PROGRAM SCHEDULED for June 12-15, 2017 | 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 Anne Anderson is a partner in Drinker Biddle & Reath's Labor & Employment Practice Group and is a practiced jury and bench trial lawyer, who has handled a wide range of employment litigation, including whistleblower cases, restrictive covenant disputes, and wage and hour class/collective actions. She routinely litigates whistleblower and retaliation claims, often involving senior executives and allegations regarding the client’s core business. She also works closely with companies to implement policies and training to limit such claims, to facilitate thorough and effective internal investigations and implement remedial measures if warranted.
Ms. Anderson regularly litigates claims relating to theft of confidential information and interference with business relationships, typically involving the transition of senior executives and key sales people. She also works with companies to implement effective restrictive covenant agreements and protocols to protect company assets, as well as limit exposure for claims when hiring new employees.
Ms. Anderson provides strategic counseling to clients implementing reductions in force either in response to changing business needs or as a result of post-M&A restructuring. She works with clients to manage all aspects of the “before, during and after” phases of a workforce restructuring, including: adoption of voluntary and involuntary separation policies/plans; selection criteria; disparate impact analysis; separation agreements including OWBPA disclosures; WARN compliance; Q&A documents; “talking point” scripts; and post-RIF communications with the remaining workforce. She also works closely with the firm’s M&A team on L&E due diligence and negotiation of executive agreements.
Ms. Anderson has been recognized by Chambers USA from 2009-2016 in New Jersey for Labor & Employment and as a Top Rated Lawyer in Healthcare by The American Lawyer and Corporate Counsel in 2013. She is a member of the invitation-only American Employment Law Council, and a senior fellow of the Litigation Counsel of America, an honorary society for trial lawyers.
Ms. Anderson received her B.A. from Mount Holyoke College, and her J.D. from Rutgers University School of Law – Camden.
Joseph Braunreuther is Deputy General Counsel at Johnson & Johnson. He joined the General Law Department of Johnson & Johnson in 2001. Previously, he held the position of General Counsel for the Pharmaceuticals Group. He has provided legal counsel to numerous Johnson & Johnson operating companies in the areas of commercial litigation, including class action cases, securities litigation, intellectual property disputes, and contract disputes. He also counsels the operating companies on how best to avoid such litigation.
Mr. Braunreuther came to Johnson & Johnson from the United States Attorney’s Office in New Jersey, where he had been Executive Assitant United States Attorney, responsible for handling both criminal prosecutions and civil actions on behalf of the United States. From 1995 to 1999, he was Chief of that office’s Civil Division, and from 1986 to 1991, Deputy Chief of its Frauds Section. He has extensive experience in the investigation and prosecution of white-collar crime.
Mr. Braunreuther has also spent time in private practice with the Haight Gardner firm, and from 1991 to 1995 as a partner with the international law firm Watson Farley & Williams, both in New York City. He was also Deputy Special Counsel to the United States Senate Banking Committee during its Whitewater investigation and hearings.
Mr. Braunreuther is a graduate of the United States Merchant Marine Academy and St. John’s University School of Law, where he was an Editor of the Law Review.
Elizabeth Carder-Thompson is a Partner at Reed Smith LLP and a member of the firm's Life Sciences Health Industry Group, practicing in the area of health 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 assisted many clients in developing and evaluating corporate compliance programs.
Ms. Carder-Thompson was named a 2015 "Star" (Regulatory) in the LMG Life Science Guide as Best Lawyers' 2015 "Lawyer of the Year" for Health Care Law in Washington, D.C. She was also named as one of America's leading lawyers in Health Care Law in the 2011-2016 editions of The Best Lawyers in America and recognized as a Washington, D.C. Super Lawyer for her Health Care practice from 2007-2016. She was named by Chambers USA as one of America's leading Health Care lawyers from 2007-2014 and in 2016, 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 from 2013-2014.
Ms. Carder-Thompson received her A.B., magna cum laude, from Brown University and her J.D. from William & Mary School of Law.
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 18 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.
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 for FDA from 2011-2016, Washington DC Super Lawyers for FDA from 2014-2015, and Legal 500 US for M&A: Commercial Deal and Contracts in 2016.
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.
Charlene Davis is Head of Healthcare Compliance, North America at Sun Pharmaceutical Industries, Inc., where she leads the development and maintenance of the U.S. comprehensive compliance program for Sun’s U.S. branded commercial businesses.
