Biography

Barbara S. Fant, Ph.D.
President and CEO
Barb_HeadshotBarbara Fant, Pharm.D. is the President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (CRC), and has 30 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 corneal, refractive, intraocular, and other ophthalmic medical devices. She has 20 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 has successfully filed over a hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. Dr. Fant is also well known for her international regulatory expertise, having served as the ophthalmic technical reviewer for one of the most highly respected notified bodies in Europe for awarding CE mark certification.

 

Dr. Fant is an active member of the ophthalmic community. Dr. Fant serves on several ANSI subcommittees for the development of ANSI standards, including clinical subcommittee chair and committee chair for the ANSI Z80.11 committee, which developed a new standard for refractive surgery lasers; participation on the ANSI Z80 committees for phakic refractive lenses, toric IOL’s, and accommodating IOL’s; and, chair of the clinical subcommittee for the ANSI Z80.32 working group for developing methodology for representation of optically induced visual phenomena.

 

Dr. Fant has significant editorial and peer review experience, having served as an editorial director for Harvey Whitney Books, and currently as a reviewer for the Journal of Refractive Surgery, Journal of Refractive and Corneal Surgery, and Cornea. Dr. Fant is one of the few non-ophthalmologists elected to membership in the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, the International Society of Refractive Surgery, the European Society of Cataract and Refractive Surgery, the Association for Research in Vision and Ophthalmology, and the American College of Ophthalmic Surgery (Founding Member). Dr. Fant is also an active member of the Ophthalmic Women Leaders, the Women in Ophthalmology, the Regulatory Affairs Professionals Society, and the Drug Information Association.

 

Dr. Fant is a frequent invited speaker at numerous national and international medical device and drug-device combination product meetings and conferences. Dr. Fant frequently trains established companies in the process of medical device development. FDA regulations, and Good Clinical Practices; and provides customized in-house training on medical device regulations for several leading educational providers. She also lectures in the medical device series for the University of Cincinnati’s Master’s Program in Drug and Device Development. 

 

Dr. Fant serves on the Board of Directors for Medennium, Inc. and directs the strategic planning for several start-up companies.  She is the founder of the VEO Research Consortium and works closely with the European Vision Institute Clinical Trial Sites of Excellence consortium. Dr. Fant holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.