Advisory Board

Each CCC Regulatory Compliance Test (RCT) is reviewed by Members of the Advisory Board to ensure that it is comprehensive, practical, and up-to-date. The Board, which is composed of leaders in FDA regulations, government guidelines, and voluntary industry codes, includes former FDA officials and regulatory lawyers in pharmaceutical and medical device companies and from independent consulting and law firms. All CCC Regulatory Compliance Tests have been designed by educational experts. Please note that the Regulatory Compliance Tests are the sole responsibility of CCC itself.

Members of the CCC Advisory Board

Ilyssa Levins, president and founder of the Center for Communication Compliance (CCC) has 30 years of healthcare communications experience, which includes regulatory compliance leadership. Over a period of two decades with Grey Global Group, her entrepreneurial accomplishments included launching the BrandEdge marketing consultancy, catapulting Grey's healthcare public relations (PR) practice to a top 10 global ranking, and leading a PR boutique, GTFH, to be named #1 in healthcare two years in a row.

Early in her career, Ilyssa recognized that regulatory compliance was an under-served area in the healthcare communication profession. In 1991, she founded the PR section of the Coalition for Healthcare Communication, an industry advocacy group focused on FDA regulatory policy and enforcement. However, there continued to be an unmet need for a standardized regulatory compliance curriculum for promotional agencies. Her priority upon leaving the corporate world was to establish a center for learning where regulatory compliance was a key focus. Ilyssa also recognized that industry would be served by a consulting firm that combined the best of regulatory compliance and marketing communications expertise.

To fill this industry need, Ilyssa founded CCC and launched the first standardized training courses, with corresponding certification tests, to enhance regulatory compliance in advertising/promotion, promotional medical education, Internet Promotion/Social Media, patient relationship marketing, and public relations. The company addresses other unmet needs as well: the first pertains to the need for increasing the role of communication professionals in the development and execution of Risk Evaluation and Mitigation Strategy (REMS) components; the second, to the need for a basic course on drug development with a focus on clinical trials for professionals new to the pharmaceutical, biotech, and device industry.

Ilyssa is an industry spokesperson and a published author on regulatory compliance healthcare communication. She was the only healthcare executive to be named a Women Achiever of the Year by the YWCA of New York in 2000, and is a Healthcare Businesswomen's Association (HBA) Rising Star. Her Board memberships include the HBA, where she served as Director of Marketing Communication, Director of Business Development and Strategic Alliances, and Director of HBA Awards. She received the HBA President's Award in 2011 and was named one of the industry's 100 Inspiring People by PharmaVoice in 2012 (see the full article).

Ilyssa graduated Phi Beta Kappa from New York University with a degree in journalism and minors in public relations and Spanish.  

