CLINICAL AND REGULATORY STRATEGIES
Partners
Global Advisors
Global Eye Ventures and its consulting associate network provide support for execution and management of clinical trials as well as due diligence for venture capital firms and investors. The scope of service includes serving as clinical investigators, the formation and execution of practitioner and consumer focus groups, literature review, technology assessment, intellectual property review and strategic consultation, market and competitive analysis and manufacturing efficacy and risk assessment.
Global EyeVentures, LLC. - 408.528.7100
Mile Brujic, OD
Dr. Gary Andrasko received his Optometry degree from The Ohio State University in 1978 and a Masters degree in Physiological Optics in 1980. He was a faculty member at the OSU College of Optometry from 1980 to 1990. For the last 18 years Gary Andrasko has been the director of a private ocular research practice in Columbus, Ohio undertaking over 400 F.D.A.-monitored clinical studies. Dr. Andrasko is also the publisher of the www.StainingGrid.com, a website showcasing the results of a recent large research project investigation contact lens/multipurpose solution biocompatibility.
The research practice, located within a large ophthalmology clinic, offers 18 fully equipped examination rooms, modern diagnostic equipment, and a highly training research staff. Three ophthalmologists on staff are also available for consultation/co-investigators as needed. A database of nearly 20,000 patients can be searched for inclusion of subjects with various ocular conditions. Since this research facility is NOT within a hospital or university setting high overhead costs and research foundation administration fees are not required.
Specific research services offered include protocol consultation and development, case report form generation, study implementation, data entry/analysis, statistical consultation, and report generation. Lecture/publication consultation is also available. On-time, accurate product assessment and complete confidentiality are the highest priorities.
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Mark A. Bullimore, MCOptom, PhD, FAAO is a Professor at The Ohio State University College of Optometry where he teaches a number of courses, including ophthalmic optics. He received his Optometry degree and PhD in Vision Science from Aston University in Birmingham, England. Prior to joining the faculty at OSU, he spent 8 years at the University of California at Berkeley.
His research interests include myopia, low vision, presbyopia, and refractive surgery. He has received a five-year grant from the National Eye Institute to study adult myopia progression. He also holds a Training Grant (T35) from the Institute that supports optometry students in a summer internship program.
He is the President of the American Optometric Foundation, a philanthropic organization devoted to the advancement of optometric education and research. He is the former Editor of Optometry and Vision Science, the Journal of the American Academy of Optometry. He served a four-year term on the U.S. Food and Drug Administration’s Ophthalmic Devices Panel and is a consultant to a number of ophthalmic, surgical, and pharmaceutical companies.
Brian Chou, OD, FAAO is a partner at Carmel Mountain Vision Care, a group optometric practice in San Diego. A graduate of UC Berkeley School of Optometry, he completed fellowship training in refractive surgery management at Jules Stein Eye Institute, UCLA School of Medicine. Dr. Chou has authored over 60 manuscripts in the eye care industry including the book, Spanish Terminology for the Eyecare Team. He received the Nuemueller Award in Optics from the American Academy of Optometry and serves on the editorial board for Review of Contact Lenses. Dr. Chou is a clinical investigator and consultant for the California Board of Optometry, CooperVision, and SynergEyes.
Robert L. Davis O.D., F.A.A.O. has spent time on both the Research/Development as well as the Clinical aspect of vision care. He is co-founder of EyeVis Eye and Research, Eyemanage LLC and Eyedeal LLC companies. He has developed many contact lens designs as well as holds various contact lens patents. Currently Dr. Davis is managing an Eye Care specialists practice outside Chicago, Illinois. Dr. Davis is a Fellow and Diplomate in the American Academy of Optometry as well as serving as a charter member of the Contact Lens and Corneal section member of the American Optometric Association. Dr. Davis has published and lectured extensively on topics related to Contact Lenses, Eye Care and the management of eye disorders. Dr. Davis has extended his experiences as a consultant to a variety of EyeCare companies as well as investment firms.
Michael DePaolis, OD, FAAO is a graduate of Pennsylvania College of Optometry and in private group practice in Rochester, New York. He also serves as a Clinical Associate faculty member at the University of Rochester Medical Center and is on the Board of Directors at TLC Vision. Dr. DePaolis is a member of the American Optometric Association and a Fellow of the American Academy of Optometry. He is the Optometric Editor of Primary Care Optometry News, and has served on the editorial review boards of Contact Lens Spectrum, Optometry, Eye & Contact Lens, Review of Optometry, and Refractive Eye Care. A frequent clinical investigator in the disciplines of contact lenses and anterior segment care, Dr. DePaolis has authored over 100 articles, papers, and textbook chapters, and has lectured at more than 450 eye care conferences.
