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.

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., is Vice President, US Regulatory Affairs at Galderma. She was previously at Propharma (previously OneSource Regulatory) where she managed the Regulatory & Medical Review staff, provided 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 25 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.

Heta Zaveri is a Practice Leader for the Opus Regulatory Advertising and Promotion team, bringing over 15 years of experience in Regulatory AdPromo and Medical Review. She partners with pharmacutical organizations to navigate complex promotional regulations and deliver compliant, strategic solutions. Heta earned her Doctor of Pharmacy (PharmD) and Master of Business Administration (MBA) from Drake University, combining clinical expertise with business insight to support effective, compliant promotional strategy.

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.

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.

Melanie is a Senior Director of Regulatory Affairs at Merck & Co., Inc. in North Wales, Pennsylvania. She oversees the promotional regulatory strategy and the regulatory review, approval, and submission of promotional materials for Merck’s oncology products that are co-promoted with other companies. She has over 24 years of industry experience, including roles in Global Medical Affairs, Global Labeling, Global Safety and Clinical Research.

Denise has worked in the regulatory space for over 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 was in the public health service as Regulatory Counsel for both CDRH and CBER, FDA and in congressional policy at the National Cancer Institute, NIH. Denise completed undergraduate & public health graduate studies at Columbia University, biomedical sciences graduate work at Rutgers, & health 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.

Katherine Armstrong is a Deputy Director for BBB National Programs’ National Advertising Division (NAD). She brings more than 30 years of of consumer protection experience from her tenure at the Federal Trade Commission (FTC), where she served in a variety of roles. In her work as an FTC Attorney Advisor to Chairman Janet Steiger and Commissioner Sheila Anthony, Katherine provided advice on all legal and policy issues related to consumer protection matters before the Commission.Prior to joining BBB National Programs, Katherine spent five years in private practice where she advised clients on privacy and data security matters as well as FTC-related investigations and inquiries.

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.

Kristine T. Khuc has been with the FDA, Center for Biologics Evaluation and Research (CBER) since 2011. She now serves as Acting Branch Chief in the Office of Compliance and Biologics Quality (OCBQ), Advertising and Promotional Labeling Branch (APLB). In her current position, she has experience in reviewing and evaluating advertising and promotional labeling. She came from the Center for Drug Evaluation and Research (CDER) in the Division of Advisory Committee and Consultant Management. She received a Doctor of Pharmacy degree from Howard University and completed a drug information residency program at Washington Hospital Center. Prior to FDA, she practiced at the Fairfax Health Center and at the Andrew Rader Health Clinic.

Phyllis Marcus serves as Vice President, BBB National Programs’ National Advertising Division. In this role, Marcus leads a team of attorneys and professionals at BBB National Programs’ National Advertising Division holding national advertising across all media types to high standards of truth and accuracy by reviewing truth-in-advertising challenges from businesses, trade associations, consumers, or on its own initiative. Through its work, thousands of misleading advertising claims have been removed from the marketplace and its case decisions represent the single largest body interpreting advertising law in the country.

Alan Minsk is a partner and chair of the Food & Drug practice at Arnall Golden Gregory LLP, advising pharmaceutical, biologic, medical device, cosmetic, food, and dietary supplement companies on legal and regulatory matters relating to the U.S. Food and Drug Administration. Additionally, Alan counsels life science companies and venture capital firms on regulatory matters involving acquisitions, divestitures, regulatory opinions, co-promotions, and licensing agreements. Recognized nationally and globally by Chambers & Partners for his legal work, Alan is a highly sought-after speaker and author in the life sciences industry. He also serves on a number of advisory boards and regularly conducts training webinars and in-house engagements.

Alexander Gaffney is a regulatory and media executive responsible for founding and leading the research division of AgencyIQ, the regulatory analysis division of the media company POLITICO. As the Vice President of Regulatory Policy and Intelligence, Alexander directs the division’s analysis of regulatory issues affecting pharmaceutical, biotechnology, medical device, chemical and food companies. Before joining AgencyIQ, Alexander analyzed life sciences regulations as part of PricewaterhouseCoopers's Health Research Institute and was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also served as Managing Editor for the company’s flagship publication, Regulatory Focus.

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.

Dr. Loss is a veterinarian and is a Branch Chief in the Division of Pharmacovigilance and Surveillance in the Office of Surveillance and Compliance at the Center for Veterinary Medicine at FDA. He leads and manages a group of veterinarians that evaluate post-market adverse drug event reports, promotion and advertising, and labeling for approved animal drugs, as well as post-market adverse events for some intentionally genetically altered animals.

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.

Rohini Sen, PhD, is a prominent advocate for patient experience data (PED) with over ten years of experience in patient-centered outcomes research, particularly in oncology and rare diseases. As the Director of Patient Centered Outcomes Research (PCOR) Oncology HEOR at AbbVie, she leads cross-functional efforts to integrate patient insights into oncology drug development. Her dedication to prioritizing patients earned her the prestigious AbbVie CAN Impact Award for successfully incorporating PED early in oncology trials.Dr. Sen has a proven history of developing innovative clinical outcome assessments (COAs) that enhance patient engagement and facilitate effective regulatory interactions with agencies like the FDA and EMA.

Deborah Wolf has been a regulatory counsel in CDRH since 1995, focusing primarily on issues related to labeling and advertising. She advises staff in many parts of CDRH on a broad range of device-related policy and regulatory issues and engages with the other medical product centers on Agency policy discussions and document development.