PROGRAM SCHEDULED for June 13-16, 2016 | Newark, New Jersey
For more than a decade, Seton Hall Law School has collaborated with experts in the healthcare and compliance fields to develop relevant, engaging curriculum and session topics for the U.S. Healthcare Compliance Certification Program. Our speaker panel includes government officials, in-house and outside counsel who are experts in pharmaceutical and medical device fraud and abuse issues, legal scholars, compliance officers, and trusted industry advisors.
Lynne Anderson is a partner in Drinker Biddle & Reath’s Labor & Employment Practice Group. She is a practiced jury and bench trial lawyer, who has handled a wide range of employment litigation, including retaliation/whistleblower, discrimination, harassment, wrongful termination, and breach of contract claims, in various state and federal courts, as well as before arbitration panels and government agencies. She regularly provides strategic counseling to clients regarding internal investigations, business restructuring, and a myriad of other employment issues.
Ms. Anderson has been recognized by Chambers USA as one of America’s leading lawyers for business, as well as by Best Lawyers in America. She has also been listed in New Jersey Super Lawyers since its inception in 2005, and has been repeatedly recognized as one of the Top 25 Women Attorneys in the state. In 2013, she was selected by The American Lawyer and Corporate Counsel magazine as a “2013 Top Rated Lawyer in Healthcare.”
Ms. Anderson is an active member of BioNJ, the current chair of the New Jersey Law & Education Empowerment Project (NJ LEEP), a member of the American Employment Law Council, and fellow of the Litigation Counsel of America, an honorary society for trial lawyers. She is a past president of the New Jersey Women Lawyers Association (NJWLA), and the 2009 recipient of the NJWLA Women’s Initiative & Leadership Platinum Award.
Ms. Anderson received her B.A. from Mount Holyoke College, and her J.D. from Rutgers University School of Law – Camden.
Dennis Barnes is Vice President and Chief Compliance Officer at PAREXEL International. Headquartered in Waltham, Massachusetts, PAREXEL is a clinical research organization focused on assisting its pharmaceutical and medical device manufacturer clients with executing the necessary clinical trials that allow their products to be evaluated by regulatory authorities in markets throughout the world.
Prior to joining PAREXEL, Mr. Barnes held various positions with pharmaceutical manufacturers and consulting firms that service the pharmaceutical industry over the last 17 years, including Sanofi US, GlaxoSmithKline, Navigant Consulting, KPMG, and PwC.
Mr. Barnes earned his B.A. in economics from Bucknell University, his J.D. from the University of Notre Dame School of Law, and an MBA from the University of Texas at Austin Graduate School of Business. Mr. Barnes is also a Certified Public Accountant and a graduate of the Seton Hall Healthcare Compliance Certification Program.
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. Mr. Bell began his legal career at Epstein, Becker & Green in Washington, D.C., 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.
Regina Cavaliere is Principal of Advisory – Regulatory Enforcement & Compliance at KPMG LLP. She joined KPMG on July 1, 2015 in its Short Hills, New Jersey U.S. Forensic Advisory Services practice. Her most recent role was as the Vice President and Chief Compliance Officer for U.S. affiliates of a Japanese-based pharmaceutical/medical device company. She led the Ethics, Quality & Compliance group and had responsibility for development and maintenance of a comprehensive ethics and compliance program that included healthcare law compliance, internal investigations, auditing and monitoring, training, privacy and information security, transparency, policies and procedures, document control, contact call center, manufacturing quality, and clinical trial/GCP quality.
Ms. Cavaliere brings experience with healthcare law compliance, having worked for three life sciences companies over the past 17 years. Her areas of expertise include sales and marketing compliance as well as non-promotional compliance (e.g., medical and clinical affairs), pharmacovigilance compliance, and quality.
In her most recent role, Ms. Cavaliere successfully completed a Corporate Integrity Agreement with HHS-OIG for her prior employer. She has also supported regulatory inspections (e.g., FDA, MHRA, EMA) involving manufacturing, pharmacovigilance, and clinical areas.
Ms. Cavaliere was a member of the Editorial Advisory Board, Rx Compliance Report and has presented at various industry conferences on the implementation of a comprehensive compliance program for a pharmaceutical manufacturer over the past decade.
Ms. Cavaliere received her B.A. from Seton Hall University and her J.D. from Rutgers School of Law – Newark.
Elizabeth B. Carder-Thompson is a partner at Reed Smith and a member of the firm’s Life Sciences Health Industry Group. She practices in the area of health care regulatory law. She represents associations and individual providers and suppliers of health services, including manufacturers of drugs and devices, providers such as hospitals, hospices, nursing homes, physicians, and home health agencies, and suppliers of DMEPOS, diagnostic, laboratory, and other items and services. She also provides regulatory, due diligence, and transactional assistance to financial services firms that support the health care industry. Her specific areas of responsibility include coverage and reimbursement, fraud and abuse matters, and regulatory, legislative, and enforcement issues, primarily involving Medicare, Medicaid, and third-party payors.
In the regulatory area, Ms. Carder-Thompson has assisted clients in obtaining Medicare and Medicaid coverage of new items and services; negotiated with the Centers for Medicare & Medicaid Services to rescind or modify coverage guidelines affecting reimbursement of services and equipment; obtained revisions to manual requirements governing reimbursement for therapeutic and diagnostic services; and served as health care regulatory counsel for a variety of public offering and financing transactions.