Dr. Eiden is president of North Suburban Vision Consultants, Ltd., a private group practice specializing in primary eye care, complex contact lens management, treatment of eye diseases, and refractive surgery. He is also co-founder and partner of the EyeVis Eye and Research Institute. Dr. Eiden is an assistant clinical professor at the University of Illinois at Chicago Medical Center in the Department of Ophthalmology, Cornea and Contact Lens Service and an adjunct faculty member of the Illinois, Salus, and University of Missouri St. Louis Colleges of Optometry. Dr. Eiden is a fellow of the American Academy of Optometry, and is chair elect of the council of the American Optometric Association’s Contact Lens and Cornea Section. Dr. Eiden is a research consultant for numerous contact lens and pharmaceutical companies. He is a respected lecturer nationally and internationally and frequently publishes in the professional literature.
Arthur B. Epstein, OD, FAAO is an internationally recognized contact lens specialist and an acknowledged expert on corneal and anterior eye disease with special interest in the medical complications of contact lenses. He is a founding partner of North Shore Contact Lens & Vision Consultants a referral based contact lens specialty and primary eyecare practice on Long Island, NY. He served as the Director of the Contact Lens Service of North Shore University Hospital, NYU School of Medicine and is Clinical Adjunct Assistant Professor, Northeastern State University College of Optometry, Tahlequah, OK.
Dr. Epstein has published more than two hundred articles, scientific papers and book chapters. He is Contributing Editor for Review of Optometry and Executive Editor of Review of Cornea and Contact Lenses. He founded, and serves as Chief Medical Editor of Optometric Physician™, the first E-Journal in optometry. Dr. Epstein, has presented over 700 invited lectures on a variety of eyecare topics throughout the world. His primary clinical and research interests include dry eye/ocular surface disease, ocular allergy, contact lens and refractive surgery complications and therapeutic (medical) and specialty contact lenses.
Dr. Epstein is a Past Chair of the Contact Lens & Cornea Section of the American Optometric Association and a founder and first President of the Optometric Dry Eye Society. He is a Distinguished Practitioner of the National Academies of Practice, a Fellow of the American and New York Academies of Optometry and a Full Member of the International Society of Contact Lens Specialists. He serves on numerous professional and industry advisory boards including the Medical Advisory Board of the National Keratoconus Foundation and the Advisory Committee of the Gas Permeable Lens Institute.
Dave Kading, OD, FAAO earned his Bachelors degree in Visual Science. He graduated from Pacific University College of Optometry before completing a residency in Cornea and Contact Lenses. He worked at the Oregon Health Science University in the contact Lens department and was the head of the contact lens service at the Portland VA hospital. He currently practices in downtown Seattle and Kirkland, Washington. Dr. Kading practices full scope optometry while enjoying a specialty in contact lens and dry eye patient care. He is active in various contact lens and contact lens solutions studies and is a consultant for several eye care manufacturers. He lectures internationally on the topics of dry eye, anterior segment disease, contact lenses and contact lens solutions. He and his wife, Dr. Kristi Kading, live in North Bend, WA where they are close to hiking, snowboarding, and fly fishing.
Richard Lippman, OD, FAAO is Vice President for Ophthalmic Regulatory Medical Products at R.P. Chiacchierini & Associates, LLC, Rockville, Maryland. He received his Doctor of Optometry degree from the New England College of Optometry and a BA degree at the University of Vermont, Dr. Lippman was the former Director of the Division of Ophthalmic Devices at the Food and Drug Administration for a period of 10 years. He has been a consultant to the ophthalmic industry in regulatory and compliance matters for the past 16 years. His experience spans the range of ophthalmic devices with responsibilities that include preparing and obtaining approvals for PMA, 510(k), IDE, PDP, HUD, and HDE applications. In addition, his expertise includes strategic development for new and novel ophthalmic devices, clinical trial design, issues related to compliance including resolution of FDA Warning Letters and other regulatory sanctions, assists in preparation of industry facilities for FDA Quality System and Good Manufacturing Practice inspections. Dr. Lippman also provides services in due diligence evaluation to venture capital firms assessing client start-ups for new ophthalmic projects.
