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Advertising and Promotion Regulatory Affairs Conference


Speakers

  • Micheline  Awad, MBA

    Micheline Awad, MBA

    • Director Regulatory Affairs, Advertising and Promotion
    • Neurocrine Biosciences, Inc., United States

    Micheline Awad leads the Neurocrine Biosciences Promotional Review Committee (PRC) as well as represents Regulatory on the Medical Review Committee (MRC). She has over 17 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 11 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for 2 years. Micheline’s Regulatory experience includes Biologic, Drug, and Device, and multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing Biotechnology from George Mason University.

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Head of Regulatory Policy & Intelligence, Regulatory Affairs
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is the Head of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals (MNK) assessing changes in the regulatory environment and applicability to the MNK portfolio and activities. Prior to Mallinckrodt, Kim was an Executive director at OneSource Regulatory responsible for AdPromo regulatory review and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals (formally Bausch + Lomb). Kim has diverse experience in medical products including Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim has more than 28 years of pharmaceutical experience, including 18 years in regulatory.

  • Catherine B. Gray, PharmD

    Catherine B. Gray, PharmD

    • Staff Supervisor, Office of Prescription Drug Promotion, OMP, CDER
    • FDA, United States

    Catherine Gray leads the Advertising and Promotion Policy Staff in OPDP at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy issues pertaining to the promotion of prescription drugs. Their work includes policy development, social science research and operational support to the full office as it realizes its mission to protect the public health. Her over twenty years of experience include roles in clinical pharmacy and the pharmaceutical industry. She completed Fellowships in the Rutgers University Pharmaceutical Industry Post-Doctoral Fellowship program and the Partnership for Public Service Excellence in Government Fellowship program.

  • Mark  Gaydos

    Mark Gaydos

    • VP, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs
    • Sanofi, United States

    Mark is VP & Head, North America Gen. Medicines & Established Products, as well as US Advertising & Promotion, within Sanofi's Global Regulatory Affairs. In this role, he is accountable for regulatory leadership and strategy for investigational and marketed products and oversees the regulatory review of promotional and other company communications to ensure compliance and best practice sharing. Prior to joining Sanofi, Mark held positions of increasing responsibility with Pfizer, Amgen, Block Drug Co., Whitehall-Robins and Biocraft Laboratories. His 24 years in industry includes successful interactions with FDA and global health authorities.

  • Rose  Berardi-Mckenna, MSc

    Rose Berardi-Mckenna, MSc

    • Counsel and Associate Director, Commercial Regulatory Affairs
    • Bristol-Myers Squibb, United States

    Rose is currently working in a hybrid role at Bristol Myers Squibb as both an Associate Director in the Regulatory Affairs Department and an attorney in the Legal Department. In addition to serving as an attorney supporting the cardiovascular therapeutic area, Rose is the regulatory lead for the U.S. Value Access and Payment team and serves as the subject matter expert for all materials relating to FDAMA 114 across therapeutic areas at BMS.

  • Kellie B. Combs, JD

    Kellie B. Combs, JD

    • Partner
    • Ropes & Gray LLP, United States

    Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She serves as co-counsel to the Medical Information Working Group, represented Pacira in its litigation against FDA, and has extensive experience handling matters implicating FDA promotional rules and the First Amendment.

  • Joanne  Curley, MBA

    Joanne Curley, MBA

    • Vice President, Head of Global Regulatory Affairs
    • Jazz Pharmaceuticals, Inc., United States

    I am the head of Global Promotional Regulatory Affairs and Labeling team at Jazz Pharmaceuticals. With a bachelor’s of pharmacy from the Philadelphia College of Pharmacy and Sciences and an M.B.A. from St. Joseph’s University in Philadelphia, I have held various roles of increasing responsibility in the pharmaceutical industry over the last 23 years, including roles in operations, marketing and regulatory affairs. In my current role at Jazz, I have oversight for the regulatory labeling function globally as well as the promotional material review process for both the United States and EU/ROW.

  • Zoe  Dunn

    Zoe Dunn

    • President & CEO
    • Hale Advisors, Inc., United States

    Zoe Dunn, President & CEO of Hale Advisors, is a digital marketing and communications specialist with 20+ years of experience in life sciences industries, driving results for clients’ business with multi-channel strategies. Zoe has worked with most of the top 25 Pharmaceutical and Biotech companies and regularly speaks at pharmaceutical and healthcare conferences about organizational readiness in multichannel marketing. Hale Advisors specializes in digital governance and competency solutions.

  • Nicole A Lare, MBA

    Nicole A Lare, MBA

    • Associate Director
    • Celgene, United States

    Nicole (Nikki) Lare is an Associate Director, Regulatory Affairs Advertising & Promotion at Celgene and manages advertising and promotional activities for products within their oncology franchise as well as providing regulatory guidance for development compounds. Prior to Celgene, Nikki was an Associate Director at Mallinckrodt and a Senior Manager, Regulatory Affairs Advertising & Promotion at AbbVie. She has over 10 years of Regulatory Affairs experience including OTC products, with 7 years in advertising and promotion. Nikki holds an MBA from Fairleigh Dickinson University in Pharmaceutical Management.

