Catherine Gray leads the Office of Prescription Drug Promotion (OPDP) at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy and operational issues pertaining to the promotion of prescription drugs. She oversees policy development, social science research, regulatory counseling, compliance activities, labeling recommendations, stakeholder engagement, and operational support to the office as it realizes its mission to protect the public. Her over twenty years of experience include roles in clinical pharmacy and the pharmaceutical industry. Dr. Gray received a B.S. from the University of Notre Dame and a Doctor of Pharmacy from Campbell University and completed several fellowships.

Georgina Lee is currently the Head of Regulatory Advertising and Promotion at Sage Therapeutics. She has over 10 years of experience in the industry specializing in advertising and promotion, labeling development, and MLR operations. She received her Pharm.D. from the University of Southern California and is the co-chair of the DIA Advertising and Promotion Committee this year.

Lynn Bowen, PhD is currently the Vice President, Regulatory Advertising Promotion & Labeling at Alkermes. Prior to joining Alkermes, she was the Senior Director and US Head of Regulatory Advertising & Promotion at Vertex Pharmaceuticals. Lynn has over 15 years of pharmaceutical industry experience including prior roles in both regulatory and medical affairs. Lynn received her BS in Biotechnology from Rochester Institute of Technology and her PhD in Microbiology from Boston University School of Medicine.

Anthony Genovese is the Group Leader, Regulatory Advertising and Promotion at Johnson and Johnson. Prior to joining Johnson & Johnson, he held roles at Bayer Healthcare Pharmaceuticals, most recently serving as the Director of Regulatory Affairs – Advertising and Promotion and Head of Regulatory Advertising and Promotion Operations. Anthony has over 15 years of pharmaceutical industry experience including roles in medical affairs, external scientific affairs, and regulatory strategy.

Nicol George, Pharm.D., R.Ph., is the Vice President, Promotional Review Services & Labeling at OneSource Regulatory (OSR) a ProPharma Group Company, where she manages the Regulatory & Medical Review staff, provides executive level consulting services including leadership mentoring,process improvements, electronic review system implementations & Advertising and Promotion Training. Before joining OSR, Nicol was at Baxter Healthcare where she held the position of Director, Global Regulatory Affairs Labeling, Advertising & Promotion & led an international team for 5 years (2012-2017). Nicol has been in the industry for over 20 years with pharma, biologic & device experience in Medical (Med Info & Medical Science Liaison) & Regulatory Affairs.

Moulakshi Roychowdhury, PharmD, JD is Global Head of Regulatory Advertising & Promotion at Allergan Aesthetics, an AbbVie Company and leads a team of professionals who advise the company on how to comply with regulations while being competitive & exceeding business goals. She is passionate about finding creative & compliant ways to communicate with customers to optimize their knowledge in making healthcare decisions and believes if intentions are ethical and in support of public health, compliant paths forward must exist. She is dedicated to growing and empowering the next generation of professionals. Moulakshi’s favorite saying is by Pablo Picasso: “Learn the rules like a pro, so you can break them like an artist.”

Virginia Foley joined Opus Regulatory as a Principal Consultant in June 2017, focused on Advertising and Promotion review and in January 2020 she transitioned to a full time role in Business Development. Before joining Opus, her 20-year tenure in Regulatory Affairs spanned positions of increasing 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, leading the strategy and execution for the consecutive waves of Hepatitis C product launches. She lives in beautiful Northport, Michigan with her husband, son and lab retriever where they enjoy spending time outside in all seasons.

Zoe Dunn, President & CEO of Hale Advisors, is a digital marketing and communications specialist with 20+ years of experience in life sciences industries, driving results for clients’ business with multi-channel strategies. Zoe has worked with most of the top 25 Pharmaceutical and Biotech companies and regularly speaks at pharmaceutical and healthcare conferences about organizational readiness in multichannel marketing. Hale Advisors specializes in digital governance and competency solutions.

Twyla Mosey is the Division Director of the Division of Advertising and Promotion Review II in the Office of Prescription Drug Promotion at the Food and Drug Administration. She supports the mission of protecting the public health by overseeing Division correspondences and is responsible for critical decision-making, strategic planning and all Division activities. Over the past 15 years, Twyla has held various roles within the Agency and pharmaceutical industry. She received her Doctor of Pharmacy degree from Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences.

Mark is Vice President and Global Head of Advertising & Promotion within Sanofi's Global Regulatory Affairs organization, with responsibility spanning the General Medicine, Specialty Care, and Vaccine portfolios. In this role, Mark is accountable for regulatory leadership and strategy in developing competitive labeling, supporting impactful product promotion and maintaining strict regulatory compliance in the interest of promoting and protecting patient health. During 30 years in industry, Mark has held leadership roles across numerous therapeutic areas, including responsibility for regulatory strategies across the product lifecycle.

Micheline leads the Advertising & Promotion and Labeling functions at Day One Biopharmaceuticals. Her experience includes Regulatory Affairs Strategy, Advertising & Promotion, and Labeling for Biologics, Drugs, and Devices. Her expertise in product launches is driven by strategic planning, risk assessment, and maintaining regulatory compliance while fostering innovation and growth. She is passionate about collaborating with cross-functional partners to drive successful product launches while ensuring adherence to complex regulations and guidances. She received her MBA from University of Southern California with a focus on Strategy and Marketing, and her BS in Biology specializing in Biotechnology from George Mason University.