As Director of the Division of Ophthalmic Devices, Dr. Lippman was responsible for the management of the division’s four branches: Contact Lenses, Intraocular Implants, and Surgical and Diagnostic Products Branches. His responsibilities were to oversee regulatory matters for all ophthalmic classified products, interact with all offices of the Device Center, and deal with public health issues related to ophthalmic devices. He is the author of a book chapter in contact lens regulation, has written numerous articles published in the ophthalmic literature, and has lectured throughout the United States and abroad on contact lens related topics. In addition, he has been a guest lecturer at several optometric colleges throughout the United States. Dr. Lippman is a fellow of the American Academy of Optometry, a member of the Contact Lens Association of Ophthalmologists, and a supporter of the American Optometric Foundation. During his years in the Public Health Service, he was appointed by the Surgeon General to a special task force for Optometry to oversee programs in the PHS hospital system and the Indian Health Service to provide recommendations for improvements in eye care delivery to all of the PHS programs. Dr. Lippman practices optometry on a part-time basis in Rockville, Maryland.
Jason R. Miller, O.D., M.B.A. received his O.D. degree from The Ohio State University (TOSU) College of Optometry in 1999 and in 2006 completed his M.B.A. degree from Ohio Dominican University. He was a consultant for Vistakon during their Executive Education MBA Pilot Program at the The Wharton School of Business in August, 2006. Dr. Miller is in a partnership private practice in Powell, Ohio and he is on the faculty as a primary care instructor for TOSU College of Optometry.
Dr. Miller is an ABO, NCLE and COPE approved speaker. He has spoken and consulted with many of the eye care companies on a broad range of topics; including Alcon’s dry eye advisory board in June, 2008. He has also been published in many of eye care national publications and has a monthly column in Review of Cornea and Contact Lens.
Dr. Miller has served in numerous leadership roles in the Ohio Optometric Association (OOA). He was elected as a Trustee on the executive board with the OOA in October, 2008. He has served as the Central Ohio InfantSEE Coordinator and was nominated for the national Dr. W. David Sullins, Jr. InfantSEE Award in 2008. He currently serves as a Key OD and has volunteered numerous times for the Realeyes / Save Our Sight classroom initiative which teaches school-aged kids the importance of eye care. He won an award for presenting the Realeyes program to the most students in the 2007-2008 school year in Ohio.
Within his community, Dr. Miller is a member of the Olentangy Rotary Club having served on the board from 2003-2005 and participated in an international eye care mission trip to El Salvador in February, 2007. Dr. Miller was recognized with a Community Service Award from the Olentangy School Board in 2004.
Jim Schwiegerling, PhD is an Associate Professor of Ophthalmology & Vision Sciences at the University of Arizona. He serves as an adviser on optical technologies to Global EyeVentures. His expertise is in hardware and software design for ophthalmic instrumentation including wavefront sensors, corneal topographers and imaging systems.
Jennifer Smythe, OD, MS, FAAO is the Dean of the Pacific University College of Optometry. Dr. Smythe, a graduate of the Pacific University College of Optometry, completed a residency in contact lenses at that same institution and a Master's of Science in Clinical Optometry. Dr. Smythe was in a private group practice in Beaverton, Oregon for twelve years. She is a contributing editor for Primary Care Optometry News, Vice-President of Women of Vision, a Fellow in the American Academy of Optometry and a Diplomate in the Section on Cornea and Contact Lenses.
Dr. Loretta Szczotka-Flynn is Associate Professor at Case Western Reserve University Department of Ophthalmology & Visual Sciences and Director of the Contact Lens Service at the University Hospitals Case Medical Center in Cleveland, Ohio. She received her Doctorate of Optometry and Masters of Physiological Optics from The Ohio State University in 1992, and she is a PhD candidate in Epidemiology from Case Western Reserve University with expected completion in 2009. She is a Diplomate in the Cornea and Contact Lens Section of the American Academy of Optometry and Diplomate Award Chair for the Section. She is serving a second term on the editorial board for Optometry and Vision Science and is a Contributing Editor for Contact Lens Spectrum. Her research interests include contact lens complications, extended wear, silicone hydrogels, keratoconus, post-surgical contact lens fittings and corneal topography. She has written 36 peer reviewed manuscripts, 10 book chapters, 56 scientific meeting abstracts, and has presented over 140 presentations world-wide. She served as the Principal Investigator at the Case Department of Ophthalmology Participating Clinic for The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study from 1996 to 2004. She was Ohio’s 1997 Young Optometrist of the Year, and she received the Nissel Award from the British Contact Lens Association (BCLA) for excellence in rigid contact lens research in London, England in 2000. In 2004, she received a Patient Oriented Research Career Development Award from the National Eye Institute to study infiltrative complications with silicone hydrogel lenses. She is the recipient of two Ezell Fellowships for the years 2004-05 and 2005-06 from the American Optometric Foundation, a Female Scholar Award from Prevent Blindness Ohio in 2007, and a CLAO Educational Research Foundation Award in 2007 which all support her research in silicone hydrogel related infiltrative complications. Her most recent interests include the genetic causes of keratoconus which she studies in collaboration with Sudha Iyengar PhD, a genetic epidemiologist from Case Western Reserve University. Additionally, she has interests in bacterial adherence and biofilm formation on contact lenses, efficacy of contact lens care solutions against biofiom, and the relationship of bacterial contamination to infiltrative contact lens complications.
