Alyson Andrikanich is a Senior Director in Regulatory Advertising and Promotion at Bayer Pharmaceuticals. She has over 15 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.

Zoë Dunn has spent her career shaping how the life sciences industry looks at risk and marketing. She is the president and CEO of Hale Advisors, bringing to bear more than 20 years’ experience in advertising and promotion governance strategy, as well as deep expertise in digital and creating readiness for omnichannel marketing, modular content, and GenAI content. Last year, Zoë penned the essential reference “Navigating the shift to omnichannel marketing” for Regulatory Focus, the peer-reviewed journal of RAPS, the Regulatory Affairs Professionals Society. MM+M acknowledged Zoë’s industry contributions in 2024, naming her an MM+M Woman of Distinction. Zoë can be contacted at zoe@haleadvisors.com.

Virginia Foley is the Founder and CEO of Compliance Forward, LLC, where she helps life-science companies navigate the intersection of compliance and innovation. A recognized thought leader and frequent speaker at industry forums, she brings over 20 years of Regulatory Advertising and Promotion experience from a variety of different pharma/biotech companies. She is a pioneer in the application of Large Language Models (LLMs) in Regulatory affairs. Besides being a Regulatory Ad Promo expert, her work style is grounded in creativity, strategic problem solving, and being natural leader and collaborator. Virginia lives in beautiful Northport, Michigan, where she enjoys being active outdoors year-round with her family and loyal Lab retriever.

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 18 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.

Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru commercialization and genericization.

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.

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.

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.

Denise has worked in the regulatory space for 20 years with combined industry, government and law firm experience. Industry roles include Regulatory overview of commercial promotion and practices at Allergan Aesthetics, Ironwood, Celgene, & Cubist. At the law firm Hughes, Hubbard, and Reed, Denise worked on drug off-label promotion & product liability litigation. Denise’s federal government tenure focused in the public health service, as Regulatory Counsel for CDRH and CBER, FDA and congressional policy at the National Cancer Institute, NIH. Denise completed undergraduate & public health graduate study at Columbia University, biomedical sciences graduate work at Rutgers, & law study at Georgetown University Law Center.

Lynne is a Certified Professional Coach and the founder of Waverly, a bespoke executive coaching firm dedicated to the success and wellbeing of legal, regulatory and compliance leaders. She previously practiced law for 20+ years and spent over 15 years in the biotech/pharma industry, including as VP of Legal at Fortune 500 and mid-sized companies. With Waverly, her mission is to help legal, regulatory and compliance leaders transcend their expertise to unlock their leadership potential and impact. Lynne holds an LLB from Université de Montréal and a Graduate Certificate in Healthcare Compliance from George Washington University, and coaching certifications from the ICF, the NeuroLeadership Institute, iPEC and Hogan Assessments.

Nada Glavan is an accomplished regulatory affairs leader with more than 25 years of experience guiding pharmaceutical companies through the complexities of advertising and promotion compliance. Throughout her career, Nada has built a reputation for her ability to bridge the gap between scientific innovation and regulatory requirements, partnering with cross-functional teams to support product launches, lifecycle management, and commercial success. She currently serves as Executive Director, Commercial Regulatory Affairs at Eisai Inc.

Melissa Sadowski is a Director, US Advertising and Promotion in Global Regulatory Affairs at EMD Serono with more than 15 years of pharmaceutical industry experience. She has provided regulatory review and guidance for commercial and developmental products across therapeutic areas and led PRC operations teams.

Heather Bañuelos is Counsel in King & Spalding’s FDA & Life Sciences practice group. She advises clients on regulatory strategies and initiatives for the labeling, promotion, and advertising of FDA-regulated products, as well as non-promotional communications, with particular focus on prescription drugs. She routinely serves on promotional review committees and medical/scientific review committees, providing practical and insightful advice and recommendations. Heather has over 25 years of experience in food and drug law, including as a former Associate Chief Counsel in FDA’s Office of the Chief Counsel and as senior in-house regulatory counsel for Fortune 500 pharmaceutical companies.

Jason Cober is the Director - Regulatory Review, AI, and Digital Transformation at ProPharma Group. He previously led FDA/OPDP's eCTD implementation and has 17 years' experience with the Agency's eCTD specification and guidance development process.

Alan Minsk is a partner and chair of the Food & Drug practice at Arnall Golden Gregory LLP. He advises pharmaceutical, biologic, medical device, cosmetic, food and dietary supplement companies on legal and regulatory matters relating to the U.S. Food and Drug Administration. He serves on the advisory board for the Food and Drug Law Institute’s Food and Drug Law Journal (FDLI) and speaks frequently at conferences, conducts training webinars and in-house engagements. He advises life science companies and venture capital firms on regulatory matters involving acquisitions, divestitures, regulatory opinions, co-promotions and licensing agreements. Alan is recognized by Chambers & Partners “Who’s Who Legal, and Best Lawyers.”

Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs Professionals Society (RAPS) and PricewaterhouseCoopers (PwC). At AgencyIQ, his research, insights and analysis is relied upon by the regulatory teams of many of the world's leading companies. He is also the author of AgencyIQ's flagship daily newsletter, "FDA Today."

Josh Oyster is a partner in Ropes & Gray’s Life Sciences Regulatory & Compliance practice. He steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Josh is frequently tapped to analyze clients’ toughest questions related to complex or ambiguous regulatory requirements, drawing on his extensive experience with key policy and enforcement priorities, including medical product promotion. In addition, Josh routinely helps companies navigate FDA inspections and other compliance and enforcement matters and also assists clients in assessing regulatory risks associated with potential acquisitions and investments.