PROGRAM SCHEDULED for October 12-15, 2015 | 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, discrimination, harassment, wrongful termination, and breach of contract claims, in various state and federal courts, as well as claims before arbitration panels and government agencies.
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, Ms. Anderson was selected by The American Lawyer and Corporate Counsel magazine as a “2013 Top Rated Lawyer in Healthcare.”
Ms. Anderson is the current chair of the New Jersey Law & Education Empowerment Project (NJ LEEP), which serves and empowers underprivileged urban youth to greater educational achievement. She is a member of the American Employment Law Council, and a 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 a member of the National Association of Women Lawyers, where she serves on the organization’s Annual Meetings & Awards Ceremony Planning Committee. She is also 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.
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 hospitals, physicians, hospices, pharmaceutical manufacturers, suppliers and manufacturers of medical devices, nursing homes, home health agencies, CORFs, and suppliers of diagnostic, laboratory, and other services, as well as financial services firms that support the health care industry. Her specific areas of responsibility include reimbursement, fraud and abuse matters, and regulatory, legislative, and enforcement issues, primarily involving Medicare, Medicaid, and third-party payors.
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 addition, she provides counseling, transactional advice, and audit and enforcement representation, and 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 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 of the American Health Lawyers Association and has been the past Chair of the AHLA’s Fraud and Compliance Forum.
Ms. Carder-Thompson received her A.B., magna cum laude, from Brown University and her J.D. from William and Mary School of Law.
Michael Clarke is the former Vice President of Ethics & Compliance – Americas at Actavis plc, a global specialty and generic pharmaceutical manufacturer. Until June 2015, Mr. Clarke managed its healthcare compliance program for North and South America, including developing and revising ethics policies; training direct employees and contracted sales representatives; monitoring sales and marketing practices and overseeing internal investigations.
Previously, Mr. Clarke was Vice President and Compliance Officer for EBI, LLC, d/b/a/ Biomet Spine & Bone Healing Technologies, a division of global orthopedic medical device company Biomet, Inc. He also served as a compliance officer or ethics officer for the University of Medicine & Dentistry of New Jersey, Edison Schools, and Medco Health Solutions. Before working in-house as a compliance professional, Mr. Clarke practiced corporate, civil, and criminal law as a litigation partner with the law firm of Drinker Biddle & Reath LLP, as an associate at the law firms of Hannoch Weisman and Scarinci & Hollenbeck, and as an Assistant Deputy Public Defender in Essex County, New Jersey, litigating criminal matters. Mr. Clarke is a past Chair of the ABA’s Business Law Section’s Corporate Compliance Committee (2006-2010); a member of the Board of Directors of the New Jersey Corporate Counsel Association; the co-chair of the Ethics & Professional Responsibility Committee of the National Bar Association; and has been a panelist or moderator for numerous presentations on internal investigations, conducting third party due diligence, or setting up and managing corporate compliance programs.
Mr. Clarke received his J.D. from Cornell Law School and his A.B. from Brown University.
Eve Costopoulos was the Vice President, Chief Ethics & Compliance Officer at Eisai Inc. from 2010 until 2015. She was responsible for leading Eisai’s commercial and R&D compliance programs, as well as internal audit activities. She also served as a member of the company’s Executive Committee.
Prior to joining Eisai in 2010, Ms. Costopoulos was employed at Schering-Plough Corp., where she was responsible for managing the activities of the company’s global compliance officers. During her tenure there, she implemented and oversaw compliance training activities, the global privacy program, integrity action line and compliance-related investigations, and compliance-related board support. Earlier in her career, Ms. Costopoulos worked as an attorney holding the position of in-house counsel with Schering-Plough and, prior to that, in private law practice.
Ms. Costopoulos is a member of the Pharmaceutical Compliance Forum (PCF), a coalition of compliance professionals and legal counsel from throughout the research-based pharmaceutical industry focused on promoting effective corporate compliance programs. In 2006, she was a recipient of the Executive Women of New Jersey Salute to the Policy Makers Award, which honors New Jersey women leaders from major corporations, as well as women leaders of comparable achievement in the public sector. She also was nominated as a TWIN (Tribute to Women of Influence) Honoree by the YWCA of Central New Jersey in 2008. She served as a trustee of the Arts Council of the Morris Area for nine years, and is currently on the board of directors for Community Hope.
Ms. Costopoulos received her B.A. in English and secondary education from Rutgers College and her J.D. from Seton Hall University School of Law.
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.
