June 10-13, 2013
Newark, New Jersey
NY/NJ CLE credits available
Michael D. Bell is Founder and President of R-Squared Services and Solutions, Inc., a healthcare consulting and technology firm that develops customized technical solutions to enhance and evidence compliance and operational effectiveness. He is a nationally recognized compliance expert who frequently consults, publishes and presents on topics of healthcare corporate compliance, state disclosure/reporting issues, privacy, and third party coverage and reimbursement and has worked closely with organizations to design and implement cost-effective, systems-based solutions that promote corporate compliance.
Mr. Bell has spent his entire career focusing on health care fraud and abuse defense and compliance and began his legal career at Epstein, Becker & Green in Washington, DC where he was a member of the Fraud & Abuse and Third Party Payment Practice Groups before moving to Mintz Levin where he became a Partner in the Health Care and Life Sciences Section. He also served as in-house counsel for a national durable medical equipment provider and was selected by Nightingale's Healthcare News as an Outstanding Young Healthcare Attorney in 2004.
Mr. Bell received his B.A. from Wake Forest University and his J.D. from Seton Hall University School of Law, with a concentration in health law from the Health Law and Policy Program.
Peter Blenkinsop is an associate in the Government & Regulatory Affairs Practice Group of Drinker Biddle & Reath LLP. Mr. Blenkinsop practice focuses on food and drug law, information management and privacy, and international regulatory compliance. He also assists in the management of several special-purpose industry consortia, including the International Pharmaceutical Privacy Consortium (IPPC), the Medical Device Privacy Consortium (MDPC), and the Rx-360 International Pharmaceutical Supply Chain Consortium.
Mr. Blenkinsop also is a member of the Privacy and Data Security practice subgroup, and he advises companies on compliance issues raised by US federal and state privacy laws including HIPAA, the HITECH Act, COPPA, the CAN-SPAM Act, and the Junk Fax Prevention Act. In this role, he assists clients in identifying privacy risks and developing information management strategies. He also advises companies on international data transfer issues under the EU Data Protection Directive and other foreign privacy laws.
Mr. Blenkinsop received his B.A. from Yale University and his J.D. from Georgetown University Law Center.
Bret A. Campbell is a partner in Cadwalader, Wickersham & Taft's Business Fraud and Complex Litigation practice where he represents clients in a broad range of complex criminal, regulatory, and civil litigation matters, including international corruption (involving the Foreign Corrupt Practices Act), money laundering, commercial fraud, securities, export control, economic sanction, and related issues. Mr. Campbell conducts internal investigations, advises clients on corporate governance issues, counsels on the implementation of compliance codes and conducts due diligence reviews in connection with complex corporate transactions. He recently advised a global pharmaceutical company in connection with internal investigations of Foreign Corrupt Practice Act issues related to the activities of subsidiaries and acquisition targets in Asia, Africa, Latin America, Europe and the Middle East.
Mr. Campbell received his B.A. from Hobart College and his J.D. from Vermont Law School.
Mary Devlin Capizzi is a partner in the Government Relations & Regulatory Affairs Practice Group at Drinker Biddle & Reath. Ms. Capizzi has served as a managing partner of the firm and was the firm's first chair of its Professional Development Committee. Her practice includes serving as secretariat and legal counsel for industry consortia addressing a range of matters affecting the life sciences industry. She consults with clients on issues impacting research, manufacturing, and commercial operations, including scientific, legal, regulatory and policy issues relating to product development, quality control and assurance, supply chain security, and data privacy and security. She particularly enjoys facilitating industry-wide initiatives focused on addressing and resolving complex regulatory issues.
Ms. Capizzi received her B.A. and M.B.A. from the University of Dallas, and her J.D. from Emory University School of Law. She is a member of several pharmaceutical and health care-related associations and serves as a member of the BNA Pharmaceutical Law & Industry Report Advisory Board.
