Our Company

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.

David Schofield, PharmD, 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.

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.).

Linda Gatto-Gambacorta, PharmD has held roles in Global Medical Affairs, Medical Information and Medical Communications at pharma/bio-pharmaceutical companies. Her expertise includes facilitating evidence-based accuracy of regulatory compliant, medical and scientific content for promotional and educational campaigns. With industry experience, including Schering-Plough, Merck and Celgene, Linda supported multi-billion dollar products and investigational drugs, providing strategic direction and program content development for oncology/hematology products. Linda was product lead for medical affairs shaping medical information/marketing strategies as well as promotional marketing/advertising with cross-functional teams. She has been involved with launch product/label updates; analysis of internal data and competitive landscape trends in disease states and therapeutic options; and product life cycle management development with cross-functional stakeholders. Prior to entering into the phama/biopharma industries, Linda was the founder and President of a consultant pharmacy firm for 13 years, ensuring proper administration and monitoring of medications according to federal and state regulation guidelines in healthcare facilities.

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.

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.

Rebecca Zobbe is a recognized subject matter expert in Marketing Operations, Rebecca has dedicated her career to driving transformative and sustainable change for multiple biotech, pharmaceutical, medtech, and health care companies and organizations. As a trusted advisor, she has helped more than 100 Life Sciences companies establish and optimize their Content Management Strategy including the critical process of Medical, Legal, and Regulatory (MLR) review. An early champion of marketing operations automation, Rebecca is a firm believer in continuous process improvement and advises her clients on how to integrate the latest technology into current established processes.

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.