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.

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.

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 joined Constellation, Inc., a NYC-based, SaaS/AI company as VP of Regulatory Affairs in early 2024 to lead the compliance efforts for their Life Sciences vertical. Before joining Constellation, her 25-year tenure in Regulatory Affairs Ad Promo spanned positions at various pharmaceutical and biotech companies across the U.S. Prior to joining Constellation, she headed up a team of >40 ad promo consultants at Regulatory firm. Besides being a Regulatory Ad Promo expert, her work style is founded in being a creative thinker, strategic problem solver and being a natural leader and collaborator. Virginia lives in beautiful Northport, Michigan with her family 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 Marketing Governance including Omnichannel, Modular Content and Artificial Intelligence programs for Pharma. Hale Advisors specializes in marketing governance and upskilling solutions.

Heta Zaveri is the Practice Leader for the Advertising and Promotional team at Opus Regulatory, Inc., bringing over 16 years of expertise in Regulatory and Medical Affairs, with a focus on Global and U.S. Advertising and Promotion. She has worked across multiple therapeutic areas, including oncology and rare diseases, providing strategic regulatory guidance to ensure compliance in a rapidly evolving landscape. Heta earned her Doctor of Pharmacy degree from Drake University School of Pharmacy and her MBA from Drake University School of Business. She is also a graduate of the Eli Lilly Visiting Scientist Pharmaceutical Industry Fellowship.

Mark most recently served as 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 was accountable for regulatory leadership and strategy in supporting impactful product promotion and maintaining strict regulatory compliance in the interest of promoting and protecting patient health. During more than 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 seasoned regulatory professional specializing in Regulatory Policy, Intelligence, and Advertising & Promotion (AdPromo). With over 30 years of global experience in the medical product industry, including more than 20 years in regulatory affairs. Her diverse background spans prescription drugs, biologics, over-the-counter products, nutritionals, cosmetics, and medical devices. She also happily co-chairs the DIA AdPromo Working Group within the Regulatory Affairs Community and is actively involved in the Regulatory Affairs Professional Society (RAPS). Kim is passionate about networking, learning, sharing insights and fostering collaboration.

Renee Ambrosio is the Executive Director and Department Head for U.S. Advertising and Promotion, Regulatory Affairs at Merck & Co., Inc. Renee oversees the regulatory review, approval, submission, and promotional regulatory strategy for all U.S. pharmaceuticals and biologic products. Renee has over thirty years of experience across the healthcare spectrum; including 25-years in the pharmaceutical industry, with an emphasis in complex regulatory strategies, overlapping product launches for indications under accelerated approval, as well as sales and marketing, she brings these valuable insights to the industry. Renee is also the current DIA Ad/Promo Working Group Co-Chairperson.

Lisa Hubbard assists pharmaceutical firms with promotional compliance and related clinical trial considerations at Opus. Her prior roles included Director, Advertising and Promotional Compliance at Alexion and Senior Regulatory and Medical Consultant at One Source Regulatory. Lisa spent 15 years at FDA’s Office of Prescription Drug Promotion. She served as Deputy Director, Division of Advertising and Promotional Review 1 from 2012 to 2021. Her role involved reviews in various data rich therapeutic areas, as well as divisional decisions related to compliance, tv ads, and complicated consistent with labeling issues. She contributed to guidance development and co-led First Amendment initiatives. Lisa spent a total of 25 years at FDA.

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.

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. 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.

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.

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.

Torrey Cope advises and represents clients in a full range of regulatory, enforcement, litigation, and transactional matters involving FDA issues. He has been recognized as a “Life Sciences Star” in the FDA: Pharmaceutical category by LMG Life Sciences since 2016 and has been included in The Best Lawyers in America for FDA Law since 2018. He was also named a “Rising Star” for Life Sciences in LMG's 2017 and 2018 Expert Guides.

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.

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.

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 14 years supporting the US business on advertising and promotion for marketed products.

As the Head of the Global Regulatory Advertising & Promotion, Gina leads the teams responsible for the US and Global review of Sanofi product portfolios. She has worked in numerous therapeutic areas during her 17 years with Sanofi. Her experience includes supporting numerous product launches and has been responsible for broad post-marketing regulatory activities beyond advertising and promotion. Gina has previously held various roles within the pharmaceutical industry on advertising & promotion and medical teams. Gina is a licensed pharmacist and received her Doctor of Pharmacy Degree from the Ernest Mario School of Pharmacy at Rutgers University. She is also a graduate of the Rutgers Institute for Pharmaceutical Industry Fellowships.

Tim Candy is a Principal Consultant for Opus Regulatory, Inc. Following pharmacy school and post-graduate residencies, he has dedicated his career to the pharmaceutical industry since 2005, serving in multiple functional areas of increasing responsibilities, including Medical Affairs, Clinical Affairs, and mostly Regulatory Affairs, supporting a variety of drugs, biologics, medical devices, vaccines, and biosimilars, across a wide array of disease states and at all stages of a product’s lifecycle. Prior to joining Opus in 2017, Tim worked in corporate headquarters locations in the northern Illinois area for TAP Pharmaceuticals, Baxter, Hospira (acquired by Pfizer), and Baxalta (acquired by Shire).

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.

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.”

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.

With more than 20 years’ experience in healthcare and pharmaceutical marketing, Josie is regarded as a strong and compassionate leader. She is a champion of the patient and consistently seeks opportunities to bring forward solutions that can elevate health outcomes. Josie has several novel biologic launches under her belt and has worked across many disease specialties. Her leadership in executing strategies and promotional campaigns has driven impactful results for new products and blockbuster brands. Josie is passionate about collaborating and welcomes diverse thinking to bring the brightest and most meaningful solutions to patients and their families.

Nazeer leads gen AI product development at Allergan's MLRC (Medical, Legal, Regulatory and Compliance). Six of his 20 years in the tech industry was in five AI types: rule-based, machine learning, deep learning, gen AI and agentic. Notably, he launched Arabic as Amazon Alexa's 9th language and has applied similar AI (NLP) techniques in regulatory reviews at Allergan. Beyond Allergan, Nazeer serves on advisory panels for various organizations (non-profits and for-profits), guiding them in building their data and AI infrastructure. He also is a gen AI instructor for product managers at Interview Kickstart.

Vera Kutsenko is the CEO at Atrix AI. Atrix works with pharma and med device companies to help turn messy data into clear, confident decisions -- because insights and automations (about MLR or otherwise) are useless if you can't act on them. She has over a decade of experience in software having previously worked as an engineer at Facebook and Uber. She holds a BS and MEng from Cornell in Computer Science and has co-authored a paper on distributed networking.

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.