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.

Glenn is a part-time faculty member at UNCW’s College of Health and Human Services teaching Regulatory Affairs (BS and MS). He also runs his own consulting company focused on providing expert advertising and promotion regulatory support to the biopharmaceutical industry. Glenn previously served over 11 years at AstraZeneca/MedImmune and has held numerous regulatory and leadership roles across pharma, biotech, and device organizations over his 30-year career in regulatory affairs. Glenn has served on the RAPS Board of Directors for the last 10 years and became Chairman of the Board in January 2021. He spent 10 years at the US FDA (CDRH&CBER), including 4 years as head of the Advertising and Promotional Labeling Branch, CBER.

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.

Mary is an Assistant Professor-Clinical at The Ohio State University, College of Pharmacy, including a role as lead faculty in the regulatory affairs specialization of the Masters in Clinical Research (MCR) program; additionally, she develops and teaches courses related to pathophysiology and drug development in the MS Translational Pharmacology. Mary also continues to consult based on over 10 years of experience supporting commercial and/or medical affairs teams as a medical strategist / scientific director, including close collaborations with regulatory affairs teams. She earned her PhD in Chemistry from Johns Hopkins University (2009) and BS in Pharmaceutical Sciences from The Ohio State University (2004).

COLEEN KLASMEIER leads the firm’s Food, Drug and Medical Device Regulatory practice within the global Life Sciences team, managing matters on behalf of leading biopharmaceutical, medical technology, and food and consumer product companies. Since joining Sidley from the Office of the Chief Counsel at the Food and Drug Administration in 2005, Coleen has concentrated her practice on FDA litigation and dispute resolution, and on regulatory strategy and risk management.

Wayne Pines is a consultant on FDA-related issues. He specializes in ad promo regulation, serving as the regulatory expert on promotional review committees for several pharma companies. He also assists pharma and device companies with product approvals and regulatory and media strategy. Mr. Pines has authored or edited a dozen books on FDA including the FDA Advertising and Promotion Manual and A Practical Guide to FDA's Laws and Regulations.

Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications at FDA. For the last 18 years she has consulted with numerous pharmaceutical companies on promotional regulations/strategy, drug development and regulatory strategy, health policy, and has enjoyed training many professionals on advertising/promotional regulations.

Michele Sharp joined Lilly in 1995 where her career has included assignments in Medical and Regulatory Affairs. Her experience in Regulatory includes labeling development, working with a product team and the FDA to obtain regulatory approvals, and for the last 13 years leading a team who advise the US business on advertising and promotion for marketed products.

Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the Global Regulatory Policy team for 6 years. She also led the Global Regulatory Policy team at Eisai for 8 years, and was Special Counsel, Regulatory Strategy and Law. Ginny was at Genentech in a similar role. Previously, she worked in CDER for 8 years, responsible for regulations development. Ginny was an Army JAG, working as a prosecutor and appellate attorney. Before that, she was a nurse in the Air Force. Ginny holds B.S.N. and J.D. degrees from UVA.

Jason Cober is the Lead Project Manager in the FDA's Office of Prescription Drug Promotion. He leads OPDP's eCTD outreach efforts and has 15 years experience with the Agency's eCTD specification and guidance development process.

Sue Duvall has worked in the pharmaceutical industry for 20 years primarily in regulatory advertising and promotion but also some time in clinical development and supply chain. She is a registered nurse with a Master’s in Public Administration at Western Michigan University and completed her doctoral course work for Medical Ethics/Medical Humanities at Drew University in Madison New Jersey. She currently is the Head of North America Advertising and Promotion, Regulatory Affairs for Mylan in Canonsburg, PA. She has held positions in both U.S. and international regulatory advertising and promotion with AbbVie, Amgen, Novartis, and Pharmacia.

Christine received her Doctor of Pharmacy Degree from Rutgers University and completed a post- doctoral fellowship in Ad Promo through the Rutgers Pharmacetuical Inddustry Fellowship Program. She has held various positions covering several therapeutic areas within the Commercial Regulatory Affairs department at Bristol-Myers Squibb.

Sheetal Patel is the Vice President, Specialty Compliance at Johnson & Johnson. Previously, she held the position of Lieutenant Commander, Senior Regulatory Review Officer, at the Food and Drug Administration, Office of Prescription Drug Promotion.

Dolores Shank-Samiec, M.S., is Executive Director of the Office of Promotion and Advertising Review at Merck & Co., Inc., with responsibility for Merck’s regulatory review of US promotional materials in support of the pharmaceutical and vaccine businesses, as well as oversight for Merck’s global review process. Dolores earned her Master’s of Science degree in Cognitive Psychology from the University of Massachusetts, and has held positions of increasing responsibility in promotional regulatory review, marketing compliance, oversight of external consulting arrangements, marketing communications, and brand marketing. She is married with two children.