In the area of fraud and abuse, Ms. Carder-Thompson provides counseling, transactional advice, and audit and enforcement representation. She has represented clients under investigation by the Office of Inspector General, the Department of Justice, and other investigatory bodies, including handling qui tam or “whistleblower” actions under the False Claims Act. She counsels clients on potential fraud and abuse aspects of promotional initiatives, mergers and acquisitions, joint ventures, contracts, and other business arrangements by and between providers, manufacturers, and other entities. She has also assisted many clients in developing and evaluating corporate compliance programs.
Ms. Carder-Thompson was named as Best Lawyers’ 2015 “Lawyer of the Year” for Health Care Law in Washington, D.C. She has been named as one of America’s leading lawyers in Health Care Law in the 2011-2014 editions of The Best Lawyers in America and has been recognized as a Washington D.C. Super Lawyer for her Health Care practice from 2007-2014. She has been named by Chambers USA as one of America’s leading Health Care lawyers from 2007-2014, recognized by Nightingale’s Healthcare News as one of America’s outstanding Healthcare Fraud and Compliance Attorneys in 2008, named by Health Law360 as an “Outstanding Woman” for her accomplishments in the legal profession, and recognized by Washingtonian magazine as a Top Lawyer in the area of Health Care Law in 2013 and 2014. She has served as President and Fellow of the American Health Lawyers Association and has been the past Chair of the AHLA’s Fraud and Compliance Forum as well as the AHLA Life Sciences Law Institute.
Ms. Carder-Thompson received her A.B., magna cum laude, from Brown University and her J.D. from William and Mary School of Law, where she served as Notes and Comments Editor of the William and Mary Law Review.
Scott Danzis is a partner in Covington & Burling's Food & Drug and Health Care practice groups. Mr. Danzis focuses his practice primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. He regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarking review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, postmarket reporting, and enforcement actions.
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 has significant experience in the following areas: FDA regulatory strategies, including strategies for the premarket review (510(k)s, PMAs) of medical devices; appeals and dispute resolution within FDA; IDEs, INDs, and clinical trial regulation; advertising, promotion, and scientific exchange, including responding to enforcement actions and investigations; imports and exports of FDA regulated products; QSR and cGMP requirements, including responding to FDA 483s and enforcement actions; product recalls; adverse event and MDR reporting; FDA consent decrees and OIG corporate integrity agreements; regulatory due diligence; and compliance with antifraud statutes, including the anti-kickback statute and the False Claims Act.
Mr. Danzis developed and edited a book on the regulation of in vitro diagnostic products and laboratory testing, In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, 2010). He currently serves as an Adjunct Professor at the Georgetown University Law Center, where he teaches a course on the regulation of drugs, biologics, and medical devices. He has been recognized in The Best Lawyers in America from 2011-2014 and Washington DC Super Lawyers from 2014-2015.
Mr. Danzis received his B.S. from Cornell University, his Master’s from George Washington University in Health Care Management and Policy, and his J.D. from the University of Virginia School of Law, where he was the Editor-In-Chief of the Virginia Law Review and elected to the Order of the Coif. In addition, Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit.
Sujata Dayal is Vice President of Health Care Compliance, Pharmaceutical at Johnson & Johnson. She is a member of the Global Health Care Compliance & Privacy Management Committee and the Johnson & Johnson (J&J) Compliance Committee. She sits on the J&J Pharmaceutical North American Leadership Team. She leads the Pharmaceutical Group Health Care Compliance team, including organizing resources, defining strategy, and addressing matters regarding J&J’s global pharmaceutical health care compliance programs.
Prior to joining J&J, Ms. Dayal held the position of Chief Ethics and Compliance Officer and Corporate Vice President at Biomet, Inc. Prior to that, she held compliance and legal roles at Abbott Laboratories, primarily in the Pharmaceutical Products businesses. She also spent time as an associate at the international law firm of Jones, Day, Reavis & Pogue.
Ms. Dayal holds a B.A. from Lady Shri Ram College, New Delhi, India; an LL.B. from Rajasthan University Law School, Jaipur, India; a J.D. from Chicago-Kent College of Law; and an LL.M. from Columbia University School of Law, New York.
Gary Del Vecchio is Executive Director of U.S. Pharmaceuticals Compliance & Ethics at Bristol-Myers Squibb Co. He has been with Bristol-Myers Squibb for 28 years. His past experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, sales learning and development, compliance and ethics program development and CIA implementation and oversight.
Mr. Del Vecchio has been a member of the U.S. Pharmaceuticals Compliance and Ethics department for 12 years. In his current role, he provides compliance and ethics leadership to the U.S. Oncology Commercial teams, U.S. Medical and is responsible for the U.S. Compliance and Ethics Education and Communication team. He has also spent time heading up the U.S. Compliance and Ethics investigations team.
Mr. Del Vecchio currently serves as a Co-Chair of the Pharmaceutical Compliance Forum (PCF), a coalition of senior compliance professionals and legal counsel from approximately 45 research-based pharmaceutical manufacturers, which was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.
Howard L. Dorfman is founder of H.L. Dorfman Pharmaceutical Consulting, a consulting resource to the pharmaceutical, biotech, and medical device industries, focusing on identifying and addressing compliance, regulatory, and risk management issues. Based on his experience in a series of senior in-house positions, he undertakes extensive in-dept reviews of current company practices, identifies shortcomings and potential risk, and prepares remedial programs to address and reduce exposure in healthcare compliance, regulatory, and legal matters. Prior to starting his consultant company, he served as the founding general counsel at Turing Pharmaceuticals, a privately-held pharmaceutical and biotechnology company, located in New York City.
