Faculty – 5th Promotional Review Committee Compliance & Best Practices

Cynthia Akue
Promotional Planner, ALLERGAN

Sergio Alegre
Vice President, Global Compliance, VERTICAL PHARMACEUTICALS

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.

Jill Charbonneau, Director, Regulatory Affairs – Marketed Products, MARATHON PHARMA

Jill Charbonneau
Director, Regulatory Affairs, AdProm, Product Launch & Labeling, MARATHON PHARMACEUTICALS

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Jill Charbonneau is the Director, of Regulatory Affairs for Ad/Prom, Product Launch and Labeling at Marathon Pharmaceuticals, LLC in Northbrook, Illinois, where she is responsible for regulatory activities related to advertising and promotion, the preparation for product launches, marketed product maintenance, and labeling.

Prior to working for Marathon Pharmaceuticals, LLC, Jill was an Associate Director of Regulatory Affairs Advertising and Promotions at Takeda Pharmaceuticals. Previously she was Associate Director of Advertising and Promotion Regulatory at Baxter International Inc. Before that she was at Abbott Laboratories for 20 years in various positions, including roles in Chemical Development, Reference Standards organization, Animal Health Regulatory, Diagnostics Regulatory and Global Pharmaceutical Regulatory – Advertising and Promotion.

She received a B.A. degree in chemistry from Lake Forest College and is currently pursuing an MBA from the Lake Forest Graduate School of Management. Jill has completed Regulatory Affairs Professional Society Certification (RAC) for the US, EU and Canada Regions.

Masha Chestukhin
Senior Manager, North America Compliance, SANOFI

Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW

Howard Dorfman
Senior Corporate Counsel, EDGE THERAPEUTICS

David Jacobs
Assistant General Counsel, Commercial Brands, DAIICHI SANKYO

Sameer Lal
Senior Vice President, INDEGENE

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Sameer heads the Promotional Medical Review business unit at Indegene and drives the overall P&L through sales and marketing efforts, capability building, innovation, and delivery. He is responsible for all new and existing client engagements. Sameer also leads the Key Account Management portfolio covering the US and Europe. He is responsible for managing a team of professionals based in these geographies with a mandate to grow Indegene’s business across its service lines. He is also the global client partner for several of the top accounts at Indegene.

Sameer has more than 19 years of pharmaceutical experience both in the industry as well as the services side. Prior to joining Indegene, Sameer has served a variety of leadership roles in companies like GlaxoSmithKline and Sudler & Hennessey. His expertise lies in building long-term strategic client relationships, developing programs to address specific business problems and effectively executing against set objectives.

Sameer has an MBA in marketing and a bachelor’s degree in chemical technology.

Nellie Mamuya
Quality and Compliance Manager, KEDRION BIOPHARMA

Anthony Molloy
Vice President, Legal and Compliance, PACIRA PHARMACEUTICALS

Doreen Morgan
Vice President, U.S. Regulatory Affairs, LEO PHARMA

Scott Morrison
Global Biosimilars Medical Review Lead, PFIZER

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Scott Morrison is a Global Biosimilars Medical Review Lead within the Global Biosimilars Medical Affairs organization at Pfizer, in the UK. He graduated with a Ph.D. in Biochemistry & Molecular Biology from the University of Leeds, the UK in 2002.

Dr. Morrison leads the global review of activities relating to the on market and in development biosimilars portfolio. This position provides input of scientific expertise into a broad range of business activities as well as acting as Subject Matter Expert on matters of medical affairs processes, responsible for the Medical compliance and consistency of Global Biosimilars communications via review of activities and materials (promotional and non-promotional).

Dr. Morrison works with both the Global team and local countries to guarantee those company policies and global/country Codes are maintained, to ensure accurate, balanced, comprehensive non-promotional and promotional activities, materials, medical communications and internal training for the biosimilars portfolio.

Leslie North
Vice President, Sales & Marketing, EAGLE PHARMACEUTICALS

Josephine Secnik
Director, Ad/Promo Regulatory Affairs, ELI LILLY

Keri F. Shugrue
Marketing Operations Manager, SUNOVION

Amy Van Sant
Director, Regulatory Advertising and Promotion, JANSSEN

Gary Wieczorek, Director, Regulatory Affairs, US Advertising & Promotion, ABBVIE

Gary Wieczorek
Director, Regulatory Affairs, U.S. Ad/Promo, ABBVIE

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Gary is a director in Abbvie’s US Advertising and Promotion department. He has more than 30 years of experience in the pharmaceutical industry, including 10 years in quality assurance and 17 years in regulatory affairs. His experience also includes working for small, mid-sized and large pharmaceutical companies. Gary has a Bachelor of Science in chemical engineering from Purdue University and a Masters in Business Administration degree from Lake Forest Graduate School of Management.