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.

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.

Fadwa Almanakly is the Vice President and Head, Regulatory Advertising and Promotion at Bayer, overseeing the review and approval of promotional, educational, and other materials, programs and activities for all prescription products in Bayer portfolio and pipeline. Her over 25 years of pharmaceutical industry experience include roles in Pharmacovigilance, Medical Information and Labeling. She received her Doctor of Pharmacy from University of Paris Sud, France.

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 20 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.

Bob is currently the Vice President of Commercial Regulatory at Myovant Sciences. Prior to that, he was Director/Team Lead at Merck & Co., Inc. in the Office of Advertising and Promotion Review. Prior to joining Merck, Bob was the Director of the Division of Advertising and Promotional Review 2 in the Office of Prescription Drug Promotion (OPDP). During his 15 years at OPDP, he oversaw core functions within FDA including advisory and labeling reviews, as well as investigations and enforcement actions. He co-developed new FDA Policies, Regulations and Guidance documents and led the efforts of the educational outreach program (Bad Ad) to help engage stakeholders in the medical community.

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.

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.

Joanne Hawana is a Member at the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, practicing in the Health Law/FDA Group and based in the firm’s Washington D.C. office. She counsels global clients on the business impact of new U.S. federal and state actions related to drugs, biologics, cellular therapies, foods, and medical devices. Her counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, both pre-market and post-market, and including enforcement matters. Joanne has a masters degree in molecular genetics from UMDNJ and a bachelors degree in biology from the College of William & Mary. She received her JD from the University of Maryland Francis King Cary School of Law in 2007.

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.

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.

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.

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.

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.

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.

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.

Katie Klemm is the Deputy Division Director of the Division of Advertising and Promotion Review I in the Office of Prescription Drug Promotion at the Food and Drug Administration. Over the past 13 years, Katie has held the positions of team leader and reviewer in OPDP. She received her Doctor of Pharmacy and Master of Science in Regulatory Science degrees from the University of Maryland School of Pharmacy.

Matthew (Matt) Falter, Pharm.D., is the Deputy Division Director, Division of Advertising and Promotion Review 2 (DAPR2) in the Office of Prescription Drug Promotion (OPDP) at the U..S. Food and Drug Administration. He joined OPDP as a reviewer in 2011. In his current role, Matt is responsible for oversight and management of the review and regulation of prescription drug promotional labeling and advertising. Prior to joining FDA, Matt was a Clinical Staff Pharmacist at Manatee Memorial Hospital in Bradenton, Florida. He holds a B.S. in Pharmaceutical Sciences from The Ohio State University in Columbus, and a Doctor of Pharmacy degree from Shenandoah University in Winchester, Virginia.

Medical Affairs professional with extensive experience in medical operations and strategy, medical information and scientific communications. Industry experience includes management roles at Johnson & Johnson (Ortho Biotech), Forest Laboratories, Allergan and Mallinckrodt Pharmaceuticals.

Dr. Janet Gottlieb is the Executive Director of Medical Compliance Excellence, Material Review at AbbVie, where she is responsible for developing and training on global policies governing promotional and non-promotional materials. In her previous role, Dr. Gottlieb led the team responsible for the medical and scientific review of Company promotional materials where she had a direct role in the formation, expansion, and training of the centralized team. These advancements resulted in greater efficiencies via improved turnaround times, consistency in guidance, and enhanced communication. Dr. Gottlieb holds an undergraduate degree in Biological Sciences and Ph.D. in Medical Microbiology from the University of California, Irvine.

Derek Naten is the Vice President of Government Affairs and Advocacy for Mallinckrodt, based in Washington, DC. He is responsible for legislative outreach and helping shape and execute the company’s policy and political agenda across all levels of government. Further, he spearheads Mallinckrodt’s philanthropic endeavors and alliance work. Derek has over two decades of experience in the pharmaceutical industry across multiple companies, where he has been responsible for lobbying in multiple states and at the federal government level, as well as directing patient advocacy engagement. Derek began his professional career as a legislative representative in the California State Legislature and was active with several political campaigns.

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.

Sapna Shah joined the FDA as a Regulatory Review Officer in FDA’s Office of Prescription Drug Promotion (OPDP) where she works across various neurology drug products, primarily focusing on rare diseases, migraines, and epilepsy. She has a passion for making a positive impact on public health and improving medical communication. Prior to working at the FDA, Sapna has worked in both inpatient and outpatient pharmacy, medical communications, and late phase research. She graduated from the Philadelphia College of Pharmacy and completed a 1 year post-graduate ASHP residency at The Valley Hospital in Ridgewood, NJ.

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.

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.

Erik's practice focuses on (medical) technology, pharmaceuticals, healthcare and life sciences in regulatory matters and he is active in litigation, commercial and transactional work in all of these fields.

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.

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.

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.

Liz is Deputy General Counsel of Mitsubishi Tanabe Pharma companies across North America. She was a partner at an AmLaw100 law firm and has supported dozens of promotional review committees as both a legal and regulatory reviewer.