Previously, Mr. Dorfman served as Vice President, General Counsel at Ferring Pharmaceuticals, Inc., in Parsippany, New Jersey, the U.S. pharmaceutical operations for the privately-held Swiss-based global pharmaceutical, biotech, and medical device company. Prior to that, he served as Counsel in the Life Sciences group at Ropes & Gray LLP in New York, where he focused his practice on pharmaceutical, medical device, and biotech industries. Prior to his time at Ropes & Gray, Mr. Dorfman was chief legal officer of the pharmaceutical division of Bayer Healthcare LLC, where he was responsible for legal oversight relating to the commercial, regulatory, and compliance activities of the company's pharmaceutical operations.
Before joining Bayer, Mr. Dorfman worked at Bristol-Myers Squibb (BMS), first as Counsel for litigation, where he oversaw and directed nationwide mass tort litigation involving hormones, antibiotic, and medical device products, and later as Counsel to the company’s U.S. Medicines Group, where he was responsible for the legal functions relating to the two largest prescription pharmaceuticals in the BMS cardiovascular franchise.
Mr. Dorfman’s areas of expertise include FDA regulatory law, fraud and abuse, compliance programs, risk management processes, mergers and acquisitions, corporate governance, and licensing and product liability. He established Office of the Inspector General compliance procedures at a major pharmaceutical company while counseling on Medicare, Medicaid, and other healthcare reimbursement matters. Liaising with international stakeholders, he has developed FDA risk management plans and global drug labeling protocols in accordance with U.S. regulatory standards.
Mr. Dorfman has been an Adjunct Professor of Law at Seton Hall Law School, where he taught a law and graduate course on pharmaceutical and medical device regulatory and compliance laws for the past four years. In addition, he has lectured widely and published articles on a range of product liability, healthcare compliance, and FDA regulatory issues. He is the Editor-in-Chief and a contributing author to the PLI text on Pharmaceutical Compliance and Enforcement – the third edition will be published in early 2016.
Mr. Dorfman received his B.A. (with honors) from Yeshiva University and his J.D. from Brooklyn Law School.
Mike Doyle is a Supervisory Special Agent for the Federal Bureau of Investigation. He has been a Special Agent of the FBI since 1996, serving his entire time in the Newark Division. He has investigated a broad array of criminal, counterterrorism, and counterintelligence matters, spending the majority of his time in the White Collar Crime arena. Mr. Doyle supervises the Public Corruption Squad in Newark, and is the FBI’s Program Coordinator for Complex Financial Crimes, which includes all Health Care Fraud cases. Of investigative note, Mr. Doyle was the Case Agent of the investigations leading to the conviction of the former Mayor of the State’s largest city, long-time Newark Mayor and New Jersey State Senator Sharpe James.
Additionally, Mr. Doyle recently concluded an investigation into corruption in the State’s capital city, which led to the conviction of twelve individuals, including the Mayor of Trenton Tony F. Mack and his brother. Mr. Doyle also led the investigation into one of the largest and longest running insider-trading conspiracies (Bauer, et al.), culminating in a co-defendant receiving the longest sentence in U.S. history for insider-trading. The case is the subject of a June 2014 CNBC American Greed episode. Mr. Doyle has held several positions within the FBI, including hostage negotiation coordinator, weapons of mass destruction coordinator, defensive tactics instructor, and national co-chair of the FBI Director’s Advisory Committee. Mr. Doyle has been nominated for the FBI Director’s Award on two occasions, and in 2008 was the recipient of the Federal Law Enforcement Foundation Investigator of the Year Award.
Mr. Doyle holds an undergraduate degree in Mechanical Engineering from the University of Delaware, an MBA in Finance from Drexel University, and a Graduate Certificate in Professional Accounting.
Jacob Elberg is the Chief of the Healthcare & Government Fraud Unit at the United States Attorney’s Office for the District of New Jersey. He supervises and directs all of the Office’s criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, violations of the Federal Food, Drug & Cosmetic Act, and the improper diversion of prescription drugs, as well as all health care-related actions brought by the Office under the False Claims Act. In addition, Mr. Elberg supervises and directs the Office’s investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs.
Prior to joining the U.S. Attorney’s Office in 2007, Mr. Elberg was an associate at Dwyer & Collora LLP (now Collora LLP) in Boston, where his areas of practice included white collar criminal defense, internal corporate investigations, and general commercial litigation.
Mr. Elberg received his J.D. in 2003 from Harvard Law School, graduating magna cum laude, after having received his B.A. in 2000 from Dartmouth College, from which he graduated cum laude. After graduating law school, Mr. Elberg served as a law clerk to the Honorable Nancy Gertner (District of Massachusetts).
Gary F. Giampetruzzi is a partner in the Litigation Department at New York office of Paul Hastings, LLP. He routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, the Foreign Corrupt Practices Act (FCPA), and oversees other complex civil and criminal litigation matters.
Prior to joining Paul Hastings, Mr. Giampetruzzi served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc, with responsibility for government investigations across the company’s multiple business units and operations globally, and associated government litigation with U.S. and international prosecutor offices. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs, with responsibility for the implementation and maintenance of compliance programs and systems across the company's international operations, with an enhanced focus on emerging markets.
Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA landscape. He has been a leader in this growing area of practice for more than a decade, having led the development of compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, Africa, Europe, the Middle East, and Latin America). He was instrumental in the development of proactive market review approaches that have been incorporated into recent government resolutions, and acquisition due diligence techniques that were cited in the Justice Department’s FCPA Guidance document.
