Healthcare Industry News: Merck
News Release - August 8, 2011
Acucela Appoints Michelle Carpenter, J.D., RAC, as Senior Vice President, Regulatory Affairs & Development OperationsExpert in Global Drug Development and Ophthalmology
SEATTLE--(Healthcare Sales & Marketing Network)-- Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, today announced that it has appointed Michelle Carpenter, J.D., RAC, as senior vice president, regulatory affairs & development operations. As a member of Acucela’s executive team, Ms. Carpenter will be responsible for operational execution of global development programs across all indications from Phase 1 through New Drug Application (NDA), as well as related activities for commercial purposes. She will report to Ryo Kubota, M.D., Ph.D., chairman, president, and chief executive officer, Acucela Inc.
“Ms. Carpenter has a solid track record in navigating numerous drugs through various regulatory systems and possesses a commanding knowledge of global drug development,” stated Dr. Kubota. He continued, “Her professional experience, academic credentials, and experience in compliance, as well as her expertise with ophthalmic products, will benefit Acucela as we build and advance our pipeline of therapies to treat patients around the world who suffer from blinding eye diseases.”
Ms. Carpenter added, “Acucela is dedicated to changing the paradigm of disease treatments in ophthalmology. I look forward to helping advance what could represent the next generation of eye disease therapies.”
Ms. Carpenter brings to Acucela over 20 years of experience in operations, regulatory affairs and commercialization strategies. She has particular expertise in leading regulatory strategies for ophthalmic products (glaucoma, dry eye and age-related macular degeneration) including due diligence, development and lifecycle management. Most recently, she held the position of executive director, regulatory affairs at Dow Pharmaceutical Sciences, where she developed and implemented global regulatory approval and lifecycle management strategies while focusing on the company’s internal research, commercialization and outsourcing capabilities.
She has also held the position of vice president, regulatory affairs at Oculus Innovative Sciences in California and vice president, regulatory affairs and medical affairs at DEY Pharma, L.P. (a subsidiary of Merck) in California. Ms. Carpenter served as vice president, international regulatory affairs and project management at Santen Incorporated, an ophthalmic products company, where she led a large global team in the development and implementation of U.S. and EU regulatory strategies. Ms. Carpenter has been responsible for the development of nonclinical, clinical and regulatory strategies for new product portfolios that have included ophthalmic indications. She is affiliated with the American and California State Bar Association, the Drug Information Association and the Food and Drug Law Institute, as well as other well-respected organizations.
Ms. Carpenter received her J.D. from the Golden Gate University of Law with a specialization in Health Law and her B.A. from the University of California, Santa Barbara, where her focus was pre-medicine. She also holds a Regulatory Affairs Certification (RAC).
About Acucela Inc.
Acucela Inc. (www.acucela.com) is a clinical-stage biotechnology company focused on leveraging promising science in visual cycle modulation (VCM) to develop new methods for treating blinding eye diseases that affect tens of millions of people worldwide. The Company’s orally delivered VCM compounds, which selectively target cells within the retina to protect visual acuity, have the potential to treat several devastating eye diseases, including dry AMD, for which there is currently no treatment options, retinopathy of prematurity, Stargardt disease and diabetic retinopathy. ACU-4429 for dry AMD is being co-developed by Acucela and Otsuka Pharmaceutical Co., Ltd. in North America, and the companies are also co-developing Rebamipide for dry eye and OPA-6566 for glaucoma in the United States. Acucela was founded by Ryo Kubota, M.D., Ph.D., a pioneer in ophthalmology and the discoverer of the gene that causes glaucoma.
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