5th Promotional Review Committee Compliance & Best Practices — Midwest -

5th Promotional Review Committee Compliance & Best Practices — Midwest
May 17 - 18, 2018
Chicago, IL

The ONLY industry event devoted specifically to uniting cross-team expertise, maximizing quality oversight during review, and improving regulatory compliance in all multimedia promotional messaging

Faculty – 5th Promotional Review Committee Compliance & Best Practices — Midwest

Ilze Antons
Senior Director, Regulatory Affairs, LUNDBECK

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Ilze started her career in the pharmaceutical industry at the Upjohn Company in Kalamazoo, Michigan over 25 years ago. Prior to her extensive time in Regulatory Affairs, she held several positions in Quality Assurance. Her regulatory path not only spanned International, US and Global approaches, but also included Pharmacia, Genzyme, Baxter and Serono before Lundbeck. While she worked on INDs, NDAs, DMFs and in numerous therapeutic areas, over the past 17 years her work has included Advertising and Promotional work, with the last 10 focused solely in this area of regulatory compliance. She now heads up a team that provides promotional review and internal as well as external compliance training, and has been involved with the development and inclusion of social media in various programs in the company.

Ilze received her B.S. from Purdue University and her M.S. from The Ohio State University. She is RAC certified; participated in developing the original Code of ethics for Regulatory Professionals for RAPS; was an organizer for RAPS’s annual meetings; and has been a presenter on both labeling and advertising, and promotional topics at various conferences.

Jennifer Banovic
Executive Medical Communications Liaison, TAKEDA

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Jennifer Banovic, PharmD, MBA, BCPS, is an Executive Medical Communications Liaison at Takeda Pharmaceuticals in Deerfield, IL. Jennifer supports multiple products in the neuroscience and rheumatology therapeutic areas from a medical information and medical review perspective. She has more than 17 years of experience in various settings with a focus on medical communications, including 10 years in the pharmaceutical industry, as well as clinical practice, managed care and academia.

Leeann Bonaventura
Associate Director, Promotional Regulatory Affairs, ASTRAZENECA

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Leeann joined AstraZeneca in 2008 in a Marketing Operations role. She has been with the company nine years in a series of roles, with increasing responsibilities in Regulatory Affairs. She is currently an Associate Director of Promotional Regulatory Affairs, primarily responsible for the Women’s Cancer Franchise. Leeann received her undergraduate degree from Lafayette College with a double major in neuroscience and English, and a Master’s degree from Binghamton University in Behavioral Neuroscience. Prior to AstraZeneca, Leeann worked at Biogen Idec in Boston in a Marketing Operations role. She lives in Frederick, Maryland with her fiancé and their 3 cats. In her spare time, she volunteers with various mentoring programs that help foster career growth and STEM support for young women.

Lynn Bowen
Director, Commercial Regulatory Oversight, VERTEX PHARMACEUTICALS

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Lynn Bowen, Ph.D., is Director, Global Regulatory Affairs and Lead U.S. Commercial Regulatory Affairs at Vertex Pharmaceuticals. At Vertex, she is responsible for ensuring alignment of regulatory guidance and advice across products in the US and regulatory oversight for product and disease state communications. She holds an undergraduate degree in biotechnology from the Rochester Institute of Technology and a doctorate in microbiology from Boston University School of Medicine. Lynn has been in the pharmaceutical industry for ten years and was previously at Bayer Healthcare in the advertising and promotion function, focused on regulatory review of product communications for oncology products, and at Forest Pharmaceuticals (now Allergan) in Medical Affairs, primarily working on medical review and publication planning in cardiovascular and gastrointestinal diseases. She started her pharma career at a medical education company where she worked with multiple pharma clients in cardiology and neurology.

Christi Bruce
Senior Manager, MLR Operations and Platforms, SANOFI

Rebecca Burnett
Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS

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In her current role as Executive Director and Head of Strategic Services for Framework Solutions, Rebecca Burnett has more than 17 years of biopharmaceutical industry experience. She was most recently the Head of North America Marketing Operations for Mylan where she was responsible for leading her team in the support of five business units and more than 1,400 products.

Ms. Burnett began her career as a clinical research associate and held numerous roles in clinical research and medical affairs before finding her true passion in advertising and promotional review management in 2008. Since that time she has worked with and led teams across a spectrum of biopharmaceutical companies. Her teams have won industry awards for excellence in implementing technology solutions to drive process review efficiency and optimization. Her expertise is in diagnosing and providing recommendations to promotional review teams to ensure compliant and efficient review processes.

Ms. Burnett received her undergraduate and masters degree from the University of Colorado and has an MBA from George Washington.

