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.

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.

Mike Sauers is Director in Eli Lilly’s Global Regulatory Affairs - US Advertising and Promotion group, advising on promotional compliance across the range of Lilly’s Oncology, Diabetes, and Biomedicines US marketed products. Prior to joining Lilly in 2017, Mike served for 10 years in the FDA’s Office of Prescription Drug Promotion. His previous work includes posts in the HHS Office of the Secretary and with Pfizer as a Healthcare Representative. Mike received his Bachelor's Degree in Neuroscience from the University of Delaware and a Master's of Public Policy from Georgetown University.

Paul Savidge is senior regulatory counsel at Spark Therapeutics, a leading gene therapy company, where he provides counsel on a broad range of issues, including those related to drug development and commercialization. Prior to joining Spark, Paul was senior vice president and deputy general counsel at Bristol-Myers Squibb and led the legal groups assigned to the company’s global commercial and research organizations. Prior to BMS, Paul held positions in the U.S. and European legal departments at Merck. Paul received his JD from Washington & Lee University, an MBA from the Kellogg School of Management at Northwestern University and a BSFS from Georgetown University’s School of Foreign Service.

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.

Rosemarie Carey has been in the pharmaceutical industry for over 29 years—five years at Merck & Co., Inc. and the remaining time at AstraZeneca and its legacy companies. She has delivered regulatory and compliance training and has conducted regulatory reviews for professional/consumer materials for many of AstraZeneca products. Recently, Rosemarie’s expertise is focused on the consumer—including broadcast, digital, and social media work. Rosemarie holds a BA in Communication Studies from Northwestern University.

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.

Bhavana Desai is Sr. Director, Advertising, Promotion, and Labeling within Regulatory Affairs at Avanir Pharmaceuticals. Bhavana has 25 years of industry experience across several therapeutic areas in providing Strategic Leadership in Advertising, Promotion, and Labeling from development phase thru launch and beyond. Prior to joining Avanir, she was at Alexion Pharmaceuticals where she was responsible for Global Advertising & Promotion function within Regulatory. Bhavana began her career at Allergan where she held positions of increasing responsibilities in Medical Information, Labeling, Advertising and Promotion, and Corporate Compliance. She received her BS in Microbiology from Mumbai University and MBA from National University.

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.

John Paul Marcus is the Associate Director, Regulatory Affairs Advertising/Promotion at AbbVie.

Tracy Rockney is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory, a consulting firm specializing in Regulatory Advertising & Promotion, Medical Review, Labeling Development and Healthcare Compliance. Tracy received her JD from Washburn University School of Law, and her BA from the University at Albany, SUNY, Rockefeller College of Public Affairs & Policy. Tracy is a board advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases.

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.

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.

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.

Albert J. D’Alonzo, Ph.D. is the Vice President of Promotion Compliance for Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) in Princeton, NJ. In this capacity, he oversees promotion compliance review of training and promotional materials directed towards sales representative, and prescription drug related materials for healthcare professionals and consumers across multiple brands. Prior to his current position, Dr. D’Alonzo was a postdoctoral fellow at University of California Los Angeles where he studied the electrophysiology of the neuromuscular junction. He also worked in drug discovery at Merck, Procter & Gamble Pharmaceuticals and Bristol-Myers Squibb.

Michelle Drozd is a Deputy Vice President in the Policy and Research department at the Pharmaceutical Research and Manufacturers of America (PhRMA). Michelle focuses on addressing the barriers to value-based contracting, and policies related to the pharmaceutical supply chain. Prior to joining PhRMA, Michelle worked in quality improvement and business planning at Partners Healthcare, an integrated delivery system. She also worked at RTI International in implementing demonstration projects for the Centers for Medicare & Medicaid Services. Michelle holds a BA in economics and public policy from Duke University and a SM in health policy and management from Harvard School of Public Health.

With more than 15 years of biopharmaceutical commercialization experience, Melissa has led the strategic planning, development, and communication of patient access programs for numerous large programs across several therapeutic areas in both small and large molecules. She is focused on patient centric program and communication development to design and implement support that helps patients start and stay on their prescribed AstraZeneca medicines.

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.

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.

Nikki Reeves is an FDA and healthcare regulatory compliance lawyer who has been advising life sciences companies on FDA regulatory matters for more than 22 years. Nikki co-chairs King & Spalding’s Life Sciences and Healthcare Industry Group, which is comprised of more than 400 lawyers across the firm. She counsels life sciences companies and investors on an array pre- and post-market FDA regulatory compliance and enforcement matters, and she has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.

James Vigil, J.D. RAC is presently Director of Advertising and Promotion, Oncology Therapeutic Area, US Regulatory Affairs, Abbvie. He has extensive experience in US Advertising and Promotion in multiple therapeutic areas with three different pharma companies. He is a founding member and on the Leadership Team of The IRISS Forum Ad Promo group which focuses on issues regarding electronic advisory submissions or 2253 submissions using US eCTD Module 1 specifications.

Kevin R. Betts, Ph.D., is a Social Science Analyst at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, where he plans and directs social science research studies and provides consultation pertaining to promotional prescription drug communications. His research has covered topics such as misinformation detection and reporting capabilities among both consumers and healthcare providers, and strategies for improving the communication of prescription drug risks and side effects.

Kristen Heinlein has almost 20 years’ experience in pharmaceutical industry, having spent the past 12 years in various leadership roles in Advertising & Promotion Regulatory. She is currently Vice President, U.S. Advertising & Promotion Regulatory, supporting the U.S. Business Unit portfolio at Takeda. Prior to joining the Regulatory team, Kristen held various positions of increasing responsibility in Medical Communications at Shire, which also included an international assignment. Preceding her time in industry, Kristen was a Clinical/Staff Pharmacist at Peninsula Regional Medical Center in Salisbury, MD.

