Faculty – 5th Promotional Review Committee Compliance & Best Practices

Cynthia Akue
Promotional Planner, ALLERGAN

Sergio Alegre
Vice President, Global Compliance, VERTICAL PHARMACEUTICALS

Kimberly Belsky
Sr. Director, Regulatory Policy and Intelligence, Regulatory Affairs, MALLINCKRODT

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Kimberly (Kim) Belsky is a Sr. Director, Regulatory Policy & Intelligence, Mallinckrodt Pharmaceuticals. 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 Rx drug, OTCs/Nutritionals/Cosmetics, and devices. Kim has more than 25 years of pharmaceutical experience, including 16 years in regulatory. Kim began her career in R&D and technology transfer, moved into a QC role, transitioned into drug development where she managed a GMP auditing function, and finally into regulatory affairs where she managed labeling, AdPromo and engaged in the development of regulatory systems and training on these systems. Kim holds a master’s degree in chemistry from SUNY Stony Brook and has several scientific publications. She is also an active member of RAPS and DIA (co-chairing the DIA Regulatory Affairs AdPromo WG).

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 and Labeling, FORMER 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.

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.

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

Howard Dorfman
Senior Corporate Counsel, EDGE THERAPEUTICS

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Howard L. Dorfman is Founder of H.L. Dorfman Pharmaceutical Consulting, LLC providing compliance, regulatory and risk management consulting services to pharmaceutical and biotech companies and law firms.
His areas of expertise include FDA regulatory law, fraud and abuse, health care compliance, risk management, corporate governance, and litigation.

Mr. Dorfman served as Vice President and General Counsel at Ferring Pharmaceuticals, Inc. in Parsippany, New Jersey where he was responsible for all legal matters relating to the U.S. affiliate of a Swiss-based global pharmaceutical and biotech company. Previously, he served as a Counsel in the Life Sciences group at Ropes & Gray LLP in New York where his practice focused on compliance and regulatory issues relating to the pharmaceutical, biotech, and medical device industries.

Prior to joining Ropes & Gray, Mr. Dorfman was chief legal officer of the pharmaceutical division of Bayer Healthcare LLC. Before joining Bayer, he was a member of the Bristol-Myers Squibb legal department as Counsel in the Litigation group involved in defense of nationwide product liability litigation and later as Counsel to the US Medicines Group involved in regulatory, compliance and commercial work.

Mr. Dorfman is an adjunct professor at Seton Hall University School of Law and has lectured and published articles on a range of issues including compliance, regulatory and litigation. He is Editor and Contributing Author of the Practising Law Institute Pharmaceutical Compliance and Enforcement Answer Book, now in its fourth edition. He received his B.A. with honors from Yeshiva University and his J.D. degree from Brooklyn Law School.

Terri Howard
Senior Manager, Medical Device Commercial Content, VEEVA

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Terri has spent more than 20 years of experience in various legal and regulatory roles, with over eight years focused on regulated content management in the medical device industry. Over the course of her career, Terri has worked with leadership teams in several companies to form or influence change in regulatory and marketing business practices, most recently at CareFusion (now BD). A few years ago, she made a slight change in her career direction and joined Veeva Systems to explore innovative ways of using technology and services to help life science companies successfully engage with their customers.

David Jacobs
Assistant General Counsel, Commercial Brands, DAIICHI SANKYO

Freddy Jimenez
Vice President, Law and Compliance, CELLDEX THERAPEUTICS

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Freddy A. Jimenez is Vice President, Law and Compliance at Celldex Therapeutics. In this role he is responsible for the development and execution of comprehensive legal and compliance strategies as well as coordination of legal services to support the R&D and commercial efforts of Celldex as it creates novel, disease-specific therapies that induce, enhance or suppress the body’s immune response to fight cancer. Previously he served as Assistant General Counsel for Johnson & Johnson (J&J) in New Brunswick, NJ. There, Mr. Jimenez was lead regulatory counsel for the pharmaceutical companies of J&J. In his more than 25 years in the industry, his practice has focused on the regulation of pharmaceutical and biotechnology products and health care compliance.

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.

