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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.

  • Mark  Bard

    Mark Bard

    • Founder
    • Digital Health Coalition, United States

    Mark Bard is a new media, marketing, and technology entrepreneur. In addition to personal ventures, he invests in technology and health startups taking an active advisory role with founders. Mark’s focus and passion includes digital, data analytics, and customer service in a connected world. He was named to the DTC Hall of Fame and the PharmaVOICE 100 - the most inspiring and influential leaders in the pharmaceutical industry. Mark co-founded the Digital Health Coalition, a non-profit think tank based in New York, in 2011. Mark previously sold Manhattan Research, a company he co-founded, to Providence Equity Partners.

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Executive Director, 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. She oversees 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.

  • Stacy  Cline Amin, JD

    Stacy Cline Amin, JD

    • Chief Counsel
    • FDA, United States

    Stacy Cline Amin serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. Stacy previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee.

  • 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.

  • 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.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

  • Kathleen M Sanzo

    Kathleen M Sanzo

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

    Kathleen M. Sanzo leads the FDA practice and is a Life Sciences industry co-leader at Morgan Lewis. She counsels and strategizes with clients on drug and related device product development, clinical testing, manufacture, approval, marketing, and distribution, including inspection and resulting deficiencies, product promotion and labeling issues and compliance and crises management issues.

  • 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., Senior Social Science Analyst and the 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 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.

  • Michele L. Buenafe, JD

    Michele L. Buenafe, JD

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

    Michele L. Buenafe advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling, and advertising of medical devices, human tissue products, pharmaceuticals, controlled substances, listed chemicals, and combination products. She also advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, telemedicine systems, wearable devices, and other health information technology. Michele serves as the leader of the firm’s digital health initiative and as co-leader for the firm’s cross-practice healthcare initiative.

  • 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.

  • 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

    Hadley Le is the Head of Medical Information at Neurocrine Biosciences as well as represents Medical on the Medical Review Committee (MRC). Prior to Neurocrine Biosciences, Hadley worked at Gilead Sciences in the Medical Affairs department responsible for Medical review in MRC and managing Phase IV studies. He has over 10 years of experience, with more than 7 years in Medical Affairs/Medical Communications. Hadley's experience includes multiple product launches in HIV, Hepatitis C, Neurology and Psychiatry.

  • 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 30 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.

  • Michele  Sharp, PharmD

    Michele Sharp, PharmD

    • Senior Director, Global Regulatory Affairs
    • Eli Lilly and Company, United States

    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.

  • Lisa L. Stockbridge, PhD

    Lisa L. Stockbridge, PhD

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

    Lisa Stockbridge, PhD is Chief of Advertising and Promotional Labeling (APLB) in FDA’s Center for Biologics Evaluation and Research (CBER). APLB reviews product labeling and promotional material for CBER. Dr. Stockbridge holds a BA in Biology and Psychology from Manhattanville College and an MS and PhD in Medical Physiology from New York Medical College. She joined FDA 25 years ago, following a Physiology Research Associateship at the University of Alberta-Edmonton and a Senior Staff Fellowship in Biophysics at NIH’s National Institute on Alcohol Abuse and Alcoholism.

  • Helen W. Sullivan, PhD, MPH

    Helen W. Sullivan, PhD, MPH

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

    Helen Sullivan 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.

  • 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

    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.

  • Kimberly  Rice

    Kimberly Rice

    • President/Chief Strategist
    • KLA Marketing Associates, United States

    As President/Chief Strategist of KLA Marketing Associates, Kimberly Rice provides strategic business development, management and marketing advisory services to firms seeking to attract more desirable clients and increase profitability. She is author of Rainmaker Roadmap: A Step-by-Step Guide to Building a Prosperous Business (Amazon) and host of Secret Sauce Marketing Tastings podcast. Kimberly is a frequent keynote to firms and professional associations across the country.