  • Hadley H Le, PharmD

    Hadley H Le, PharmD

    • Associate Director, Medical Affairs
    • Neurocrine Biosciences, Inc., United States

  • Kevin  Stark, MBA, RAC

    Kevin Stark, MBA, RAC

    • Director, Office of Promotion and Advertising Review, Regulatory Affairs
    • Merck & Company Inc., United States

    Kevin Stark is Director, Office of Promotion and Advertising Review, Regulatory Affairs at Merck where he leads a team of regulatory reviewers for multiple products within primary care and hospital portfolios. Kevin has over 29 years in the pharmaceutical industry, with positions in a broad range of experiences. Kevin has held positions in the areas of sales, marketing, managed markets, business compliance and regulatory. Kevin has a BA in biochemistry from the University of Wisconsin and a Master’s in Business Administration degree Lehigh University and is RAC-US certified.

  • Eileen  Valenta, MBA

    Eileen Valenta, MBA

    • President
    • Valenta Consulting , United States

    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.

  • Kevin M Madagan

    Kevin M Madagan

    • Partner
    • Reed Smith, LLP, United States

  • Kathryn J. Aikin, PhD

    Kathryn J. Aikin, PhD

    • Senior Social Science Analyst, Research Team Lead, OPDP, CDER
    • FDA, United States

    Kathryn (Kit) Aikin, Ph.D., is a Senior Social Science Analyst and the Research Team Lead in the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP). Dr. Aikin’s research focuses on topics related to promotion of prescription drugs, including consumer perceptions of direct-to-consumer (DTC) advertising, disease awareness ads, corrective advertising, marketing claims, and improvements to the consumer brief summary in DTC print ads. In addition to her research work, Dr. Aikin consults on regulatory policy and enforcement review of consumer and professional prescription drug promotional pieces.

  • Kevin  Betts, PhD

    Kevin Betts, PhD

    • Social Science Analyst, OPDP
    • FDA, United States

    Kevin R. Betts is a Social Science Analyst at the Food and Drug Administration’s Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, where he provides research and consulting services pertaining to promotional prescription drug communications. His areas of expertise include individual and group perception, judgment, and decision-making.

  • Kristen  Hartman

    Kristen Hartman

    • VP, Sponsor Programs
    • WEGO Health, United States

    Kristen is passionate about improving the patient experience and has been a part of the WEGO Health team since 2010. In her current role, she oversees client services and leads the strategy and development for integrated digital and social marketing initiatives. Over her career she's helped dozens of pharmaceutical companies navigate the regulatory world, execute successful patient programs and connect leading pharma and healthcare companies with their most important stakeholder, the patient.

  • Amie C O'Donoghue, PhD

    Amie C O'Donoghue, PhD

    • Social Science Analyst, OPDP, CDER
    • FDA, United States

    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 25 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. Before joining OPDP in 2003, Dr. O’Donoghue taught psychology at St. Mary’s College of Maryland. She received her doctorate in psychology from Washington University in St. Louis.

  • Helen W. Sullivan, PhD, MPH

    Helen W. Sullivan, PhD, MPH

    • Social Science Analyst, OPDP, CDER
    • FDA, United States

    Helen Sullivan, PhD, MPH is a Social Science Analyst in the Office of Prescription Drug Promotion at the U.S. Food and Drug Administration (FDA). 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.

  • Rosemarie  Carey

    Rosemarie Carey

    • Director, Promotional Regulatory Affairs
    • AstraZeneca Pharmaceuticals LP, United States

    Rosemarie has been in the pharmaceutical industry for 26 years—five years at Merck & Co., Inc. and for the past 21 years, she has been at AstraZeneca and its legacy companies. She has conducted regulatory reviews of field-generated promotional materials, delivered regulatory and compliance training to regional sales teams and physicians, and has been responsible for regulatory reviews of professional/consumer materials for many AstraZeneca products. Most recently, Rosemarie’s expertise has been focused on the consumer—including print, broadcast, digital, and social media work. Rosemarie has a BA in Communication Studies from Northwestern University.

  • Kathleen M Sanzo

    Kathleen M Sanzo

    • Partner
    • Morgan, Lewis & Bockius LLP, United States

  • Michael  Swit, JD

    Michael Swit, JD

    • Partner
    • Law Offices of Michael A. Swit, United States

    MICHAEL SWIT has been solving vital legal and regulatory issues since 1984. Before relaunching his FDA law practice in 2017, he served for three years at Illumina, the leader in gene sequencing technology, as its chief regulatory counsel. Prior to that, Swit was in the FDA Law Practices at three global law firms, served as a vice president at The Weinberg Group, a premier regulatory consultancy, and was general counsel of Par Pharmaceutical, a major generic drug maker. He earned his AB, magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University

  • Glenn N. Byrd, MBA, RAC

    Glenn N. Byrd, MBA, RAC

    • Senior Director, Oncology Promotional Regulatory Affairs
    • AstraZeneca, United States

    Glenn heads the AstraZeneca Oncology Promotional Regulatory Affairs team and sits on the Oncology Business Leadership Team. He has held numerous regulatory roles over the last 28 years with the last 11 years at AstraZeneca. Glenn also has served on the RAPS Board of Directors for the last 9 years and is currently President. He spent 10 years at the US FDA in CDRH as a device reviewer and in CBER as head of the Advertising and Promotional Labeling Branch. Glenn’s experience includes government, industry, consulting firms and Clinical Research Organizations (CROs). He received his MBA from Hood College and his BS in Aerospace and Ocean Engineering from Virginia Tech.