Mr. Giampetruzzi was named to Ethisphere magazine’s 2015 Attorneys Who Matter listing in the Specialists – Private Practice category.
Mr. Giampetruzzi received his B.S.E.E from New York Institute of Technology and his J.D. from St. John’s University School of Law.
Timothy Glynn is the Associate Dean for Graduate & Professional Education and Miriam T. Rooney Professor of Law at Seton Hall Law School. Since joining Seton Hall in 1999, he has taught various courses in the corporate law, employment law, and compliance areas, as well as first-year Civil Procedure and Torts.
Professor Glynn has published many articles addressing issues in corporate and employment law, and he is the author of a leading employment-law textbook, Employment Law: Private Ordering and Its Limitations (3rd ed. 2015) (with Charles Sullivan and Rachel S. Arnow-Richman). His scholarship focuses on a variety of topics, including the allocation of decision-making authority and legal accountability within the corporation, the role and limits of enforcement mechanisms in employment law, and the impact of enterprise structures on legal protections and legal compliance. He frequently presents on these topics to professional and academic organizations.
Professor Glynn received his B.A., magna cum laude, from Harvard University, and his J.D., magna cum laude, from the University of Minnesota Law School, where he served as Editor-in-Chief of the Minnesota Law Review. He clerked for the Honorable Donald P. Lay, United States Court of Appeals for the Eighth Circuit. He then practiced law as an associate at the firm of Leonard, Street and Deinard in Minneapolis, Minnesota, focusing in the areas of securities, business, and employment litigation. Prior to joining Seton Hall, he again served a judicial clerk, this time for the Honorable John R. Tunheim, United States District Court for the District of Minnesota.
Please find Professor Glynn's full profile here.
Sandra González is an associate in the Litigation practice of Paul Hastings and is based in the firm’s New York office. She 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 (“HCP”) interactions, sample compliance, and anti-corruption and anti-bribery laws, including the Foreign Corrupt Practices Act and the UK Bribery Act.
Ms. González’s experience includes: advising pharmaceutical, medical device, and biotechnology companies on the continued enhancement of global anti-bribery and anti-corruption compliance programs, including conducting proactive reviews, and advising on core program components such as monitoring, investigations, and remediation; serving on in-house review committees to provide legal or regulatory review and assessment of branded and unbranded promotional materials and marketing activities directed towards consumers and HCPs, as well as sales training materials and scientific communications, supporting new product launches and providing guidance on lawful preapproval communications strategies, including disease awareness campaigns; drafting, editing, and reviewing compliance and ethics manuals, field handbooks, policies, procedures, and guidelines in areas of promotion, off-label communications, consultants and speakers, HCP interactions, privacy, patient assistance programs, medical science liaisons, dissemination of medical/scientific information to HCPs, research activities, grants and charitable contributions, training, monitoring, investigations of suspected non-compliance, disciplinary measures, and enforcement procedures, and developing compliance implementation plans with milestones to assess progress; developing company-wide compliance training materials, as well as department-specific materials, and training promotional speakers on company policies and procedures related to FDA-regulated promotion and permissible conduct; conducting investigations into payments to HCPs in violation of state gift limitation and ban laws; performing audits, gap analyses, and risk assessments of overall compliance programs, sampling activities, and disclosure reporting and gift limitation compliance as well as drafting and presenting executive summaries of audit and assessment results; and drafting and reviewing agreements, including fee-for-service, clinical study, investigator initiated study, and third party.
Ms. González received her B.A. in Political Science with a Minor in Latin American Studies from the State University of New York – New Paltz, and her J.D. from Rutgers University School of Law.
Nicolas Harbist is a partner at Blank Rome LLP. He concentrates his practice in complex criminal and commercial litigation. He represents clients in many industries in matters related to: healthcare fraud and abuse, defense contract fraud, securities and tax fraud, environmental crimes, antitrust and FCPA crimes, export crimes, and general business fraud; RICO, anti-trust, securities, trade secrets, healthcare, and professional licensing litigation; corporate internal investigations; corporate compliance programs; and Qui Tam/Federal False Claims Act and whistleblower 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 is consistently recognized by The International Who’s Who of Business Crime Defense Lawyers and The International Who’s Who of Business Lawyers. He was also recognized in the 2014 edition of The International Who’s Who of Investigations Lawyers. He has received the highest possible rating from Martindale-Hubbell. In 2010, Mr. Harbist was appointed to serve as National Co-Chair of the American Bar Association’s White Collar Crime Committee. He was recently appointed as Co-Executive Director of the ABA Criminal Justice Section White Collar Crime Division and is the former Vice-Chair of the ABA White Collar Crime Committee for the Mid-Atlantic Region. He is also a Former Chair of the New Jersey State Bar Association Criminal Law Section and serves as a Trustee for the Association of Criminal Defense Lawyers for New Jersey.
Mr. Harbist received his B.S., magna cum laude, from The College of New Jersey, and his J.D., magna cum laude, from Rutgers University School of Law–Camden.
Bruce A. Levy is the Director of the Criminal Defense Department at Gibbons, PC. Mr. Levy defends clients across the healthcare industry against administrative, civil, and criminal fraud allegations brought by the government and whistleblowers. He has more than 20 years of experience in healthcare law and focuses on defending against government enforcement initiatives, complex healthcare litigation, and regulatory compliance. He has extensive experience representing pharmaceutical and device manufacturers, hospitals, home health agencies, and a variety of healthcare providers, covering a broad range of issues relating to the federal anti-kickback statute; the Stark law and its regulations; 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 healthcare professionals and off-label promotion and works with clients to develop and improve compliance plans and compliance training. He has extensive criminal, civil, and appellate experience in administrative, state, and federal courts and has personally handled leading national cases relating to allegations of criminal and civil health care fraud and abuse.
