Boston — Ora has launched a new Clinical Intelligence Committee designed to give drug and device developers access to expert guidance on clinical, operational and regulatory decisions in ophthalmic research.
The ophthalmic clinical research organization said the committee brings together 14 specialists from across the global ophthalmology community and is intended to help sponsors evaluate study design, endpoints, patient populations and other development decisions.
“The ophthalmology landscape is becoming increasingly complex,” said Gus De Moraes, M.D., Ph.D., M.P.H., Chief Medical Officer at Ora. “We created the Clinical Intelligence Committee to bring together some of the most respected experts in our field and give innovators direct access to practical, experience-based guidance when it matters most. Combined with Ora’s development expertise, the CIC helps teams gain clarity, reduce risk, and make better decisions for patients.”
The inaugural committee includes Anat Loewenstein, M.D., M.H.A.; Carl D. Regillo, M.D., F.A.C.S.; Dale W. Usner, Ph.D.; Eleonora Lad, M.D., Ph.D.; Giacomina Massaro-Giordano, M.D.; Iqbal Ike K. Ahmed, M.D., F.R.C.S.C.; Leanne T. Labriola, D.O., M.B.A.; Marion R. Munk, M.D., Ph.D., F.E.B.O.; Mark Hinds; Mark Pennesi, M.D., Ph.D., F.A.R.V.O.; Michael Goldstein, M.D., M.M.; Susan Benton, M.B.A.; Patricio G. Schlottmann, M.D.; and Victor L. Perez, M.D.
Ora said the committee is intended to provide a more structured alternative to a traditional scientific advisory board by applying expert input directly to real-world development challenges.
The company said the group will help sponsors pressure-test development strategies, identify potential risks and evaluate opportunities before clinical trials begin.
“Some of the most important development decisions are made long before a trial begins,” said John Trein, M.D., Ora Therapeutic Lead, Posterior. “Choices around study design, endpoints, patient populations, and operational execution can ultimately shape the trajectory of an entire program. The strength of the Clinical Intelligence Committee is the diversity of experience around the table.”
Ora said the committee will support sponsors developing ophthalmic therapies and technologies by combining outside clinical expertise with the company’s therapeutic, operational and regulatory experience.
