Faculty – 7th Promotional Review Committee Compliance & Best Practices


Kimberly Belsky
Executive 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 INC.

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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.


Alex Celius
Senior Manager, Compliance, PACIRA PHARMACEUTICALS

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Alex Celius is Senior Manager, Compliance for Pacira Pharmaceuticals, Inc., with 10 years of experience in the Life Sciences industry. He has extensive experience in the pharmaceutical industry in regulatory and compliance matters, including field-based auditing and monitoring, investigations, evaluation of promotional and non-promotional materials and marketing activities, KOL training, federal and state transparency reporting, and interactions with healthcare practitioners.


Ian DeMeritt
Medical Director, FINGERPAINT

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Ian DeMeritt’s passion for clear and concise medical communications is contagious. That’s why, as leader of Fingerpaint’s medical strategy team, he provides strategic medical direction and content for the health and wellness agency’s clients. An accomplished virologist, Ian’s primary area of expertise is infectious disease, and his skill set includes scientific and market research, medical writing, medical strategy and data analysis. One could say he knows a thing or two about viral marketing.

After earning his PhD in microbiology and immunology at Louisiana State University Health Sciences Center, Ian served as assistant scientific director for medical education company, where he was responsible for creating scientific content. From there, Ian transitioned to advertising, working his way up from senior medical writer to medical director. In the past five years in his role at Fingerpaint, Ian has further fleshed out the agency’s medical strategy team, ensuring they create all medical communications with the same eye for clarity as he does.

Ian has mastered a lot of things (science, the written word, unicycle riding, the Rubik’s Cube and marathons), but space travel still eludes him. He once applied to the NASA astronaut program, but didn’t make the final cut. But since he’s also mastered optimism, he couldn’t be prouder of his official NASA rejection letter.


Howard Dorfman
Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW

Founder, H.L. DORFMAN CONSULTING

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HOWARD L. DORFMAN is Founder of H.L. Dorfman Pharmaceutical Consulting, LLC, which provides compliance, regulatory, and risk management consulting services to pharmaceutical and biotech companies and law firms. In addition, he is an Adjunct Professor and Distinguished Practitioner in Residence at Seton Hall Law School, where he teaches courses on FDA Law and related subjects in the Health Law and Healthcare Compliance programs. Previously, Mr. Dorfman served in various senior capacities in national and international pharmaceutical and biotech companies. He 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 the Swiss-based global pharmaceutical and biotech company. Previously he served as Counsel in the Life Sciences group at Ropes & Gray LLP in New York, where his practice focused on providing legal and compliance representation to the pharmaceutical, medical device, and biotech industries.

Mr. Dorfman’s areas of expertise include FDA regulatory law, fraud and abuse, healthcare compliance programs, risk management processes, corporate governance, and product liability. Prior to his time at Ropes & Gray, he was chief legal officer of the pharmaceutical division of Bayer Healthcare LLC, where he was responsible for legal oversight relating to the commercial, regulatory, and compliance activities of the company’s U.S. pharmaceutical operations. Before joining Bayer, he worked at Bristol-Myers Squibb (BMS) where he served as Counsel in the Litigation department and subsequently as Counsel to the company’s U.S. pharmaceutical operations.

Mr. Dorfman has established compliance processes and SOPs across a wide range of issues including advertising and promotional review and interactions with healthcare professionals and provides counseling on regulatory, compliance and risk management issues to global, national and start-up companies in the healthcare field as well as advising companies on compliance with the Foreign Corrupt Practices Act (FCPA). He has lectured nationally and published articles on a range of regulatory, compliance and product liability issues. Mr. Dorfman received his B.A. with honors from Yeshiva University and his J.D. from Brooklyn Law School.


Janet Gottlieb
Executive Director, Medical Communications, ALLERGAN

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Dr. Janet Gottlieb is the Executive Director of Medical Communications at Allergan, where she leads the team responsible for the medical review of Company advertising and promotional materials. At Allergan, she had a direct role in the formation, expansion, and training of the centralized team, which resulted in greater efficiencies via improved turnaround times, consistency in guidance, and enhanced communication.