Scott Cunningham is a partner at Covington & Burling and a member of the firm's Food and Drug practice group. Mr. Cunningham represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies. He has significant experience in areas including new product development and clinical trials, IRBs, new product approvals, Hatch-Waxman exclusivities and product life-cycle management, advertising and promotion, False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations, Orphan Drug, pediatric exclusivity manufacturing and cGMPs, import/export, controlled substances, SEC disclosure, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
Mr. Cunningham also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in neglect and abuse, and child custody cases.
Mr. Cunningham received his B.A. from the University of Pennsylvania and his J.D. from the University of Pennsylvania Law School.
Scott Danzis is a partner in Covington & Burling's Food & Drug and Health Care practice groups. Mr. Danzis regularly advises clients in the medical device, biotechnology, and pharmaceutical industries. He has substantial experience advising clients on FDA regulation of clinical trials, advertising and promotion, support for continuing medical education, drug and device labeling, imports and exports, good manufacturing practice, adverse event reporting, the Hatch Waxman Act, and the Freedom of Information Act. He also counsels clients on compliance with federal anti-fraud statutes, including the Federal Anti-kickback Statute, the Federal False Claims Act, and the Medicaid Drug Rebate Program.
From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration (FDA). While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.
Mr. Danzis received his B.S. from Cornell University, his M.H.S.A. from The George Washington University, and his J.D. from the University of Virginia School of Law.
Howard L. Dorfman is Vice President and General Counsel at Ferring Pharmaceuticals Inc., the U.S.-based subsidiary of Ferring Holding, a pharmaceutical, medical device and biotech company based in St. Prex, Switzerland, where he is responsible for all legal matters relating to the company’s U.S. operations. Prior to joining Ferring, Mr. Dorfman was Counsel in the Life Sciences group at Ropes & Gray LLP in New York City where his practice focused on providing guidance to the pharmaceutical, medical device and biotech industries.
Before joining Ropes & Gray, Mr. Dorfman served as chief legal officer of the pharmaceutical division of Bayer Healthcare LLC and a member of the Bayer Corporate Compliance Committee where he was responsible for legal oversight relating to the commercial, regulatory and compliance activities of the company's pharmaceutical operation and for providing counsel relating to a wide range of areas, including advertising and promotion, as well as labeling activities for the various Bayer therapeutic areas.
Prior to joining Bayer in 2001, Mr. Dorfman worked at Bristol-Myers Squibb for 23 years in a range of areas including defense of mass torts litigation, commercial law, FDA regulatory practice and health care compliance.
Mr. Dorfman has lectured and published on a wide range of pharmaceutical product liability and food and drug law regulatory issues, and his articles have appeared in the Food and Drug Law Journal, the Rutgers Law Review, and the Seton Hall Law Review, among others. He is currently an adjunct professor at Seton Hall Law School where he teaches a course on Pharmaceutical and Medical Device Promotion, Advertising and Communication.
Mr. Dorfman received his B.A. (with honors) from Yeshiva University and his J.D. from Brooklyn Law School.
Judy Fernandez is the Chief Health Care Compliance Officer for the Ethicon Franchise of Johnson & Johnson (J&J). Ms. Fernandez also serves as a board member for the J&J Patient Assistance Foundation, a non-profit organization that assists qualified patients in obtaining free products donated by the operating companies of J&J. Ms. Fernandez has held a number of senior compliance roles within J&J contributing to the development of an effective compliance program for the company, including as VP Quality and Compliance for J&J Health Care Systems and Worldwide Health Care Compliance Officer for the Ortho Clinical Diagnostic Franchise. During her time as Director, Medical Devices and Diagnostics for the J&J Worldwide Office of Health Care Compliance she was responsible for partnering with the Medical Device & Diagnostics companies to implement Health Care Compliance strategies worldwide.
Prior to her time in compliance, Ms. Fernandez held positions in Hospital Sales and Sales Management, Sales Training, and Management Development within the J&J pharmaceutical sector. She established the Management Development Program and was Director of Training for Janssen and the North America Pharmaceutical Centers of Excellence organization. Prior to joining the pharmaceutical industry, Ms. Fernandez was a critical care nurse.