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. During his time there, he participated in dozens of False Claims Act investigations and tried more than a dozen criminal cases to verdict including healthcare, bank, and tax fraud matters.
Mr. Levy has taught as an adjunct professor of healthcare fraud and abuse at Seton Hall Law School. He is a frequent lecturer to private and government groups regarding healthcare fraud enforcement and compliance.
Mr. Levy has been listed in Best Lawyers®, for Criminal Defense: White-Collar, Chambers USA Guide to America’s Leading Lawyers for Business, for Healthcare and Litigation: White-Collar Crime & Government Investigations, and has been selected to the New Jersey Super Lawyers list, for Criminal Defense: White Collar.
Mr. Levy received his B.A., cum laude, from Brandeis University and his J.D. from New York University School of Law.
Scott Liebman is a Partner at Loeb & Loeb LLP. As the head of the FDA Regulatory & Compliance practice, he counsels pharmaceutical, medical device, and biotechnology clients on federal and state requirements. He works with in-house legal, compliance, and regulatory colleagues to address compliance concerns while considering business interests.
Mr. Liebman develops legal and regulatory strategies to commercialize healthcare and medical innovations. Over the course of his career, he has worked with firms of all sizes, from virtual companies with fully outsourced functions, to nearly three quarters of Fortune 500 companies in the Pharmaceuticals and the Medical Products/Equipment categories.
Mr. Liebman navigates increasingly complex regulations, frequently writing and speaking on emerging compliance topics. He delivers practical advice regarding Food, Drug & Cosmetic Act (FDCA), Patient Protection and Affordable Care Act (ACA), Food and Drug Administration Modernization Act (FDAMA), Food and Drug Administration Safety & Innovation Act (FDASIA), False Claims Act (FCA), Foreign Corrupt Practices Act (FCPA), and other legislation.
Prior to joining Loeb & Loeb, Mr. Liebman was a principal with Porzio, Bromberg & Newman P.C. and served as chair of the firm’s Life Sciences Practice Group as well as vice president of their subsidiary, Porzio Life Sciences.
Mr. Liebman was named a “Rising Star” by the New York Law Journal and a “New York Rising Star” in Health Care by Thomson Reuters in 2014, a “Rising Star” in Health Care Law by New Jersey Super Lawyers in 2013, and named in “New Leaders of The Bar” by New Jersey Law Journal in 2012.
Mr. Liebman received his B.A. with High Honors, from Lehigh University, and his J.D. from Seton Hall University School of Law.
Karen Lowney is Senior Director of Global Compliance and Privacy at Astellas. She is responsible for supporting Global functions, including R&D and Medical Affairs. She also serves as the Privacy Officer. Previously, Ms. Lowney was the Senior Director of Global Compliance at Cephalon, where she managed compliance across business units including the development, implementation and oversight of policies, procedures and processes, employee training, aggregate spend tracking and government reporting, monitoring, incident management and investigations, and providing day-to-day advice to business partners.
Ms. Lowney also served as the Director of International Compliance at Schering-Plough, where she was responsible for implementation of compliance initiatives within the Global Pharmaceutical Business, coordination of their compliance officer network, and ensuring that policies, procedures, and processes adhered to corporate guidelines as well as local laws, codes, and regulations.
Seth Lundy is a partner at King & Spalding's Washington, D.C. office, as well as a deputy chair of the FDA & Life Sciences Practice Group. He focuses his practice on healthcare matters, concentrating on the federal and state regulation of medical device and pharmaceutical device manufacturers and of healthcare providers and suppliers, including corporate compliance, the Anti-Kickback Statute, the Stark Law, False Claims Acts, state law compliance and reporting regulations, and Medicare and Medicaid reimbursement.
Mr. Lundy’s experience includes working closely with federal regulators and legislators to create, revise, and interpret new laws, regulations, and policies in the healthcare field; developing business and marketing strategies to cope with changing federal regulatory schemes; corporate compliance; government investigations; healthcare contracting; effecting mergers and the creation of new healthcare entities; Medicare and Medicaid reimbursement and billing advice; and civil and criminal litigation. His clients include medical device manufacturers, pharmaceutical companies, durable medical equipment suppliers, hospitals, health systems, academic medical centers, institutes of mental health, physician groups, nursing facilities, and hospices.
Mr. Lundy is a frequent author and speaker on healthcare compliance, Medicare and Medicaid fraud and abuse, and the Stark Law. He has been recognized as a Top Healthcare Attorney in Washington, D.C. by Chambers USA Guide, 2008 to Present, as a leading healthcare lawyer in the U.S. by Expert Guides, Guide to the Leading Healthcare Lawyers, 2014 edition, and as an Outstanding Healthcare Lawyer by Washington DC Super Lawyers, 2011, 2012, and 2013 editions. He has also been recognized in Washingtonian Magazine, Top Lawyers, December 2013.
Mr. Lundy received his B.A., cum laude, from Amherst College and his J.D., with honors, from George Washington University.
Joseph W. Metro is a partner at Reed Smith’s Washington, D.C. office and a member of its Life Sciences Health Industry Group. He 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 20 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. He has been listed in the LMG Life Sciences Guide since its inception as a life science “star” in the pricing and reimbursement arena.