Dr. Gottlieb holds an undergraduate degree in Biological Sciences and Ph.D. in Medical Microbiology from the University of California, Irvine.


Stacy Harker
Manager, Promotional Compliance, ALLERGAN

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Stacy Harker brings over 25 years of pharmaceutical experience to her role at Allergan, where she is a Director of Medical Promotional Review managing Medical review for multiple products in the Medical Aesthetics profile, including BOTOX Cosmetic. In this role she provides proactive and reactive medical guidance on concepts, campaigns and promotional materials. Prior to her current role, Ms. Harker was a reviewer for Regulatory Advertising and Promotion where she oversaw more than ten launches and new indications across Allergan’s Eye Care, Dermatology, and Facial Aesthetics therapeutic areas. Due to her diversified background and experience, Ms. Harker is able to provide a more well-rounded perspective on promotional materials and FDA feedback, which further models and supports the team’s “solutions-oriented” approach to review. She holds degrees in Biological Sciences from the University of California, Irvine and Aeronautics from San Jose State University.


Kate Ho
Senior Manager, Regulatory Affairs – Advertising and Promotion, TESARO, A GSK COMPANY

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Kate Ho is currently a Senior Manager in Regulatory Affairs – Advertising and Promotion at TESARO, a GSK company. In this role, she is currently the lead regulatory reviewer for TESARO’s marketed product and helps to ensure product information is truthful and non-misleading while helping to further the mission of the company. She also supports various labeling assignments. Prior to her role at TESARO, she completed a 2-year Post-PharmD fellowship at Biogen, where she gained experience working on advertising, promotion and labeling from a regulatory perspective.
Kate received her Doctor of Pharmacy degree from Purdue University.


Stacy Joseph-Reese
Director, Regulatory Promotion and Labeling, TEVA PHARMACEUTICALS

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Stacy Joseph-Reese is currently the Director of Regulatory Advertising and Promotions at Teva Pharmaceuticals where she leads the Oncology, Biosimilar, and Health System Management promotional review teams. Stacy also represents regulatory on a number of cross functional initiatives including the Digital Center of Expertise, Global Medical Review, guidance document development, and responding to FDA call for comments. Stacy began her regulatory career at AstraZeneca in 1997 and joined Shire Pharmaceuticals as Director of Regulatory Advertising and Promotions in 2011. Her expertise spans all stages of a product’s life cycle and diverse media outlets.

Stacy brings value to the larger organization by providing strategic direction and viable regulatory solutions that meet the business objectives. She accomplishes this by understanding the overall business strategy, collaborating with other functional areas, identifying regulatory opportunities, and keeping up to date on the evolving FDA landscape. By proactively researching FDA guidance, correspondence, enforcement actions, and industry trends, Stacy comes to the table prepared with tools and resources to increase understanding and consistency across the organization.


Anita Kachappilly
Senior Manager, Regulatory Affairs – Advertising and Promotion, CELGENE


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

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Nicole (Nikki) Lare joins us from Mallinckrodt Pharmaceuticals where she was an Associate Director, Regulatory Affairs Advertising and Promotion where she managed mature products and provided guidance for development compounds. Prior to Mallinckrodt, Nikki was a Senior Manager, Regulatory Affairs Advertising and Promotion at AbbVie. She has over 10 years for Regulatory Affairs experience including OTC products. Nikki holds an MBA from Fairleigh Dickinson University in Pharmaceutical Management.
In her spare time, Nikki enjoys traveling, biking and skiing.


Richard Lem
Associate Director, Regulatory Affairs, Advertising and Promotion, BAYER

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Richard Lem is an Associate Director of Regulatory Affairs, Advertising and Promotion, at Bayer Healthcare. In this capacity, he serves as the regulatory lead in the review of company communications for multiple oncology products during their pre-commercial and commercial launch phase. Prior to Bayer Healthcare, Richard held positions of increasing responsibilities in the Regulatory Affairs, Advertising, Labeling, and Promotion group at Biogen.