Ms. Fernandez received her B.A. from Fordham University and her R.N. from the Westchester School of Nursing.
Gary F. Giampetruzzi is Assistant General Counsel and Chief of Government Investigations at Pfizer, Inc. He is responsible for government investigations of the company's operations around the world as well as associated government litigation before U.S. and international prosecutor's offices. In previous years, he served as Deputy Compliance Officer, International Investigations and Programs in the Corporate Compliance Group. Working with a headquarters team, a dedicated staff of regional compliance directors, and a network of international compliance liaisons, Mr. Giampetruzzi was responsible for the implementation and maintenance of compliance programs and systems throughout Pfizer's international operations, with an enhanced focus on emerging markets. He is a frequent speaker at industry conferences on compliance programs, internal investigations, and the Foreign Corrupt Practices Act. He has been instrumental in the development of Pfizer's compliance function and has been involved with the development of many critical aspects of its compliance program.
Mr. Giampetruzzi received his J.D. from St. John's University School of Law.
Nicholas C. Harbist is a partner in Blank Rome's White Collar Defense & Investigations practice group. His practice focuses on white collar criminal defense litigation, including anti-trust, health care fraud and abuse, defense contract fraud, securities fraud and tax fraud, environmental, export crimes and general business fraud, corporate internal investigations (including investigation client internal misconduct issues), corporate compliance programs (including structuring and implementing business corporate compliance programs), Qui Tam/Federal False Claims Act and whistleblower litigation, and complex commercial litigation (including RICO, anti-trust, securities, trade secrets, health care and professional licensing litigation).
Mr. Harbist is a former assistant U.S. attorney for the Eastern District of Pennsylvania (1984–1996), where he served as the special fraud coordinator and special assistant U.S. attorney involving litigation under the Classified Information Procedures Act.
Mr. Harbist received his B.S. from The College of New Jersey and his J.D. from Rutgers University School of Law – Camden.
Jack Hartwig is currently with the Deloitte Financial Advisory Services LLP (Deloitte FAS) Forensic and Dispute Services Practice in Philadelphia. Mr. Hartwig joined Deloitte in October 2001 after a 30-year career in the Federal Government, including seven years as Deputy Inspector General for Investigations at the Office of Inspector General. Since joining Deloitte, he has worked on a number of healthcare dispute engagements, including testifying as an expert witness in federal court. Mr. Hartwig has assisted outside legal counsel on Medicare voluntary disclosure matters and he has worked with large healthcare insurers to improve their anti-fraud efforts. He has conducted forensic investigations involving defalcations by senior executives in healthcare and other entities. Mr. Hartwig also has lectured extensively on a variety of health care issues, including the federal voluntary disclosure program and research integrity, and before a variety of groups including the Health Care Compliance Association and the Alliance of Independent Academic Medical Centers.
Mr. Hartwig has substantial experience in conducting both criminal and civil fraud investigations, specifically in healthcare fraud issues. He has met with Congressional staff on a number of high profile topics and has testified before congressional committees on issues such as home health agency fraud and Medicare fraud. Mr. Hartwig lectured extensively before numerous seminars and conferences on white-collar crime and auditing topics. He has served as a member of the Board of Governors of the National Health Care Anti-Fraud Association and Co-Chair of the Investigations Advisory Sub-Committee, President’s Council of Integrity and Efficiency.
Mr. Hartwig received his B.A. from Rutgers University and his M.A.S. from University of Illinois. He is a Certified Public Accountant in both New York and Pennsylvania, and is a member of the American Institute of Certified Public Accountants.
Professor John Jacobi is the Dorothea Dix Professor of Health Law & Policy, and the Faculty Director of the Center for Health & Pharmaceutical Law & Policy at Seton Hall Law School. Professor Jacobi teaches in the areas of Health Law, Health Finance, Disability Law, Public Health Law, Mental Health Law, and Torts. He also writes and speaks on issues including disability rights, health access and finance, public health, and mental health.
