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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 16 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 10 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for 1.5 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

    • Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals. In latter role, Kim was responsible for a diverse portfolio that included Rx drug (brand and generic) OTCs/Nutritionals/Cosmetics, and devices. Kim has 26 years of pharma experience, with 16 in regulatory affairs.

  • Glenn N. Byrd, MBA, RAC

    Glenn N. Byrd, MBA, RAC

    • Senior Director, Specialty Care Promotional Regulatory Affairs
    • AstraZeneca, United States

    Glenn heads the AstraZeneca Promotional Regulatory Affairs (PRA) team that supports the US Oncology business. He has held a variety of regulatory roles over the last 27 years with the last 10 at AstraZeneca/MedImmune. Glenn spent 10 years at the US Food and Drug Administration in both the Center for Devices and Radiological Health as a device reviewer and at the Center for Biologics Evaluation and Research as head of the Advertising and Promotional Labeling Branch. Glenn’s experience includes government, industry, consulting firms and CROs. He received his MBA from Hood College and his BS in Aerospace and Ocean Engineering from Virginia Tech.

  • Dale  Cooke, MA

    Dale Cooke, 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, which was published by the Food & Drug Law Institute.

  • Mary L Raber  Johnson, PhD, RAC

    Mary L Raber Johnson, PhD, RAC

    • Assistant Professor, Clinical
    • The Ohio State UniversityCollege of Pharmacy, United States

    Since 2009, I have worked at pharmaceutical agencies to support marketing and/or medical affairs teams. I served as lead medical/scientific director for products in various stages of their lifecycles - all while intersecting with regulatory affairs in various capacities. In 2012, I earned a US Regulatory Affairs Certification from RAPS, which covers regulatory functions throughout product lifecycles. Recently I became regular faculty at The Ohio State University, College of Pharmacy where I develop and teach in the online MS Pharmacology program and within the Regulatory Affairs specialization of the Masters of Applied Clinical and Preclinical Research (MACPR) program.

  • Coleen  Klasmeier, JD

    Coleen Klasmeier, JD

    • Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
    • Sidley Austin, LLP, United States

    She leads the firm’s Food, Drug and Medical Device Regulatory practice within the global Life sciences team, managing matters on behalf of leading biopharmaceutical, medical technology, and food and consumer product companies. Since joining Sidley from the Office of the Chief Counsel at the FDA in 2005, Coleen has concentrated her practice on FDA litigation and dispute resolution, and on regulatory strategy and risk management. She has been deeply involved as FDA regulatory counsel in defending numerous off-label marketing investigations, as well as in a wide variety of product liability, consumer fraud, Hatch-Waxman, criminal, and appellate matters on behalf of life sciences industry clients

  • Wayne L. Pines

    Wayne L. Pines

    • President, Regulatory Services and Healthcare
    • 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 Rose, CEO of Lucy Rose and Associates, LLC is an award-winning NYC based pharmaceutical health strategy, regulatory, and communications expert. Her education and experience includes: Wake Forest University Physician Assistant graduate, MBA, led FDA’s DDMAC and the Office of Training and Communications, worked in Pharma in sales and marketing, and has consulted with hundreds of companies (large and small) in regulatory, medical, and strategic drug/business development and communications considerations. She speaks extensively on these topics all over the world and is easy to spot – she’ll be the one in running shoes!

  • Michele  Sharp, PharmD

    Michele Sharp, PharmD

    • Senior Director, Global Regulatory Affairs - US
    • 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 12 years leading a team who advise the US business on advertising and promotion for marketed products.

  • Virginia  Beakes-Read, BSN, JD

    Virginia Beakes-Read, BSN, JD

    • Amgen, United States

    Ms. Beakes-Read is Exec Dir, Global Regulatory Policy and Intelligence at Eisai. She helps respond to regulatory/policy initiatives of FDA and other agencies. She also worked at Genentech in a similar role. Previously, she worked in CDER for 8 years, and was responsible for regulations development. Prior to her tenure at FDA, Ginny was a US Army JAG, working as a prosecutor and appellate attorney, and before then a nurse in the US Air Force. Ginny holds B.S.N. and J.D. degrees from UVA.

  • Sue  Duvall, MPA, RN

    Sue Duvall, MPA, RN

    • Head, North America Advertising and Promotion
    • Mylan, United States

    Sue Duvall has worked in the pharmaceutical industry for 20 years primarily in regulatory advertising and promotion but also some time in clinical development and supply chain. She is a registered nurse with a Master’s in Public Administration at Western Michigan University and completed her doctoral course work for Medical Ethics/Medical Humanities at Drew University in Madison New Jersey. She currently is the Head of North America Advertising and Promotion, Regulatory Affairs for Mylan in Canonsburg, PA. She has held positions in both U.S. and international regulatory advertising and promotion with AbbVie, Amgen, Novartis, and Pharmacia.

  • Christine  Novak, PharmD

    Christine Novak, PharmD

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

  • 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. In this role, Sheetal provides regulatory guidance of promotional and marketing activities to ensure compliance with federal laws and regulations. Previously, she held the position of Lieutenant Commander, Senior Regulatory Review Officer, at the Food and Drug Administration, Office of Prescription Drug Promotion.

  • Dolores Marie Shank-Samiec, MS

    Dolores Marie Shank-Samiec, MS

    • Executive Director, Office of Promotion and Advertising Review
    • Merck, United States

    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 U.S. promotional materials in support of the pharmaceutical and vaccine businesses. Ms. Shank-Samiec joined Merck in 1997 and has held positions of increasing responsibility in promotional regulatory review, marketing compliance, oversight of external consulting arrangements, marketing communications, and brand marketing.