Howard L. Dorfman is Senior Vice President and General Counsel at Turing Pharmaceuticals, a privately-held pharmaceutical and biotechnology company, located in New York City, which is engaged in preclinical and clinical development, as well as commercialization and related pharmaceutical activities across a range of therapeutic areas.
Prior to joining Turing, 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. Previously, 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 three years. In addition, he has lectured widely and published articles on a range of product liability, healthcare compliance, and FDA regulatory issues.
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).
Daniel Garen is Vice President, Global Compliance Leader at Danaher. He joined Danaher in October of 2014, bringing a deep skill set in implementing and managing corporate compliance programs for large multinational companies. He has held senior compliance officer positions with Wright Medical, Siemens Corporation, Bayer Healthcare, and the Red Cross.
Mr. Garen successfully led the completion of two Deferred Prosecution Agreements and led the implementation of a compliance program for an Office of the Inspector General (OIG) Corporate Integrity Agreement. In addition, he principally managed corporate response to a Department of Defense raid, OIG site visit, and multiple government investigations. Since entering the compliance arena in 1999, he has been a frequent industry speaker on government policy and the regulatory enforcement environment.
Mr. Garen received his B.A. from the University of Michigan, and his J.D. and L.L.M. in Health Law from Loyola University Chicago School of Law. He is a member of the Illinois bar, the District of Columbia bar, and the Federal Supreme Court bar.
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 at Porzio, Bromberg & Newman and a member of the firm’s Life Sciences Compliance, Commercialization and Regulatory Counseling Department. Ms. González 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 Prescription Drug Marketing Act (PDMA) compliance. She provides support during new product launches to in-house promotional review committees by reviewing and assessing promotional materials and marketing activities directed towards consumers and healthcare professionals. She develops and implements compliance programs for companies governing the sale and marketing of drugs and devices and drafts agreements with vendors, consultants, and other third parties. Ms. González performs audits, gap analyses, and risk assessments in a variety of areas, including sampling activities and compliance with industry standard. She also counsels manufacturers and distributors on issues related to practitioner prescriptive authority and state marketing disclosures and gift prohibition laws.
Ms. González is also a Director of Regulatory and Compliance Services for Porzio Life Sciences, LLC., a subsidiary of the law firm. As the Director, she is involved in the development and implementation of the Porzio AggregateSpendID system, an internet-based aggregate spend tracking and reporting solution.
Ms. González received her B.A. 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.
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.
Maureen McGirr is Vice President, Office of Ethics, Policy Training Communications at Merck & Co., Inc. She is an experienced legal and compliance leader with over two decades of pharmaceutical industry experience. In her current role, she is responsible for leading the Office of Ethics, including oversight of global compliance programs for investigations, anti-bribery and corruption, third party, policies, training, and communications. During her 21 years of work experience at Merck, Ms. McGirr held a number of positions within Merck’s Office of General Counsel, including Managing Counsel in legal supporting the U.S. Human Health, Vaccines and Research divisions.
Prior to joining the Global Compliance Organization, Ms. McGirr was on international assignment based in Japan as Chief Legal Counsel Strategic Initiatives from January 2009 through June 2011. In this role, she was a member of the Japan Executive Committee and provided legal support for key strategic initiatives, including oversight of the legal integration in Japan with the subsidiary of another major multinational company. During her international assignment, she was also interim leader of the Japan Compliance Organization from January to June 2011. She has held various leadership roles, including responsibility for International Compliance and interim leader for Merck Research Laboratories Compliance.
Ms. McGirr practiced law at the firm of Arnold & Porter in the firm’s litigation and pharmaceutical law practice groups from 1988 to 1993 and was also a litigation associate at Hughes, Hubbard & Reed prior to that.
Ms. McGirr has spoken at a number of pharmaceutical legal conferences on a range of topics, including pharmaceutical advertising and promotion regulation, anti-bribery and corruption, and compliance training.
Ms. McGirr received her bachelor’s degree in Political Science and Economics from Boston College, and her J.D. from American 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 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 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, and has an extensive pharmaceutical regulatory and compliance background. He spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.
Mr. Oroho received his B.S. from the United States Merchant Marine Academy, where he graduated with honors, 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.
Maureen Ruane is Partner and Chair of Health Care Litigation, Investigations & Compliance at Lowenstein Sandler, LLP. She represents and advises multi-national and domestic life science and health care companies, as well as other corporate entities and individuals. She applies her experience to help clients avoid becoming the focus of government investigations or enforcement actions, and to best position them to minimize any exposure if they should find themselves subject to government scrutiny. She also represents corporate and individual clients in civil litigations and investigations, and she regularly counsels clients on regulatory and compliance issues. She has extensive experience guiding companies through whistleblower complaints and conducting internal investigations after reports of potential misconduct by company employees.