Prior to her current role, Ms. Davis was Senior Compliance Counsel for U.S. affiliates of a Japanese pharmaceutical/medical device company, spending several years providing healthcare law guidance for devices, digital, and neuroscience drug products, development and maintenance of a centralized North American contact center to support the handling of medical and pharmacovigilance inquiries, development of sales force automation systems integrating compliance requirements, federal and state law reporting regarding prescription drug samples, assistance with investigations, and drafting policies and procedures on a variety of healthcare law topics. Her experience also includes supporting regulatory inspections related to pharmacovigilance compliance.
Prior to her experiences as in-house counsel for pharmaceutical companies, Ms. Davis practiced corporate defense litigation in Pennsylvania and New Jersey. Her case portfolio included matters related to healthcare, products liability, commercial disputes, white collar crime, and insurance disputes.
Ms. Davis has received various recognitions including the New Jersey Law Journal’s 50 under 40 New Leaders to the Bar Award. She has accomplished both publications and speaking engagements including being the featured radio and television guest for station WIMG’s program, “Healthcare & Ethics in a Technologically Advanced Age.”
Ms. Davis is a graduate of Temple University Beasley School of Law, having received the Barrister’s Award for Trial Advocacy, and Cornell University, where she received induction into the National Society of Collegiate Scholars, Cornell Chapter.
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. He supervises all White Collar Crime investigators in the Trenton and Franklin Township Resident Agencies of the FBI Newark. He is responsible for all programs, including health care, public corruption, and a myriad of complex financial crimes. Of investigative note, he was the Case Agent on 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, as well as the Mayor of Trenton Tony F. Mack and his brother. He also led the investigation into one of the largest and longest running insider-trading conspiracies in U.S. history (Bauer, et al.). Recently, Mr. Doyle supervised the FBI’s involvement on the successful “Bridgegate” investigation through trial, and a related matter regarding David Samson, former Chairman of the Port Authority of NJ & NY. He 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. He 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).
Maggie Feltz is Executive Director of Ethics & Compliance at Purdue Pharma. Her primary focus at Purdue is on the Sales & Marketing functions. She also oversees Purdue’s aggregate spend efforts, ensuring compliance with state and federal marketing reporting requirements.
In her role, Ms. Feltz collaborated with other attorneys and compliance professionals to negotiate Purdue’s Corporate Integrity Agreement (CIA). Since the initiation of the CIA in July 2007, she has partnered with Purdue colleagues and management to ensure its smooth implementation.
Outside of Purdue, Ms. Feltz served as Co-Chair of the Pharmaceutical Compliance Forum (PCF) from 2009 to 2015, a non-profit coalition founded in 1999 of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers.
Prior to joining Purdue, Ms. Feltz served as Compliance Counsel at Boehringer Ingelheim Pharmaceuticals, Inc. and practiced health care law at McDermott, Will & Emery. She received a B.A. in Bioethics from Wellesley College, an M.A. in Medical Ethics from Case Western Reserve University, and she received her J.D. from Case Western Reserve University School of Law.
Gary F. Giampetruzzi is a partner in the Litigation Department at New York office of Paul Hastings, LLP. He is based in the firm’s New York office in its Investigations and White Collar practice. 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. While his practice cuts across numerous sectors, including defense, energy, and private equity, he possesses particularly deep experience in the life sciences sector, representing many of the world’s most prominent biotech, pharmaceutical, and medical device companies.
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 provides day-to-day compliance counseling around program design, monitoring and proactive testing, and conducts internal investigations regarding a variety of issues, including those involving anti-kickback and off-label promotion laws, patient support programs, and specialty pharmacies. He has overseen several of the more significant government investigations in the pharmaceutical industry in recent years, as well as the defense and resolution of numerous whistleblower qui tam suits involving claims under the False Claims Act and related state statutes. He has been asked by pharmaceutical companies to defend their practices associated with patient support programs and specialty pharmacies in connection with federal investigations by several prominent prosecutor offices.
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 Senior Associate Dean and Andrea J. Catania Endowed Professor of Law at Seton Hall Law School. He specializes in employment and corporate law, and the intersection between these two areas. Since joining Seton Hall in 1999, he has taught various corporate-and employment-law courses, as well as first-year Civil Procedure and Torts. He also has created and taught online courses addressing legal issues and compliance in the workplace, the laws governing whistleblowing, and internal investigations. In 2016, he was named the Andrea J. Catania Endowed Professor of Law.
