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Bethesda North Marriott Hotel and Conference Center

Feb 28, 2019 7:00 AM - Mar 01, 2019 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference


Micheline  Awad, MBA

Micheline Awad, MBA

Sr. Director, Regulatory Advertising, Promotion, and Labeling, Day One Biopharmaceuticals, United States

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.

Mark  Bard, MBA, MHA

Mark Bard, MBA, MHA

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. 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

Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States

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.

Catherine  Gray, PharmD

Catherine Gray, PharmD

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

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.

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

Former Global Head, Advertising & Promotion, Global Regulatory Affairs, Sanofi, United States

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.

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  Aikin, PhD, MS

Kathryn Aikin, PhD, MS

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

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.

Kevin R. Betts, PhD

Kevin R. Betts, PhD

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

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.

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  O'Donoghue, PhD

Amie O'Donoghue, PhD

Social Science Analyst, OPDP, OMP, 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 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.

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  Stockbridge, PhD

Lisa Stockbridge, PhD

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

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 W. Sullivan, PhD, MPH

Helen W. Sullivan, PhD, MPH

Social Science Analyst, OPDP, OMP, 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). 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.

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  Madagan, JD

Kevin Madagan, JD

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. 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.

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

Glenn N. Byrd, MBA

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

Glenn is a part-time faculty member at UNCW’s College of Health and Human Services teaching Regulatory Affairs (BS and MS). He also runs his own consulting company focused on providing expert advertising and promotion regulatory support to the biopharmaceutical industry. Glenn previously served over 11 years at AstraZeneca/MedImmune and has held numerous regulatory and leadership roles across pharma, biotech, and device organizations over his 30-year career in regulatory affairs. Glenn has served on the RAPS Board of Directors for the last 10 years and became Chairman of the Board in January 2021. He spent 10 years at the US FDA (CDRH&CBER), including 4 years as head of the Advertising and Promotional Labeling Branch, CBER.

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

Group Leader, Regulatory Advertising and Promotion, Johnson & Johnson Office of Health Care Compliance & Privacy, United States

Jia-Huey Huey is Group Leader of Regulatory Advertising and Promotion, within 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 currently manages a team and have overall responsibility for setting strategic direction and developing and managing a robust regulatory compliance program. Jia is a licensed New Jersey pharmacist with both a Doctor of Pharmacy and a BS in Pharmacy from the Ernest Mario School of Pharmacy at Rutgers University. She is a Certified Compliance and Ethics Professional and holds the Seton Hall Law School Health Care Compliance Certification.

Alexis  Miller, JD

Alexis Miller, JD

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding diversity & inclusion into R&D, and protection of innovation despite impact of other laws on regulatory strategy. Alexis' work in the industry spans over 20 years, across regulatory and legal functions, including FDA's Office of Reg Policy in CDER, and work at an international law firm as both an associate and partner advising a range of regulated industry clients on FDA, FTC, CPSC, and other regulatory, legal, and commercial issues.

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

Executive Director, Regulatory Affairs, Mallinckrodt, 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 30 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, operations 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 certified.

Thomas W. Abrams, MBA, RPh

Thomas W. Abrams, MBA, RPh

Retired, Director, Office of Prescription Drug Promotion, OMP, CDER, Former 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 includes 10 years in global CMC and for the last 8 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 and Promotion, Eli Lilly and Company , United States

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.

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  Wolf, JD

Deborah Wolf, JD

Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States

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.

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