Professor Jacobi spent five years working for the New Jersey Department of the Public Advocate as Special Assistant to the Commissioner, where he worked on health, civil rights, and disability issues through litigation and advocacy in legislatures and regulatory agencies. He then became a Gibbons Fellow at the Gibbons firm, where he pursued health, prisoners’ rights, and disability issues. During 2007-2008 he was on leave from the law school, serving as Senior Associate Counsel to N.J. Governor Jon S. Corzine on Health, Human Services, and Children’s Issues. Professor Jacobi serves on the Board of the Greater Newark Healthcare Coalition, and the North Jersey Community Research Initiative, an HIV service organization. He has also served on the Governor’s Task Force on Mental Health, the Board of Advisors of the New Jersey Office of Child Advocacy, the New Jersey Olmstead Advisory Council on disability rights, and on other government and non-profit boards and committees.
Professor Jacobi received his B.A. from the State University College of New York at Buffalo and his J.D. from Harvard Law School.
Please find Professor Jacobi's full profile here.
Elizabeth H. Kim is a Manager, Regulatory and Compliance Services, with Porzio Pharmaceutical Services, an associate at Porzio, Bromberg & Newman P.C., and a member of the firm’s Life Sciences Compliance, Commercialization and Regulatory Counseling Department.
Ms. Kim counsels pharmaceutical, medical device and biotechnology companies on a variety of compliance-related issues, including federal and state fraud and abuse laws, FDA promotional regulations, industry standards regarding healthcare professional interactions, and PDMA compliance. Ms. Kim develops compliance programs for companies governing the sale and marketing of drugs and devices and the distribution of samples under federal and state law. She drafts agreements with vendors, consultants and other third parties, and reviews and evaluates promotional materials and marketing activities directed towards consumers and healthcare professionals. Ms. Kim also conducts management and sales force training and performs audits and gap analyses and risk assessments in a variety of areas, including sampling activities and medical publications. Additionally, she counsels manufacturers and distributors on issues related to record-keeping and pedigree as well as general wholesale distribution and licensing requirements for pharmaceutical, medical device and human and non-human tissue products.
Ms. Kim received her B.A. from Wellesley College, her M.S.W. from Columbia University School of Social Work, and her J.D. from Rutgers School of Law–Newark.
Jeff Klimaski is the Global Ethics and Compliance Officer at BTG, and has responsibility for developing and leading BTGs comprehensive global compliance program designed to strengthen and complement BTG's strategy, culture and values and ensure full adherence to regulatory and legal requirements. Mr. Klimaski leads the Compliance Steering Committee, and is a member of both the Corporate Risk Committee and the Commercial Leadership Team.
Mr. Klimaski joined BTG from Stiefel, a GSK Company, where he held the role of Vice President, Global Ethics & Compliance Officer, designing and implementing Stiefel's first global corporate compliance program from the ground up. Prior to Stiefel, he was with Compliance Implementation Services, a pharmaceutical consulting practice specializing in US healthcare compliance, as VP, Regulatory Compliance. Mr. Klimaski brings additional experiences in business and finance, having held positions such as the Director of Business Planning and Operations and Controller for Barnett International, a division of PAREXEL.
Mr. Klimaski received his BBA in Accounting from Temple University and his MBA in Marketing from St. Joseph's University. He is licensed certified public accountant in Pennsylvania.
Bruce A. Levy is the Director of the Criminal Defense Department at Gibbons, PC. Mr. Levy has more than 15 years’ experience in criminal, civil, and administrative matters arising from federal and state health care fraud investigations including government investigations, internal investigations, corporate compliance and complex civil litigation. He has extensive experience representing pharmaceutical and device manufacturers as well as a variety of health care providers covering a broad range of issues relating to the federal anti-kickback statute, Stark laws, the False Claims Act, the Food, Drug and Cosmetic Act, and Medicare and Medicaid reimbursement. He also counsels drug and device manufacturers regarding sales and marketing compliance issues relating to interactions with health care professionals and off-label promotion and works with clients to develop and improve compliance plans and compliance training. Prior to joining Gibbons, Mr. Levy served as an Assistant U.S. Attorney with the U.S. Attorney’s Office for the District of New Jersey from 1991-2001 and was the Criminal Health Care Fraud Coordinator from 1995-2001.