Nicole Lare
Associate Director, Regulatory Affairs Advertising and Promotion, MALLINCKRODT

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Nicole (Nikki) Lare is an Associate Director, Regulatory Affairs Advertising & Promotion at Mallinckrodt Pharmaceuticals and manages several mature product portfolios as well as providing guidance for development compounds. Prior to Mallinckrodt, Nikki was a Senior Manager, Regulatory Affairs Advertising & Promotion at AbbVie. She has over 10 years of Regulatory Affairs experience including OTC products. Nikki holds an MBA from Fairleigh Dickinson University in Pharmaceutical Management.

Nellie Mamuya
Quality and Compliance Manager, KEDRION BIOPHARMA

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Nellie Mamuya is a QA Compliance Manager at Kedrion Biopharma with a focus on advertising and promotions. Ms. Mamuya is responsible for developing best practices; training; document control, and internal audits. She advises internal teams on a broad array of advertising and promotional topics, including the emerging rules and policies on internet and social media marketing issues. She also has experience conducting internal compliance audits of sales and marketing practices and materials.

Anthony Molloy
Vice President, Legal and Compliance, PACIRA PHARMACEUTICALS

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Anthony Molloy is the Vice President of Legal and Compliance at Pacira Pharmaceuticals. Prior to joining Pacira, Mr. Molloy worked for two Am Law 100 international law firms, where he focused his practice on Intellectual Property, Litigation, and Regulatory matters. He was part of the seminal case, Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al., 15-cv-07055 (S.D.N.Y. Sept 9, 2015), where Pacira brought suit against the U.S. Government claiming violation of the First and Fifth Amendments and the Administrative Procedures Act in connection with a later-rescinded Warning Letter. Mr. Molloy received his Bachelors in Chemistry and Chemical Engineering from SUNY Geneseo and Buffalo, his Masters in Technology Management from Stevens Institute of Technology, and his J.D. from Rutgers University School of Law.

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

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With over 25 years in the healthcare industry, Dr. Morgan’s experiences include both clinical development and commercial drug development with concentrations in strategic global regulatory affairs, promotional review, regulatory operations, publishing, drug safety and initiating fellowships within the regulatory affairs area.

Dr. Doreen V. Morgan joined LEO Pharma as VP, U.S. Regulatory Affairs in October 2015. Dr. Morgan leads the U.S. Regulatory team, ensuring U.S. regulatory strategies and initiatives support successful U.S. launches for LEO Pharma Inc. Dr. Morgan responsibilities also include oversight for U.S. regulatory operations, labeling, chair of the legal, medical and regulatory committee, and working with cross functional processes to facilitate strong collaboration between the U.S. organization and Regulatory Affairs in LEO Pharma in Ballerup, Copenhagen.

Dr. Morgan holds a Doctor of Pharmacy and a Masters of Science in Clinical Pharmacy from St. John’s University.

Leslie North

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Leslie North is Principal at TLBF Consulting, TLBF is a biopharmaceutical consulting company established to provide commercial services to small and start-up companies with limited sales or marketing resources. Leslie is an accomplished marketing and sales executive with an established track record of success across a broad range of therapeutics and channels. Leslie is a unique Commercial Leader with a different approach to pharma/biotech/device brand success. Her greatest financial and stakeholder outcomes have come from planning and commercial preparation far in advance of product approval and using science to mitigate the situation when planning isn’t possible. This unique approach comes from her Nursing, Clinical Research, Sales, and Marketing background, which gives her insights others may miss. She has honed these skills with inline and launch brands for startups through Global Fortune 500 organizations in primary care and specialty (including Orphan Drug) markets. Leslie is a registered nurse and holds a B.S. degree from the University of Pennsylvania in Philadelphia, PA. Leslie is based in CT where she resides with her husband and three dogs.

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

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Jo Secnik joined Lilly in 1990 where her career has included assignments in Biopharmaceutical Development, Quality Assurance and Regulatory Affairs. Her experience in Regulatory includes global CMC and for the last 10 years supporting the US business on advertising and promotion for marketed products.

Keri F. Shugrue
Marketing Operations Manager, SUNOVION

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After 20 years in the Meetings and Events Industry, Keri decided to change careers and embark on an adventure in Promotional Review. Currently the Manager of Marketing Operations at Sunovion Pharmaceuticals, Inc., Keri supports the Respiratory Brand Franchise and manages the PMRC training curriculum for both internal and external stakeholders. Keri holds a Bachelor of Arts degree from Bay Path University as well as the Certified Meeting Professional designation.

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.