Aron M. Shapiro is Senior Vice President for Ora, Inc., where he has held a number of leadership roles in ophthalmology over the past 20+ years. He has developed and currently heads the retina, glaucoma, refractive, inflammation, and infection therapeutic areas for drugs and biologics, leading and overseeing scientific, pre-clinical and clinical strategy for international ophthalmic development programs. He designs, manages, and leads clinical development programs for global multi-center Phase I-IV ophthalmology clinical trials with a team of 30 staff, including directors and clinical project managers. He has developed a clinical investigator network of more than 200 sites in North America and 100 sites in Europe. He is a sought-after presenter at industry conferences and is the author of several peer-reviewed publications.
Working with clients ranging from small startups to venture-capital-backed biotech, and from small- to mid-cap pharma to Top 25 revenue pharma companies, Aron is a strategist and liaison between clients with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and other international regulatory agencies to negotiate pre-clinical and clinical development plans and requirements.
Aron collaborates with clients on writing protocols and designing clinical development plans. He also advises and conducts due diligence for clients on development and licensing opportunities, as well as marketing and advertising strategies. He also represents Ora at national ophthalmology conferences.
Aron earned a Bachelor of Science in Biological Chemistry from Bates College in Maine, where he was an NCAA Academic All-American and on the Dean’s List for four years.