PROGRAM SCHEDULED for June 8-11, 2015 | Newark, New Jersey
Dennis K. Barnes is Vice President, Chief Compliance Officer at PAREXEL International. Headquartered in Waltham, Massachusetts, PAREXEL is a clinical research organization focused on assisting its pharmeutical 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, Dennis K. Barnes held various positions with pharmaceutical manufacturers and consulting firms that service the pharmaceutical industry over the last 16 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 Vice President of Ethics & Compliance – Americas at Actavis, Inc., a global specialty and generic pharmaceutical manufacturer. Mr. Clarke manages 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 the immediate 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 is Vice Presdient, Chief Ethics & Compliance Officer at Eisai, Inc. She is responsible for leading Eisai’s commercial and R&D compliance programs, as well as internal audit activities. She also serves 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 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 in 2014.
Mr. Danzis received his B.S. from Cornell University, his M.H.S.A. from The George Washington University, and his J.D. from the University of Virginia School of Law. In addition, Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit.
Meena Datta is a partner at Sidley Austin. She specializes in counseling on all aspects of health care regulatory law that impact pharmaceutical, medical device, and electronic health record manufacturer activities, including health care reform; fraud and abuse, particularly the Federal Anti-Kickback Statute; pharmaceutical government price reporting obligations; federal health care program coverage and reimbursement issues; health care compliance programs, including drafting policies and procedures, counseling on implementation issues, and conducting audits and internal reviews; managed care contracting; HIPAA and HITECH implementation and compliance; and federal and state transparency and reporting laws, including the Sunshine Act and similar state laws.
Ms. Datta was recognized as a top health care lawyer in the U.S. by Legal 500 United States: 2013 Edition, where she was characterized as a “pricing and fraud and abuse specialist.” She has spoken at a variety of national and state conferences, including BIO and AdvaMed.
Ms. Datta received her B.A. from Brown University and her J.D. from the University of Chicago Law School.
Howard L. Dorfman is Associate Vice President of U.S. Litigation and Government Affairs at Ferring Pharmaceuticals Inc., the U.S.-based subsidiary of Ferring Holding, a pharmaceutical, medical device and biotech company based in St. Prex, Switzerland. He is responsible for all legal matters relating to the company’s U.S. operations.
Prior to joining Ferring, Mr. Dorfman was Counsel in the Life Sciences group at Ropes & Gray LLP in New York City where his practice focused on providing guidance to the pharmaceutical, medical device and biotech industries.
Before joining Ropes & Gray, Mr. Dorfman served as chief legal officer of the pharmaceutical division of Bayer Healthcare LLC and a member of the Bayer Corporate Compliance Committee where he was responsible for legal oversight relating to the commercial, regulatory and compliance activities of the company's pharmaceutical operation and for providing counsel relating to a wide range of areas, including advertising and promotion, as well as labeling activities for the various Bayer therapeutic areas.
Prior to joining Bayer in 2001, Mr. Dorfman worked at Bristol-Myers Squibb for 23 years in a range of areas including defense of mass torts litigation, commercial law, FDA regulatory practice and health care compliance.
Mr. Dorfman has lectured and published on a wide range of pharmaceutical product liability and food and drug law regulatory issues, and his articles have appeared in the Food and Drug Law Journal, the Rutgers Law Review, and the Seton Hall Law Review, among others. He is currently an adjunct professor at Seton Hall Law School where he teaches a course on Pharmaceutical and Medical Device Promotion, Advertising and Communication.
Mr. Dorfman received his B.A. (with honors) from Yeshiva University and his J.D. from Brooklyn Law School.
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 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 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 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 and employment law 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 (2nd ed. 2011) (with Rachel Arnow-Richman and Charles Sullivan). His recent scholarship focuses on 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 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 as a judicial clerk, this time for the Honorable John R. Tunheim, United States District Court for the District of Minnesota. 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.
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 Manager of Regulatory and Compliance Services for Porzio Life Sciences, LLC., a subsidiary of the law firm. In that role, she collaborates on the creation of new products and services and the management of existing offerings.
Prior to working at Porzio, Bromberg & Newman, Ms. González was a summer associate at Day Pitney LLP, and Porzio, Bromberg & Newman. She also was a judicial intern for the Honorable Barry T. Albin, Supreme Court of New Jersey.
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.
Chris Hall is a partner at Saul Ewing and the chair of the firm’s White Collar and Government Enforcement group. He regularly draws on his experience as a former federal prosecutor in representing corporations and individuals who face the prospect of an indictment or the commencement of a civil enforcement action. He assists clients during internal assessments, criminal investigations, civil enforcement actions, and related proceedings, such as False Claims Act and securities fraud suits. He places particular emphasis on the healthcare, financial service, defense, and government contract industries. Mr. Hall has a thorough and current understanding of the workings of the FDA, the HHS OIG, the Antitrust, Criminal, and Civil Divisions of the Department of Justice, the SEC, the IRS, HUD, EPA, and the Departments of Defense, Homeland Security, and Labor.
