Advertising and Promotion Regulatory Affairs Conference
Micheline Awad, MBA
- Director Regulatory Affairs, Advertising and Promotion
- Neurocrine Biosciences, Inc., United States
Micheline Awad leads the Neurocrine Biosciences Promotional Review Committee (PRC) as well as represents Regulatory on the Medical Review Committee (MRC). She has over 17 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 12 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for 3 years. Micheline’s Regulatory experience includes Biologic, Drug, and Device, and multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing Biotechnology from George Mason University.
Kimberly Belsky, MS
- Executive Director Regulatory Policy & Intelligence and Labeling Operations, Reg
- Mallinckrodt Pharmaceuticals, United States
Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals (MNK) assessing key changes in the global regulatory environment and providing strategic insights to the company regarding impact on the portfolio and activities. With over 29 years of global experience in the medical product industry, including 19 years in regulatory affairs, Kim's diverse experience including scale up and tech transfer, quality/compliance, advertising & promotion, labeling, and regulatory policy intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices.
- Senior Director, Regulatory Affairs, Advertising and Promotion
- Blueprint Medicines, United States
Dale Cooke, JD, MA
- 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.
- Principal Consultant
- Opus Regulatory Inc, United States
Virginia Foley joined Opus Regulatory, Inc. as a Principal Consultant in June 2017, focused on Advertising and Promotion review. Before joining Opus, her career spanned positions of increasing Regulatory responsibility at a variety of pharmaceutical and biotechnology companies across the U.S. Immediately prior to Opus, she worked at Gilead Sciences as the Therapeutic Area head of Liver Diseases, responsible for the Hepatitis C franchise product launches. She now lives in beautiful Traverse City, Michigan with her husband, son and lab retriever where they enjoy spending time outside in all seasons.
Catherine B. Gray, PharmD
- Staff Supervisor, Office of Prescription Drug Promotion, OMP, CDER
- FDA, United States
Catherine Gray leads the Advertising and Promotion Policy Staff in OPDP at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy issues pertaining to the promotion of prescription drugs. She oversees policy development, social science research and operational support to the full office as it realizes its mission to protect the public health. Her over twenty years of experience include roles in clinical pharmacy and the pharmaceutical industry.
Joanne Hawana, JD, MS
- Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
Joanne Hawana is a Member at the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, practicing in the Health Law/FDA Group and based in the firm’s Washington D.C. office. She counsels global clients on the business impact of new U.S. federal and state actions related to drugs, biologics, cellular therapies, foods, and medical devices. Her counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, both pre-market and post-market, and including enforcement matters. Joanne has a masters degree in molecular genetics from UMDNJ and a bachelors degree in biology from the College of William & Mary. She received her JD from the University of Maryland Francis King Cary School of Law in 20007.
Mary L Raber Johnson, PhD, RAC
- Assistant Professor, Clinical
- The Ohio State Universitycollege of Pharmacy, United States
Since 2009, I have worked at pharmaceutical agencies to support marketing and/or medical affairs teams. I served as lead medical/scientific director for products in various stages of their lifecycles - all while intersecting with regulatory affairs in various capacities. In 2012, I earned a US Regulatory Affairs Certification from RAPS, which covers regulatory functions throughout product lifecycles. Recently I became regular faculty at The Ohio State University, College of Pharmacy where I develop and teach in the online MS Pharmacology program and within the Regulatory Affairs specialization of the Masters of Applied Clinical and Preclinical Research (MACPR) program.
Kevin M Madagan, JD
- Reed Smith, LLP, United States
Kevin is a health care attorney and member of Reed Smith’s Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. Kevin specializes in providing legal and strategic advice regarding advertising and promotion, FDA enforcement, and supply chain logistics. Among other things, Kevin has spent the last 15+ years advising compliance teams and serving as legal counsel to startup and global drug and medical device clients.
Sheetal Patel, PharmD
- Head, Regulatory Advertising and Promotion
- Johnson & Johnson International, United States
Sheetal Patel is the Head, Regulatory Advertising and Promotion, within Pharmaceutical Group Health Care Compliance organization at Johnson & Johnson. Previously, she held the position of Lieutenant Commander, Senior Regulatory Review Officer, at the Food and Drug Administration, Office of Prescription Drug Promotion.
Victoria Tamarkin, MS
- Victoria Tamarkin Consulting LLC, United States
Victoria Tamarkin is an FDA and healthcare regulatory compliance consultant with more than 18 years’ experience at large, multinational companies and virtual, venture-backed start-ups. Founder of Victoria Tamarkin Consulting, LLC group, Victoria advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from regulatory strategies to advertising and promotion and labeling of FDA-regulated products. Victoria has been the lead FDA regulatory advisor to her clients on 100+ transactional matters. Victoria counsels pharma and device companies on promotional compliance, advertisement, social media platforms, and digital marketing.
- Vice President NA General Medicines/US Advertising and Promotion
- Sanofi, United States
Mark is VP, US Marketed Product Strategy & Maintenance/Advertising & Promotion within Sanofi's Global Regulatory Affairs organization. In his role, Mark is accountable for regulatory leadership and strategy for marketed products, including lifecycle management. He also oversees the review of promotional, medical and other company communications across US business units to ensure regulatory compliance. Prior to joining Sanofi, Mark held positions of increasing responsibility with Pfizer, Amgen, Block Drug Co., Whitehall-Robins Healthcare and Biocraft Labs. Mark has 25 years of pharmaceutical industry experience, which includes development of regulatory strategies in the areas of advertising & promotion, labeling and product development.
- President, Health Care
- APCO Worldwide Inc., United States
Wayne Pines is a consultant on FDA-related issues. He specializes in ad promo regulation, serving as the regulatory expert on promotional review committees for several pharma companies. He also assists pharma and device companies with product approvals and regulatory and media strategy. Mr. Pines has authored or edited a dozen books on FDA including the FDA Advertising and Promotion Manual and A Practical Guide to FDA's Laws and Regulations.
Lucy Rose, MBA
- Lucy Rose and Associates, LLC, United States
Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications at FDA. For the last 18 years she has consulted with numerous pharmaceutical companies on promotional regulations/strategy, drug development and regulatory strategy, health policy, and has enjoyed training many professionals on advertising/promotional regulations.