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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.

  • 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.

  • 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, now in its second edition, 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

    COLEEN KLASMEIER 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 Food and Drug Administration in 2005, Coleen has concentrated her practice on FDA litigation and dispute resolution, and on regulatory strategy and risk management.

  • 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 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.

  • 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.

  • Virginia  Beakes-Read

    Virginia Beakes-Read

    • Executive Director, Global Regulatory and R&D Policy
    • Amgen Inc., United States

    Ms. Beakes-Read is Exec Dir, Global Regulatory Policy and Intelligence at Amgeni. 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.

  • Jason  Cober

    Jason Cober

    • Lead Project Manager, OPDP
    • FDA, United States

    Jason Cober is the Lead Project Manager in the FDA's Office of Prescription Drug Promotion. He leads OPDP's eCTD outreach efforts and has 10 years experience with the Agency's eCTD specification and guidance development process.

  • 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

    Christine received her Doctor of Pharmacy Degree from Rutgers University and completed a post- doctoral fellowship in Ad Promo through the Rutgers Pharmacetuical Inddustry Fellowship Program. She has held various positions covering several therapeutic areas within the Commercial Regulatory Affairs department at Bristol-Myers Squibb.

  • 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.

  • 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 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.

  • 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.

  • Lori  Hall, BSN

    Lori Hall, BSN

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

    Lori K. Hall, RN is the Advisor of Health Literacy at Lilly. She brings to this role over 30 years of health care experience in the clinical setting as well as in the diagnostics and pharmaceutical industries. Her scope of work and responsibility is centered on providing visibility and guidance as well as helping to set organizational expectations and accountability for all aspects of communications with patients as it plays a direct role in supporting Lilly’s corporate priorities around medication adherence, patient safety, clinical innovation, launch preparedness, real world evidence, corporate responsibility, value-based contracting, and informed patient engagement.

  • 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).

  • Thomas J. Moskal, DVM

    Thomas J. Moskal, DVM

    • Veterinary Medical Officer
    • FDA/CVM, United States

    Dr. Moskal is a Veterinary Medical Officer with Food and Drug Administration’s Center for Veterinary Medicine (CVM). He serves as a reviewer of labeling and promotional materials for approved and unapproved animal drugs and medical devices, and is CVM’s contact for Promotion and Advertising. He received his B.S. in Biology from the University of Maryland, a D.V.M. from the Virginia-Maryland Regional College of Veterinary Medicine, and a Master of Library and Information Science (M.L.I.S.) from Drexel University. Dr. Moskal is a Diplomate of the American College of Laboratory Animal Medicine.

  • Robert F. Quinn

    Robert F. Quinn

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

    Rob supports the AstraZeneca Promotional Regulatory Affairs (PRA) team that supports the US Oncology business. He has held roles in promotional regulatory, medical affairs and Compliance over the last 15 years while at AstraZeneca.

  • Eugene J Sullivan, MD

    Eugene J Sullivan, MD

    • Principal
    • EJS Consulting, LLC, United States

    Eugene J. Sullivan, MD is an independent consultant in the area of strategic regulatory and clinical drug development at EJS Consulting, LLC, and is the Chief Product Strategy Officer at Insmed, Inc. Past pharmaceutical industry positions include VP, Global Regulatory Affairs for Respiratory, Inflammation and Autoimmunity products at Astra Zeneca Pharmaceuticals, Chief Medical Officer at United Therapeutics (UT), and Chief Medical Officer/Chief Clinical Development Officer of Lung Rx/Lung LLC. Prior to joining industry, Dr. Sullivan worked at the FDA where he served as a medical reviewer, medical team leader, and Deputy Director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

  • Amy  Van Sant, PharmD, MBA

    Amy Van Sant, PharmD, MBA

    • President, Medical Affairs
    • Ashfield Healthcare LLC, United States

    Ashfield is an international healthcare services organization. Amy recently assumed her position at Ashfield Healthcare as the head of the U.S. Medical Affairs business unit consisting of Medical Information, Pharmacovigilance and Medical Science Liaison services. Prior to joining Ashfield Healthcare, she served as Director, Regulatory Advertising & Promotion for the Pharmaceutical Sector within the Johnson & Johnson Health Care Compliance & Privacy Organization. Amy holds a Doctorate of Pharmacy from the University of the Sciences, Philadelphia, and an MBA in Pharmaceutical Management from Drexel University. Amy also holds a Health Care Compliance Certification from Seton Hall Law School.