  • Peter  Dannenfelser

    Peter Dannenfelser

    • Associate Vice President Communications and Digital Innovation
    • Ferring Pharmaceuticals , United States

  • Jia-Huey  Huey, PharmD, RPh

    Jia-Huey Huey, PharmD, RPh

    • Director, Regulatory Advertising and Promotion – ID/Vaccines/SCG/R&D
    • Johnson & Johnson Office of Health Care Compliance & Privacy, United States

    Jia-Huey Huey is Director of Regulatory Advertising and Promotion, within Pharmaceutical Group Health Care Compliance organization at Johnson & Johnson with responsibility for providing regulatory and compliance advice to the commercial, medical, research and development teams on a wide-range of matters. Jia’s focus includes product launches, appropriate pre-approval activities, scientific exchange, patient interactions, digital/social media initiatives, and patient support programs.

  • Alexis Reisin Miller, JD

    Alexis Reisin Miller, JD

    • Senior Director, Regulatory Science and Policy, NA
    • Sanofi, United States

    Alexis Reisin Miller is Senior Director, Regulatory Policy and Intelligence at Eisai. Alexis is a member of Eisai’s Global Regulatory Affairs, helping to influence the regulatory environment in areas of interest for the company. Prior to joining Eisai, Alexis worked for in the Washington, D.C., FDA regulatory practice group at the law firm, Morgan Lewis, both as an associate and a partner. Alexis also worked in the Office of Regulatory Policy at FDA’s Center for Drug Evaluation and Research.

  • Elizabeth  Pepinsky

    Elizabeth Pepinsky

    • Health Science Policy Analyst
    • FDA, United States

    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.

  • Tara  Barbanell

    Tara Barbanell

    • Director, Regulatory Promotion & Material Compliance
    • Amgen, Inc., United States

    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.

  • Josephine  Secnik, MBA, MS

    Josephine Secnik, MBA, MS

    • Director – Ad/Promo Regulatory Affairs
    • Eli Lilly and Company, United States

    Jo Secnik joined Lilly in 1990 where her career has included assignments in Biopharmaceutical Development, Quality Assurance and Regulatory Affairs. Her experience in Regulatory includes10 years in global CMC and for the last 7 years supporting the US business on advertising and promotion for marketed products.

  • Lisa L. Stockbridge, PhD

    Lisa L. Stockbridge, PhD

    • Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
    • FDA, United States

    Lisa Stockbridge, Ph.D. is Chief of Advertising and Promotional Labeling (APLB) in CBER’s Office of Compliance and Biologics Quality. She holds undergraduate degrees in Biology and Psychology, and a doctorate in Medical Physiology (New York Medical College). Before joining FDA, Dr. Stockbridge was a Research Associate in Physiology (University of Alberta -Edmonton) and a Senior Staff Fellow in Biophysics at NIH’s National Institute on Alcohol Abuse and Alcoholism. At FDA, she is a recognized subject matter expert in labeling. To many, she also is known as the Program Manager responsible for the implementation of Structured Product Labeling across the Agency.

  • Thomas W. Abrams, MBA

    Thomas W. Abrams, MBA

    • Director, Office of Prescription Drug Promotion, OMP, CDER
    • FDA, United States

    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.

  • Michael S. Labson, JD

    Michael S. Labson, JD

    • Partner
    • Covington & Burling LLP, United States

    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 A. Sauers, RAC

    Michael A. Sauers, RAC

    • Director, Global Regulatory Affairs - Advertising, Promotion and Policy
    • Eli Lilly and Company , United States

    Michael Sauers is the Supervisor of the Advertising and Promotion Policy Staff within the Office of Prescription Drug Promotion (OPDP) at FDA. The staff leads OPDP’s guidance, regulatory, and other policy development, social science research, legal analysis, and project management support. Mr. Sauers has held multiple roles within OPDP, including Deputy Division Director, Team Leader, and Regulatory Review Officer. Mr. Sauers previous experience includes work in the HHS Office of the Secretary and for Pfizer, Inc. Mr. Sauers received his Bachelor's Degree in Neuroscience from the University of Delaware and a Master's of Public Policy from Georgetown University.

  • Deborah A. Wolf, JD

    Deborah A. Wolf, JD

    • Regulatory Counsel, Office of Compliance, CDRH
    • FDA, United States

    Deborah Wolf has served as regulatory counsel in both CDER and CDRH since coming to FDA in 1991. She has been in CDRH since 1995 and has worked primarily in areas related to device labeling, both in premarket and postmarket issues, and device promotion and advertising.