Kathryn (Kit) Aikin, Ph.D., is the Senior Social Science Analyst and Research Team Lead in the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP). Dr. Aikin conducts research and provides consultation on regulatory policy and enforcement review of consumer and healthcare provider prescription drug promotional pieces.

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.

Lori K. Hall, RN is the Advisor of Health Literacy at Lilly. She brings to this role over 30 years of health care experience in the clinical setting as well as in the diagnostics and pharmaceutical industries. Her scope of work and responsibility is centered on providing visibility and guidance as well as helping to set organizational expectations and accountability for all aspects of communications with patients as it plays a direct role in supporting Lilly’s corporate priorities around medication adherence, patient safety, clinical innovation, launch preparedness, real world evidence, corporate responsibility, value-based contracting, and informed patient engagement.

Jean-Ah Kang, Special Assistant to the Director in the Office of Prescription Drug Promotion (OPDP), has over 22 years of experience in prescription drug promotion. She focuses on policy/guidance development and communications, with a special interest in social media/accelerated approval issues. Prior roles include senior consultant at SAIC, team leader in the Division of Drug Marketing, Advertising, and Communications (DDMAC), and DDMAC oncology reviewer. She began her career as an assistant professor at Shenandoah University after completing a drug information residency at the University of Pittsburgh Medical Center. She earned a Pharm.D. from the University of Maryland and B.A.’s in Biochemistry and Music from the University of Virginia.

Dr. Moskal is a Veterinary Medical Officer with Food and Drug Administration’s Center for Veterinary Medicine (CVM). He serves as a reviewer of labeling and promotional materials for approved and unapproved animal drugs and medical devices, and is CVM’s contact for Promotion and Advertising. He received his B.S. in Biology from the University of Maryland, a D.V.M. from the Virginia-Maryland Regional College of Veterinary Medicine, and a Master of Library and Information Science (M.L.I.S.) from Drexel University. Dr. Moskal is a Diplomate of the American College of Laboratory Animal Medicine.

Rob supports the AstraZeneca Promotional Regulatory Affairs (PRA) team that supports the US Oncology business. He has held roles in promotional regulatory, medical affairs and Compliance over the last 15 years while at AstraZeneca.

Eugene J. Sullivan, MD is an independent consultant in the area of strategic regulatory and clinical drug development at EJS Consulting, LLC, and is the Chief Product Strategy Officer at Insmed, Inc. Past pharmaceutical industry positions include VP, Global Regulatory Affairs for Respiratory, Inflammation and Autoimmunity products at Astra Zeneca Pharmaceuticals, Chief Medical Officer at United Therapeutics (UT), and Chief Medical Officer/Chief Clinical Development Officer of Lung Rx/Lung LLC. Prior to joining industry, Dr. Sullivan worked at the FDA where he served as a medical reviewer, medical team leader, and Deputy Director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

With nearly 20 years of experience in the healthcare and pharmaceutical industry, Amy has held various roles of increasing responsibility within the areas of Medical Affairs and Regulatory. As the current head of US Medical Affairs, she is responsible for developing, communicating and driving strategy and leading the organization to success with a prioritized focus on the design and delivery of MI and MSL programs. Prior to joining Ashfield, Amy spent more than 10 years at Johnson & Johnson supporting the biopharmaceutical business in the areas of Immunology, Infectious Diseases, Vaccines, Global Public Health, Strategic Customer Group (Market Access), Established Products Group, and the Research & Development areas.

Kristi Wolff is a partner in the firm’s Washington, D.C. office. Ms. Wolff's practice focuses on food, drugs, dietary supplements, medical devices, personal care and consumer health products, as well as wearable technology and health privacy issues. She has extensive experience advising clients whose products are within the overlapping jurisdictions of the Food and Drug Administration and the Federal Trade Commission. Having served as in-house counsel in the healthcare and food products industries, Ms. Wolff is particularly attuned to balancing business objectives with legal considerations. She was recently peer-selected as one of the Best Lawyers in America for Advertising for 2018.

John Wong is a pharmacist graduate from Université Laval, Quebec, Canada. He started his career at the Toronto General as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), a national regulatory body for the review of drug advertising, and later became the Deputy Commissioner. After 10 years at PAAB, John decided to cross over to the ‘other side' and landed at Ogilvy CommonHealth as an Account Director where he helped launch specialty products in Oncology, Hematology and HIV. John was recently the Director, Regulatory Drug Advertising & Promotion at TPIreg/ Innomar Strategies, providing consultation and review services for drug and medical device advertising.