Elke Carter

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Elke Carter is the Manager of Regulatory Affairs for Zavation Medical Products, LLC where she provides the expertise and leadership to assure the company is in full compliance with the regulatory requirements for the FDA, FTC, and ISO 13485. Ms. Carter also ensures Zavation’s adherence to best practices outlined in AvaMed code. From 2008-2017, Ms. Carter served in the same capacity as Director of Regulatory Affairs with Pernix and Cypress Pharmaceutical, Inc., which was acquired by Pernix in 2012. Prior to her Director of Regulatory Affairs roles, Ms. Carter served as an R&D Chemist for Vistakon (a Johnson & Johnson Company) in Jacksonville, FL, where she worked on developing multiple combination drugs and device products and was promoted to the role of R&D Operations Manager, where she and her team was responsible for the manufacture, testing and record keeping of these products, including clean room practices and FDA reviews.

Ms. Carter earned a bachelor’s degree in chemistry from The University of South Alabama. She currently resides in Jackson, MS.

Erica Chertow
Director, Regulatory Affairs, U.S. Prescription Drug Promotion, ABBVIE

Jessica Cirillo
Director, HEOR — Acute Care Lead, MALLINCKRODT

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Jessica Cirillo, MHS is a Director, Health Economics & Outcomes Research and Acute Care Lead at Mallinckrodt Pharmaceuticals. She is responsible for leading the development and execution of the value evidence generation and dissemination strategies for pain management and hemostats businesses.

Jessica has a broad range of experience supporting the pharmaceutical and medical device industries. Previously, Jessica was a Director in the Value Evidence and Outcomes division of GlaxoSmithKline, Inc. where she developed and implemented strategies to establish value propositions, market access, and health economics tools to support the business. Her work spanned regions around the world, including North and South Americas.

Jessica also previously worked in the Global Health Economics and Market Access division at Ethicon, Inc. (Johnson & Johnson family of companies) supporting hernia solutions. Jessica also worked at Janssen (Johnson & Johnson family of companies) in the areas of schizophrenia, major depression disorder, and bipolar disorders within in the US Health Economics and Outcomes Research team. Prior to joining Johnson & Johnson, Jessica has been a manager in operations for Wolters Kluwer Health. She was a healthcare advisor, specifically in building corporate compliance programs for major pharmaceutical clients, at PricewaterhouseCoopers. Jessica’s career began at Merck as a health outcomes intern, a medical writer, a publications coordinator, and a customer analyst located in Hoddesdon, England for 6 months.

With over 20 years of healthcare industry experience, she has developed expertise in data analytics, project management, as well as economic value modeling. Jessica is passionate about keeping patients’ well-being at the center of her work.

Jessica graduated with a Masters in Health Science from the Johns Hopkins Bloomberg School of Public Health, specializing in Health Finance and Management, which included a yearlong fellowship. She holds a BS from The Pennsylvania State University. More recently, she has earned a graduate certificate in Health Policy from the Jefferson School of Population Health. Jessica is a member of her alumni groups, the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) as well as the Healthcare Businesswoman’s Association (HBA). Over the course of her career, Jessica has received numerous awards and recognition.

Sue Duvall
Head, North America Advertising and Promotion, Regulatory Affairs, MYLAN

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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 coursework 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.

Prior to working in the pharmaceutical industry, Sue worked in healthcare systems including critical care nursing at Butterworth Hospital in Grand Rapids, Michigan; psychiatric nursing with the State of Michigan and as a public health inspector for the State of Michigan. She currently is the Head of North America Advertising and Promotion, Regulatory Affairs for Mylan in Canonsburg, PA. She previously was the head of International Advertising and Promotion with AbbVie and held advertising and promotion positions with Amgen, Novartis, and Pharmacia.

Sue is an avid reader, tries to walk several miles every day, enjoys music and wandering through any kind of museum.

Megan Francis-Sedlak
Associate Director, Medical Affairs, HORIZON PHARMA

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Megan Francis-Sedlak, Manager, Global Medical Affairs, BAXALTA

Megan Francis-Sedlak is an Associate Director of Medical Affairs at Horizon Pharma in Lake Forest. Prior to working for Horizon Pharma, Megan served as a senior member of the advertising and promotional review committee in Medical Affairs at Baxalta U.S. Inc. (now Shire) and Baxter Healthcare. Megan has 12 years of experience as a research scientist and manager in the healthcare field. Megan earned a Bachelor of Science in biomedical engineering from Saint Louis University as well as a Ph.D. in biomedical engineering from Illinois Institute of Technology.

Marge Garcia
Associate Director, Program Review Operations, GENENTECH

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Marge Garcia is Associate Director, Program Review Operations (PRO) at Genentech.

In collaboration with Genentech Commercial Regulatory, PRO’s remit is to implement a consistent approach to the Promotional Review Committee (PRC) submission process, develop and implement training on PRC processes and develop and report PRC metrics of success. She leads teams that are accountable for providing non-technical quality review and operational support to the Immunology, Infectious Disease, Ophthalmology, and Neuroscience PRC teams. The team optimizes business effectiveness and drives efficiencies throughout the end-to-end process.

