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.

Doug Hallward-Driemeier is a partner at Ropes & Gray and head of the firm's Appellate and Supreme Court practice. Before that, he was an Assistant to the U.S. Solicitor General. Doug filed an amicus brief for twelve pharmaceutical companies in the Caronia appeal.

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.

A Senior Director in Eisai's Global Regulatory Affairs Dept. heading up the Commercial Regulatory Affairs function including Global Labeling and the Copy Review Committees for the review and approval of all US product advertising and promotion materials. Received her BPharm in JHB, S. Africa.

Sandra Kerr, RPh is Executive Director of the Office of Promotion and Advertising Review at Merck. She has responsibility for regulatory review of U.S. promotion and advertising materials supporting both the pharmaceutical and vaccine businesses. She is also responsible for promotion review standards for international markets. Ms. Kerr joined Merck in 1989 and has held positions in quality assurance, labeling and marketing. Prior to joining Merck, Ms. Kerr worked at The Upjohn Company where she held various positions in manufacturing and pharmacovigilence. Ms. Kerr received her B.S. in Pharmacy from Butler University.

Scott Liebman develops legal and regulatory strategies to commercialize healthcare and medical innovations. Over the course of his career, he has worked with firms of all size, from virtual companies with fully outsourced functions to nearly three quarters of Fortune 500 companies in the Pharmaceuticals and the Medical Products/Equipment categories.

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.

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped plan and moderated the majority of those, and is also working on novel methodologies for capturing patient experience data. Mr Valentine has also authored an analysis cataloguing FDA's flexibility in assessing efficacy in the approval of drugs for rare, or orphan, conditions.

Scott Moren is the Director, Medical Alignmnent in AstraZeneca's US Medical Affairs group, focusing on AZ's Immuno-Oncology portfolio. As Director, Medical Alignment, Scott is responsible for ensuring that the US Medical Affairs strategy in Immuno-Oncology aligns across the Clinical Develoment and the Commerical organizations.

Bill Sarraille is a senior member of the Healthcare Practice group and a nationally-recognized lawyer in healthcare law.

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.

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.

Vice President, Head of Regulatory Affairs, North America for Sobi Inc. Previous positions: Various positions within Merck Serono from 2009-2014, most recently as Director of Digital and Social Media, Global Marketing Excellence (2012-2014). Director US Regulatory Affairs (2009-2012). Director US Regulatory Affairs, Sanofi (US) 2005-2009. Associate Director Global Promotion Compliance and Labeling, Bristol-Myers Squibb (US) 2001-2005. MBA - Indiana University, Kelley School of Business, B.Sc. in Pharmacy - University of the Sciences, Philadelphia College of Pharmacy.

Laura has over 20 years of regulatory experience, providing regulatory leadership on product development teams and commercial teams in various therapeutic areas. She has also lead teams through numerous product launches throughout her regulatory career. Laura is currently the Regulatory Head of the Oncology Marketed Products team at Sanofi. Her team is responsible for the post-marketing regulatory requirements for the US oncology portfolio, with a focus on labeling and advertising. Prior to joining sanofi in 2015, Laura was at Eisai, where she was the regulatory lead for the advertising and labeling within Oncology and Neurology.

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.

Michael Listgarten is the head of Genentech's Healthcare Law Group, which provides legal support for the company's Product Development, Regulatory, Medical Affairs, Sales & Marketing, Managed Care, and Government Affairs functions.

Hematologist/Oncologist Executive experience in large pharmaceutical companies, Oncology Medical Affairs and Clinical Development Academic and clinical practice experience Coaching and mentoring focus

Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in areas such as compliance and ethics, leadership development, and commercial. Most recently Joe served as SVP - Chief Compliance Officer for global companies Actavis plc., and Forest Laboratories, Inc. (both now part of Allergan). Joe became CCO of Forest in 2004 establishing the function and managing the teams providing compliance support through several major expansions and numerous branded drug launches. Joe became a member of CEO’s Executive Leadership Team at both Forest and Actavis and chaired the respective company’s Healthcare Compliance Committee.

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.

She focuses her practice on the life sciences industry. She has extensive experience with the laws and industry standards that apply to the marketing and sale of pharmaceuticals, medical devices, biologics, dietary supplements, and medical foods.