Ilyssa Levins
President, CENTER FOR COMMUNICATION COMPLIANCE

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Ilyssa Levins is President and founder of the Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money, and manage risk, when promoting drugs and devices. Her combined regulatory, marketing communications, and change management expertise transforms compliance into a business enabler. Ilyssa has conceived and developed business solutions for review efficiency, including CCC’s new AI-powered software called SecureCHEK(tm) AI to increase the percentage of submission-ready promotional materials for review. She also launched the Compliance Gaming Arcade to increase retention of basic regulatory compliance requirements. A futurist, industry spokesperson, published author/columnist and NYU Phi Beta Kappa, Ilyssa was named 2014 HBA STAR in 2004 and received an HBA President’s Award for pioneering association initiatives in 2011. Ilyssa was also named one of the industry’s 100 Inspiring People by PharmaVoice.


Cristina Masseria
Methods and Capabilities Lead, PFIZER

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Cristina is currently leading the Methods and Capability team for HEOR and Market Access at Pfizer. Cristina has extensive experience in HEOR and RWD generation and communication in Pharma (Pfizer and GSK).

Before joining the pharmaceutical industry in 2011 at GSK, Cristina was a lecturer at the London School of Economics. She led various health policy initiatives with the European Commission and OECD. Cristina holds a PhD in economics, an MSc in economics, and an MSc in Health Economics.


Anthony Molloy
Esq, Vice President, Legal and Compliance, General Counsel, Deputy Compliance Officer, PACIRA

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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, VP OF U.S REGULATORY AFFAIRS AND QUALITY ASSURANCE

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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.


Tiffany Mura
Senior Brand Strategist, BIZPROX

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Tiffany Mura has almost 20 years’ experience in Pharmaceutical Marketing across consumer and HCP audiences, a wide variety of therapeutic categories, and all marketing channels including social and digital. She is the Founder and Senior Strategist at bizprox, a boutique pharma marketing agency based in Boston. Prior to restarting bizprox, she spent 6.5 years as Director of Consumer/Digital Marketing for Alkermes’ VIVITROL. She was also one of the original founders of Cadient Group in Philadelphia. In her spare time she is an avid runner, writer and improv actor.


Nneka Onwudiwe, Pharm.D., Ph.D., MBA
Founder and Chief Executive Officer, PHARMACEUTICAL ECONOMICS CONSULTANTS OF AMERICA (PECA) LLC

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Nneka C. Onwudiwe, Ph.D., Pharm.D., MBA, received her doctorate in Pharmacy (Pharm.D.) from the University of Maryland School of Pharmacy, Ph.D. in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and an MBA (Honors) from the University of Baltimore. In addition, she received an honor of Rho Chi in Pharmacy in 2002 and an honor of Beta Gamma Sigma in Business Administration in 2012.

Dr. Onwudiwe is a Patient-reported outcomes (PRO) and Pharmacoeconomics (PE) Regulatory Review Officer at the Food and Drug Administration (FDA). Dr. Onwudiwe is the technical expert and point of contact in the review of PRO, PE, and other types of claims in prescription drug promotion for the Division of Advertising and Promotion Review II (DAPR II) within the Office of Prescription Drug Promotion.

Dr. Onwudiwe teaches Comparative Effectiveness Research (CER) & Pharmacoeconomics at the University of Maryland School of Pharmacy. Dr. Onwudiwe has received several awards and accolades over the years. She has received funding as a Principal Investigator from NIH/NHLBI. Dr. Onwudiwe currently serves on the Food and Drug Law Institute’s (FDLI) Publications Peer Review Committee as well as a member of the ISPOR Value Assessment Frameworks Stakeholder Advisory Panel.

Dr. Onwudiwe has served on several ISPOR Scientific and Health Policy Working Groups (Task Forces and Special Interest Groups) that have developed products and tools used by decision makers and researchers around the world. She is currently serving on the Value Assessment of Medical Device Special Interest Group and Statistical Methods in Health Economics and Outcomes Research Special Interest Group. In addition to this work, Dr. Onwudiwe has presented at various professional conferences and published in several peer-reviewed journals such as Value in Health Regional Issues, Spine, Journal of the American Medical Association (JAMA), Obesity, Oncologist, Cancer Medicine, and Ethnicity and Disease.