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, responses to subpoenas and other internal and external investigations, and conducting health care regulatory due diligence in the context of product and company acquisitions.
Mr. Metro received his B.A., magna cum laude, in Political Science and Russian/Soviet Area Studies from Dickinson College and his J.D., with high honors, from George Washington University Law School, where he was a member of the George Washington University Law Review and the Order of the Coif.
John P. Oroho is a principal at Porzio, Bromberg & Newman in Life Sciences Compliance, Commercialization & Regulatory Counseling. His practice is concentrated in the areas of regulatory compliance with respect to Aggregate Spend, Physician Payment Sunshine Act, the Prescription Drug Marketing Act (“PDMA”), Anti-Kickback Statute, False Claims Act, and Medicare and Medicaid fraud and abuse. He is a noted expert on pharmaceutical compliance, specifically OIG and state compliance with Sales and Marketing and product distribution. He has written and lectured extensively on these, as well as other life science compliance issues. He has worked with companies under Corporate Integrity Agreements to ensure their compliance with the standards established for pharmaceutical marketing and sales.
Mr. Oroho is also Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC., a wholly owned subsidiary of the law firm. He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their understanding of acceptable practices and conduct in meeting compliance requirements of all 50 states and the District of Columbia.
Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance. He has been responsible for the development of Aggregate Spend systems and PDMA-compliant sample tracking systems.
Mr. Oroho was recognized by Who’s Who Legal: Life Sciences 2015. He received his B.S., with honors, from the United States Merchant Marine Academy, and his J.D. from the University of Notre Dame School of Law.
Professor Jordan Paradise is a professor at Seton Hall Law School. She researches and publishes on the legal, ethical, and societal implications of emerging science and technologies, such as genetics and nanotechnology. Currently the Schering-Plough Professor of Law, she joined the law school in 2008 as an Associate Professor, and teaches Food & Drug Law, Administrative Law, and an Advanced Writing Seminar.
Professor Paradise is actively involved in collaborative, interdisciplinary projects that examine the intersection of law, science, and technology. She has served as an Investigator on several other private and federal grants addressing topics of law and science, including grants from the Greenwall Foundation, the National Science Foundation, and the National Institutes of Health. Her publications have appeared in both peer-reviewed and legal publications, including Science; Nature Reviews Genetics; Risk Analysis; Journal of Law, Medicine & Ethics; Food & Drug Law Journal; Yale Journal of Health Policy, Law & Ethics; Minnesota Journal of Law, Science & Technology; Temple Journal of Science, Technology & Environmental Law; and the International Journal of Intellectual Property Management.
Professor Paradise previously served as the Associate Director of Research & Education for the Joint Degree Program in Law, Health & the Life Sciences and the Contortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota Law School from 2005-2009. She was also an Adjunct Associate Professor of Law, a Research Associate in the Center for Bioethics, and the Faculty Editor-in-Chief of the Minnesota Journal of Law, Science & Technology during her time at the University of Minnesota. From 2003 – 2005, Professor Paradise served as a Research Fellow at the Institute for Science, Law and Technology housed at Chicago-Kent College of Law and the Illinois Institute of Technology in Chicago, Illinois.
Professor Paradise received her B.S. from the University of Michigan in Ann Arbor and her J.D. from Chicago-Kent College of Law with a certificate in Intellectual Property Law.
Please find Professor Paradise's full profile here.
Marc Raspanti is a Partner at Pietragallo Gordon Alfano Bosick & Raspanti LLP, where he practices in the areas of government enforcement, compliance, internal investigations, federal and state white collar litigation, federal and state qui tam litigation, criminal, civil, and administrative health care fraud litigation, and complex commercial litigation. He is the founder of the firm’s national Affirmative Qui Tam practice group as well as the firm’s White Collar Criminal Defense practice group.
Mr. Raspanti was selected by his peers as one of Pennsylvania’s Super Lawyers from 2004 to 2015 in the field of White Collar Criminal Defense, an honor reserved for 5% of the Pennsylvania Bar. In addition, from 2007 to 2014, he was listed as one of the Top 100 Pennsylvania Super Lawyers. From 2008 through 2015, he was selected as one of the Top 100 Philadelphia Super Lawyers. He was also selected by his peers for the 2006 through 2015 editions of Best Lawyers in America in the area of Health Care Law ligitaion. He was also included in the 2015 edition of Best Attorneys in Pennsylvania.
In 2012, Mr. Raspanti was elected as a Fellow of the American College of Trial Lawyers, an organization devoted to recognizing outstanding civil and criminal trial lawyers in the U.S. and Canada. LexisNexis® Martindale-Hubbell® also recognizes him as an AV® Preeminent™ rated attorney, the highest such rating available to any individual lawyer in both legal ability and ethical standards. He has a 10, superb, rating with AVVO, which evaluates attorney qualifications based on years in practice, professional achievements, and industry recognition.
Mr. Raspanti’s past legal positions include Assistant District Attorney at the Philadelphia District Attorney’s Office, as well as several well-respected Philadelphia litigation firms. He is on the Board of Governors of the Justinian Society, having served as Secretary to the Society from 1998 to 2002. He has been recognized as a national leader in his field by such organizations as Law Dragon 500 magazine and the US Healthcare Expert Guide. He is an active member of the Health Care Compliance Association as well as the American Health Lawyers Association, where he frequently lectures and writes on current topics of interest.