Susannah O'Donnell, MPH, RAC, is currently a promotional review team leader in FDA/CDER's Office of Prescription Drug Promotion, where she has spent the last 13 of her 20 years with FDA. Susannah received her Bachelor of Science degree in microbiology from Michigan State University, her Master of Public Health degree in epidemiology from the Rollins School of Public Health at Emory University, and is certified in U.S. Regulatory Affairs.

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.

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.

Kathryn Dennehy is a Veterinary Medical Officer at the FDA Center of Veterinary Medicine. She works in the Division of Surveillance and is responsible for monitoring the safety and effectiveness of animal drugs after they are marketed as well as the promotion and advertising of animal drugs. Prior to joining the FDA, Dr. Dennehy worked as a small animal associate veterinarian in a private practice in Northern Virginia. She received her BS from The College of William and Mary, and her DVM from the Virginia-Maryland College of Veterinary Medicine.

Richard Lem is the Head of the Regulatory Affairs, Advertising and Promotion group at TG Therapeutics. In this role, he is responsible for providing promotional regulatory strategy for commercialized and late stage clinical programs and overseeing the review process for promotional, medical, and corporate communications, with a focus on building effective and collaborative review teams to support product launches. Prior to TG Therapeutics, Richard worked at Bayer Healthcare and Biogen. He received his PharmD from Rutgers University.

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.

Karen joined the pharmaceutical industry in 2002, following a successful career in teaching and worked in various sales and marketing roles at Eli Lilly Ireland, BMS, Lilly UK and Shire. Following a successful launch of Elvanse in the UK in 2013 Karen and her family relocated to Zug in Switzerland in 2014 with Shire in a Global Marketing role. Karen decided to broaden her commercial experience in 2016 and joined the IA&P team as a reviewer and people manager. Following the integration with Takeda Karen took on the Head of the IA&P role and is now leading the team based in Zurich and Boston. Our main focus is to ensure the review and approval process and system is fit for the business needs and delivers an agile approach where we can.

Kathleen (Katie) David is the Division Director for the Division of Promotion Policy, Research, and Operations in the Office of Prescription Drug Promotion (OPDP) at the Food and Drug Administration (FDA). Katie joined OPDP in 2012 as a Regulatory Review Officer and has also held the position of Team Leader and Deputy Supervisor for Policy, Research and Operations. Prior to joining FDA, Katie worked in the fields of corporate intelligence and oncology nursing. She has a B.A. in history from Washington University in St. Louis and a BSN from University of Maryland.

Lisa Kelsey is the Head of Commercial Labeling in Product Development Regulatory at Genentech, Inc. She has 21 years regulatory experience and manages a group of 8. In her role she enjoys collaboration, coaching, and partnering with her team to grow, learn, lead and broaden their visibility throughout the organization. The team focuses on the commercial printed labeling for product launches, human factor studies and maintenance of labeling changes for the full US portfolio. She majored in psychology and earned her Bachelor of Arts at San Francisco State University and her Masters of Arts at the College of Notre Dame.

Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001, 2008, 2014), the Patient Focused Impact Assessment Act (PFIA) which became the Patient Experience Data provision within the 21st Century Cures Act (sec 3001), engagement with the FDA and Industry around regulatory policy and therapeutic pipelines, led access efforts as the first therapies were approved in Duchenne, engaged with ICER around the development of the modified framework for the valuation of ultra-rare diseases, and leads US newborns screening efforts.

Amy Muhlberg is Deputy Director of the Division of Promotion Policy, Research, and Operations in the Office of Prescription Drug Promotion (OPDP). She joined OPDP in 2021 as a Staff Fellow leading the development of guidance documents, regulations, and citizen petition responses related to prescription drug promotion. She held a similar role in FDA’s Office of Policy for Pharmaceutical Quality, working on drug product quality and manufacturing issues across the product lifecycle. She has over two decades of FDA policy experience in trade associations, regulated industry, and on Capitol Hill. Amy earned her Ph.D. in Biochemistry from The Scripps Research Institute, and received her undergraduate degree from McGill University.

Jennifer Chen is a Regulatory Review Officer in the Office of Prescription Drug Promotion at the FDA. Prior to joining FDA, she received her MBA while completing a regulatory pharmaceutical fellowship in Regulatory Advertising and Promotion with Eli Lilly, FDA, and Purdue University. She earned her Doctor of Pharmacy degree from Purdue University.

CAPT Elekwachi, PharmD, MPH, is the CBER Lead for the Proprietary Name Review Team in CBER at FDA. She also serves as the principal advertising, promotion, and health communications reviewer for all of the Nation’s COVID-19, travel, and bioterrorism vaccines. She has served as the Principal Investigator on two intramural grant research programs from the FDA Offices of Minority Health and Health Equity as well as the Office of Women’s Health. CAPT Elekwachi is a pharmacist in the United States Public Health Service (USPHS) where she is appointed as the Communications Lead for the Surgeon General’s Education Team. CAPT Elekwachi is also an Opioid Overdose, Naloxone Administration, and Vaping.