OPHTHALMIC DEVICES PANEL ROSTER
FEBRUARY 5-6, 2004 MEETING
JAYNE S. WEISS, M.D.
Dr. Weiss, a specialist in corneal and
refractive surgery, is Professor of Ophthalmology and Pathology, Director of
Refractive Surgery, and Director of Ophthalmic Pathology at the Kresge Eye
Institute, Wayne State University in Detroit, Michigan. Dr. Weiss received her M.D. from the Mt.
Sinai School of Medicine in New York with fellowships in ocular pathology at
Harvard University's Massachusetts Eye and Ear Infirmary in Boston and in
corneal disease and refractive surgery at Emory University in Atlanta. Dr. Weiss has served as a regular member of
the National Institutes of Health Visual Sciences Study Section for the National
Eye Institute and is Principle Investigator of an RO1 grant on Genetic Mapping
of Schnyder's Crystalline Corneal Dystrophy.
She is currently a member of the research committee of the Eye Bank
Association of America as well as multiple American Academy of Ophthalmology
Panels including the Preferred Practice Patterns Cornea/External Disease Panel,
the Basic and Clinical Science Course (BCSC) on Cornea/External Disease and
chairs the recently created BCSC on Refractive Surgery. She is a member of the
editorial board of Cornea and is a reviewer for many other ophthalmology
journals. Dr. Weiss is nationally and
internationally recognized for her lectures and publications.
ARTHUR BRADLEY, Ph.D.
ANNE L. COLEMAN, M.D., Ph.D.
Dr. Coleman is an Associate Professor of
Ophthalmology at the Jules Stein Eye Institute of the University of California
at Los Angeles School of Medicine. In
addition she is the Director of the Center for Eye Epidemiology at the
Institute. Dr. Coleman is a graduate of
Duke University and the Medical College of Virginia and completed her
ophthalmology residence at the University of Illinois School of Medicine in
Chicago and a fellowship in glaucoma at the Johns Hopkins School of Medicine in
Baltimore. She received her Ph.D. in
epidemiology from the University of California at Los Angeles, CA. Dr. Coleman currently serves as a reviewer
for Ophthalmic Epidemiology, Current Eye Research, Ophthalmology,
Journal of Glaucoma, Archives of Ophthalmology, and Investigative
Ophthalmology and Research among others.
She has published and lectured extensively and is internationally
recognized for her expertise in the diagnosis and management of glaucoma
MICHAEL R. GRIMMETT, M.D.
Dr. Grimmett is an Assistant
Professor of Ophthalmology at the Bascom Palmer Eye Institute of the University
of Miami School of Medicine. He
graduated from Loyola Marymount University in Los Angeles, CA and received his
M.D. from the University of California at Irvine. Dr. Grimmett is board certified in both internal medicine and
ophthalmology and completed his fellowship in corneal and external disease at
the University of Minnesota in Minneapolis in 1993. He is a recognized expert on the medical/legal/ethical issues
associated with refractive surgery, publishing The Call of the Sirens, Ethically Navigating the Sea of Nonvalidated
Therapies, in the Journal of Refractive Surgery, the journal of the
International Society of Refractive Surgery.
He is a peer reviewer for the Journal of Refractive Surgery, the American
Journal of Ophthalmology, and Cornea. Dr. Grimmett has been actively involved in the Eye Bank
Association of America since 1994, and contributes his expertise to the
American Academy of Ophthalmology’s continuing medical education (CME) program
and the development of their CME website.
WILLIAM D. MATHERS, M.D.
Dr. Mathers is a Professor of Ophthalmology at
the Oregon Health Sciences University, Casey Eye Institute in Portland,
OR. He received undergraduate education
at Allegheny College, and his medical doctorate at Stanford University. After a residency in ophthalmology at the
University of Washington, he completed a fellowship in Cornea and External
Disease at Georgetown University Medical School in Washington, DC. Dr. Mathers is very active in research and
has been a principal investigator on many National Institutes of Health grants
related to tear production and dry eyes, the molecular genetics of corneal
dystrophys, and acanthamoeba keratitis.
In addition, he has served on the NIH study section, multiple editorial
boards and as president of CLAO (Contact Lens Association Organization and the
Pan American Association for Contact Lenses and Refraction. Dr. Mathers has authored many publications
and book chapters and is internationally recognized for his clinical expertise
and scholarship.
TIMOTHY T. McMAHON, O.D.,
F.A.A.O.
Dr. McMahon
is a Professor of Ophthalmology in the Department of Ophthalmology & Visual
Sciences at the University of Illinois at Chicago College of Medicine. He received his Doctor of Optometry from the
Illinois College of Optometry in 1980, and completed a residency at the Kansas
City Veterans Administration Medical Center in 1981. He is a Fellow of the American Academy of Optometry and is a
Diplomate in Cornea and Contact Lenses.
He is a past Chair of the Academy’s Research Committee and is a member
of the AOA Council on Research. Dr.