Mr. Levy has taught as an adjunct professor of health care fraud and abuse at Seton Hall Law School. He is a frequent lecturer to private and government groups regarding health care fraud enforcement and compliance.
Mr. Levy received his B.A. from Brandeis University and his J.D. from New York University School of Law.
Michael B. McCulley joined the Johnson & Johnson Law Department in 1982 from American Hospital Supply Corporation where he served as Senior Regulatory Counsel. Mr. McCulley is currently an Assistant General Counsel for Government Contracts, and Reimbursement and Health Care Compliance matters.
Over the years Mr. McCulley has served as the Management Board Lawyer for various J&J companies such as Extracorporeal, J&J Cardiovascular, Codman, Ethicon Endosurgery, Ortho Biotech, J&J Health Care Systems, and the Johnson & Johnson Patient Assistance Foundation. His present assignments include work in the areas of general corporate and U.S. and International Health Care regulation.
Mr. McCulley served for many years as the chair of AdvaMed’s legal committee, member of the PhRMA legal committee, and on various government advisory committees. His current primary focus is on pricing, reimbursement, patient assistance programs and Health Care Compliance issues, and he is an advisor to the Seton Hall Law School Health Care programs.
Kathleen McDermott is a Partner in the Washington, DC office of Morgan, Lewis & Bockius LLP and has been involved in health industry government enforcement and compliance matters for 20 years. Ms. McDermott has served as an Assistant U.S. Attorney and DOJ Health Care Fraud Coordinator, and is a recipient of the HHS-OIG Inspector General's Integrity Award for her work in government health care fraud matters.
Ms. McDermott has a national corporate defense practice devoted exclusively to health industry matters in a broad array of government enforcement and litigation representations and has handled investigations in over 36 diverse jurisdictions relating to allegations of off-label promotion, anti-kickback, reimbursement, privacy and quality of care violations. She has been recognized as a leading False Claims Act practitioner with both government and defense experience in this unique practice area and designated as one of the top fraud and abuse compliance attorneys in the country by Nightingale's and a D.C. Super Lawyer in white collar corporate matters. She also represents various health industry sectors on government voluntary disclosures, mandated compliance matters, including OIG-CIAs and DOJ consent decrees, compliance policy development for global operations, and fraud and abuse, transparency and codes of ethics counseling.
Ms. McDermott received her B.A. from Wright State University and her J.D. from Suffolk University School of Law.
Mary Anne McDonald is Chief of Legal Affairs and Compliance at Visiting Nurse Association Health Group. She previously held the position of Vice President, Corporate Social Responsibility at Stryker Corporation where she worked with Stryker divisions globally to set strategy and implement programs supporting socially responsible activity, including charitable donations, environmental sustainability, and other activity in the marketplace and the workplace.
Ms. McDonald previously served as Chief Legal Counsel at Stryker Orthopaedics in Mahwah, NJ from 2005-2008, where she managed the legal department, which handled all matters for Stryker Orthopaedics, a global leader in joint replacement products. During this period, Ms. McDonald instituted regular reporting from the legal department to the business leaders, using metrics to demonstrate the cost of legal issues. She has also held positions as Executive Vice President and General Counsel of the Henry H. Kessler Foundation, General Counsel at Kessler Institute for Rehabilitation, and partner at Gibbons, PC.
Ms. McDonald received her MS in Health Service Administration from the New School University and her J.D. from Seton Hall University School of Law.
Joseph W. Metro is a member of the Life Sciences Health Industry Group in Reed Smith's Washington, D.C. office and practices in the area of health care regulatory law. Mr. Metro's practice focuses on counseling health care manufacturers, distributors and providers on reimbursement, regulatory, and fraud and abuse issues.
