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

Wayne Pines, Chair of the CCC Advisory Committee
Wayne Pines is a nationally recognized expert on regulatory aspects of healthcare advertising and promotion. Wayne served at the FDA for 10 years as chief of consumer education and information, chief of press relations, and associate commissioner for public affairs. He was the FDA’s chief spokesman to the media for seven years, and was the founding editor of its consumer magazine. In 2004, Wayne was named FDA’s Alumnus of the Year.

Wayne has been published widely on regulatory and crisis management topics. He is the author of the FDA Advertising and Promotion Manual, the standard reference in the field. Wayne has taught graduate-level courses in PR and frequently speaks at educational symposia. He has chaired the annual advertising meetings for both the Drug Information Association and the Food and Drug Law Institute since 1989, and has been given each organization’s highest award. Wayne is a graduate of Rutgers University.
Jill Alvarez, JD
Jill Alvarez is a partner in Nixon Peabody's Technology & Intellectual Property Group and leads the firm's FDA Regulatory Practice. She advises regulated companies on FDA and other regulatory matters. She also assists manufacturers with coding, coverage, and reimbursement issues and importing/exporting issues, and conducts due diligence for life science companies and institutional investors. Before joining Nixon Peabody she was a partner in the health care and life-sciences practice groups of two national law firms in Washington and New York.
Alan R. Bennett, JD
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, MBA, RAC
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.
Mark E. DuVal, JD
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.
Anthony M. Iacono
Anthony M. Iacono is president and founder of Access Medical Network, Inc., a company specializing in medical education strategic planning and design. Previously, Tony was Assistant Vice President, Wyeth Pharmaceuticals, where he played a key role in medical education and grant-funding activities, and served as chair of the firm’s Promotional Guidelines Committee. Formerly, Tony was a member of the AMA’s Working Group on Gifts to Physicians from Industry, and education chair and board member of the Healthcare Marketing Council. Tony currently serves on the CME subcommittee of the Coalition for Healthcare Communication.
John F. Kamp, JD, PhD
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.
Coleen Klasmeier, JD
Coleen Klasmeier is a partner in Sidley Austin's Life Sciences Practice in Washington, where she focuses on regulatory, litigation, transactional, and enforcement matters. She counsels companies on promotional issues and writes and lectures frequently on promotion and other FDA-related matters. She is the author of Thompson Publishing's two-volume FDA Advertising and Promotion Manual. From 2002 to 2004, she was Special Assistant to the Chief Counsel at the FDA. She has been practicing food and drug law for a dozen years.
Alan Minsk, JD
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, RPh, JD, CHC
Michael Misocky is President of the Misocky Consulting Group. He is a registered pharmacist and an attorney, and is nationally certified in healthcare compliance. He was a Regulatory Review Officer for the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC). 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.
Nancie Zecco, MPH
Nancie A. Zecco, MPH, is Senior Regulatory Associate at the biotechnology company, Alkermes, Inc., where she is responsible for all regulatory aspects of new product development and commercialization, as well as overseeing all aspects of FDA submissions, including INDs and NDAs. As a Regulatory Affairs professional, Nancie has extensive experience in managing and regulatory audit of Phase I through Phase IV clinical studies. Nancie has worked in both pharmaceutical and device companies – at such firms as Genzyme Corporation – as well as in clinical research settings, such as at the Harvard Medical School, Mass General Hospital, and the Dana Farber Cancer Center. At the Cancer Research Center of the University of Massachusetts Medical School, Nancie was the Director of the Oncology Clinical Research Office and was responsible for overseeing all regulatory compliance. Nancie has an MPH in Epidemiology from the University of Massachusetts Medical School-Worcester, and has taken many additional courses at the Harvard School of Public Health.

Education and Testing Advisor

Lester Hoffman, PhD
Dr. Lester Hoffman is a nationally recognized expert in test construction 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.

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 such major organizations as Pfizer, Merck, GlaxoSmithKline, Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Amgen, the National Institutes of Health, the National Cancer Institute, and Grey Global Group.