SAN DIEGO, CA--(Marketwire - January 26, 2012) -
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Leading allergy experts from Ora, Inc. will present at the GTC Bio Allergy Drug Discovery & Development Conference in San Diego. The meeting, taking place January 30-31st at the Paradise Point Resort & Spa in San Diego, CA, will offer insight from Mark Abelson, MD, CM, FRCSC, FARVO, Scientific Advisor, Founder, Ora, Inc.; Paul Gomes, MS, Vice President, Allergy, Ora, Inc.; and Keith Lane, Director of Research & Development, Ora, Inc. These distinguished experts will facilitate discourse on topics such as allergic rhinitis, allergic conjunctivitis, and allergy disease modeling.
Keith Lane will moderate a panel discussion on the Future Directions in Allergic Rhinitis with panelists Dr. Warren Carr, Associate Medical Director, Southern California Research; Dr. William Berger, M.B.A., Clinical Professor, Pediatrics, Division of Allergy and Immunology, University of California, Irvine; Doral Fredericks, ISTA Pharmaceuticals and Dr. Ken Newman, Acton Pharmaceuticals, Inc.
Mark B. Abelson, MD, CM, FRCSC, FARVO, Scientific Advisor, Founder, Ora, Inc., Clinical Professor of Ophthalmology, Harvard Medical School, Senior Clinical Scientist, Schepens Eye Research Institute will present Allergy Drug Discovery: Disease Modeling 101. In this session Dr. Abelson will discuss how experimental models are essential tools for understanding the patho-physiology of disease processes, emphasizing on the need for including objective assessments in clinical research.
“There are several elements essential to any clinical model,” explained Dr. Abelson. “First, the model must present a reliable, reproducible facsimile of the natural disease process. Second, it must allow for quantifiable, objective measures of disease severity. Third, the model should provide sufficient symptomatology to allow for reliable dose-ranging or comparator assessments. This triad can be established by appropriate validation and verification criteria in addition to testing to confirm the reliability and reproducibility of specific model parameters,” he explained.
Later in the afternoon Paul Gomes will present Allergic Conjunctivitis Models: Past, Present and Future. In this session Paul Gomes will provide details on the clinical models that have led to the approval of allergic conjunctivitis therapies. Ora’s conjunctival allergen challenge (CAC™), a clinical model that has become the gold standard for assessment of therapies targeting allergic conjunctivitis. The newest model in development aimed at the evaluation of anti-inflammatory agents in subjects with chronic allergic conjunctivitis will also be presented.
Ora’s current efforts are focused on developing novel technologies to study anti-allergic therapies using the CAC™ model, Allergen BioCube™, or other similar models. In particular they are interested in anti-allergics with a long duration of action, and those treatments that can alleviate signs and symptoms of chronic allergy. To do this, Ora uses a combined approach of basic research to identify new drug targets, as well as clinical studies to define better endpoints and specific patient populations. These efforts, together with their robust clinical models allow them to focus on the best new candidates and the optimal pathways for clinical and regulatory success.
For more information, please contact Shreelekha Mandal at (978) 685-8900, ext. 9415 or by email at smandal@oraclinical.com. Visit Ora’s Allergen BioCube website at www.allergenbiocube.com.
About Ora
Ora is the world’s leading ophthalmic CRO. We have more than 30 years of highly focused ophthalmic expertise, during which time we have helped our clients obtain 34 product approvals. We provide consulting and development services to the ophthalmic drug and device industry, including biotech start-ups, global pharmaceutical companies and investors. We have specific expertise in ophthalmic clinical-regulatory strategies, CMC development, pre-clinical studies, phase I-IV clinical development, marketing support and due-diligence. We work across all ophthalmic indications and conduct research in North America, Europe, Asia and South America. For more information, visit www.oraclinical.com.
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