Dr. Onwudiwe holds a license in pharmacy and practices as a pharmacist in the community providing medication therapy management (MTM) and other services.


Preeti Pinto
Former Executive Director, ASTRAZENECA PHARMACEUTICALS

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Preeti Pinto is a regulatory and compliance expert with over 30 years experience in the pharmaceutical and healthcare industries, with a strong working relationship with FDA and the Office of Prescription Drug Promotions (OPDP). Her experience extends to both drug development and marketing of Rx products. After many years in senior corporate roles, she is now an independent consultant and advises businesses in overcoming both the organizational and regulatory challenges in ensuring compliance with marketing regulations. Preeti is a recognized expert in promotional regulations. She has a passion for regulatory science and as an adjunct professor at the School of Pharmacy at Temple University, teaches a course entitled “Advanced Topics: Regulation of Advertising and Promotions.”

During her tenure as the Executive Director and head of Promotional Regulatory Affairs (PRA) from 1999 to 2010, Preeti increased the efficiency of the organization while decreasing staffing. She founded the Medical Education Grants Office at AstraZeneca and made major contributions to the policies regarding the scientific exchange of information. She led the department to develop and implement a new organization model for PRA, including risk algorithms and streamlining the review process.

As a speaker and panelist for several Healthcare Businesswomen’s Association programs, Preeti has shared her experiences with her colleagues. She has been inspirational to other women on how to excel professionally while maintaining a work-life balance. Along with her husband, Preeti raised two children while working full-time. Preeti resides in West Chester, PA.


Linda Pissott Reig
Co-Chair, BIONJ LEGAL, COMPLIANCE, & REGULATORY GROUP

Adjunct Professor, Management and Global Business, RUTGERS BUSINESS SCHOOL

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Linda Pissott Reig, Esq. has over twenty years of experience including but not limited to lawful advertising and promotion, adverse event monitoring, compliance program development, health economic & value claims, and reprint dissemination. An executive leader and shareholder at Buchanan Ingersoll & Rooney, PC., Linda counsels companies focused on Rx and OTC drugs, biologics, medical devices, medical foods and dietary supplements. She is a co-chair of the FDA/Biotechnology Group at her law firm. In addition she co-chairs the Bio NJ Legal, Compliance & Regulatory Group, which she was instrumental in forming in 2008. Linda clerked for NJ Supreme Court Justice Marie L. Garibaldi and is a past recipient of the NJ Law Journal “40 Lawyers Under 40” accolade. Linda regularly speaks & writes about “hot” topics affecting the industry and teaches a pharmaceutical legal, regulatory & ethics class in the Rutgers MBA program’s Pharmaceutical Concentration program. She is a cum laude graduate of Georgetown University Law Center & summa cum laude graduate of Rutgers Newark College of Arts & Sciences.


Linda Pollitz
Senior Director, Regulatory Affairs, Advertising and Promotion, ALKERMES

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Linda Pollitz has been working in Regulatory Affairs for more than 20 years, currently as Senior Director of Regulatory Affairs, Advertising and Promotional Labeling, at Alkermes, Inc. Her regulatory experience includes preparation of US and global submissions for medical devices, as well as oversight of drugs, biologics, medical device, IVD, and cell therapy promotion. Linda is a visiting lecturer at Regis College in their Masters in Drug Discovery and Product Regulation, where she lectures on product advertising, promotion and labeling. Linda also serves on the Regulatory Affairs Professionals Society (RAPS) Editorial Advisory Committee, and helps in developing monthly themes and topics for Regulatory Focus, as well as providing technical review for feature articles and books. Linda has published articles and book chapters for RAPS, and is a frequent speaker at conferences on labeling, advertising, promotion and compliance.