Wayne L. Pines is an internationally-known consultant on FDA-related regulatory issues for the pharmaceutical and medical devices industries. He specializes in regulatory strategy and medical advertising and promotion regulatory issues. Wayne served 10 years in senior positions at the United States Food and Drug Administration (FDA). He was FDA’s chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He was the chief media spokesman for the FDA for seven years and also was the founding editor of FDA consumer magazine. In 2004, Pines was named the FDA’s Alumnus of the Year. Wayne is author or editor of several books about risk management and FDA regulatory processes. He wrote the FDA Advertising and Promotion Manual, the standard reference for the field. Pines also co-authored A Framework for Pharmaceutical Risk Management and Pharmaceutical Risk Management: Practical Applications, both of which deal with risk management for pharmaceuticals. Wayne also edited A Practical Guide to Food and Drug Law and Regulation; How to Work with the FDA; FDA: A Century of Consumer Protection; and the Marketing Compliance Guide for Drug and Device Manufacturers. Wayne chairs the Center for Healthcare Communication (CCC) Advisory Board of medical, legal, regulatory, and compliance professionals. Tracy Acker, PharmD, is President of The Acker Group LLC, a consultancy specializing in promotional regulatory affairs for medicinal products. From 1995-2000, Tracy served as Branch Chief in the Division of Drug Marketing, Advertising, and Communications (DDMAC) at FDA's Center for Drug Evaluation and Research (CDER). After leaving DDMAC, she worked as Director of Regulatory Affairs for Advertising and Promotion at Johnson & Johnson. Tracy most recently served as Executive Director of the Regulatory Promotion Group at Amgen. Previously, Tracy worked as a Regulatory Affairs Analyst in the FDA Practice Group at Reed Smith LLP. Tracy is an oncology subject matter expert and registered pharmacist. Lewis P. Amsel Ph.D. is President of Pharmaceutical Consulting Services, Inc., a consultancy specializing in drug formulation and development, including manufacturing scale-up and process optimization. Formerly with Watson Pharmaceuticals as VP of Pharmaceutical Technology, Dr. Amsel has also held positions at Searle/Pharmacia/Pfizer as Executive Director of Worldwide Pharmaceutical Technology. His areas of expertise include drug formulation and development, OTC product development, reformulation of existing products to enhance market share, cGMP issues, and regulatory affairs support to the drug development and manufacturing processes, including submission of applications for investigational new drugs and NDAs to the FDA. Dr. Amsel holds a PhD degree from the School of Pharmacy at the State University of New York at Buffalo. Alan Bennett is managing partner in the Washington office of Ropes & Gray and formerly was co-chair of its Life Sciences Group. He focuses on issues surrounding the development and marketing of medical products. His publications include The Legislative History of the Drug Price Competition and Patent Term Restoration Act, and articles on the Orphan Drug Act and the Hatch-Waxman Act. He served in the FDA General Counsel’s Office and was legislative assistant to the late Sen. Jacob Javits and Counsel to the Senate Governmental Affairs Committee. Glenn N. Byrd is a Director of Regulatory Affairs at MedImmune, where he leads the Advertising and Promotion team. His background includes several years in private industry and more than 10 years at the FDA, including as the Chief of the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER), where he managed the team responsible for regulatory review and enforcement of advertising and promotional labeling for biologic drugs and devices. Tom Chakraborti is an attorney registered in England and Wales specializing in pharmaceutical law, including regulatory compliance. After training as a doctor at Charing Cross and Westminster Medical School (part of the University of London) Tom worked as a physician at various NHS hospitals in England. He then trained as a solicitor at the prestigious international law firm, Slaughter and May. Tom has held a global position with Novartis as Senior Legal Counsel and an international position at Gilead Sciences Europe Ltd, as a Director within its international legal department, with responsibility for promotional compliance. He has also acted as a legal consultant to leading global pharmaceutical companies and been a member of Sidley Austin's European life sciences team. Howard L. Dorfman is an expert in FDA regulatory law, fraud and abuse, compliance programs, and risk management procedures. He provides compliance, regulatory and risk management consulting services to pharmaceutical and biotech companies and law firms. Howard is the editor-in-chief and contributing author of the Practicing Law Institute’s Answer Book on Pharmaceutical Compliance and Enforcement, and a Visiting Distinguished Professor at Seton Hall Law School. He has lectured and published articles on a range of legal and compliance issues pertaining to the pharmaceutical industry. Howard has served as Senior Vice President and General Counsel at Turing Pharmaceuticals, Vice President and General Counsel at Ferring Pharmaceuticals, Inc., and Vice President Assistant General Counsel at Bayer Pharmaceuticals (U.S.). Mark E. DuVal is President of DuVal & Associates in Minneapolis. He counsels companies on FDA issues. Previously, he was an in-house FDA, Anti-Kickback, and False Claims Act expert for Medtronic business units and Division Counsel for 3M Pharmaceuticals and Drug Delivery Systems. He is on the boards of the Food and Drug Law Institute and the Minnesota BioBusiness Alliance, on the Advisory Board for a new Masters Degree program in FDA Regulatory Affairs at St. Cloud State University, and on the Editorial Advisory Board for Medical Device Compliance. Henrique Krüger Frizzo is an associate at the law firm of Trench, Rossi and Watanabe, a division associated with Baker & McKenzie International, specializing in pharmaceutical and healthcare law. Frizzo specializes in contracts with Brazil's public administration and is widely published on the topic of promoting pharmaceutical drugs and medical devices globally. Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication and of counsel with the law firm Wiley Rein. A well-known advocate for First Amendment rights of individuals and corporations, he previously spent ten years each in the Washington office of the American Association of Advertising Agencies, in public policy positions at the Federal Communications Commission, and as a professor of journalism law and ethics. Bonnie Lappin brings 25 years of human resources experience in helping companies develop their leaders, nurture innovation and fuel change. She frequently speaks on these topics at lifescience and healthcare companies throughout the US and Europe.

Bonnie is recognized globally as a visionary coach for hundreds of men and women in the life sciences industry. She understands how to help organizations mobilize their internal assets to serve as leadership models for continued growth.

Bonnie currently sits on the Board of Directors of the Healthcare Businesswomen's Association (HBA) for its Florida Chapter. She has also held Board positions for the Boston and European chapters.

