Faculty – 2018 Off-Label Regulatory Compliance Congress

Jacqueline Armani,
Medical Science Liaison, Surgical, ALCON

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Jacqueline S. Armani, O.D., F.A.A.O., graduated from the New England College of Optometry, externed at Bascom Palmer and practiced at the VA as a primary care and ocular disease resident optometrist. Jackie has extensive experience training and mentoring residents and students and is a Fellow of the American Academy of Optometry. She joined industry following years of clinical practice as Executive Clinical Outcomes Specialist at Bausch and Lomb. Jackie is now a Medical Science Liaison at Alcon Surgical where she supports over 20 products in 6 product categories. Jackie’s career has included her medical mission in Colombia with VOSH and South Africa with OneSight Global. She resides in New York, volunteers on her alumni board, and loves to travel and plan events.

Alma Azua-Cassady
Corporate Compliance Manager, THE MOUNT SINAI HEALTH SYSTEM

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Ms. Alma Azua-Cassady’s expertise concentrates primarily on strategic development and management of integrated healthcare and regulatory campaigns. She has enjoyed particular success in Corporate branding, Physician Marketing Patient Education programs, Consumer Marketing and Corporate Compliance education. Her commitment to Healthcare Marketing Communications Management has consistently yielded innovative programs developed on behalf of several brands of the AstraZeneca maker as well as for other leading pharmaceutical companies.

Ms. Azua-Cassady branding practice started over 17 years ago with a Banking Investment program for African-debt relief in the United Nations and she has worked across national and global brands such as Swatch, Humira, Sculptra, and Crestor to name a few. Her passion for specialty branding has been reflected in marketing programs with circulation in at least 70 countries. Alma is a graduate of Universidad de las Americas-Puebla and holds a BA in International Relations and Marketing. Received Exec. Certificate in Global Marketing Strategy from the Thunderbird School of Global Mgmt. in Dec. 2009 and currently has submitted her MPH candidacy.

In previous years, Alma was the recipient of prestigious industry Awards / Honors: such as
2011 Elite American Executives; 2010 Cambridge Who’s Who; 2009 XLPharma Multicultural Strategies for Life Sciences; 1st prize at 2008 PhAME; 2008 Direct To Consumer (DTC) industry awards; Honorable mention in 2008 HispanicAd.com awards amongst others.

John Paul Benitez

Glenn N. Byrd, MBA, RAC
Senior Director, Promotional Regulatory Affairs, ASTRAZENECA

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Glenn N. Byrd, MBA, RAC
Senior Director, Promotional Regulatory Affairs

Glenn heads the AstraZeneca Oncology Promotional Regulatory Affairs (PRA) team and sits on the Oncology Business Leadership Team. He has held a variety of regulatory roles over the last 28 years with the last 10 ½ years at AstraZeneca/MedImmune.

Glenn also spent 10 years at the US Food and Drug Administration in both the Center for Devices and Radiological Health as a device reviewer and at the Center for Biologics Evaluation and Research as head of the Advertising and Promotional Labeling Branch.

Glenn has served on the Regulatory Affairs Professionals Society (RAPS) Board of Directors for the last 7 years and is currently President-elect.

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.

Ethan Davis
Deputy Assistant Attorney General, DEPARTMENT OF JUSTICE

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Ethan P. Davis is the Deputy Assistant Attorney General for the Consumer Protection Branch at the Department of Justice. In that role, he oversees the Branch’s efforts to enforce the Food, Drug, and Cosmetic Act throughout the United States. Before joining the Justice Department, Ethan was a partner at King & Spalding LLP, where his practice spanned a wide range of civil and criminal life sciences and healthcare matters. Ethan has argued in many federal and state courts around the country, including the U.S. Supreme Court. Earlier in his career, Ethan was a trial attorney in the Justice Department’s Civil Division and, before that, a law clerk to Judge Diarmuid F. O’Scannlain of the Ninth Circuit. He is a graduate of Yale Law School and Amherst College.

Howard Dorfman


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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.

Leslie Gladstone Restaino, General Counsel, VALIDUS PHARMACEUTICALS

Leslie Gladstone Restaino

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Leslie is a life sciences attorney and compliance professional with diverse background in all aspects of drug and medical device development, approval, commercialization, compliance, intellectual property and commercial transactions. She has been a partner with several international law firms and currently serves as General Counsel to Validus Pharmaceuticals. In this capacity, Leslie works with her executive team on all legal matters relating to acquiring, manufacturing and selling pharmaceutical products including product launch, commercialization, complex licensing arrangements, joint ventures and clinical development. She is responsible for all legal support for corporate matters, healthcare law and regulatory compliance, sales and marketing, intellectual property, and commercial transactions. Leslie also serves as Lead Compliance Counsel with direct responsibility for developing, implementing and monitoring business-wide business, ethics and regulatory compliance programs including Codes of Conduct and Ethics and policies, systems and processes to reduce the risk of Anti-kickback, FCA and related healthcare law violations.

Bruce A. Leicher
Sr. Vice President and General Counsel, MOMENTA PHARMACEUTICALS, INC.