BECKY WOOD is co-leader of Sidley’s Food Drug and Medical Device Regulatory practice and the D.C. Healthcare and FDA group. Until recently, Becky served as Chief Counsel to the Food and Drug Administration (FDA). At FDA, she worked on virtually every significant initiative addressed by the Commissioner and agency leadership. She was the principal legal advisor on major initiatives including efforts to streamline the drug and device development approval process, modernize the agency’s regulatory framework, combat addiction to opioids and nicotine, enhance the product safety and labeling of food and medical products, and address drug pricing. She also focused on First Amendment and preemption issues.

Katlin McKelvie Backfield is an attorney and consultant who advises on issues related to the regulation of pharmaceuticals and biotechnology products. Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years and as a regulatory counsel in the Office of Prescription Drug Promotion for two years. Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock. She graduated cum laude from Georgetown University Law Center and received her undergraduate degree from Davidson College. She is based in Washington, D.C.

Dwight Bowen received his Pharm.D. degree from Philadelphia College of Pharmacy in 2011. He then accepted a position with the Eli Lilly and Company Visiting Scientist Fellowship. His fellowship year was spent in the regulatory affairs US Advertising and Promotions group. After completing the fellowship, Dwight remained at Lilly in the ad/promo group for about 6 years and served as the regulatory reviewer for multiple compounds across the company's portfolio as well as some commercialization alliances. Currently he works at Shire and is a director within the ad/promo group.

Michael is the General Counsel of Lilly's BioMedicine's Business Unit, which develops, markets and sells the companies' products in immunology, pain, neuroscience, and men's and women's health. He also leads legal teams supporting the company's global regulatory, clinical development, medical affairs, manufacturing and quality, HSE and privacy functions. Before coming to Lilly, Michael was a litigator first at Kirkland & Ellis and then at Barnes & Thornburg. He graduated magna cum laude from the Indiana University School of Law.

Geoff McCleary is a leading Digital Health consultant for Pricewaterhouse Cooper's Digital & Connected Health Advisory group. Focused on helping pharma, providers, payors and new health entrants maximize their value to their customers and the health care system by strategically using emerging digital and connected health technologies.

Linda Neuhauser, DrPH, MPH, is Clinical Professor of Community Health Sciences at the University of California, Berkeley School of Public Health and Co-PI of the Health Research for Action center. She has over 25 years experience in research and practice related to health communication and health literacy. She focuses on participatory design of communication to meet the literacy, language, cultural and functional access needs of diverse users in the US and globally. She was a founding member of the FDA Risk Communication Advisory Committee.

Amie C. O’Donoghue, Ph.D., is a Social Science Analyst in the Office of Prescription Drug Promotion (OPDP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration. She has published over 50 articles on professional and direct-to-consumer (DTC) advertising and the communication of information to physicians and consumers. She also provides technical assistance on research and communication issues to FDA staff and external organizations.

Leah Palmer, PharmD is currently a consultant in FDA prescription drug promotion regulations. Most recently, she served as Executive Director in Regulatory Affairs at Amgen Inc., as a Regulatory Promotion lead with oversight of a wide range of product promotional activities. Prior to joining Amgen in 2001, Dr. Palmer was a Branch Chief in DDMAC (now OPDP) overseeing product advisories and enforcement actions, and she also served as Senior Enforcement Advisor. Prior to joining FDA, she completed her Doctor of Pharmacy at Purdue University College of Pharmacy and an Industrial Clinical Pharmacy Fellowship affiliated with Rutgers University and Parke-Davis. She received her B.S. in pharmacy from the UMKC School of Pharmacy.

Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in the area of prescription drug promotion. This includes her most previous role as the Policy Team Leader for the Office of Prescription Drug Promotion. Her experience at FDA has also included overseeing compliance programs for tobacco products and managing oncology drug applications. She has pharmacy degrees from the University of Pittsburgh and University of Maryland, along with a Master of Public Health from the University of North Carolina.

Lisa Schatz is biopharmaceutical professional with over 12 years of leadership and results driven experience in industry, including commercial regulatory affairs and medical affairs with extensive knowledge of working in a global multifunctional team environment. Over the past several years, she has had a focus in global product launches.

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.

Lisa Stockbridge, Ph.D., has been with FDA for 30 years, during which time she has worked in CDRH, CDER, and CBER. With a background in Psychology, Medical Physiology, and Neuroscience, she has held researcher, reviewer, project manager, program manager, and supervisory positions. The last 12 years, she has been Chief of the Advertising and Promotional Labeling Branch (APLB) in CBER's Office of Compliance and Biologics Quality.