Bonnie plays a principle role in CCC's Myth Busting methodology designed to help companies save time and money, while managing risk
Maurits J. F. Lugard is a partner in the Brussels office of Sidley Austin LLP, where he leads the firm's EU Life Sciences Regulatory team. Maurits advises on a variety of EU regulatory issues involving drugs, medical devices, cosmetics, biotechnology, and chemicals, including pharmacovigilance, GMP compliance, post-authorization safety studies, and clinical trials. He was with the European Commission for nine years, including a three-year term at the European Commission's Legal Service. Maurits was responsible for analyzing draft legislation prepared by the Directorate-General for Environment and the Directorate-General for Health and Consumer Protection. He was also the European Commission's legal counsel on its communication on the "precautionary principle." In addition, Maurits spent six years at the European Commission's Directorate-General for Enterprise, where he led the European Union's "de-regulation" efforts in Japan for EU industrial products, including drugs and medical devices. Alan Minsk is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP. He advises companies on legal and regulatory matters. He also conducts in-house training on FDA and fraud- and abuse-related topics. He serves on the Editorial Boards of Pharmaceutical Formulation & Quality and Product Liability: Law and Strategy and is the General Counsel of the PDMA Alliance, a trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability. Michael Misocky is President of the Misocky Consulting Group. He is a registered pharmacist and an attorney. He was a Regulatory Review Officer for the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), now Office of Prescription Drug Promotion (OPDP). He also was Assistant Vice President and Deputy Compliance Officer at ImClone Systems and worked at Abbott Labs and Bristol-Myers Squibb. He is on the Editorial Board of the FDA Advertising and Promotion Manual. Preeti Pinto is an independent regulatory consultant with over 25 years of experience in pharmaceutical industry in research, development, and post marketing regulatory activities. After many years in senior corporate roles, she now heads Preeti Pinto and Associates, LLC. The company provides consultation in all aspects of promotional regulations including review of promotional material, risk assessment and regulatory strategies for using digital and social media platforms. Preeti provides advice on the procedural aspects of the medical, regulatory review boards and how to increase efficiency and efficacy of copy review committee. Preeti is a recognized expert in promotional regulations. She is an adjunct professor at the School of Pharmacy at Temple University, teaches a course entitled "Advanced Topics: Regulation of Advertising and Promotions."

As a member of the industry Social Media Working Group, Preeti met with DDMAC to propose and discuss regulatory guidance for the use of social media in pharmaceutical promotional activities. Under her direction, AstraZeneca was an early adopter of social media in marketing activities. Preeti also led the social media team at AstraZeneca to respond to FDA's Call for Comments regarding regulatory guidance on social media.
David Schofield is a consultant on Medical Information/Medical Affairs matters involving pharmaceuticals, biopharmaceuticals, and medical devices. David has over 20 years of experience in the field of Medical Information supporting pharmaceuticals, biological products, and medical devices at GlaxoSmithKline and Auxilium Pharmaceuticals. At both companies, David was responsible for and/or directed staff involved with responding to unsolicited questions from healthcare professionals, developing standard response letters, promotional material review and approval, and training sales representatives. David also was responsible for assuring the consistency of medical information provided globally. Prior to joining the pharmaceutical industry, David was a Director of Pharmacy at a 400+ bed hospital. He also was a consultant to the VHA buying group. Heloisa Barroso Uelze is partner at the law firm of Trench, Rossi and Watanabe, a division associated with Baker & McKenzie International, specializing in pharmaceutical and healthcare law. Barroso Uelze specializes in food, drug, and cosmetic regulatory law within Brazil.  Tammy Woffenden is a partner at the law firm of Locke Lord, LLP. Her principal area of practice focuses on transactional, regulatory, and administrative health law issues. She advises clients on matters relating to the Health Information Portability and Accountability Act (HIPAA), Health Information Technology for Economic and Clinical Health (HITECH) Act, and implementing regulations. She routinely works with clients on drafting and negotiating arrangements concerning the use and protection of health information, developing privacy and security compliance and breach notification policies and procedures, and investigating and reporting data breaches. She also advises clients regarding state data privacy and security laws. Nancie A. Zecco, MPH, is Director, Regulatory Affairs Labeling and Compliance at Precision Dermatology. She is responsible for all regulatory aspects of new product development and commercialization, as well as overseeing FDA submissions, including INDs and NDAs.  She oversees promotional regulatory compliance and is the primary liaison with the FDA/OPDP for all marketed products . Nancie also supports OTC and cosmetic product label development and product packaging and maintains annual licenses, registrations, drug and device listings, and patent information.

Nancie has extensive regulatory affaris experience in managing and auditing Phase I through Phase IV clinical studies both with pharma companies such as Genzyme, and in clinical research settings, such as at the Harvard Medical School, Mass General Hospital, and the Dana Farber Cancer Center. She was formerly the Director of the Oncology Clinical Research Office at the Cancer Research Center of the University of Massachusetts Medical School.

Education and Testing Advisor

Dr. Lester Hoffman is a nationally recognized expert in test construction, course design, and educational standards quality control. He has created certification and mastery tests and developed training programs on Regulatory Compliance in pharmaceuticals, financial services, and other regulated industries. Clients have included Novartis, Citigroup, Avon, Bank of America, JP Morgan/Chase, Lockheed-Martin, Merrill-Lynch, Alcoa, and AT&T. Dr. Hoffman has also designed and evaluated many Web-based training programs for baseline competencies in regulated industries. He has designed, developed, or revised more than 120 e-learning programs and on-line tools.

Dr. Hoffman has a PhD from Harvard University, where he did advanced academic research and graduate teaching in Instructional Design and Cognitive Psychology. This, combined with his 25 years of business experience, has enabled Dr. Hoffman to apply in business settings the principles of human learning and educational testing. At AT&T and Bell Labs, where the disciplines of mastery testing and competency models were first established in American industry, he worked with the pioneers of educational testing quality control and skill modeling. In the healthcare industry, he has worked with half of the global pharma top 20, including such major organizations as Novartis, Pfizer, Merck, GlaxoSmithKline, Eli Lilly, AstraZeneca, the National Institutes of Health, the National Cancer Institute, and Grey Global Group.