For more than 15 years, Mr. Metro has provided analysis and counseling on behalf of manufacturers with respect to government pricing matters including: the Medicaid drug rebate statute, the Veterans Health Care Act's drug pricing standards, the federal Anti-kickback Statute, and other state and federal laws relating to the promotion of prescription drugs and medical devices. In this area, he has assisted with day-to-day methodological counseling, contract pricing strategies, recalculation matters, government pricing investigations, and due diligence on government pricing matters. In addition, Mr. Metro regularly works with manufacturers on health care fraud and abuse compliance, including regulatory, transactional and litigation matters. He has helped companies in various aspects of compliance program development and financial relationship reporting, as well as day-to-day counseling, the preparation of OIG advisory opinion requests, and responses to subpoenas and other internal and external investigations.
Mr. Metro received his B.A. from Dickinson College and his J.D. from The George Washington University National Law Center.
Professor Frank Pasquale is the Schering-Plough Professor in Health Care Regulation and Enforcement at Seton Hall Law. Professor Pasquale has taught information and health law at Seton Hall since 2004. He has published over 20 scholarly articles, and is currently writing a book called The Black Box Society: Technologies of Search, Reputation, and Finance (under contract with Harvard University Press). His research agenda focuses on challenges posed to information law by rapidly changing technology, particularly in the health care, internet, and finance industries.
Professor Pasquale is a member of the Harvard-Georgetown Working Group on Market Democracy, and an Affiliate Fellow of Yale Law School’s Information Society Project. He has been named to the Advisory Board of the Electronic Privacy Information Center. He is on the executive board of the Health Law Section of the American Association of Law Schools (AALS), and has served as chair of the AALS section on Privacy and Defamation. He has blogged at Concurring Opinions since 2006, and he also writes at Balkinization, Madisonian, Health Reform Watch, and the Health Law Profs Blog. He has been quoted in the Financial Times, New York Times, Economist, CNN, and many other media outlets, and has written for the Boston Review.
Professor Pasquale received his B.A. from Harvard University, his M.Phil from Oxford University, and his J.D. from Yale Law School.
Please find Professor Pasquale's full profile here.
Linda Pissott Reig is a shareholder at Buchanan Ingersoll & Rooney. Ms. Reig has extensive experience with state and federal laws and industry standards relating to the marketing and sale of FDA-regulated products. She reviews promotional materials, evaluates marketing initiatives, provides guidance on lawful preapproval communication strategies, conducts compliance training for life sciences companies, prepares Standard Operating Procedures and Policies for corporate compliance programs, drafts agreements and advises on consulting arrangements with key opinion leaders. She also evaluates continuing medical education grants and other sponsorship opportunities. Ms. Reig guides companies on how to minimize legal risk while achieving business objectives. She assists clients with state law obligations, such as aggregate spend, marketing disclosure, data-mining, clinical trial disclosure, adherence to compliance codes and other matters. Before joining Buchanan, Ms. Reig served as principal for Porzio, Bromberg, and Newman, and Vice President, Compliance Services of its pharmaceutical services subsidiary.
She serves as co-chair of the BioNJ Legal Forum Advisory Committee, a group that she was instrumental in forming in 2008. She garnered an AV® Preeminent certification from Martindale-Hubbard Peer Review Ratings, the highest available mark for professional excellence. In 2007, Ms. Reig was recognized by the New Jersey Law Journal on its annual "40 Under 40" list. She was also selected for inclusion on the 2006-2008 New Jersey Super Lawyers® Rising Stars list, representing the top 2.5 percent of young attorneys practicing in New Jersey.
Ms. Reig received her B.A. from Rutgers Newark College of Arts & Sciences and her J.D. from Georgetown University Law Center.
Maureen Ruane is the Chief of the Health Care & Government Fraud Unit, Criminal Division, at the U.S. Attorney's Office for the District of New Jersey. In that role, Ms. Ruane directs and supervises the Office's investigations and prosecutions involving fraud and abuse in the health care industry (including those involving sales of unapproved or altered drugs, illegal marketing of drugs for unapproved uses, illegal kickbacks, improper billing, and improper diversion of controlled substances), Foreign Corrupt Practice Act violations, as well as fraud against certain government agencies and programs.
