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.

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.

Madhavi is a seasoned medical device regulatory affairs professional with extensive, specialized experience in advertising and promotion. She has been employed with the cardiovascular medical devices division of Abbott since 2007 and worked on high-tech based medical devices with Cisco Systems Inc. She has extensive experience in leadership, management and execution of digital and social media programs in addition to authoring and implementing regulatory policies globally, to address evolving regulations. Madhavi is an expert trainer and has led several training workshops worldwide. She is currently Global Director for Regulatory Affairs for Abbott’s Vascular 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.

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.

As Director of Regulatory Affairs, Ratinder has a broad knowledge in Regulatory Affairs covering the medical device, pharmaceutical and combination product industries. She has served in several medical device and pharmaceutical regulatory affairs roles with Abbott Neuromodulation (formerly St. Jude Medical), Cantox Health Sciences (now Intertek), Sanofi Pasteur, Dalton Pharma Services and Novopharm. During her time at Abbott Neuromodulation, Ratinder served as the lead regulatory representative for new product development teams and CAPA teams. Her role included the development and implementation of regulatory strategies for Class III Premarket Approval (PMA) products, Class II 510k devices and EU Active Implantable Medical Devices.

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.

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.

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).

Kevin is a health care attorney and member of Reed Smith’s Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. Kevin specializes in providing legal and strategic advice regarding advertising and promotion, FDA enforcement, and supply chain logistics. Among other things, Kevin has spent the last 15+ years advising compliance teams and serving as legal counsel to startup and global drug and medical device clients.

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.

Cheryl Roberts is a Senior Director in Regulatory Advertising and Promotion at Mylan Pharmaceuticals. Her 20 years of experience in the Advertising and Promotion space began at FDA in DDMAC (currently OPDP) and included positions at AstraZeneca and Genzyme/Sanofi. Prior to becoming an Advertising and Promotion regulatory professional, Cheryl was an attorney in the Baltimore/DC area. She holds a JD from the University of Maryland School of Law and a MS from the Arnold & Marie Schwartz School of Pharmacy at LIU. She did her undergraduate studies in Biology at Cornell University and SUNY Albany.

Victoria Tamarkin is an FDA and healthcare regulatory compliance consultant with more than 20 years’ experience at large, multinational companies and virtual, venture-backed start-ups. Founder of Victoria Tamarkin Consulting, LLC group, Victoria advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from regulatory strategies to advertising and promotion and labeling of FDA-regulated products. Victoria has been the lead FDA regulatory advisor to her clients on 100+ transactional matters. Victoria counsels pharma and device companies on promotional compliance, advertisement, social media platforms, and digital marketing.

Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of life science industry clients on compliance with federal and state laws relating to pre- and post-marketing operations, including clinical development, quality systems, and advertising and promotion. He guides companies through developing corrective action plans and communicating with regulatory authorities following inspections or enforcement actions. He also provides counsel on clinical trial contract negotiations, regulatory strategy for obtaining marketing authorization, and compliance with government grant requirements.

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.

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.

Pamela Goldberg is an internationally recognized leader in medical technology innovation, leading strategy to affect change for industry and regulators. Her focus on collaboration and driving change have been instrumental in making progress with the medical device industry in partnership with the FDA, patient advocacy groups and clinical sites. Goldberg was previously CEO of the Massachusetts Technology Collaborative. Goldberg worked closely with industry, academic and government leaders to advance technology-based solutions that improved the health care system, expanded high-speed Internet access and strengthened the growth of the state’s technology sector. Goldberg received her BA from Tufts University and MBA from Stanford University.

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding.  She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006. 

Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 25 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit was also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program till 2022. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

Mark Stinson is s founder and principal of Bioscience Bridge, LLC. He also serves as a brand strategy consultant for 83bar, a patient activation company. He is a medical industry veteran in brand innovation – an experienced marketer, venture catalyst, and group facilitator. His work has included market assessment, branding, and marketing strategy for health, science, and technology products in pharmaceuticals, diagnostics, medical devices, provider networks, and clinical research tools. He is the author of three books, Patient Activation, ForwardFast Branding, and N-of-8. Mark is a recipient of the Brand Leadership Award from Asia Brand Congress, and he has been included in the PharmaVoice 100 Most Inspiring People.

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.

Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru commercialization and genericization.

Bill Aprea is responsible for providing regulatory and compliance legal advice and strategic support to Bristol-Myers Squibb therapeutic franchises and its compliance function. Bill’s expertise includes FDA laws, regulations and guidance, anti-bribery and fraud and abuse and other laws, rules, regulations, policies, industry codes and guidelines applicable to the biopharmaceutical industry. Bill joined Celgene (now part of BMS) in 2016 and his experience as an in-house attorney in the biopharmaceutical industry spans almost 15 years with prior positions at multiple medium and large sized companies. He began his career as a corporate attorney in law firm practice. He is a 1999 graduate of Rutgers School of Law in Newark, NJ.

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.