Professor Glynn was appointed Associate Dean in 2015, and now serves as a Senior Associate Dean. In this role, he oversees various aspects of the law school’s J.D. program. He also oversees Seton Hall’s Master of Science in Jurisprudence (MSJ) and online graduate certificate programs in financial services compliance, and healthcare, pharmaceutical, and intellectual property law. In addition, he supervises the law school’s six live healthcare compliance certificate programs in the United States, Europe, and Asia.
Professor Glynn's scholarship focuses on enforcement mechanisms in employment and corporate law, the allocation of decision making authority and legal accountability within the corporation, and the impact of enterprise structures on legal protections and legal compliance. In addition, he has written on the troubling implications of school ranking systems. He is a co-author of leading employment and labor law casebooks, Employment Law: Private Ordering and Its Limitations (3rd ed. 2015) (with Charles Sullivan and Rachel S. Arnow-Richman); and Cox and Box’s Labor Law: Cases and Materials (16th ed. 2016) (with Robert A. Gorman and Matthew W. Finkin). He has published numerous articles addressing issues in employment and corporate law, and frequently presents on these and other legal topics to professional and academic organizations. Moreover, along with Professor Charles Sullivan, Professor Glynn founded the Seton Hall Employment & Labor Law Junior Scholars Forum in 2006, and continues to host it annually.
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 as 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.
Nicholas Harbist is a Partner at Blank Rome LLP. A seasoned trial lawyer, 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, antitrust, securities, trade secrets, healthcare, and professional licensing litigation; corporate internal investigations; corporate compliance programs; and Qui Tam/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. As a federal prosecutor, he conducted dozens of high-profile investigations and trials. Based on this experience, he developed a keen understanding of the compliance challenges facing corporate boards and CEOs.
Mr. Harbist is a nationally-recognized lecturer on white collar criminal law topics. He was a featured speaker at the American Bar Association’s 4th Annual International White Collar Crime Institute Conference in London in October 2015, where he spoke on “Crisis Management in Litigation.” He is a skilled appellate lawyer and has argued cases before the Third Circuit Court of Appeals and the New Jersey Supreme Court. He is consistently recognized by The International Who’s Who of Business Crime Defense Lawyers and The International Who’s Who of International Investigations Lawyers. He was recognized from 2010-15 in The International Who's Who of Investigations Lawyers, from 2010-15 as a Super Lawyer in the New Jersey and Pennsylvania editions of Super Lawyers, and has received the highest possible rating from Martindale-Hubbell.
Mr. Harbist is a member of numerous community and professional organizations. In 2010, he 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. He also serves as a board member of the Long-Range Planning Committee for the Justinian Society.
Mr. Harbist received a B.S., magna cum laude, from The College of New Jersey, and his J.D., magna cum laude, from Rutgers University School of Law.
Elizabeth Kim is Senior Counsel at Loeb & Loeb LLP. She counsels pharmaceutical, medical device, and biotechnology companies on a variety of regulatory and compliance-related issues, including federal and state fraud and abuse laws, FDA promotional regulations, industry standards regarding healthcare professional interactions, and PDMA compliance. She develops compliance programs for companies and negotiates and drafts agreements with vendors, consultants, and other third parties. She conducts compliance training for Boards of Directors, senior management, field force personnel, and Medical Affairs groups, and also performs audits, gap analyses, and risk assessments of overall compliance programs as well as sampling activities and medical publications. She also counsels manufacturers and distributors on issues related to record-keeping and pedigree as well as general wholesale distribution and state licensing requirements for pharmaceutical, medical device, and human and non-human tissue products.
Ms. Kim frequently serves on in-house promotional review committees to review and evaluate promotional materials (including broadcast ads, print materials, digital/social media) and marketing activities directed towards consumers and healthcare professionals. She has been involved in a number of new product launches and provides guidance on lawful preapproval communication strategies as well as disease awareness campaigns. She also serves as acting in-house counsel and compliance director at small to mid-size companies.
Ms. Kim received her B.A. from Wellesley College, an M.S. in Clinical Practice from Columbia University, and her J.D. from Rutgers University School of Law, where she was a member of the Rutgers Business Law Journal.
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.
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. He was named a Regulatory “Star” in the LMG Life Science Guide for 2012-2015.
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 Executive Vice President and Chief Strategy Officer at Porzio Life Sciences, LLC. He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia.