Marge joined Genentech in 2005 and brings depth and diversity of experience in organizational development, leadership, training, account management and operations. She has a passion for developing others, a focus on stakeholder and customer engagement and a collaborative leadership style. Marge holds a Master’s degree in Organizational Development from the University of San Francisco and BA in Psychology from the Ateneo De Manila University. She lives in Foster City, CA with her husband and two children.

Mimi Giordano
Senior Copy Editor, UCB

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Mimi Giordano is a senior copy editor at UCB. She joined the company in 2011 and has been responsible for editorial review of U.S. promotional materials for the neurology patient value unit. During this time, Mimi has collaborated on several new products and new indication launches. She is a co-developer of the UCB U.S. Style Guide used by marketing managers and agency partners. Before joining UCB, she was a writer in the healthcare and news sectors. Mimi received a B.A. degree in English from Saint Joseph’s University in Philadelphia. She lives in the Atlanta area with her husband and children.

Kevin Hollister
Senior Director, Regulatory Affairs, TESARO

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Kevin Hollister is currently head of Regulatory Advertising and Promotion at TESARO. He created this function within TESARO and is growing it to become a sustainable and scalable function. Prior to this role, he created a similar function at Cubist Pharmaceuticals. His focus over the last 10 years has been to identify how the vital function of advertising and promotion, as well as the review process, should best be created, implemented and incorporated into existing practices. In addition to working at smaller companies, he has also worked at medium-sized companies such as EMD Serono, and large companies such as Amgen and Merck.

Kevin began his career as a molecular biologist working at The City of Hope national medical center in Southern California before “stumbling” into regulatory affairs. He then transitioned into the pharmaceutical industry, focusing on general regulatory strategy and regulatory intelligence. After several years, he found his true passion for advertising and promotion, which combines the need to have a strong scientific knowledge base with the ability to create and think outside the box.

Kevin received a B.S. from the University of California, San Diego, and also holds a Masters degree in Regulatory Affairs from San Diego State University and an MBA from Azusa Pacific University.

Richard Kim
Associate Director, Medical Review, ABBVIE

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Richard Kim is an Associate Director in Healthcare Solutions at AbbVie, specializing in managed care medical review of advertising and promotion to the payer audience. For the past 8 years, he has worked with a cross-functional team within AbbVie to interpret and develop guidance for the promotion of healthcare economic information under FDAMA 114 and the 21st Century Cures Act. Prior to joining AbbVie, Richard worked as a Pharmacy Manager for Walgreens. He earned his Bachelor of Science in Pharmacy from the University of Wisconsin-Madison.

John Marcus
Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

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John Paul Marcus leads the Regulatory Affairs team on the Promotional Review Committee at Horizon Pharma. He has over ten years of experience in the Pharmaceutical industry working within advertising and promotion as part of both Regulatory Affairs and Medical Affairs. John received his Pharm.D. from Howard University and Bachelors in Microbiology from The University of Texas at Austin.

Michael Saad
Senior Manager, Marketing Operations, ABBVIE

Zafar Toor, Pharm.D.
Senior Director, Commercial Regulatory Affairs, LEXICON PHARMACEUTICALS

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Zafar Toor, Senior Director, Global Regulatory Affairs, EISAI

Dr. Toor is the Head and Senior Director of Commercial Regulatory Affairs at Eisai Inc. He provides strategic direction to the organization on ways to optimize the promotional review process and plays a key role in introducing technologies to enhance the efficiency of the review and approval process for promotional materials.

Previously, Dr. Toor was the Director of Client Services at an advertising firm, Bimark Inc., where he worked with many pharmaceutical industry clients in the development of promotional campaigns for a variety of therapeutic areas. His experience has spanned most therapeutic areas, although he has worked extensively in the areas of oncology, cardiometabolic disorders, GI, and allergy and asthma.

James Vigil
Director, U.S. Regulatory Affairs, Advertising and Promotion, ABBVIE

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Jim has been in regulatory affairs for 21 years, of which 18 have been in the area of advertising and promotion. He is presently with AbbVie as Director US Regulatory Affairs Advertising and Promotion for the Oncology Therapeutic Area. Jim is a founding member of the IRISS Forum Ad Promo Topics Group and is currently on the leadership team. He is a member of DIA. Jim earned a J.D. from Indiana University School of Law at Indianapolis and has a B.A. in molecular cellular and development biology and chemistry from the University of Colorado.

Alexander Zachos, J.D.
Associate Director, U.S. Regulatory Advertising and Promotion, SHIRE

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Alex has been in Regulatory Affairs for eight years, six of which he has specialized in Advertising and Promotion, and he presently serves as Associate Director, U.S. Regulatory Advertising and Promotion with SHIRE supporting the Neuroscience portfolio. Alex earned his J.D. from Mercer University School of Law in Georgia, where he focused in the area of Healthcare and FDA Law. Alex also has a B.A. in Political Science from Huntingdon College.

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