Larry Wan, OD is an EyeCare Center in Campbell, California.
Dr. Wan has been involved in clinical research for over 15 years and has been a consultant to numerous biotech and startup companies in and around Silicon Valley. Dr. Wan has conducted many contact lens design and solutions research studies for companies such as Bausch & Lomb, Johnson & Johnson, CIBA Vision, Cooper Vision, Alcon, American Optical, Wesley-Jessen, and Dow Corning. Dr. Wan has been involved in numerous FDA clinical trials that include contact lens materials and designs, solution interactions and drug therapies. He has written articles for Allaboutvision.com, Occupational Health and Safety and several optometric trade magazines. Wan is a member of the Santa Clara County Optometric Society, California Optometric Association, and American Optometric Association. Dr. Wan serves on several advisory boards including Primary Eye Care Network and Signet Armorlite. He is past president of Kiwanis International and a member of the exclusive think tank group, The American Society of Eye Care Specialist. He received his OD degree from Pacific University College of Optometry in 1983.
Graeme Young, MPhil, PhD, FCOptom, DCLP, FAAO is Managing Director of Visioncare Research Ltd, a UK-based contract research organisation (CRO) specialising in eyecare clinical research. Visioncare Research has conducted or supervised over 250 clinical studies, >50 of which have been multi-center studies in Europe and N America. After graduating in Optometry from City University, London, he spent five years in private practice in Jersey in the Channel Islands. He returned to England in order to study for a higher degree receiving a Master's degree and later a PhD for contact lens related research projects. Prior to forming Visioncare Research, Dr Young worked for Hydron Europe as Director of clinical research and later for Allergan Optical as UK Director of R&D. He is an ex-president of the British Contact Lens Association. He has published and lectured widely on contact lens related topics.
Dr. Stiegemeier is in private practice in Beachwood and Hudson, Ohio where she specializes in contact lens fitting. She is a graduate of The Ohio State University College of Optometry where she earned the Bausch and Lomb Contact Lens Award. Dr. Stiegemeier was also presented with a Distinguished Teaching Award from Mt. Sinai Hospital.
Dr. Stiegemeier is an adjunct associate clinical professor from Pacific College of Optometry. She is a Diplomate of The Cornea and Contact Lens Section of The American Academy of Optometry. She is also a Fellow of The American Academy, a member of the American Optometric Association and a member of the AOA Contact Lens Section.
Dr. Stiegemeier has lectured extensively on the topic of contact lenses, has done numerous clinical studies and pre-market tests, as well as research in the area of contact lenses. She has authored or co-authored several scientific publications and abstracts.
John Schachet, O.D. has been in private practice in Englewood, CO, since 1973; president of Colorado Optometric Association, 1980-81; director and chairman of the board, Colorado Vision Service Plan 1985-1996; lectured widely in US, Australia, New Zealand, Europe, Japan and Canada; authored numerous articles; former adjunct professor, SCCO; currently contributing editor, Review of Optometry, contributing editor, Optometric Physician, former contributing column writer, Primary Care Optometry News; FDA clinical investigator for many manufacturers from 1974-present. He currently has a large group primary care and contact lens practice, specializing in dry eye, allergy and Corneal Refractive Therapy. He recently completed his tenure as chairman of the SnowVision Optometric Conference for Review of Optometry, a position he held since 1995.
