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Advertising and Promotion Regulatory Affairs Conference

DIA Your Way! Join us live in-person or later from the comfort of your home/office at your own pace. This event offers two learning avenues depending on your schedule!


Speakers

  • Micheline  Awad, MBA

    Micheline Awad, MBA

    • Senior Director, Regulatory Affairs - Advertising, Promotions, and Labeling
    • Turning Point Therapeutics, Inc., United States

    Micheline Awad leads the Advertising & Promotion and Labeling functions at Turning Point Therapeutics. She has over 20 years of Biotechnology/Pharmaceutical industry experience, including Regulatory Affairs (RA) strategy, RA - Advertising & Promotion, and recently RA Labeling. Micheline’s Regulatory experience includes Biologic, Drug, and Device, with 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 in Biotechnology from George Mason University.

  • Sheetal  Patel, PharmD

    Sheetal Patel, PharmD

    • Head, Regulatory Advertising and Promotion
    • Johnson & Johnson International, United States

    Sheetal Patel is the Head, Regulatory Advertising and Promotion, within Pharmaceutical Group Health Care Compliance organization at Johnson & Johnson. Previously, she held the position of Lieutenant Commander, Senior Regulatory Review Officer, at the Food and Drug Administration, Office of Prescription Drug Promotion.

  • Fadwa  Almanakly, PharmD

    Fadwa Almanakly, PharmD

    • Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas
    • Bayer Pharmaceuticals, United States

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

  • Heather  Banuelos, JD

    Heather Banuelos, JD

    • Counsel
    • King & Spalding LLP, United States

    Heather Bañuelos is Counsel in King & Spalding’s FDA & Life Sciences practice group. She advises clients on regulatory strategies and initiatives for the labeling, promotion, and advertising of FDA-regulated products, as well as non-promotional communications, with particular focus on prescription drugs and medical devices. She routinely serves on promotional review committees and medical/scientific review committees, and provides practical and insightful advice and recommendations. Heather has over 20 years of experience in food and drug law, including as a former Associate Chief Counsel in FDA’s Office of the Chief Counsel and as senior in-house regulatory counsel for multiple clients, including two large pharmaceutical companies.

  • Carla  Brooks, MSc, RAC

    Carla Brooks, MSc, RAC

    • Senior Director, Regulatory Affairs, Advertising and Promotion
    • Blueprint Medicines Corporation, United States

    Carla is the Head of Promotional Regulatory Affairs responsible for overseeing the review and submission of prescription drug marketing communications and materials at Blueprint Medicines Corporation (BPMC) to the health authorities serving as an expert on international and other regional regulations and guidance governing the promotion of prescription drug products and disease activities. Carla joined BPMC with 19 years of biopharma experience ranging from pre-clinical and clinical research to prescription drug launch and marketing. Prior to joining BPMC, she was a leader at United Therapeutics Corporation, Astra Zeneca and Medimmune in Global Regulatory Affairs, Research and Development, and Quality Assurance.

  • Robert  Dean, MBA

    Robert Dean, MBA

    • Director, Advertising and Promotion
    • Merck, United States

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

  • Virginia  Foley

    Virginia Foley

    • Head of Marketing and Strategic Business Development
    • Opus Regulatory Inc, United States

    Virginia Foley joined Opus Regulatory as a Principal Consultant in June 2017, focused on Advertising and Promotion review and in January 2020 she transitioned to a full time role in Business Development. Before joining Opus, her 20-year tenure in Regulatory Affairs spanned positions of increasing responsibility at a variety of pharmaceutical and biotechnology companies across the U.S. Immediately prior to Opus, she worked at Gilead Sciences as the Therapeutic Area head of Liver Diseases, leading the strategy and execution for the consecutive waves of Hepatitis C product launches. She lives in beautiful Northport, Michigan with her husband, son and lab retriever where they enjoy spending time outside in all seasons.

  • Catherine  Gray, PharmD

    Catherine Gray, PharmD

    • Director (Acting), 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, stakeholder engagement, and operational support to the 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. Dr. Gray received her B.S. from the University of Notre Dame and her Doctor of Pharmacy from Campbell University.

  • Joanne  Hawana, JD, MS

    Joanne Hawana, JD, MS

    • Member
    • Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States

    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.