  • Kristi L. Wolff

    Kristi L. Wolff

    • Partner
    • Kelley Drye & Warren LLP, United States

    Kristi Wolff is a partner in the firm’s Washington, D.C. office. Ms. Wolff's practice focuses on food, drugs, dietary supplements, medical devices, personal care and consumer health products, as well as wearable technology and health privacy issues. She has extensive experience advising clients whose products are within the overlapping jurisdictions of the Food and Drug Administration and the Federal Trade Commission. Having served as in-house counsel in the healthcare and food products industries, Ms. Wolff is particularly attuned to balancing business objectives with legal considerations. She was recently peer-selected as one of the Best Lawyers in America for Advertising for 2018.

  • John K. Wong, MPharm

    John K. Wong, MPharm

    • Director, Regulatory Drug Advertising and Promotion
    • TPIreg/Innomar Strategies, 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

    Rebecca K. Wood is Chief Counsel to the Food and Drug Administration and Associate General Counsel in the Office of the General Counsel, U.S. Department of Health and Human Services. Becky is an experienced and accomplished litigator who has managed complex litigation and appeals in federal and state courts, including matters arising under the Federal Food, Drug, and Cosmetic Act and U.S. Constitution. Becky received her B.A. from Yale University and her J.D. from New York University School of Law. She previously served as a law clerk to the Honorable Pasco M. Bowman II of the United States Court of Appeals for the Eighth Circuit.

  • 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.

  • Dwight Alben Bowen, PharmD, RPh

    Dwight Alben Bowen, PharmD, RPh

    • Senior Lead (Director), US Advertising and Promotion Regulatory Affairs
    • Shire, United States

    Dwight Bowen received his Pharm.D. degree from Philadelphia College of Pharmacy in 2011. He then accepted a position with the Eli Lilly and Company Visiting Scientist Fellowship. His fellowship year was spent in the regulatory affairs US Advertising and Promotions group. After completing the fellowship, Dwight remained at Lilly in the ad/promo group for about 6 years and served as the regulatory reviewer for multiple compounds across the company's portfolio as well as some commercialization alliances. Currently he works at Shire and is a director within the ad/promo group.

  • Wolf  Gallwitz, PhD, MBA

    Wolf Gallwitz, PhD, MBA

    • Chief Science Officer
    • RFH, United States

  • Michael J Hulka

    Michael J Hulka

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

    Michael is the General Counsel of Lilly's BioMedicine's Business Unit, which develops, markets and sells the companies' products in immunology, pain, neuroscience, and men's and women's health. He also leads legal teams supporting the company's global regulatory, clinical development, medical affairs, manufacturing and quality, HSE and privacy functions. Before coming to Lilly, Michael was a litigator first at Kirkland & Ellis and then at Barnes & Thornburg. He graduated magna cum laude from the Indiana University School of Law.

  • Geoff   McCleary

    Geoff McCleary

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

    Geoff McCleary is a leading Digital Health consultant for Pricewaterhouse Cooper's Digital & Connected Health Advisory group. Focused on helping pharma, providers, payors and new health entrants maximize their value to their customers and the health care system by strategically using emerging digital and connected health technologies.

  • Linda  Neuhauser, DrPH, MPH

    Linda Neuhauser, DrPH, MPH

    • Clinical Professor, Community Health Sciences
    • University of California – Berkeley, School of Public Health, United States

    Linda Neuhauser, DrPH, MPH, is Clinical Professor of Community Health Sciences at the University of California, Berkeley School of Public Health and Co-PI of the Health Research for Action center. She has over 25 years experience in research and practice related to health communication and health literacy. She focuses on participatory design of communication to meet the literacy, language, cultural and functional access needs of diverse users in the US and globally. She was a founding member of the FDA Risk Communication Advisory Committee.

  • 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.

  • Leah  Palmer, PharmD

    Leah Palmer, PharmD

    • Consultant, Regulatory Promotion
    • L Palmer RegPromo Consulting, LLC, United States

    Leah Palmer, PharmD is currently a consultant in FDA prescription drug promotion regulations. Most recently, she served as Executive Director in Regulatory Affairs at Amgen Inc., as a Regulatory Promotion lead with oversight of a wide range of product promotional activities. Prior to joining Amgen in 2001, Dr. Palmer was a Branch Chief in DDMAC (now OPDP) overseeing product advisories and enforcement actions, and she also served as Senior Enforcement Advisor. Prior to joining FDA, she completed her Doctor of Pharmacy at Purdue University College of Pharmacy and an Industrial Clinical Pharmacy Fellowship affiliated with Rutgers University and Parke-Davis. She received her B.S. in pharmacy from the UMKC School of Pharmacy.