An officer with the United States Public Health Service. CDR Saini is responsible for reviewing promotional labeling and advertising, proposed proprietary names and product labeling. Prior to joining CBER, he spent over 12 years working as a Senior Reviewer and Senior Regulatory Project Manager in the Center for Drug Evaluation and Research (CDER). CDR Saini completed the Rutgers University Pharmaceutical Industry Post-Doctoral Fellowship and received his PharmD from Howard University and MBA from University of Maryland.

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.

Reviewing promotional materials for pulmonary, allergy, and rheumatology products, CDR Szydlo also serves as a SME for OPDP regarding regulatory submission requirements. Before joining OPDP in 2010, CDR Szydlo was a Project Manager in the Office of Generic Drugs at FDA in the Division of Labeling and Program Support. Prior to FDA, she worked as a pharmacist in home infusion, long-term care, and retail. CDR Szydlo received her Bachelor of Science in Pharmacy from the University of Connecticut and her Master of Business Administration from Trident University International. She has also obtained Regulatory Affairs Certification and is a Certified Geriatric Pharmacist.

Emily Wright is Senior Corporate Counsel at Pfizer Inc., supporting the Oncology and Global Innovative Pharma businesses, as well as the Payer and Channel Access group. She advises on a variety of commercial, advertising and promotion, regulatory and compliance-related issues, as well as managed care contracting and government pricing matters. Before joining Pfizer she was a litigation associate at DLA Piper and clerked on the 9th Circuit.

Joanne Curley is currently Vice President, Global Regulatory Affairs at Jazz Pharmaceuticals. Joanne has spent the majority of her 27 year career within regulatory affairs function at both small and large pharmaceutical organizations. Her experience within regulatory has included label development and negotiations with Health Authorities, primary regulatory review for multiple product launches as well as line extension both in the US and internationally and working with product teams and health authorities to gain new product approvals. Joanne holds a B.S. in Pharmacy from the University of the Sciences and an M.B.A. from St. Joseph's University.

Howard L. Dorfman is Founder of H.L. Dorfman Pharmaceutical Consulting which provides compliance, regulatory and risk management consulting services to pharmaceutical and biotech companies. Previously, Mr. Dorfman served in various senior positions in national and international life science companies including BMS, Bayer and Ferring. His areas of expertise include FDA regulatory law, fraud and abuse, health care compliance, risk management processes, M&A, corporate governance and litigation. Mr. Dorfman is adjunct professor at Seton Hall University School of Law, and has lectured and published articles on a range of issues including compliance, regulatory and litigation.

Felecia Ettenberg heads up BMS' promotion regulatory group known as Promotion Integrity which has responsibility for all US marketed products. She is an attorney and has been with BMS since 2001 in various roles of increasing responsibility including BMS' litigation group and legal commercial/regulatory group. Prior to joining BMS, Felecia worked at private law firms working on product liability litigation representing various pharmaceutical companies. Felecia received a BA, magna cum laude, from Cornell University and a JD from Boston University.

Alpita Popat, PharmD, MBA is a Consumer Safety Officer in the Advertising and Promotional Labeling Branch (APLB) of the Division of Case Management, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), FDA. She is responsible for reviewing promotional labeling and advertising, proposed proprietary names and product labeling. Prior to joining CBER, she was an Account Supervisor with Abelson-Taylor, a healthcare advertising agency and a Medical Science Liaison with Abraxis Oncology. Dr. Popat completed the Post-Doctoral Fellowship in Medical Communications through Rutgers University and received her PharmD and MBA from Drake University.

Kelly M.Treonze, MS Director, Worldwide Product Labeling, Merck & Co., Inc. Kelly leads a team of 9 direct reports with responsibility for global labeling operations and strategy supporting Merck’s oncology and vaccine products. In addition, Kelly is responsible for establishing and refining processes and strategies with the overall goal of develop high quality labeling. Kelly joined Merck in 2000 and has also held positions in Immunology, Basic Research. Kelly received her M.S. in Molecular Biology from Lehigh University and her B.S. in Biology from Boston College.

Nicole Smith, MPH, is a Senior Manager, Regulatory Affairs at Amgen, Inc. and currently serves as a product reviewer in the Regulatory Promotion & Material Compliance Group with key responsibilities including regulatory review of materials and advising on strategy for labeling and claims development. She has experience in various therapeutic areas and across the product lifecycles, including multiple labeling changes. Ms. Smith joined Amgen in 2006, working in Global Development Operations before joining the Promotion Group. Prior to joining Amgen, she worked in county and international public health and on neurologic and Human Genome Project research.

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.

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.