  • Georgina  Lee, PharmD

    Georgina Lee, PharmD

    • Senior Director, Regulatory Affairs Advertising & Promotion and Labeling
    • Acceleron Pharma, United States

    Georgina Lee is the Head of Regulatory Advertising and Promotion and Global Labeling at Acceleron, a wholly-owned subsidiary of Merck & Co., Inc. Over the past 9 years, her focus in industry has been to develop labeling for small molecules and biologics, including the management of REMS materials, and to oversee the regulatory review for commercial and medical materials across various review committees. Prior to Acceleron, she worked at Agios and Biogen serving in similar capacities. She received her Pharm.D. from the University of Southern California.

  • Dale  Cooke, JD, MA

    Dale Cooke, JD, MA

    • President
    • PhillyCooke Consulting , United States

    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.

  • Mark  Gaydos

    Mark Gaydos

    • Vice President & Global Head, Advertising, Promotion & Labeling
    • Sanofi, United States

    Mark is Vice President and Global Head of Advertising, Promotion & Labeling 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 more than 27 years in industry, Mark has held leadership roles across numerous therapeutic areas, including responsibility for regulatory strategies across the product lifecycle.

  • Wayne  Pines

    Wayne Pines

    • President, Health Care
    • APCO Worldwide Inc., United States

    Wayne Pines is a consultant on FDA-related issues. He specializes in ad promo regulation, serving as the regulatory expert on promotional review committees for several pharma companies. He also assists pharma and device companies with product approvals and regulatory and media strategy. Mr. Pines has authored or edited a dozen books on FDA including the FDA Advertising and Promotion Manual and A Practical Guide to FDA's Laws and Regulations.

  • Lucy  Rose, MBA

    Lucy Rose, MBA

    • President
    • Lucy Rose and Associates, LLC, United States

    Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications at FDA. For the last 18 years she has consulted with numerous pharmaceutical companies on promotional regulations/strategy, drug development and regulatory strategy, health policy, and has enjoyed training many professionals on advertising/promotional regulations.

  • Kathryn  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.

  • Renee  Ambrosio

    Renee Ambrosio

    • Department Head, Advertising & Promotion, Regulatory Affairs
    • Merck & Co., Inc., United States

    Renee Ambrosio is Head, Advertising and Promotion Regulatory Affairs at Merck & Co., Inc. Renee oversees the regulatory review, approval, submission, and promotional regulatory strategy for all U.S. pharmaceuticals and biologic products. Renee has over twenty-nine years of experience across the healthcare spectrum; including 22 years in the pharmaceutical industry, with an emphasis in regulatory requirements and strategies, overlapping product launches for indications under accelerated approval, as well as sales and marketing. Renee is also the current DIA Ad/Promo Working Group Co-Chairperson.

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Executive Director Reg Policy & Intelligence and AdPromo Regulatory Affairs
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence and Advertising and Promotion at Mallinckrodt Pharmaceuticals. 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. She is an active member in several industry organizations and is passionate about networking and collaboration.

  • Kathleen  Klemm, MS, RAC

    Kathleen Klemm, MS, RAC

    • Deputy Director
    • FDA | CDER | OMP | Office of Prescription Drug Promotion | Division of Advertisi, United States

  • 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). 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.

  • Kevin R. Betts, PhD

    Kevin R. Betts, PhD

    • Social Science Analyst
    • 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.

  • Jean-Ah  Kang, PharmD

    Jean-Ah Kang, PharmD

    • Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
    • FDA, United States

    Jean-Ah Kang, Special Assistant to the Director in the Office of Prescription Drug Promotion (OPDP), has over 22 years of experience in prescription drug promotion. She focuses on policy/guidance development and communications, with a special interest in social media/accelerated approval issues. Prior roles include senior consultant at SAIC, team leader in the Division of Drug Marketing, Advertising, and Communications (DDMAC), and DDMAC oncology reviewer. She began her career as an assistant professor at Shenandoah University after completing a drug information residency at the University of Pittsburgh Medical Center. She earned a Pharm.D. from the University of Maryland and B.A.’s in Biochemistry and Music from the University of Virginia.

  • Amie  O'Donoghue, PhD

    Amie 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 35 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.