Dr. Minerva Hughes serves as the Regulatory Counsel for the Office of Clinical Evidence and Analysis in the Food and Drug Administration’s Center for Devices and Radiological Health, which provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders. Dr. Hughes has over 15 years of experience in medical product development and FDA regulatory matters. She received her doctorate degree from the Department of Chemistry at the Johns Hopkins University and her law degree from the University of Maryland School of Law.

Francis Nguyen is an Assistant Director at Bayer HealthCare Pharmaceuticals and represents Regulatory on the Promotional Review Team (PRT) to help ensure compliance with FDA regulations. Prior to Bayer, Francis was a post-doctoral fellow in Regulatory Affairs - Advertising and Labeling at Allergan. He received his Pharm.D. from the University of Maryland School of Pharmacy.

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.

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.

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

Julie Tibbets is a partner in Goodwin’s Technology and Life Sciences group and a member of its FDA practice. Ms. Tibbets focuses her practice on FDA-regulated product development, marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product areas of focus include biologics, drugs, medical devices, in vitro diagnostics, lab-developed tests, as well as digital health tools and apps. Ms. Tibbets advises clients on product development strategy, interactions with the FDA, clinical trial documentation, adverse event reporting, commercial strategy, product labeling and advertising.

Julia is an associate in Reed Smith’s Life Sciences Health Industry Group in the firm’s Philadelphia office. Her practice is split between litigation and regulatory matters for life sciences clients, including a specialization in providing legal and strategic advice regarding advertising and promotion. Most recently, Julia was seconded to a life sciences client and provided full-time ad-hoc legal support to several commercial brands and sat on promotional and non-promotional review committees.

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.

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.

Jon Bigelow is Executive Director of the Coalition for Healthcare Communication, a non-profit health policy group. He previously was CEO and President of KnowledgePoint360 Group, a leading provider of multichannel medical communications, strategic consulting, benchmarking, and workflow solutions in the U.S., U.K., and Germany; president of Cliggott Publishing, provider of clinical journals and medical communications; president of the Association of Medical Media; and a consultant providing strategic support on health communications, pharma services, and health policy.

M. Jason Brooke, MSE, JD, CSQE is an attorney and the Managing Member at Brooke & Associates—a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant, bringing a focused expertise in the medical device industry that combines 20 years of experience ranging from science and technology development to business strategy and operations to legal and regulatory compliance.

Rick is an Executive Director in Global Medical Affairs supporting the General Medicine and Women’s Health physician team which includes responsibility for review of US and Global scientific and promotional materials in support of the pharmaceutical and vaccine businesses. After practicing general obstetrics and gynecology for 17 years he joined Merck and has held positions of increasing responsibility within medical affairs including medical information, US medical affairs strategy and supply-related issues.

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.

Lisa J. Pieretti is Executive Director and co-founder of the global non-profit, International Hyperhidrosis Society (IHhS). With a master’s in marketing and international economics, and a passion for ethical, inclusive collaborations, Lisa’s life's work is leading programs for the greater good. Lisa oversees all IHhS activities including developing programs for sufferers, providers, industry, regulators, and the public. Lisa also leads research; advocates for access to treatments; educates; and fosters grassroots impact. Throughout, she believes that patients, the medical profession, and industry leaders can partner for positive change. Prior to becoming IHhS Executive Director in 2003, Lisa worked at Digitas Health, SCIREX Corp. and Merck.

HEATHER RENNIE is currently Managing Counsel in the Commercial & Compliance Legal Group of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Previously, she was Managing Counsel in Merck's Regulatory Legal group, where she provided regulatory legal support for a variety of products, including pharmaceuticals and biologics. Prior to joining Merck, Ms. Rennie was a litigation partner at a large firm, where she handled a broad variety of litiation matters, including product liability and complex commercial litigation.

George Wan, Ph.D., is VP, Health Economics and Outcomes Research at Mallinckrodt Pharmaceuticals where he is responsible for leading the development and execution of the value evidence generation and dissemination strategy for the company. He has over 20 years of experience in this area. Prior to this, he lived in Belgium as Global Market Access Leader with Janssen, a division of Johnson & Johnson (J&J). Previously, he held roles of increasing responsibility at other J&J affiliates, Wyeth and Merck. George holds a B.A. in Economics/Political Science from the University of Richmond, a Master’s in Public Health from Virginia Commonwealth University and a Ph.D. in Health Services Research/Epidemiology from Saint Louis University.

Donald May Executive Vice President, Payment and Health Care Delivery Policy Donald May serves as executive vice president, payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed). He is responsible for leading AdvaMed’s advocacy efforts on health care delivery policy and serves as the association’s lead representative on Medicare payment, coverage and access issues. He plays a key role in shaping AdvaMed’s policy development and leads the organization’s advocacy research aimed at highlighting impact of federal regulations on patient access to advanced medical technologies, the value, cost, and clinical benefits of medical technologies, and trends in health care spending. Prior to serving at Adv

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.

CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.