Dr. Michael Lipson is an optometrist/assistant professor at the University of Michigan’s Kellogg Eye Center at the Livonia location. He works with all types of contact lenses with emphasis on specialty contact lens fitting for overnight corneal reshaping, keratoconus, post-corneal transplant, post-refractive surgery and for severe dry eye patients. He has spoken to optometrists and ophthalmologists nationally on the subject of overnight corneal reshaping and conducts fitting workshops on corneal reshaping for private doctors and at schools of optometry. He has been the principle investigator for studies on corneal reshaping, visual quality of life and new lens designs (Synergeyes) that have been published in peer-reviewed journals. He received his optometry degree from Illinois College of Optometry and did undergraduate studies at Michigan State University.
Dr. Anderson earned a bachelor of science degree in biology from Rockford College in Rockford,IL and is a graduate of Indiana University School of Optometry. She is a member and Fellow of the American Academy of Optometry (AAO), a member of the Illinois Optometric Association, American Optometric Association (AOA), and the AOA Cornea and Contact Lens Section (CLCS). She authors the CLCS’s monthly industry e-news column “Making E-Contact”,
Dr. Anderson specializes in contact lens fittings. This includes soft, rigid gas permeable and hybrid lenses. Her major area of interest is keratoconus and post-surgical contact lens fits such as corneal transplants and post-refractive surgical cases. Her other areas of particular interest are corneal reshaping lenses for myopia control and the study of topography for corneal interpretation and contact lens designing. She is a featured author and member of the editorial advisory board and for Optometric Management, as well a clinical investigator for new contact lens designs and diagnostic equipment.
Dr. Anderson is affiliated with Arbor Centers for Eyecare and DuPage Medical Group Eye Specialists, two prominent ophthalmology practices in suburban Chicago. She has also developed specialty contact lens clinics within two LensCrafters locations in suburban Chicago. She and her husband, Ron, reside in Batavia, IL with their three daughters, Angela, Emily and Sarah.
Global Advisor Bios
Jerry Legerton, OD, MS, MBA, FAAO was the managing partner of a seven doctor, four office, multi-specialty practice in San Diego. During his twenty six years in practice, he was honored as the California Optometric Association Young Optometrist of the Year in 1971 and the San Diego Optometric Society Optometrist of the Year in 1987. He is a Fellow of the American Academy of Optometry, member of the American Optometric Association Low Vision and Contact Lens Sections, and a life member of the American Optometric Foundation and Southern California College of Optometry Alumni Association.
With his extensive clinical experience and two post-doctoral Masters degrees (MBA and MS), Dr. Legerton offers a wealth of knowledge in clinical science, research design, and visual function; human behavior, personnel management and team-building; and strategic planning, business development and marketing.
Dr. Legerton is an accomplished author and lecturer, as well as consultant to the ophthalmic industry. In addition, Jerry has provided management and consulting services to optometrists throughout the United States for The EPIC Group, a business he founded in 1988. He served as the 1997-98 Benedict Professor of Practice Management for the University of Houston, College of Optometry.
Dr. Legerton served as the Director of Clinical Research for Pilkington Barnes Hind, a multinational manufacturer and distributor of contact lenses and as Vice President, Advanced Technology and Market Development for Paragon Vision Sciences. He was recruited for his multifaceted approach to clinical research and product design. Dr. Legerton is an inventor on 18 issued US patents and more than twenty additional applications for contact lenses, refractive surgery and myopia control. He is the co-founder of SynergEyes, Inc. the developer of a high oxygen permeable hybrid contact lens.
Dr. Kenneth Daniels is an Adjunct Assistant Clinical Professor in the Centers for International Studies and is a National Eye Institute Clinical Investigator: CLEK (Collaborative Evaluation of Keratoconus) at the Pennsylvania College of Optometry (Salus University) was also the Director of Cornea and Contact Lens Research. As well, he enjoys a thriving private practice in with his associates Dr. Mimi Lee Parma, PhD, OD and Dr. Patricia Leggin, OD, and Dr. David Reynolds, MD.
He is a graduate of Temple University and the New England College of Optometry. While in graduate school in Boston, he also worked with the ophthalmology department in a Harvard affiliated health plan. Dr. Daniels is the former Director of Clinical Research for Allergan Pharmaceuticals and has collaborated in several research projects in Sydney, Australia at the University of New South Wales with the world renowned Corneal and Contact Lens Research Unit (CCLRU) working with Brien Holden, PhD.
Dr. Daniels has been a clinical research, academically and in private practice on multitude of research and development projects for the majority of contact lens and medical device manufacturers and sits on several corporate advisory panels such as Hydrogel Corporation, Wavetouch Technologies, Tomey, Alcon Speakers Bureau, Coopervision, and Sarnoff Corporation.