McMahon was appointed Secretary/Treasurer of the American Optometric Foundation
in 2002. Recently the National
Academies of Practice named him a Distinguished Clinical Fellow. Dr. McMahon is an investigator in several
NIH and VA funded research projects, including the Collaborative Longitudinal
Evaluation of Keratoconus Study, where he serves on the Executive
Committee. He currently serves on the
editorial boards of Cornea and Eye & Contact Lens. He has published extensively in the areas of
contact lenses, corneal topography and the clinical course and therapeutic
modalities of anterior segment diseases.
He has lectured nationally and internationally. The breadth of his expertise in optometry
and experience in clinical research methodology are widely recognized.
CONSULTANTS
KAREN BANDEEN-ROCHE, Ph.D.
Dr. Bandeen-Roche is a
Professor of Biostatistics in the School of Hygiene and Public Health, The
Johns Hopkins University, in Baltimore, MD.
She graduated from the Andrews University in Berrien Springs, MI and received
her master’s and doctorate in Operations Research and Industrial Engineering
from Cornell University in Ithaca, NY.
Dr. Bandeen-Roche has contributed extensively to many publications
including the American Journal of Epidemiology, Investigative
Ophthalmology and Vision Science, and the Journal of American
Statistical Association, Biometrika, and Statistics in Medicine. She is nationally recognized in the
professional areas of multi-variate and longitudinal data analysis, quality of
life assessment, and clinical study issues.
She has authored journal articles on research related to ophthalmic
issues, particularly with respect to the non-invasive assessment of the visual
system, women’s health, and aging. In
1997, Dr. Bandeen-Roche was awarded a Brookdale National Fellowship for
excellence in research on aging. A
paper she co-authored received the American Academy of Optometry’s 1999 Garland
Clay Award as the most cited paper in the preceding five years’ issues of
Optometry and Vision Science.
RICHARD CASEY, M.D.
Dr. Casey is the
Interim Chairman of the Department of Ophthalmology at the Charles Drew
University of Medicine and Science and Associate Professor of Ophthalmology at
the Jules Stein Eye Institute in Los Angeles, CA. He is a graduate of Harvard Medical School and completed his
residency and a fellowship in cornea and external disease at the Massachusetts
Eye and Ear Infirmary in Boston, MA.
The focus of his surgical profession is the management of ocular surface
disease, anterior segment derangements, cataract, corneal transplantation and
laser refractive surgery. His clinical
research involves ocular allergy and ocular neovascularization, particularly
the study of angiogenesis inhibitors.
He has authored book chapters, published in many scientific journals and
has lectured nationally and internationally on these topics.
ANDREW J. HUANG, M.D., M.P.H.
Dr. Huang is
an Associate Professor and the Director of the Cornea and External Disease
Service of the Department of Ophthalmology at the University of Minnesota in
Minneapolis. He received his medical
doctorate at National Taiwan University, a Masters of Public Health as well as
a post-doctoral fellowship in the Division of Biophysics from The Johns Hopkins
University School of Public Health. He
completed a research fellowship at the Eye Research Institute and Massachusetts
Eye and Ear Infirmary, Harvard Medical School and his ophthalmic residency
training and clinical corneal fellowship at the Bascom Palmer Eye Institute,
University of Miami. Dr. Huang has
published numerous peer-reviewed journal articles as well as book chapters on
the management of cornea and external diseases. He has lectured extensively to international organizations and is
an active participant in Project Orbis, volunteering for numerous missions to
provide ophthalmic education and clinical service to underdeveloped
countries.
MARIAN S. MACSAI, M.D.
Dr. Marian
S. Macsai is Chief of the Division of Ophthalmology at Evanston Northwestern
Healthcare and Professor and Vice Chair of the Department of Ophthalmology at
Northwestern University. She completed
her medical education at Rush Medical College followed by a residency was at
the University of Illinois and fellowship in cornea and external disease at the
University of Iowa. In 1989, Dr. Macsai
was recruited to West Virginia University where she was the Director of the
Cornea External Disease and Refractive Surgery Service for ten years. During that period of time, Dr. Macsai also
served as the Medical Director of the Medical Eye Bank of West Virginia. She has served as the Chair of the
Scientific Program Committee, the Research Committee and the Accreditation
Committees of the Eye Bank Association of America. She has served on the Board of Directors for eight years and on
the Certification Board for the past four.
Dr. Macsai was recently awarded the Paton Award by the Eye Bank
Association of America and will receive this award in November of 2003. Dr. Macsai has also served on the Board of
Directors of the Cornea Society formerly known as the Castroviejo Society and
has served as the Chair of the Scientific Program Committee for the Society for
the past four years. In addition, she
has served on many academies for the American Academy of Ophthalmology
including the committee on eye banking.
She is a former voting member of the FDA Ophthalmic Devices Panel. In
1996, Dr. Macsai co-edited the book, Eye and Skin Disease. She has authored 11 book chapters and
published over 40 papers in peer review journals.