  • Sheila  Ryan

    Sheila Ryan

    • Policy Team Leader, OPDP
    • FDA, United States

    Sheila Ryan, PharmD, MPH, RAC is currently the Policy Team Leader within FDA’s Office of Prescription Drug Promotion. She has over 15 years of FDA regulatory experience, including almost 10 years in the area of prescription drug promotion. Her experience at FDA has also included overseeing compliance programs for tobacco products and managing oncology drug applications. She has pharmacy degrees from the University of Pittsburgh and University of Maryland, along with a Master of Public Health from the University of North Carolina.

  • Lisa  Schatz, PharmD, MBA

    Lisa Schatz, PharmD, MBA

    • Director, International Regulatory Affairs Advertising and Promotion
    • Abbvie, United States

    Lisa Schatz is biopharmaceutical professional with over 12 years of leadership and results driven experience in industry, including commercial regulatory affairs and medical affairs with extensive knowledge of working in a global multifunctional team environment. Over the past several years, she has had a focus in global product launches.

  • 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.

  • Eileen  Valenta, MBA

    Eileen Valenta, MBA

    • President
    • Valenta Consulting , United States

    Eileen has over 25 years of experience in global regulatory affairs including deep expertise in advertising and promotion, compliance and strategic labeling initiatives for drugs, devices, and biopharmaceuticals. Eileen has served in senior leadership roles in multiple pharma companies where she has been responsible for process and system development for creating and optimizing promotional review and integrated launch programs.

  • KEMI  ASANTE, PharmD, MPH, RAC

    KEMI ASANTE, PharmD, MPH, RAC

    • POLICY ANALYST
    • FDA, United States

  • Brandon  Ashcraft

    Brandon Ashcraft

    • SVP, Digital Solutions
    • Razorfish Health, United States

    Brandon has 25 years of experience driving internal and client-facing technology solutions by leveraging a range of core competencies, including user experience, architecture, software engineering, business analysis and program management. At Razorfish Health, Brandon has led Mobile, CMS, CRM and VeevaCLM solutions for AstraZeneca and Otsuka, as well as digital marketing implementations for Bayer and Purdue Pharma, among others. Before joining Razorfish Health, Brandon spent 17 years designing, leading and building Technology solutions for Kaplan Test Prep, including Enterprise CMS, content authoring tools, data analytics solutions, and enterprise business systems.

  • Blythe  Buchanan

    Blythe Buchanan

    • Director, Regulatory Advertising and Promotion
    • Biogen , United States

    Blythe Buchanan heads the US Regulatory Advertising and Promotion group at Biogen, having spent more than 16 years in regulatory affairs advertising, labeling & promotion and various commercial roles with increasing responsibility including sales, training/leadership development and competitive intelligence throughout Pharma and Biotech. Her tenure at Eli Lilly, Sepracor, Endo and Auxillium spanned consumer, HCP and managed markets segments. Blythe has successfully launched more than 10 products both from the regulatory and commercial sides of the business. A broad and diverse experience in the industry makes Blythe uniquely adept at providing regulatory guidance with a lens to real-world commercial application.

  • Julie  Cain

    Julie Cain

    • Vice President, Product Strategy
    • PatientPoint, United States

    Julie Cain is an expert in designing and implementing products and marketing initiatives that drive results.As Vice President of Product Strategy, Julie develops the product roadmaps and market strategies that position PatientPoint as the leading innovator of point of care. She led the launch of the PatientPoint physician-facing mobile application and is responsible for key partnerships within the healthcare space. Prior to joining PatientPoint, Julie held management roles at U.S. Bancorp, Proctor & Gamble and Express Scripts. She has a bachelor’s degree in English literature from Miami University and a master’s degree in global marketing communications and advertising from Emerson College.

  • John  Kamp

    John Kamp

    • Washington Counsel
    • Coalition For Healthcare Communication (CHC), United States

    John Kamp is the Executive Director of the Coalition for Healthcare Communication, comprised of medical marketing agencies, medical mass media and medical journals. The CHC believes that truthful communication about medical products and services advances the public health.

  • 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.

  • 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.

  • 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.

  • 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.

  • Alexander  Bragg

    Alexander Bragg

    • Strategic & Planning Advertising Executive
    • Fingerpaint Marketing , United States

    For the past 20 years, Alex Bragg has worked in advertising with the goal to bring inspiration and insight to businesses through brand strategy. As the lead account planner at Fingerpaint Marketing, he operates under the firm belief that there’s rich human emotions and truths to tap into that drive our decisions to engage with brands, and nowhere is this more apparent than in the healthcare category.

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