Ora, Inc.
ANDOVER, MA, June 24, 2010 – During the recent GTCbio Conference in Boston two leading experts, Dr. Avner Ingerman, MD, MSc and George Ousler, both from Ora, Inc., shared their industry expertise on retinal imaging and dry eye therapies with high-level industry executives, clinical researchers, and government officials.
Dr. Avner Ingerman, MD, MSc, Senior Vice President, General Manager, Retina, at Ora, Inc. presented Retinal Imaging in Clinical Practice and Research: Can We See Our Vision? The presentation covered the broad spectrum of imaging modalities available today both for clinical practice as well as research.
Dr. Ingerman explained, "The advancements in retinal imaging in recent years allow us to view the retina with non-invasive tools, with high magnification and high resolution, almost at the histological level. We are beginning to image the tissue function at a cellular level in the living retina." Dr. Ingerman leads Ora's team of experts in retinal disease research with specific experience in both wet and dry AMD, as well as experience in diabetic retinopathy, retinal detachment, inherited retinal diseases, gene- and cell-based therapies, retinal epidemiology, and retinal disease animal models.
An experienced executive and program leader with highly relevant and hands on management of the most recent Phase I, II, and III clinical stage wet AMD development program, Dr. Ingerman is an ophthalmologist, and prior VP Therapeutic Head of Ophthalmology at Regeneron Pharmaceuticals, where he was responsible for VEGF Trap-Eye development program for wet AMD, RVO, DME, as well as new molecule and indications.
In addition to Dr. Ingerman’s presentation, George Ousler, Director, Dry Eye, Ora, Inc. presented Development of Dry Eye Therapies: Trial Designs and Pipeline at the GTCbio Conference.
Mr. Ousler discussed clinical models such as the Controlled Adverse Environment (CAE™). He outlined its usefulness in identifying the appropriate patient population for evaluation in dry eye trials and its unique ability to minimize 'background noise' that is typically observed with dry eye endpoints and environmental trials. Mr. Ousler finished his presentation by presenting a survey of the various therapeutic approaches to treating dry eye and the landscape of therapies currently under investigation.
According to Mr. Ousler, "Over the past 12 years, we have been able to identify a full range of challenges and pitfalls associated with dry eye trials, including the multitude of underlying causes and influential factors of dry eye that contribute to the complexity of studying this disease. While dry eye trial design has been very challenging, our ongoing research at Ora has enabled us to optimize our trial designs."
Mr. Ousler has spent well over a decade of his career pioneering pharmaceutical development in the area of Dry Eye. He has authored over 100 publications, and has been invited to present his research at numerous national and international symposia. He serves on several noted Dry Eye research committees, including the Dry Eye Workshop (DEWS) that are devoted to identifying the appropriate diagnostic tools and methods to evaluate this disease. As the Director of the Dry Eye Department at Ora, he has been responsible for developing clinical models and regulatory pathways for the evaluation of dry eye therapies, and has conducted the studies of virtually all of the agents currently under investigation.
"Ora's team stands at the forefront of global dry eye research with a combination of technology and expertise that no other development firm in the world can match. It is important to share our findings with our colleagues and the rest of the industry and we are always pleased to speak at high level events," said Stuart Abelson, president and CEO of Ora, Inc. Ora's validated CAETM model accelerates dry eye clinical research, while requiring fewer patients, lowering standard deviations, and yielding precise results that increase the likelihood of achieving clinical relevance. Ora is currently working with the world's leading dry eye pioneers to support them in developing the next generation of dry eye treatments.
About Ora
Ora, Inc. (www.oraclinical.com) is the world's leading independent ophthalmic product development firm, with more than 30 NDA approvals during its 30-year history. Ora helps clients garner NDA approvals by providing strategic clinical-regulatory guidance and complete turnkey clinical-regulatory services. Ora's technology-based, concept-to-market services and solutions accelerate development timelines and improve the scientific quality of clinical research along every step of the development pathway.
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