Ora benoemt Simon Chandler tot hoofd klinische operaties en regelgeving in Europa
LONDEN & BOSTON–(BUSINESS WIRE)– Ora, Inc., wereldwijd partner in oogheelkundige farmacie en apparatuur, is verheugd aan te kondigen dat Simon Chandler aantreedt als hoofd klinische operaties en regelgeving in Europa. Simon werkt vanuit het Verenigd Koninkrijk. Ora staat Europese oogheelkundebedrijven bij in alle fases van productontwikkeling. Daarbij heeft Ora een een breed dienstaanbod, dat onder meer bestaat uit preklinisch onderzoek, een wettelijke strategie, de uitvoering van klinische onderzoeken, databeheer, statistiek, medisch schrijven, productie-expertise, kwaliteitsgaranties, bedrijfsontwikkeling en financiering.
“Onze cliënten eisen uitvoering van klinische onderzoeken met verregaande kennis van de regio en specialistische expertise in oogheelkunde. Chandler is een belangrijke toevoeging aan Ora’s team en brengt ons uitgebreide ervaring in internationale klinische operaties en regelgeving, inclusief keuringsprocedures bij de FDA, het Europees Geneesmiddelenbureau en de PMDA. Zijn ervaring in gentherapie is zeer relevant, gezien de mogelijkheden van deze nieuwe therapeutische benaderingswijze voor onvervulde behoeften van patiënten”, zei Stuart B. Abelson, topman van Ora.
Ora® Names Simon Chandler to Lead Regulatory and Clinical Operations in Europe |
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LONDON & BOSTON–(BUSINESS WIRE)– Ora, Inc., the world’s leading partner for ophthalmic pharmaceutical and device product development, is pleased to announce the addition of Simon Chandler, PhD as Senior Director to lead regulatory and clinical operations for Europe. Simon will be based in the UK. Ora currently supports ophthalmology drug and device companies in Europe at all stages of product development with a broad range of services including: preclinical research, regulatory strategy, clinical trial execution, data management, statistics, medical writing, manufacturing expertise, quality assurance, business development and financing. “Our clients demand global clinical trial execution with in-depth regional knowledge and deep category expertise in ophthalmology. Dr. Chandler is a key addition to Ora’s team and brings extensive experience in global clinical and regulatory operations, including overseeing approvals by the FDA, EMA and PMDA. His current experience in gene therapy is highly relevant given the potential of this new therapeutic modality to address unmet patient needs,” said Ora’s President and CEO, Stuart B. Abelson. Dr. Chandler has more than 15 years of ophthalmic industry experience across Europe and the US focusing on retina and anterior segment indications. He has led successful drug development teams in anti-infective, anti-allergic, glaucoma and refractive surgery. Dr. Chandler holds a bachelor’s degree in molecular biology from University of Portsmouth and a Ph.D. in epigenetic gene regulation from the University of Southampton, both in the UK. “I have personally experienced the quality, timely execution, and strategic planning Ora delivers to ensure successful programs for their industry partners. I am proud to be joining a company with proven expertise in ophthalmology and a deep commitment to scientific rigor and innovation,” said Dr. Simon Chandler, Senior Director, Clinical Research and Regulatory Operations. Ora is uniquely positioned to provide an integrated service offering to support global development in ophthalmology. The expanded foothold in Europe demonstrates Ora’s continued commitment to bringing category focus as a global service organization with regional expertise. About Ora, Inc. Ora is the world’s leading full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 30 years, we helped our clients earn 41 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives. For more information about Ora, please follow @oraclinical on Twitter, like us on Facebook (/Ora-Inc), follow on LinkedIn ( http://bit.ly/1TgHErs) or go to www.oraclinical.com. Ora ® and Ora Logo are registered trademarks of Ora, Inc. View source version on businesswire.com: http://www.businesswire.com/news/home/20160329006536/en/ Contacts Ora, Inc. |
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