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.

Kimberly (Kim) Belsky is a regulatory professional with expertise in Regulatory Policy & Intelligence and AdPromo. With over 30 years of global experience in the medical product industry, including 20+ years in regulatory affairs, Kim's diverse experience including scale up and tech transfer, quality/compliance, advertising & promotion, labeling, and regulatory policy and intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim is the co-chair of the DIA AdPromo WG (part of the RegAffairs Community) and is an active member in RAPS. Kim is passionate about networking, learning, and collaboration.

Shruti Gadhia, PharmD, is currently the Senior Director, Head of Regulatory Affairs Advertising and Promotion Compliance, at Kyowa Kirin, where she provides guidance to ensure promotional and nonpromotional materials adhere to FDA regulations and company requirements. Prior to joining Kyowa Kirin, she held roles at Bayer HealthCare Pharmaceuticals and Merck. She has more than 15 years of pharmaceutical experience, including roles in both regulatory and medical affairs. She received her Doctor of Pharmacy from the Ernest Mario School of Pharmacy at Rutgers University.

Dr. Adam Goodcoff, CEO of MedFluencers and emergency medicine physician, revolutionized healthcare content during the pandemic, amassing over 800M views and 2M followers. A thought leader named MM+M’s 2024 40 Under 40, he elevates healthcare through compliant Digital Opinion Leader campaigns and digital innovation.

Dr. Janet Gottlieb’s experience in research, diagnostics, medical devices, and pharmaceuticals in a career spanning over two decades provides critical insight into medical review. She is adept in the formation, expansion, and training of centralized Medical Promotional Review teams, resulting in greater efficiencies via improved turnaround times, consistency in guidance, enhanced communication, and successful commercial launches. She is a recognized subject matter expert in the field, presenting as an invited speaker at multiple industry conferences. Dr. Gottlieb holds an undergraduate degree in Biological Sciences and Ph.D. in Medical Microbiology and Molecular Virology from the University of California, Irvine.

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.

Kevin is a seasoned regulatory affairs professional with over 20 years of experience in global medicinal product commercialization. He specializes in optimizing drug promotion through strategic regulatory alignment and is committed to advancing public health. Currently, he leads global advertising and promotion at Alexion and has held key roles at Moderna, GSK, EMD Serono, Cubist, and Amgen. Kevin holds advanced degrees in public health, regulatory affairs, and business administration. He has contributed to several key publications and is active in shaping industry practices through strategic leadership and collaboration with regulatory bodies.

I am currently the Director of MLR Operations Excellence for Sage Therapeutics, supporting both medical and promotional reviews in our own internal review programs as well as review programs with a collaboration partner. Having been in this role for three years now, I have led these programs through a number of significant events, included the following: new product launch, label updates, clinical trial data read outs, and a product retirement. We aim to carry learnings and best practices across programs to maximize efficiency and optimize these programs in support of our broad base of stakeholders.

Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective disease awareness initiatives. At launch and in the post-marketing stage, Dara works closely with corporate communications and marketing to help achieve their goals. Dara serves as the legal reviewer on promotional review committees and conducts company training programs.

Josh Simon leads Centered, CMI Media Group’s Social Center of Excellence, as Senior VP. Josh has grown the agency’s content and social media services including digital media production, influencer, community management and enterprise guidance. Josh is particularly energized by the emergence of influencer activations within pharma and finding unique ways to minimize content gaps with media plans. Josh has over 14 years of social media experience with 9+ years focused in pharma, in both agency and in house settings.

Georgia Gayle serves as the Director and Head of Promotional Review and Operations at Alexion, AstraZeneca Rare Disease. With a dedication to enhancing patient outcomes, Georgia spearheads the evolution of promotional review procedures, ensuring compliance, operational excellence, and innovation. Georgia cultivates a culture of collaboration across various departments including marketing, medical, legal, and regulatory teams to create impactful communications prioritizing patient safety. Leveraging AI and analytics, she optimizes efficiency while developing strategies that harmonize industry standards with patient needs in mind. Her leadership is instrumental in indirectly supporting the delivery of life-changing therapies in rare disease.

Jo Secnik joined Lilly in 1990 where her career has included assignments in Biopharmaceutical Development, Quality Assurance and Regulatory Affairs. Her experience in Regulatory includes 10 years in global CMC and for the last 12 years supporting the US business on advertising and promotion for marketed products.