From 2007 through 2010, Mr. Raspanti was appointed as a Commissioner by Governor Edward G. Rendell as the criminal defense representative to serve on the Pennsylvania Commission on Sentencing, which creates a state-wide sentencing policy that promotes fair, consistent sentencing practices to provide judges with a common reference point for sentencing those convicted of felonies and misdemeanors. Mr. Raspanti was also previously appointed by Governor Rendell as a Commissioner on the Pennsylvania Commission on Crime and Delinquency. From 2003 through 2009, Mr. Raspanti served as Chair of the Pennsylvania Disciplinary Board’s education committee.
Mr. Raspanti received his B.A. from Villanova University and his J.D. from Temple University School of Law.
Maureen Ruane is Partner and Chair of Health Care Litigation, Investigations & Compliance at Lowenstein Sandler, LLP. She has extensive experience defending entities and individuals who are the subject of government investigations in both criminal and civil matters – with a particular emphasis on representing life science and health care companies and executives. As the Chief of the Health Care & Government Fraud Unit at the U.S. Attorney’s Office for the District of New Jersey from 2010-2013, she actively supervised and directed the Office’s investigations and prosecutions involving health care fraud, including claims brought under the False Claims Act (FCA), the Federal Food, Drug & Cosmetic (FD&C) Act, the Anti-Kickback Statute (AKS), among others, the Foreign Corrupt Practices Act (FCPA), and other significant fraud cases.
In private practice, Ms. Ruane has defended numerous criminal and civil enforcement actions by the Department of Justice, HHS-OIG, FDA, and state Attorneys General. She also has extensive experience guiding companies through whistleblower complaints and conducting internal investigations after reports of potential misconduct by company employees.
In addition to her litigation and investigations practice, Ms. Ruane counsels life science and health care companies on enforcement risks, regulatory matters, and compliance. She has significant experience in helping companies negotiate, implement, and operate under HHS-OIG Corporate Integrity Agreements.
Ms. Ruane she was selected to be included in The Best Lawyers in America (2015 & 2016) for her work in health care litigation, white collar criminal defense, and commercial litigation. She was ranked as a leading individual in the white collar crime and government investigations practice area by Chambers USA: America’s Leading Lawyers for Business (2007-2010), acknowledged by Super Lawyers (2009-2010) and Rising Star (2007) for white collar criminal defense, business litigation, and appellate work, and was listed as one of Forty under 40 promising professionals by the New Jersey Law Journal in 2007.
Ms. Ruane received her B.A., with honors, in English and Political Science from Rutgers University and her J.D. from Rutgers University School of Law–Newark, where she was Senior Articles Editor of the Rutgers Law Review.
Suzanne Seferian is Global R&D Health Care Compliance Officer at Johnson & Johnson Pharmaceuticals. Her team is responsible for the implementation and maintenance of programs designed to ensure compliance with applicable regional/local health care fraud and abuse laws, anti-corruption and anti-bribery laws, advertising and promotion laws, privacy laws, codes of conduct and Johnson & Johnson company policies governing the R&D organization’s activities.
Ms. Seferian joined the Johnson & Johnson Law Department in 1999, where she provided legal support for the creation, implementation, and management of corporation-wide fraud and abuse and compliance programs. In 2006, Ms. Seferian joined the World Wide Office of Health Care Compliance & Privacy (WWOHCC&P), where she provided support and oversight to the medical device franchise HCC programs. In 2008, she joined the Pharmaceuticals Group Health Care Compliance organization.
Prior to joining Johnson & Johnson, Ms. Seferian worked at Reed Smith and other major law firms in the Philadelphia area, practicing health care law. She represented academic medical centers, pharmaceutical and device companies, physicians, long term care facilities, and other health care entities. She also clerked for the criminal division of the New Jersey Judiciary.
Ms. Seferian holds a B.A from Barnard College/Columbia University and a J.D. from Temple University School of Law.
James Sheehan is the Chief of the Charities Bureau at the Office of the New York Attorney General. Prior to his current position, Mr. Sheehan was Chief Integrity Officer/Executive Deputy Commissioner for the New York City Human Resources Administration. Mr. Sheehan is the former New York State Medicaid Inspector General, where he oversaw the fraud and abuse enforcement activities of New York’s $50 billion Medicaid program. Previously, he was the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania.
Mr. Sheehan’s practice has emphasized health care fraud since 1987. He has personally handled or directly supervised over 500 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 300 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.
Anna Spencer is a partner at Sidley Austin. She is a nationally-regarded lawyer whose practice focuses on the privacy and security of health information. As the firm’s practice area team leader for health information privacy, she helps companies leverage data assets, respond to data breaches, and develop rules involving the electronic exchange of health information.
Ms. Spencer helps her clients protect and maximize the value of their data assets and increase efficiencies, lower costs, and improve their delivery of health care. Her experience includes: counseling a broad range of clients, including pharmaceutical and medical device manufacturers, health care providers, auditing firms, employers that sponsor group health plans, health information technology companies, and entities that qualify as business associates, on federal, state, and international privacy issues, including global data protection and compliance programs, data breaches, cybersecurity, and consumer protection issues; counseling clients with respect to HIPAA and amendments made to HIPAA by HITECH; advising clients on various state health care privacy laws, including state health information privacy and marketing laws; investigating and responding to data breaches and information security incidents; representing clients in connection with data breach reporting obligations under state laws and the HITECH regulations for breaches of protected health information; defending health care providers in investigations initiated by the Office of Civil Rights, Department of Health and Human Services; advising clients on privacy and security compliance issues associated with cloud computing, mobile applications, big data, clinical trials, patient assistance programs, point-of-sale messaging, sales and marketing practices, and de-identification of data sets, among others; addressing emerging issues, such as the applicability of genetic information privacy law and HIPAA to tissue samples collected during clinical trials.