Bill Robinson
Director of Commercial Content Strategy, VEEVA

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Bill Robinson is the Director of Commercial Content Strategy for Veeva Systems.

He has spent over 20 years in the advertising and promotion space, beginning his career developing go-to-market strategies for pre-launch and established brands. In the early 2000s, Bill transitioned to the client side. He served in various roles including global director of marketing operations at Shire, where he oversaw the review, approval, and lifecycle management of promotional materials. Most recently, as a director of regulatory affairs at Teva, he was responsible for managing the operational aspects of promotional review and approval as well as the regulatory review of content.

In his current role at Veeva, Bill is responsible for the strategic direction of the Veeva Vault PromoMats product.

Bill has a BS in Communications from Millersville University and an MBA from Holy Family University.


Denice Simon
Assistant General Counsel, TAKEDA

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Denice Simon is an attorney with Takeda Pharmaceuticals U.S.A., Inc. in Deerfield, IL, where her practice areas include healthcare law, regulatory affairs and compliance. She earned the B.S. degree in Pharmacy and Pharmaceutical Sciences from Purdue University and is a registered pharmacist. She earned a Juris Doctorate from John Marshall Law School where she achieved high scholastic recognition on the Dean’s List. She is an adjunct professor at John Marshall Law School and is currently a member of the Board of Directors for the Association of Corporate Counsel (ACC) Chicago and the Advisory Board for the National Association for Minority and Women Owned Law Firms (NAMWOLF).


Kathy Tavakoli
Regulatory Affairs Advertising and Promotion, LUPIN PHARMACEUTICALS

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Kathy currently leading the Promotional Review Committee (PRC) at Lupin Pharmaceuticals. She is operating as the only permanent Regulatory Ad & promo member and frequently liaising with legal, compliance, marketing and sales on a variety of topics and issues. Kathy also serves on promotion review teams for multiple therapeutic areas in brand & generic products and processes all 2253 submissions. At Lupin Pharmaceuticals, she has a direct role in changing and training the PRC process and team, which resulted in the greater efficiencies via improved turnaround times, consistency in guidance, and enhanced communication.
Kathy holds an undergraduate degree in Biological Sciences from Chapman University and M.S in Biotechnology & Enterprise from Johns Hopkins University.


Keren Tenenbaum
VP and Assistant General Counsel, Head of Legal, Salix, BAUSCH HEALTH


Gary Wieczorek
Director, Regulatory Affairs, ABBVIE

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Gary is a director in Abbvie’s U.S. Advertising and Promotion department. He has over 30 years of experience in the pharmaceutical industry, including 10 years in Quality Assurance and 20 years in Regulatory Affairs. His experience also includes working for small, mid-sized, and large pharmaceutical companies. Gary has a Bachelors of Science Chemical Engineering degree from Purdue University and a Masters in Business Administration degree from Lake Forest Graduate School of Management.


Maura Wiswall
Manager, Product Management, Content Management Solutions, IQVIA

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Maura is a Product Manager for ePromo at IQVIA. Since 2017, Maura has contributed to the design of innovative product features for IQVIA. Maura has an MSLIS in Digital Libraries and over four years of hands-on experience in modular content management and promotional materials lifecycle for Merck & Co., Inc.


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


Dan Zavodnick
General Counsel, KEDRION BIOPHARM, INC

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Dan Zavodnick currently serves as U.S. General Counsel at Kedrion Biopharma, providing proactive legal support to senior management, product brand teams, and client groups across the organization, and advising and educating on regulations pertaining to branded pharmaceutical products. He sits on multiple brand advertising and promotional review committees, reviewing and analyzing risk-benefit profiles of commercial and medical communications, activities, and initiatives. Dan has previously served as senior regulatory counsel at a number of large, multi-national pharmaceutical manufacturers, including Allergan, Bayer, Astellas, Leo Pharma, and Eisai. He received his bachelor’s degree from the University of Pennsylvania and his Juris Doctorate from Fordham University School of Law. Dan’s favorite surf spot is Nosara, Costa Rica.