Ms. Ruane previously served as Chief of the Health Care & Government Fraud Unit at the United States Attorney’s Office for the District of New Jersey from 2010-2013, where she 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, and the FCPA, among others. She also created and led the first stand-alone Health Care & Government Fraud Unit while there. Under her leadership, the Office changed the way that health care fraud cases are investigated and prosecuted so that criminal and civil Assistant U.S. Attorneys (AUSAs) began working side-by-side in a more coordinated manner, which resulted in the Unit realizing substantial growth and success. By the time she left the office in 2013, she was supervising 10 criminal AUSAs and 4 civil AUSAs; the Unit had recovered over $510 million in health care fraud and government fraud settlements, judgments, fines, restitution, and forfeiture under the FCA, the FD&C Act, and other statues; and more than 150 defendants had been convicted for health care fraud and other offenses. As Chief, Ms. Ruane also coordinated with partner investigative agencies, including HHS-OIG, FBI, FDA, and IRS, as well as the U.S. Department of Justice’s Civil Division, its Consumer Protection Branch, and various states’ Attorney General’s Offices.
Based on her more than nine years as an AUSA and her more than 11 years in private practice, Ms. Ruane has vast experience conducting internal investigations, as well as successfully litigating and trying cases. She is also a skilled appellate attorney, having written appellate briefs in more than 45 cases, and having argued before the Third Circuit Court of Appeals on more than a dozen occasions. She has also achieved tremendous success in resolving her clients’ matters on favorable terms early in the process, thereby avoiding the need for full-scale investigations and/or litigation.
Ms. Ruane received the U.S. Department of Justice Performance Award in 2002, for Sustained Superior Performance, and received awards and commendations from numerous federal agencies, including HHS-OIG, FBI, FDA, IRS, DEA, Secret Service, Postal Inspection Service, Department of Transportation, Department of Labor, Office of Personnel Management, and Department of Veteran’s Affairs, for her work as Chief of the Health Care & Government Fraud Unit. In addition, she was selected to be included in The Best Lawyers in America (2015) 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.
Lynn Shapiro Snyder is on the Board of Directors and a Member of Epstein Becker Green. She is a Senior Member of Epstein Becker Green in the Health Care and Life Sciences and Litigation practices in the firm’s Washington, D.C. office, and she is Strategic Counsel with EBG Advisors, Inc. She has over 35 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 publishes extensively and is a frequent speaker, particularly on topics related to health reform.
Modern Healthcare magazine named Ms. Snyder as one of the “100 Most Powerful People in Healthcare” in its inaugural list, in August 2002. In April 2005, the magazine named her as one of the “Top 25 Women in Healthcare.” In the May 2006 issue of Nightingale’s Healthcare News, Ms. Snyder was named one of the “Oustanding Fraud & Compliance Lawyers for 2006.” She has been selected by her peers for inclusion in The Best Lawyers in America© (2006-2015) in the field of Health Care Law; named to the Washington, DC Super Lawyers list (2007-2014) in the area of Health Care; recommended by The Legal 500 United States (2014); and, over the years, recognized in Chambers USA. Ms. Snyder received an “AV Preeminent” Peer Review Rating by Martindale-Hubbell, signifying the highest level of professional excellence. In 2007, she was presented with the Women to Watch Award by the Jewish Women International. She has also been quoted in the New York Times and other leading publications.
Ms. Snyder serves on the firm’s Board and Finance Committee, and is Chair of the Third-Party Payment Practice Group. She also co-chairs the Health Care Fraud Pratice Group and the Health and Employment Law (HEAL) Group. In addition, she works on matters in the Pharmaceutical Industry Health Regulatory Practice Group and the Managed Care/Integrated Delivery System Practice Group.
Ms. Snyder is Founder and President of the Women Business Leaders of the U.S. Health Care Industry Foundation™, and has authored “Advancing Women in Business: 10 Best Practices” and co-authored “Answering the Call: Understanding the Duties, Risks and Rewards of Corporate Governance.”
Ms. Snyder joined the firm in 1979 and is admitted to practice law in the District of Columbia, the State of Florida, and before the United States Supreme Court. She was board recertified as a Specialist in Health Law in the State of Florida beginning August 1, 2003.
Ms. Snyder earned a B.A. in Economics from Franklin & Marshall College in 1976 and her J.D. from the George Washington University National Law Center in 1979.
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.
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.