In addition, Ms. Spencer has developed multiple privacy and security compliance and training programs on behalf of healthcare entities. She also has negotiated hundreds of Business Associate Agreements on behalf of various clients.
Ms. Spencer speaks on privacy/security matters on behalf of numerous groups such as BNA and the American Conference Institute. She recently authored the book Health Information Privacy and Security, published by Bloomberg BNA, and has authored a variety of articles on privacy/security issues, Medicare coverage, and fraud and abuse.
Ms. Spencer has been recognized in the 2013-15 editions of The Legal 500 United States in Technology: Data Protection and Privacy.
Ms. Spencer received her B.A., magna cum laude, from Sewanee and her J.D. from Vanderbilt University Law School. After graduating law school, she clerked for the Honorable Jerry E. Smith, Tennessee Court of Criminal Appeals.
Dr. Carlos Tessi is Vice President of Compliance at Shionogi, Inc. He has over 30 years of experience in global pharma, having worked in a variety of different medical, marketing, and management roles and is recognized as a proven leader in Pharma Ethical Business Practices & Compliance.
As the former vice president of Business Practices & Compliance for the Global Human Health division at Merck & Co. Inc., Dr. Tessi built and continued to strengthen Merck’s worldwide compliance infrastructure. Partnering with Merck’s Corporate Office of Ethics, he implemented a Compliance Metrics Assessment Tool for the commercial division. This ensured that the company met, on a worldwide basis, all internal and external obligations, as established by applicable laws, regulations, and industry codes.
Dr. Tessi developed a global risk assessment methodology that enabled aggregation of individual country data and provided multi-level visibility to the worldwide divisional business risk footprint. With Merck’s acquisition of Schering Plough in 2009, he was instrumental in the alignment of both compliance organizations, identifying best practices and common processes, and making strategic recommendations for “value capture” in the consolidated organization.
After retiring from Merck, Dr. Tessi joined Bausch & Lomb as the Compliance Director for Global Pharmaceuticals. He established a robust global compliance infrastructure for the Pharma division, including a global due diligence process to evaluate potential partners and monitor third parties and vendors across geographies. In this capacity, he was also instrumental in Bausch & Lomb’s acquisition of ISTA Pharmaceuticals and Laboratorio Pfortner-Waicon.
Following the acquisition of Bausch & Lomb by Valeant Pharmaceuticals, Dr. Tessi joined Shionogi Inc. to lead the U.S. Compliance Office. In this role, he has developed a strategic vision for ethical business practices and compliance, which accelerated top line growth by simplifying and enhancing compliance systems and processes, and protected that growth by identifying gaps, effectively assessing risk, and providing appropriate risk mitigation strategies.
Dr. Tessi has been extremely active at the IFPMA’s Code Compliance Council, and participated in the Pharmaceutical Compliance Forum, World Economic Forum’s PACI program, ECOA, and WHO’s Program for Good Governance in the Pharma sector.
Dr. Tessi holds an M.D. and a Ph.D. in Clinical Pharmacology from the University of Buenos Aires, where he was an Assistant Professor in the Pharmacology department. He is fluent in Spanish and Italian, and effective in French.
Robert Wanerman is a Member of the Epstein Becker Green’s Health Care and Life Sciences practice in Washington, D.C. His practice concentrates on regulatory, reimbursement, and compliance matters affecting health care manufacturers, service providers, and investors in health care organizations. He has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs, administrative law and procedure, the False Claims Act, clinical research rules, grant administration rules, the Anti-Kickback and Stark laws, HIPAA, and EMTALA.
Mr. Wanerman advises clients in connection with coverage, coding, and reimbursement for medical technologies under Medicare, Medicaid, and commercial health plans; provides counsel on administrative law issues affecting health care manufacturers, suppliers, and providers, and represents clients in administrative hearings and appeals; represents clients in government audits, investigations, and litigation arising under the Medicare and Medicaid programs and under the False Claims Act, including negotiating settlements and corporate integrity agreements; counsels manufactures and providers on clinical research contracting and compliance; and he develops and implements compliance programs and policies for medical device and pharmaceutical manufacturers, hospitals, academic medical centers, and long-term care facilities.
Mr. Wanerman is a guest lecturer at the Johns Hopkins Carey Business School, Discovery to Market program. He regularly gives presentations at industry conferences and is consistently ranked by participants as a top speaker.
Ms. Snyder is Founder and President of the Women Business Leaders of the U.S. Health Care Industry Foundation™, authored “Advancing Women in Business: 10 Best Practices,” and co-authored “Answering the Call: Understanding the Duties, Risks and Rewards of Corporate Governance.”
Outside of the office, Mr. Wanerman is the Vice President of The Ivymount Foundation, which provides financial support to educational programs for children with developmental delays, speech/language deficits, learning disabilities, health impairments, and autism/PDD.
Mr. Wanerman received an A.B. in Economics from the University of Chicago, his J.D. from New York Law School, and an M.P.H. from Columbia University, School of Public Health.
Chris Zalesky is Vice President of Global Policy & Guidance at Johnson & Johnson's 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 has published numerous articles on regulatory, FDA, and health care policy matters and has contributed to several successful regulatory policy and legislative initiatives. He 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.