Mr. Hall was previously an Assistant U.S. Attorney, a role in which he prosecuted a number of significant, complex matters, including one of the first criminal healthcare cases brought to trial in the Eastern District of Pennsylvania, for which he received the Director’s Award from the Department of Justice for outstanding performance.
Mr. Hall received his B.A., cum laude, from Amherst College, and received his J.D. degree from Georgetown University Law Center, where he served as editor of The American Criminal Law Review. He also clerked for the Honorable James S. Holden, United States District Court Judge for the District of Vermont.
Melissa LaFrain is Senior Manager, Corporate Compliance at Wright Medical Technology, Inc. She has 14 years of Compliance and Audit experience with progressive focus in the medical device industry. Her expertise includes policy management and training, aggregate spend and transparency, Sarbanes-Oxley, anti-bribery and corruption, internal audit, and project management. She has been actively involved in three Corporate Integrity Agreements and one Deferred Prosecution Agreement.
During Ms. LaFrain’s tenure at Wright Medical, she has led Aggregate Spend, Professional Affairs, Review and Monitoring, and most recently, Policies and Training.
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. Mr. Levy 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 Medicaid and Medicare 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. Mr. Levy 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.
Mr. Levy has taught as an adjunct professor of health care fraud and abuse at Seton Hall Law School. He is a frequent lecturer to private and government groups regarding health care fraud enforcement and compliance.
Mr. Levy received his B.A., cum laude, from Brandeis University and his J.D. from New York University School of Law.
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, from Dickinson College and his J.D., with high honors, from George Washington University Law School.
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.
Mark Petrille is Vice President and Chief Compliance Officer at Siemens Healthcare Sector, North American Cluster. He has accountability for developing and directing Siemens’ comprehensive compliance program designed to strengthen and complement the organization's strategy, culture, and values, and ensuring full adherence to regulatory and legal requirements. This includes federal and state fraud and abuse laws, as well as state and federal disclosure laws. Mr. Petrille chairs the Compliance Committee and is a member of the Leadership Team, and is responsible for all activities relating to standards of conduct and ethical relationships with customers, business partners, and suppliers. In addition, Mr. Petrille is responsible for leading management and sales force compliance training and education. He also has oversight of the company’s investigations, and gap and risk assessment processes.
Prior to joining Siemens’ compliance organization, Mr. Petrille was employed by Siemens Healthcare for 23 years in a range of accounting and finance areas, and served as the Financial Officer for their Health Services Business.
Mr. Petrille received his B.S. in Business Administration from Kutztown University and his MBA in Finance from St. Joseph’s University. He received his J.D. from Widener University School of Law.
J. Carson Pulley is Senior Corporate Counsel, Compliance Division – Anti-Corruption Program Office at Pfizer, Inc. Prior to joining Pfizer in 2011, Mr. Pulley developed FCPA-related experience at Chadbourne & Parke LLP, where he worked as a litigation associate. His practice at Chadbourne included advising clients regarding their compliance with anti-corruption legislation and standards, and a wide array of complex commercial litigation in courts throughout the U.S. and abroad.
Mr. Pulley received his B.A. from the University of Richmond and his J.D. from Fordham University School of Law.
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. Ms. Ruane 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 afte 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, the Federal Food, Drug & Cosmetic Act, the Anti-Kickback Statute, and the FCPA, among others.
Ms. Ruane 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 College and her J.D. from Rutgers School of Law–Newark. After graduating law school, she clerked for the Honorable Murry D. Brochin, Superior Court of New Jersey, Appellate Division.
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.
Robert Wanerman is member of Epstein Becker & Green’s Health Care and Life Sciences practice in the firm's Washington, DC, office. 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 is a guest lecturer at the Johns Hopkins Carey Business School, Discovery to Market Program and regularly gives presentations at industry conferences.
Mr. Wanerman received his A.B from University of Chicago, his J.D. from New York Law School, and his M.P.H. from Columbia University School of Public Health.
Mr. Zalesky is Vice President, Global Policy & Guidance, Johnson & Johnson Office of Health Care Compliance & Privacy. He has more than 20 years of 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. Mr. Zalesky provides guidance on a range of commercial and scientific matters and is admitted to practice in Pennsylvania.
Mr. Zalesky received his B.A. from the University of California at Santa Barbara and his J.D. from Widener University School of Law. He is Regulatory Affairs Certified (RAC).