination product meetings and conferences. Dr. Fant recently co-chaired the Drug Information Association’s (DIA) Medical Device Symposium, is a past chairperson of the DIA’s Medical Device Special Interest Group Program Committee, and coordinates the medical device lecture series for the University of Cincinnati’s Master’s Program in Drug and Device Development. Dr. Fant frequently trains established companies in the process of medical device development and provides customized in-house training on medical device regulations for a leading educational provider.
Located in Cincinnati, Ohio, Dr. Fant is the founder of the VEO Research Consortium, comprised of the leading refractive surgeons and cornea specialists in the world with the common goal of establishing the organization and infrastructure necessary to complete ophthalmic clinical trials internationally and in the U.S. to support FDA product approvals. Dr. Fant is also a founding member of VEO, an international clinical research consortium, and the Integrated Center for Device Development, a unique consortium of consultants with the capability to take medical devices from the concept stage through regulatory approval, manufacturing, and distribution. Dr. Fant also serves on the Board of Directors for Medennium, Inc. and directs the strategic planning for several start-up companies. She holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati. |