Mike is a partner in the Food, Drug & Device practice at Covington & Burling LLP. He provides strategic advice to biopharmaceutical clients in dealing with FDA and other agencies. He has litigated extensively and works actively on transactional and legislative matters. Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School. He was an officer of the Harvard Law Review, and clerked for the Hon. David Ebel on the U.S. Court of Appeals for the 10th Circuit.

Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication. McCaughan speaks frequently on regulatory, reimbursement and policy developments affecting the biopharmaceutical industry.

Ami Patel is Senior Counsel in the Law Department at Johnson & Johnson. She provides regulatory legal support to the Janssen pharmaceutical family of companies as well as the health care compliance organization. Prior to joining Johnson & Johnson, she was a member of King & Spalding’s FDA & Life Sciences practice in Washington, DC, where she counseled pharmaceutical and medical device manufacturers on FDA and healthcare regulatory issues, including compliance with the Open Payments program.

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.

Jess Amchin, MD, JD is President of Jess Amchin Consulting, LLC, a firm providing medical and business consultation and training services for pharmaceutical, biotechnology, and other companies in a wide range of therapeutic areas. He has worked extensively in both clinical research and medical affairs. Among his various assignments as a consultant, Dr. Amchin has served as a medical monitor for clinical research trials and as a medical reviewer on advertising and promotional review committees.

Tara is the Director of the Regulatory Promotion Group for the Oncology Business Unit at Amgen. Tara has worked in the biotech/pharmaceutical industry for over 16 years, with over 13 years of experience in regulatory advertising and promotion. She previously worked for Abraxis BioScience, Inc. and Genzyme. She received her Bachelor of Science degree in Chemistry from Carnegie Mellon University in Pittsburgh.

Jeanne Green is a Program Director specialized in pharmaceutical marketing at imre, a transformative marketing agency, where she crafts digital strategies that build meaningful connections between brands and consumers. A content strategy and delivery enthusiast with a respect and tact for the use of audience data and insights to drive campaign success and improved outcomes, Jeanne holds years of experience navigating the every-changing landscape of direct drug marketing in the digital space. She has helped to impart black box products a voice on social media and build global website frameworks and compliant content solutions that meet the financial and informational needs of pharmaceutical brands and their stakeholders in the US and abroad.

Sanjay Narayan is Division Counsel at AbbVie. Sanjay has been with Abbott/AbbVie for 7 years and previously worked in a law firm in Washington, DC. In his role at AbbVie, he oversees a team that provides legal, regulatory and compliance advice to the Commercial, Medical, Regulatory and Clinical teams on a wide-range of matters. Sanjay’s particular focus includes, product launches, appropriate pre-approval activities, scientific exchange, patient interactions, First Amendment-related issues, Specialty Pharmacy distribution, and patient interactions and patient support programs. Sanjay’s role is to ensure AbbVie operates in compliance with various laws, regulations, industry codes and corporate policies and procedures.

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.

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.

Morgan Romine, MPA, is Chief of Staff at the Duke-Margolis Center. In this role, he helps to guide and implement the Center’s strategic priorities across its research portfolio by serving as a coordination and communications bridge within the Center and with external collaborators. This includes oversight of a number of strategic projects and policy efforts, development of key public and private sector relationships, and the occasional all-hands hijinks. Prior to Duke-Margolis, Morgan worked as a researcher at the Brookings Institution in Washington, DC, and the Stowers Institute for Biomedical Research in Kansas City, MO.

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.

Elisabeth Walther is a health scientist policy analyst at the US Food and Drug Administration where she currently leads regulatory policy development related to patient prescription drug product information. She also continues to practice as a community pharmacist. She holds a Doctor of Pharmacy and Juris Doctor from Drake University.

Jennifer McIlvaine is the Marketing Leader at AstraZeneca Pharmaceuticals LP, United States.

Denise Rieker Clark, Director of Regulatory Affairs at Sanofi Pasteur, has over 28 years of experience in FDA-regulated industry, including 20 years in regulatory affairs, where she has participated in regulatory strategy, policy and promotional review. She is currently responsible for all vaccine advertising and promotional review and has led this review for numerous vaccine launches over the past 11 years. Denise received her M.S. in Biochemistry at Lehigh University in 1990.

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.

Kathleen A Taylor, PhD received a doctorate in Microbiology and Immunology from The Bowman Gray School of Medicine of Wake Forest University. She completed two postdoctoral fellowships in the field of pathogenesis before joining Lilly Research Laboratories as a Team Leader for In Vivo Biology in Infectious Diseases. In 2002, she joined the US Medical Division of Lilly USA supporting clinical osteoporosis research and has made significant contributions to the design, implementation and disclosure of several important clinical studies. Dr. Taylor is recognized as a medical leader in support of commercialization efforts and has served on promotional review boards for over 14 years.

Michael is a seasoned marketing leader in the pharmaceutical and device marketplace, with 26 years of healthcare marketing, medical education, managed markets strategy and professional promotion expertise. He is the President of Ogilvy Payer Marketing, a healthcare communications agency focused on payer marketing and reimbursement consulting. Previously, he led the medical education division where he repositioned ProCom from CME to promotional medical education. Prior to joining Ogilvy, Michael was Group Director of Marketing for the Interventional Division at B. Braun Medical, a leader in medical devices.

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.