  • Glenn N. Byrd, MBA, RAC

    Glenn N. Byrd, MBA, RAC

    • President
    • GByrd Ad-Promo Solutions, LLC, 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
    • Sanofi, United States

    Alexis is a Senior Director for Sanofi Global Regulatory Science & Policy, helping to shape the regulatory and policy environment on topics like patient-focused drug development, digital health technology regulation, and various PDUFA initiatives and FDA program implementation. Prior to working on regulatory policy initiatives for industry, Alexis worked in CDER's Office of Regulatory Policy, responding to citizen petitions, drafting guidance and regulations, and providing policy input on regulatory and legal matters. Alexis also worked in Morgan Lewis's FDA regulatory practice group, both as an associate and a partner, advising a variety of regulated industry clients on legal and regulatory issues arising throughout the product lifecycle.

  • Elizabeth  Pepinsky, JD

    Elizabeth Pepinsky, JD

    • 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.

  • Kate  Robinson

    Kate Robinson

    • Executive Director, Integrated Account Management, Strategic Insights
    • Merck, United States

    Kate Robinson leads the Strategic Insights team within Integrated Account Management (IAM) at Merck, tasked with developing strategies for payer, provider, and employer customer segments and evolving Merck’s approach to value-based contracting and more broadly to price, value, and affordability.

  • 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.

  • Thomas W. Abrams, MBA, RPh

    Thomas W. Abrams, MBA, RPh

    • 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.

  • 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.

  • Rosemarie  Carey

    Rosemarie Carey

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

    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.

  • Joanne  Curley, MBA

    Joanne Curley, MBA

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

    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.

  • Bryan M. Johnstone

    Bryan M. Johnstone

    • Vice President, Evidence Based Medicine
    • Sanofi-aventis U.S., United States

    Bryan M. Johnstone, Ph.D., is Vice President & Head, Evidence Synthesis & Communications, Health Economics & Value Assessment (HEVA) at Sanofi US in Bridgewater, New Jersey. He leads global evidence synthesis and epidemiology and communications capabilities for HEVA, and previously led US Evidence Based Medicine. Before joining Sanofi, he held various leadership roles at Eli Lilly and Company, including head of U.S. Outcomes Research and head of Global Phase IIIB/IV Outcomes Research.

  • 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.

  • 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.

  • 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

    Mike Sauers is Director in Eli Lilly’s Global Regulatory Affairs, US Advertising/Promotion/Policy group. 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.

  • Joe  Shields

    Joe Shields

    • President & Co-founder
    • Health Accelerators, LLC, United States

    As an EMMY-award winning filmmaker and digital pioneer, Joe Shields infuses storytelling with technology to systematically move audiences to action. Applying his unique perspective to business, he has led global marketing, new product development, digital strategy and enterprise innovation for Fortune 100 companies in specialty chemicals, telecommunications, biopharmaceuticals, medical devices and diagnostics. In 2018 Joe co-founded Health Accelerators, a business-to-business marketing strategy and services agency supporting suppliers to life sciences companies.

  • Jen  DeCamara

    Jen DeCamara

    • VP Law, US Pharmaceutical Strategic Customer Group
    • Johnson & Johnson, United States

    Jennifer is VP Law, Johnson & Johnson, supporting the U.S. Pharmaceutical Strategic Customer Group (SCG). She sits on the management board of SCG and advises its senior management on legal matters supporting all levels of engagement with payers, institutional customers and patient access programs and the rapidly evolving health care environment in which they operate. Prior to joining Johnson & Johnson in 2007, Jennifer held positions at Bristol Myers Squibb and Merck & Co., Inc. She began her career practicing with firms specializing in health care law in the District of Columbia and New York. Jennifer received her law degree from the University of Virginia School of Law and her undergraduate degree from James Madison University.

  • Deborah A. Wolf, JD

    Deborah A. Wolf, JD

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

    Deborah Wolf is an attorney and regulatory counsel in the Office of Compliance in FDA’s Center for Devices and Radiological Health. She offers guidance to staff who address device labeling and advertising regulation. She has worked in CDRH’s promotion and advertising program since 1995 except for a three year period during which she supervised CDRH’s Regulations Staff.