OLIVER D. SCHEIN, M.D., M.P.H.
Oliver Schein, M.D., M.P.H. is the
Grossman Professor of Ophthalmology at the Wilmer Eye Institute, Johns Hopkins
University School of Medicine. He holds
a joint appointment in the Department of Epidemiology at the Johns Hopkins
University School of Public Health and Hygiene. His clinical expertise is in the medical and surgical management
of patients with corneal disease and problems involving the anterior segment of
the eye. Research interests have
centered on the application of epidemiologic and public health principles to
the study of eye disease, the practice of ophthalmology, and the evaluation of
ophthalmic technology. The focus of
recent publications has been on the assessment of outcomes of cataract surgery
using a variety of research methodologies including randomized clinical trials,
longitudinal cohort studies and case-control studies. Another major focus has been the development of standardized
questionnaires to measure the functional impact of common ophthalmic interventions
(eg. cataract surgery, refractive surgery) from the patient perspective. Dr. Schein is an author of the American
Academy of Ophthalmology’s (AAO) Preferred Practice Pattern on management of
cataract in the adult and is a member of the AAO’s Quality of Care Committee.
JANINE A. SMITH, M.D.
Dr. Smith is the Deputy Clinical Director of the National Eye Institute
(NEI) and works within the Clinical Trials Branch of the Division of
Epidemiology and Clinical Research. She
received her medical doctorate from Howard University College of Medicine and
completed an ophthalmology residency at the Medical College of Virginia in
Richmond. She pursued sub-specialty
training and completed fellowships in Cornea and External Disease at the Wilmer
Ophthalmological Institute at Johns Hopkins University and in Ocular Immunology
at the National Eye Institute. The
focus of her basic science research has been immune-based diseases of the
ocular surface. Dr. Smith is integrally
involved with the NEI Institutional Review Board and Data Safety Monitoring
Committee and represents NEI on several NIH committees. The focus of her clinical research is the
identification of outcome measures for ocular surface disease clinical studies
and is a key contributor to the research, education and consultation
responsibilities of the NEI intramural clinical research program.
WOODFORD S. VAN METER, M.D.
Dr. Van Meter is Associate
Clinical Professor, Department of Ophthalmology, University of Kentucky School
of Medicine in Lexington, KY and is in private practice. He is a graduate of Davidson College in
North Carolina and Vanderbilt University School of Medicine. He completed a residency in Ophthalmology at
the Mayo Graduate School of Medicine and a fellowship in Corneal and External
Disease at Emory University, Atlanta, GA.
Dr. Van Meter, an internationally recognized expert on cornea and
external disease is on the Board of Directors of the Castroviejo Cornea Society
and the Eye Bank Association of America, and is assistant treasurer of the
EBAA. He has published and lectured
extensively on cataract surgery, corneal transplantation, and contact lenses.
Ms. Such is the Director of Computer Training Program, Department of
Career Services, Lighthouse International in New York, NY. She received her Bachelor of Arts in
Psychology and Pre-Law at Norwich University in Montpelier, VT and a Master of
Education in Education of the Visually Impaired at the Pennsylvania College of
Optometry in Philadelphia, PA. She is a
recognized expert in the field of adaptive technology for visual impairments
and the functional implications of visual disabilities, particularly low
vision. In addition to teaching
students who are visually impaired, she lectures at Temple University Graduate
School, Harcum College, and Saint Joseph's University Graduate School in areas
relating to working with clients who are visually impaired. She served for four years as a board member
of the Council of Citizens with Low Vision International and was a member of
the Institutional Review Board of Pennsylvania College of Optometry.
INDUSTRY REPRESENTATIVE - February 5, 2004 (Acting )
ANDREW K.
BALO
Mr. Balo is the Vice President for
Regulatory and Clinical Affairs with DEXCOM, Inc. in San Diego, CA. He also serves as the Industry
Representative on the Neurological Devices Advisory Panel. Mr. Balo has a Bachelor of Science in
microbiology and chemistry from the University of Maryland and has done
graduate work in business and executive management at the University of
California in Los Angeles, and Stanford University, respectively. He has over twenty years of experience in
regulatory and clinical affairs with both domestic and international device
firms.
INDUSTRY REPRESENTATIVE - February 6, 2004
RONALD E.
McCARLEY
Mr. McCarley is President,
CEO and founder of Ophtec USA, Inc. an ophthalmic medical device firm that
manufactures cataract, refractive and iris reconstruction implants in Boca
Raton, FL. He has over 19 years
experience in domestic and international business operations and extensive
knowledge in the areas of regulatory affairs, clinical studies and quality
assurance. Mr. McCarley has
participated in bringing a wide range of ophthalmic devices to market through
positions he has held with small manufacturers as well as large firms. In addition, he has demonstrated leadership
within the device industry through his participation in the International
Standards Organization and American National Standards Institute standards
development working groups.