Expert No. 1684
Director Clinical Research
• Lead and coordinate clinical research teams to develop and test new products
• Design protocol for pilot and/or multicenter clinical trials & analyze/interpret data
• Represent R & D developments internally and externally by summary reports, presentations in peer reviewed and industry forums, and by published research articles
• Provide regulatory strategies and solutions to obtain FDA approval if required
Extensive background in Vision Science/Physiological Optics and Clinical Optometry
Experience providing pre-planning and post-study strategies for FDA product approval
Proactive approach to all aspects of product development by providing:
• Detailed and scientifically sound critical review at earliest stages and throughout process
• Intuitive and creative problem solving for unexpected, unexplained results
• View to marketability based on clinical experience and talent for innovationSPECIALTIES
Clinical trials, IRB, AINSI, Biostatistics, Protocol Design and PublishingAreas of Expertise:
Accommodation, Emmetropization, Myopia, Presbyopia, Refractive Solutions, Psychophysics & the Measurement of Visual Function, Binocular Vision, Color Vision
Licensed O.D. in several states EDUCATION
O.D., School of Optometry, University of California, Berkeley, 1999.
Ph.D. in Physiological Optics, University of California, Berkeley, 1997.
M.S. in Vision Science, College of Optometry, State University of New York, 1990.
B.A. in Natural Science, Hampshire College, Amherst, Massachusetts, 1981.EXPERIENCE
Exec Director, A PRIVATE COMPANY. Jan 2001 to present.
Established non profit 501(c) (3) corporation to conduct research and provide eye care to medically underserved children. Implemented school screening program for Fullerton Public School system to screen and treat children for functional vision problems that could interfere with learning. Over 450 children have benefitted to date.
Retained as Vision Science Consultant, A PRIVATE COMPANY 2010 to present
Vision Science Consultant, A PRIVATE COMPANY, Irvine, CA. Dec 2005 to 2010. (Acquired by Abbott in 2009 for $400 million)
Hired to help acquire FDA approval of the dual optic Synchrony IOL: Protocol Writing, Data analysis and interpretation, Lead Author for peer reviewed Scientific Publications and Internal Reports, Scientific rationales in response to FDA reviews (100% success rate), Participant in AINSI for FDA AIOL standards to develop Subjective Accommodation methods and targets, and Functional Vision & Reading Speed Standards
Vision Science Consultant, Cooper Vision Pleasanton, CA. Jan 2008-March 2008.
Evaluated efficacy of contact lens to control myopia by reviewing pilot data and lens design. Worked with a team of scientists, clinicians, and engineers to develop the Multicenter Investigational Device Clinical Trial Protocol for submission to the FDA. Wrote up final protocol with scientific references and rationale. Work completed in 3 mos. MiSightLens is currently available in Singapore as a disposable daily wear lens.
Associate Professor, Southern California College of Optometry 2001-2007 Developed and taught Basic Science courses including Measurement of Visual Function, Binocular Vision, Color Vision, Geometric and Physiological Optics & Post Natal Visual Development. Clinical Supervisor in Primary Eye Care, Binocular Vision, Pediatrics, and Clinical Research, provided eye care and supervised 2nd and 3rd year students in optometry clinic.PROFESSIONAL APPOINTMENTS
- Research Diplomate, College of Optometrists in Vision Development since 2003; member since 1987. Research Fellow, American Academy of Optometry since 2002; member since 1987.
- Invited Reviewer for Ophthalmic and Physiological Optics since 2006.
- Invited Reviewer for Optometry & Vision Science since 2000.
- Board Member, Marran Oil LLC est 1891.
- Board Member, Fullerton Rec Riders.
- Parents Arts Council Member, Orange County High School of the Arts
$100,000 National Institute for Clinical Eye Research
New York State Finalist & National Merit Semi-Finalist 1975CE LECTURES: Upon RequestPUBLICATIONS: Upon Request