Drug and Biologic Ad Promo Primer
Instructors
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Bob Dean, MBA
- Head of Global Labeling Strategy & Ad/Promo
- EMD Serono, United States
Bob is currently the Vice President of Commercial Regulatory at Myovant Sciences. Prior to that, he was Director/Team Lead at Merck & Co., Inc. in the Office of Advertising and Promotion Review. Prior to joining Merck, Bob was the Director of the Division of Advertising and Promotional Review 2 in the Office of Prescription Drug Promotion (OPDP). During his 15 years at OPDP, he oversaw core functions within FDA including advisory and labeling reviews, as well as investigations and enforcement actions. He co-developed new FDA Policies, Regulations and Guidance documents and led the efforts of the educational outreach program (Bad Ad) to help engage stakeholders in the medical community.
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Dale Cooke, JD, MA
- President
- PhillyCooke Consulting , United States
Dale Cooke is president of PhillyCooke Consulting, which helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Dale is the author of Effective Review & Approval of Digital Promotional Tactics, now in its second edition, which was published by the Food & Drug Law Institute.
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Amy Toscano, PharmD, CPA, RPh, RAC
- Senior Director
- Myovant Sciences, United States
Amy Toscano, PharmD, RAC, is a Senior Director in commercial regulatory affairs at Myovant Sciences. She has over seven years of experience in the pharmaceutical industry , specializing in advertising and promotion in regulatory affairs. Prior to working in the pharmaceutical industry, she worked for over ten years as a reviewer and a team leader at the FDA’s Office of Prescription Drug Promotion. Dr. Toscano completed a post-doctoral industry fellowship through Rutgers University and Bristol Myers Squibb Toscano in Medical Information. She holds a B.S. in accounting and a PharmD, both from Rutgers University.
