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.

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 life science 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.

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.

Francoise Simon, PhD, is an internationally known author, speaker and consultant with recognized expertise in the digital transformation of healthcare. She is highly experienced in strategy consulting in the Americas, Europe, Asia and Africa, with clients including healthcare leaders, new venture firms, several governments and the United Nations. Dr. Simon’s new book, Managing Biotechnology: From Science to Market in the Digital Age (Wiley), covers the new role of infotech in healthcare, and shows how to capitalize on digital technologies, from R&D to the market. New models and cases contributed by senior executives combine as a roadmap to best practices at each stage of a patient-centered, digitally enabled, value chain. Dr. Simon’s academic teaching focuses on executive programs. She also chairs symposia at major conferences and she conducts industry seminars globally on digital business strategy, including disruptive innovation, customer experience, precision marketing, multi-channel communications and patient centric organization design.

Dr. Gerald Mosely helps leaders and their teams achieve business objectives by focusing on people-oriented leadership components that impact an organization. Gerald has spent over 20 years in the pharmaceutical industry in roles including sales, marketing, and country management across multiple therapeutic areas, and was a general manager as well as a medical science liaison. Leading commercial and technical teams globally up to >2,000 in headcount while managing US, ex-US and global P&L's, Gerald has also led organizational design, involving structure, standards, strategy as well as people, and has driven multiple product launches in different international markets. He earned his PhD at The University of Washington in Seattle in Experimental Pathology.

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.

Dr. Michael (Mike) Peterson is a professor and Chair of the Department of Behavioral Health and Nutrition at the University of Delaware. An author, speaker and consultant, Mike’s research focus is health promotion and behavior change programs at the community and individual level. Mike is internationally recognized as a leading authority on workplace culture, stress, and the dualistic approach to organizational and employee health.

Dr. Peterson is the creator of the “Culture-Work-Health” model which has been instrumental in helping businesses move towards more effective health promotion strategies in the workplace. More recently, Mike is applying his expertise to behavior change interventions for life sciences companies. Specifically, he applies a behavioral lens to corporate compliance programs to enhance ethical decision-making. He has also developed a psychometric tool to increase patient retention in clinical trials and to enhance patient engagement with their prescribed treatment regimens.

Mike created and founded the graduate Health Promotion Certificate program at the University of Delaware which trains students in community health and behavior change strategies. His health promotion programs in corporate, government, and educational settings include the highly successful Get Up and Do Something social marketing project which he created and directed for the past 18 years.

Mike has been primary investigator on many state and federal funded grant projects that promote health in communities throughout the Mid-Atlantic region. He serves as an advisor to the International Consortium of Health and Wellness Coaches, and created and founded the Graduate Health Coaching Research and Training Center at the University of Delaware where he is currently the Director.

Michael Varadian, JD, is a nationally recognized leader and innovator of progressive private and public sector healthcare systems, health reform, value/outcome based services, and integrated physical/behavioral health systems management and development.

For over thirty years, he has operated at the highest levels of state government, hospitals, national provider and managed health corporations, clinical outcome agencies, and consulting and law firms. He has specialized in national and statewide operations, pilots and program implementation involving health care and payment reform, fiscal oversight, integrated physical/behavioral health system development and hospital and payer regulations.

He has lectured and developed training programs on outcome based purchasing of healthcare services for the behavioral health field.

Relevant background for Outcomes Based Purchasing Initiatives:

CEO of Behavioral Health Laboratories- a leading national clinical outcomes company providing behavioral health outcomes reporting and management for providers, third party payers and Medicaid in over 30 states

Executive Director, RI Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, responsible for Department operations and policy, and oversight of all national health reform and integrated care pilots and state Medicaid waiver programs, including the nation’s first Chronic Disease Integrated Health Home Pilot Program

Senior Vice President and National Director of Health Reform, Providence Service Corporation, responsible for development, expansion (through M&A) training and transition of this multi-billion dollar international home and community based human services provider into integrated care and national health and payment reform initiatives, partnering with academic medical centers, Accountable Care Organizations, multinational employers and national managed care payers

Executive Vice President, First Health Services- a national Medicaid managed care corporation operating innovative statewide Medicaid privatization pilot programs in 12 states, including Early Periodic Screening, Diagnosis and Treatment (EPSDT) programs for children, External Quality Review, Behavioral Health Management, Beneficiary Enrollment and Capitated State Medicaid Services

Vice President, Newton Wellesley Hospital- 300 bed community teaching hospital and member of Partners Healthcare, including oversight of all Pediatric, OB/GYN, Pharmacy, Intensive/Cardiac Care/Emergency Department Units, Operating and Recovery Suites, Physical/Occupational Therapy Departments and Physician Recruitment.

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.

Dr. Susan Winter is a nationally known expert in applying cognitive techniques to optimize stakeholder collaboration and solve complex business challenges. She helps companies to manage conflict situations arising from diverse functional styles, skills, competencies and the interplay of personalities. Susan leverages decades of experience with cognitive processes and skills training to boost workplace performance enhance competitive advantage and increase professional satisfaction. She earned her PhD at the Albert Einstein College of Medicine at Yeshiva University, a premier, research-intensive medical school dedicated to innovative biomedical investigation.

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.

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.

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.