  • 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 Team Leader of FDA's Office of Prescription Drug Products Research Team. She has 20 years designing, contracting, implementing, analyzing, and publishing research on diverse topics related to advertising and promotion of medical products. She is considered FDA’s authoritative source on direct-to-consumer (DTC) prescription drug advertising research and is a frequent speaker domestically and internationally on DTC advertising of prescription drugs.

  • Catherine B. Gray, PharmD

    Catherine B. Gray, PharmD

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

    Dr. Gray is a Management Advisor in the Division of Drug Marketing, Advertising, and Communications at the FDA. She currently focuses on higher level issues facing the Division as it transitions to an office structure. Previous DDMAC roles include Professional Group Leader and Professional Reviewer.

  • Lori  Hall, BSN

    Lori Hall, BSN

    • Director – Health Literacy
    • Eli Lilly and Company, United States

  • 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), focuses on policy and guidance development initiatives, with a special interest in the use of social media and the accelerated approval regulations for prescription drug promotion. Her prior roles include senior regulatory affairs consultant for the pharmaceutical industry at Science Applications International Corporation (SAIC), professional group leader and oncology reviewer in OPDP (formerly DDMAC), and assistant professor at Shenandoah University. She completed a drug information residency (University of Pittsburgh Medical Center) after earning her Pharm.D. (University of Maryland) and B.A. (Biochemistry/Music, University of Virginia).

  • Eugene J Sullivan, MD

    Eugene J Sullivan, MD

    • Principal
    • EJS Consulting, LLC, United States

  • Amy C. Van Sant, PharmD, MBA

    Amy C. Van Sant, PharmD, MBA

    • Director, Regulatory Advertising and Promotion
    • Johnson & Johnson, United States

  • 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.

  • Kristi L. Wolff

    Kristi L. Wolff

    • Partner
    • Kelley Drye & Warren LLP, United States

  • John K. Wong, MPharm

    John K. Wong, MPharm

    • Executive Director, Regulatory Drug Advertising and Promotion
    • TPI Reg, Canada

    John Wong is 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) 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 is currently the Executive Director at TPIreg, a regulatory consulting group, and leads the Regulatory Drug Advertising and Promotion services.

  • Rebecca K Wood

    Rebecca K Wood

    • Chief Counsel
    • U.S. Food and Drug Administration, United States

  • 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.

  • Katlin McKelvie Backfield, JD

    Katlin McKelvie Backfield, JD

    • Principal
    • Backfield PLLC, United States

    Katlin McKelvie Backfield is an attorney and consultant who advises on issues related to the regulation of pharmaceuticals and biotechnology products. Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years and as a regulatory counsel in the Office of Prescription Drug Promotion for two years. Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock. She graduated cum laude from Georgetown University Law Center and received her undergraduate degree from Davidson College. She is based in Washington, D.C.

  • Wolf  Gallwitz, PhD

    Wolf Gallwitz, PhD

    • Chief Medical Officer
    • Razorfish Health, United States

  • Michael J Hulka

    Michael J Hulka

    • Senior Director, Assistant General Counsel
    • Eli Lilly and Company , United States

  • Geoff   McCleary

    Geoff McCleary

    • Mobile & Connected Health Executive, Director Digital Health
    • PricewaterhouseCoopers, United States

  • Linda  Neuhauser

    Linda Neuhauser

    • Clinical Professor, Community Health and Human Development; Principal Investigat
    • University of California – Berkeley, School of Public Health, United States

  • 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.

  • Sheila  Ryan, PharmD, MPH

    Sheila Ryan, PharmD, MPH

    • Regulatory Health Project Manager, OPDP
    • FDA, United States

  • Lisa  Schatz, PharmD, MBA

    Lisa Schatz, PharmD, MBA

    • Manager, Regulatory Affairs
    • Abbvie, United States

  • 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.

  • Eileen  Valenta, MBA

    Eileen Valenta, MBA

    • Regulatory Affairs
    • Validant, United States

  • Kemi  Asante, PharmD, MPH, RAC

    Kemi Asante, PharmD, MPH, RAC

    • Health Science Policy Analyst
    • FDA Office of Prescription Drug Promotion, United States

  • Julie  Cain

    Julie Cain

    • Vice President, Product Strategy
    • PatientPoint, United States

  • Ritesh  Patel

    Ritesh Patel

    • EVP, Chief Digital Officer
    • Ogilvy CommonHealth Worldwide, United States

  • 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.

  • Tammy J Phinney, MSc

    Tammy J Phinney, MSc

    • Sr Director, Regulatory Affiars
    • Biogen Idec Inc., United States

  • Margaret  Sparks

    Margaret Sparks

    • Associate Vice President
    • Sanofi US, United States

    Margaret has been with Sanofi US or its predecessor company since November 2001, when she joined the Aventis Pharmaceuticals Legal Department, supporting the Respiratory franchise. Margaret moved to the Compliance team in 2007, and now supports a variety of business groups and compliance functions. Prior to Sanofi US, Margaret was part of the Litigation group at Patterson, Belknap, Webb & Tyler, LLP in New York. Margaret is a graduate of the University of Virginia School of Law, received an M.A. degree from the Harvard University Graduate School of Arts and Sciences, and a B.A. degree from the University of Georgia.

  • 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.

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Call for Posters Extended: January 16

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Complimantary Webinar

Navigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange
Jan. 17 | 11:00AM-12:00PM ET


Preconference Short Course Options

Ad Promo Primer