Ms. Ruane re-joined the USAO in May 2010, having previously served as an AUSA from 1998 to 2004 in both the Criminal and Appeals Divisions. Between 2004 and 2010, she was a partner at Lowenstein Sandler, P.C., where she represented pharmaceutical companies, health care companies, hospitals, and individuals, in a wide variety of civil and criminal cases and investigations.
Ms. Ruane re-joined the United States Attorney's Office in May 2010, having previously served as an Assistant United States Attorney from 1998 to 2004 in both the Criminal and Appeals Divisions. Between 2004 and 2010, Ms. Ruane was a partner at the law firm Lowenstein Sandler, where she represented pharmaceutical companies, health care companies, hospitals, and individuals in a wide variety of civil and criminal cases and investigations.
Ms. Ruane received her B.A. from Rutgers College and her J.D. from Rutgers School of Law –Newark.
James Sheehan is the Chief Integrity Officer/Executive Deputy Commissioner of the New York City Human Resources Administration. Previously, Mr. Sheehan was the New York State Medicaid Inspector General. There he oversaw the fraud and abuse enforcement activities of New York's $50 billion Medicaid program. The New York State Office of the Medicaid Inspector General audits and investigates Medicaid providers, recovers revenue through its enforcement system, and develops and operates automated health care data detection systems. Mr. Sheehan also served as the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania. His practice has emphasized health care fraud since 1987 and he has personally handled or directly supervised over five hundred health care fraud cases. In 1997, he was lead counsel in U.S. v. SmithKline Beecham Clinical Labs, which resulted in a $332 million recovery for the United States. He has given over three hundred presentations on health care fraud issues to a variety of professional, governmental, consumer, and business groups.
Mr. Sheehan received his B.A. from Swarthmore College and his J.D. from Harvard Law School.
Lynn Shapiro Snyder is a Senior Member of Epstein Becker & Green, P.C. in the Health Care and Life Sciences and Litigation practices in the firm's Washington, DC, office, and she is Strategic Counsel with EBG Advisors, Inc. Ms. Snyder has over thirty years of experience at the firm, advising clients about federal, state, and international health law issues, including Medicare, Medicaid, TRICARE, compliance, and managed care issues. Her clients include health care providers, payors, pharmaceutical/device manufacturers, and those companies and financial services firms that support the health care industry. She is a frequent speaker and publishes extensively.
Ms. Snyder serves on the firm's Board and Finance Committee. The firm's Health Care and Life Sciences practice is one of the largest health law practices in the United States. She is Chair of the Third-Party Payment Practice Group, which concentrates on legal and regulatory matters arising under third-party payment programs such as Medicare, Medicaid, and TRICARE. Ms. Snyder cochairs the Health Care Fraud Practice Group that focuses on federal and state fraud issues, including anti-kickback, self-referral, false claims, secondary payor issues, and false billings. She also cochairs the Health And Employment Law (HEAL) Group, leading the Health Care and Life Sciences practice in its partnership with the firm's national Labor and Employment practice. Ms. Snyder also works on matters in the Pharmaceutical Industry Health Regulatory Practice Group and the Managed Care/Integrated Delivery System Practice Group.
Ms. Snyder received her B.A. from Franklin & Marshall College and her J.D. from The George Washington University National Law Center.
Mr. Zalesky is Vice President, Global Policy & Guidance, Johnson & Johnson Office of Health Care Compliance & Privacy. He has more than 20 years experience in regulatory affairs, quality assurance and research and development functions within the medical device and pharmaceutical industries. He received his J.D. degree, cum laude, from Widener University School of Law and earned his undergraduate degree in biochemistry and molecular biology from the University of California at Santa Barbara and is Regulatory Affairs Certified (RAC). He has published numerous articles on regulatory, FDA and health care policy matters and has contributed to several successful regulatory policy and legislative initiatives. Mr. Zalesky provides guidance on a range of commercial and scientific matters and is admitted to practice in Pennsylvania.
Mr. Zalesky received his B.A. from the University of California at Santa Barbara and his J.D. from Widener University School of Law.