Eileen is the principal of Valenta Consulting, LLC and has over 25 years of experience in global regulatory affairs encompassing drugs, devices and biologics. Eileen has deep expertise in regulatory advertising and promotion, labeling, operations and compliance developed in companies that range from start-ups to pharma giants. During her industry tenure she has held promotional responsibility for many product launches and managed multiple billion-dollar brands.

Brandon has 25 years of experience driving internal and client-facing technology solutions by leveraging a range of core competencies, including user experience, architecture, software engineering, business analysis and program management. At Razorfish Health, Brandon has led Mobile, CMS, CRM and VeevaCLM solutions for AstraZeneca and Otsuka, as well as digital marketing implementations for Bayer and Purdue Pharma, among others. Before joining Razorfish Health, Brandon spent 17 years designing, leading and building Technology solutions for Kaplan Test Prep, including Enterprise CMS, content authoring tools, data analytics solutions, and enterprise business systems.

Blythe Buchanan heads the US Regulatory Advertising and Promotion group at Biogen, having spent more than 16 years in regulatory affairs advertising, labeling & promotion and various commercial roles with increasing responsibility including sales, training/leadership development and competitive intelligence throughout Pharma and Biotech. Her tenure at Eli Lilly, Sepracor, Endo and Auxillium spanned consumer, HCP and managed markets segments. Blythe has successfully launched more than 10 products both from the regulatory and commercial sides of the business. A broad and diverse experience in the industry makes Blythe uniquely adept at providing regulatory guidance with a lens to real-world commercial application.

Julie Cain is an expert in designing and implementing products and marketing initiatives that drive results.As Vice President of Product Strategy, Julie develops the product roadmaps and market strategies that position PatientPoint as the leading innovator of point of care. She led the launch of the PatientPoint physician-facing mobile application and is responsible for key partnerships within the healthcare space. Prior to joining PatientPoint, Julie held management roles at U.S. Bancorp, Proctor & Gamble and Express Scripts. She has a bachelor’s degree in English literature from Miami University and a master’s degree in global marketing communications and advertising from Emerson College.

John Kamp is the Executive Director of the Coalition for Healthcare Communication, comprised of medical marketing agencies, medical mass media and medical journals. The CHC believes that truthful communication about medical products and services advances the public health.

Elizabeth Pepinsky is a Health Science Policy Analyst in FDA's Office of Prescription Drug Promotion, where she focuses on guidance and policy development. Prior to joining OPDP, she served as a Regulatory Counsel in FDA’s Center for Tobacco Products. Ms. Pepinsky received her B.S. from Wake Forest University and her J.D. from the University of Baltimore School of Law.

Margaret has been with Sanofi US or its predecessor company since November 2001, when she joined the Aventis Pharmaceuticals Legal Department, supporting the Respiratory franchise. Margaret moved to the Compliance team in 2007, and now supports a variety of business groups and compliance functions. Prior to Sanofi US, Margaret was part of the Litigation group at Patterson, Belknap, Webb & Tyler, LLP in New York. Margaret is a graduate of the University of Virginia School of Law, received an M.A. degree from the Harvard University Graduate School of Arts and Sciences, and a B.A. degree from the University of Georgia.

Helen Sullivan is a Social Science Analyst in the Office of Prescription Drug Promotion at the U.S. Food and Drug Administration (FDA). Dr. Sullivan’s research examines the communication of prescription drug information to consumers and healthcare professionals. Prior to joining FDA, she was a Cancer Prevention Fellow at the National Cancer Institute. She received her BA from Yale University; her PhD in psychology from the University of Minnesota, Twin Cities; and her MPH from Johns Hopkins Bloomberg School of Public Health.

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.

Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. Mr. Abrams has held the positions of Acting Director, Acting Deputy Director, and Branch Chief in DDMAC. He joined FDA as a reviewer in DDMAC where he was primarily responsible for reviewing promotional material for cardiovascular products. Prior to joining FDA, Mr. Abrams worked in pharmaceutical sales and marketing for Merck and Company. Mr. Abrams received his B.S. degree in pharmacy from the School of Pharmacy, Rutgers University and his M.B.A. degree from Rutgers School of Business.

For the past 20 years, Alex Bragg has worked in advertising with the goal to bring inspiration and insight to businesses through brand strategy. As the lead account planner at Fingerpaint Marketing, he operates under the firm belief that there’s rich human emotions and truths to tap into that drive our decisions to engage with brands, and nowhere is this more apparent than in the healthcare category.