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Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., an innovator biotechnology company engaged in the development of complex generic products, biosimilars, interchangeable biologics and novel products. Mr. Leicher has advised biotechnology companies for over 25 years. Mr. Leicher is a frequent lecturer on biotechnology law. Mr. Leicher is also Chair of the Board of the Biosimilars Council, a Division of the Association for Accessible Medicines (AAM). Before joining Momenta, he served in senior legal positions at Altus Pharmaceuticals Inc., Antigenics Inc., Millennium Pharmaceuticals, Inc., Curis, Inc., Genetics Institute, Inc., and Wyeth. In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale and Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the U.S. District Court for the District of Columbia after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.

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

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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.

Richard Liner
Senior Compliance Counsel, BAYER

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Richard Liner is Senior Compliance Counsel for the Bayer’s pharmaceuticals division. He advises on compliance and fraud and abuse issues, including anti-kickback, anti-corruption and off-label promotion laws, regulations and guidance. He routinely works on the development of policies, procedures and guidance for the Bayer pharmaceutical business and manages both external and internal compliance investigations. Richard joined Bayer in 2009 after spending six years at the law firm Arent Fox in Washington, D.C., where he counseled and defended manufacturer and healthcare provider clients on a variety of fraud and abuse and regulatory matters.

Sabrina Mays-Diagne
Senior Corporate Attorney, OPDC Legal Affairs, OTSUKA

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Sabrina Mays-Diagne, J.D., is a Senior Corporate Attorney with Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) supporting the company’s research and commercial activities in the cardio-renal therapeutic area in the United States of America and globally. She works with and leads interdisciplinary teams to develop and implement business solutions and to ensure that pharmaceutical investigational and promotional product activities and other business initiatives, including social media activities, are executed in compliance with applicable legal and regulatory requirements and company policies.

Prior to joining Otsuka, Sabrina was with Pfizer, Inc. where she enjoyed a successful sales career as a Professional Healthcare Representative and launched a variety of pharmaceutical products, while pursuing a law degree. She subsequently leveraged her sales background and law school education and transitioned into a legal career in the pharmaceutical industry. She served as a Corporate Counsel, Regional Attorney at Pfizer, Inc. providing counsel and legal support to the Mid-Atlantic Region Sales Leadership and field force.

Sabrina is a native Washingtonian. She holds a Bachelor of Science degree in business administration with a concentration in marketing from Howard University and a Juris Doctorate from James E. Beasley School of Law at Temple University. Sabrina is licensed to practice law in Pennsylvania and New Jersey and is a member of the Association of Corporate Counsel, Corporate Counsel Women of Color, CABLIBR Global Leadership Network and Alpha Kappa Alpha Sorority, Inc.

Jennifer M. Williams, Ph.D., J.D., MBA, RN, MSM
Chief Global Compliance and Ethics Officer, VP of Government Affairs Assistant Professor, UNIVERSITY OF SOUTHERN INDIANA

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Over the past 25 years, Dr. Williams has devoted her intellectual energy to eliminating the traditional distinction made between the medical and legal arenas. Having been employed by various healthcare organizations in a number of professional capacities over the course of her career, she has gained invaluable experience within hospital organizations, regulatory agencies, academic institutions and the medical device industry. By supplementing this experience with service as a faculty member in multiple departments of hospital organizations, as well as participation in a CEO Fellowship program, she has been able to develop a greater degree of perspective on what it means to operate a healthcare-related business entity. As such, she has come to recognize the importance of “top-down” educational communication, a process which ensures that important information is available at all levels of the business infrastructure. In order to make sure that such a goal could be effectively and efficiently accomplished, Dr. Williams developed her own educational programs, putting them to work in organizational and institutional capacities for the purpose of securing the support of local, state and federal agencies in the proliferation of technological and pedagogical patient safety and prevention efforts. Dr. Williams’s extensive experience in research, education and writing has enabled her to painstakingly translate research ideas into fundable opportunities and successful projects with the goal of improving people’s lives.

As both an executive leader and clinical scientist, her area of expertise lies not only in the development and proliferation of professional medical strategies, but in the global integration of physician-targeted training programs. Dr. Williams has established and implemented scientific teams while leading tactical execution plans in order to implement strategies to engage scientific thought leaders. She is a member of the Health Law Society, the American College of Healthcare Executives and the Medical Science Liaison Society. She serves as an adjunct and visiting professor for graduate level courses on health law, legal aspects of healthcare and ethics. Her interests as a healthcare advocate are broad, assuring fundamental rights are protected. In addition to lecturing and writing on the importance of First Amendment rights as they relate to healthcare, she also works to ensure that the rights of the underprivileged are preserved. She has published extensive review articles on the subject of elder law and age discrimination in healthcare, which received writing merits. She also served as a Legal Intern at Western Michigan’s Sixty-plus Law Clinic.

In addition, Dr. Williams has traveled internationally for the MSL Society, Nascent Medical and ExL Events, lecturing on a variety of subject matters relating to the MSL and Medical Affairs role. She has contributed her time to mentoring candidates promoting a MSL Certificate Program, chairs an advisory committee for release of MSL guidelines, resides on the Editorial Board for the MSL Journal, and is a contributor for Nascent Medical.

Dr. Williams has also served as a Medical Science Liaison and Medical Affairs leader, during which time she implemented a program to develop an MSL group within a medical device organization. Medical Science Liaisons, like Dr. Williams, are vital in the success of a company, and their roles can be observed within the pharmaceutical, biotechnological, medical device, CRO and other healthcare industries. She serves as a scientific peer and provides educational resources within the medical community.