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.

Alyson Andrikanich is a Senior Director in Regulatory Advertising and Promotion at Bayer Pharmaceuticals. She has over 14 years experience in the pharmaceutical industry, specializing in advertising and promotion in regulatory affairs. Alyson completed a post-doctoral industry fellowship program through Rutgers University and Bayer in Medical Communications/Medical Affairs.

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.

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.

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.

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 2007.

Amy Muhlberg is Deputy Director of the Division of Promotion Policy, Research, and Operations in the Office of Prescription Drug Promotion (OPDP). She joined OPDP in 2021 as a Staff Fellow leading the development of guidance documents, regulations, and citizen petition responses related to prescription drug promotion. She held a similar role in FDA’s Office of Policy for Pharmaceutical Quality, working on drug product quality and manufacturing issues across the product lifecycle. She has over two decades of FDA policy experience in trade associations, regulated industry, and on Capitol Hill. Amy earned her Ph.D. in Biochemistry from The Scripps Research Institute, and received her undergraduate degree from McGill University.

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.”

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.

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.