Mr. Oroho is also a principal of the law firm Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Regulatory Counseling Department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Antikickback statute, False Claims Act, and Medicare and Medicaid fraud and abuse.
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 an extensive pharmaceutical regulatory and compliance background. He also spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.
Mr. Oroho 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.
Lucy Rose is President of Lucy Rose & Associates. She provides training and consulting to the pharmaceutical industry and its service support providers. From 1995-97, she served as the Director of the Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). There she designed and implemented programs to improve external communications with the pharmaceutical industry, health care professionals, and consumers. Additionally, she designed and implemented programs to improve employee performance, including leadership and management development. Examples of programs introduced during her leadership include: design and implementation of CDER’s World Wide Web Site, Live Satellite Educational TV programs with the pharmaceutical industry, comprehensive introductory training programs for new reviewers, and design and implementation of CDER’s crisis communication program.
Ms. Rose led CDER’s Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers. Among those challenges encountered during her leadership were the CME (Industry Supported Scientific and Educational Activities) Guidance and Direct to Consumer Broadcast Advertising considerations.
Prior to joining FDA, Ms. Rose was associated for seven years with Mead Johnson Pharmaceuticals, a division of Bristol-Myers Squibb Pharmaceuticals. She began her career as a sales representative, served as a regional sales trainer, and for four years was the District Sales Manager of the Washington, D.C. district.
Ms. Rose has been honored with a number of awards. The FDA twice selected her for their highest leadership accolade, the Award of Merit, for her leadership at DDMAC and at the Office of Training and Communication. DTC Perspectives and PHAME have elected her to their respective Direct To Consumer Hall of Fames for her many years of leadership in the DTC arena. Additionally, she speaks extensively at professional conferences on the regulatory and compliance issues surrounding the promotion of prescription drugs.
Ms. Rose earned a B.S. degree in biology from Salem College in Winston-Salem, N.C., and an MBA from Averett College. In addition, she graduated from the Wake Forest University Physician Assistant Program as a board-certified Physician Assistant.
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. As an Assistant U.S. Attorney in the District of New Jersey, she successfully tried federal cases as first chair, and she argued before the Third Circuit Court of Appeals on more than a dozen occasions.
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 - 2017) 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), and acknowledged by Super Lawyers (2009-2010) and Rising Star (2007) for white collar criminal defense, business litigation, and appellate work.
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.
Lynn Shapiro Snyder is on the Board of Directors and 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, she was named one of the “Outstanding Fraud & Compliance Lawyers for 2006.” She has been selected by her peers for inclusion in The Best Lawyers in America© (2006-2016) in the field of Health Care Law; named to the Washington, DC Super Lawyers list (2007-2016) in the area of Health Care; recommended by The Legal 500 United States (2014, 2016); and, over the years, recognized in Chambers USA. She 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, which concentrates on legal and regulatory matters arising under third-party payment programs such as Medicare, Medicaid, and TRICARE. She co-chairs the Health Care Fraud Practice Group, which focuses on federal and state fraud issues, including anti-kickback, self-referral, false claims, secondary payor issues, and false billings, and she co-chairs the Health and Employment Law (HEAL) Group and contributes to its blog. 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™, 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 in 2003.
Ms. Snyder earned a B.A. in Economics from Franklin & Marshall College and her J.D. from the George Washington University National Law Center.
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 LLP. She is a nationally-regarded lawyer, whose practice focuses on the privacy and security of health information. As Sidley’s team leader for this practice area, she helps companies leverage data assets, respond to data breaches, and develop rules involving the electronic exchange of health information. Under her leadership, Sidley received a Chambers USA Spotlight Table ranking in Privacy & Data Security: Healthcare (Nationwide) in 2010, and has every year since then. Ms. Spencer has repeatedly been recognized by The Legal 500 US for her health-related counseling experience, and in 2016 was recognized for her work in cyber law.
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. She regularly counsels clients with respect to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and amendments made to HIPAA by the Health Information Technology for Economic and Clinical Health Act (HITECH). She also advises clients on various state health care privacy laws, including state health information privacy and marketing laws.
Ms. Spencer has experience investigating and responding to data breaches and information security incidents. She has represented clients in connection with data breach reporting obligations under state laws and the HITECH regulations for breaches of protected health information, and defended healthcare providers in investigations initiated by the Office of Civil Rights, Department of Health and Human Services. She also advises 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. In connection with these matters, she frequently addresses 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 and has negotiated hundreds of Business Associate Agreements on behalf of various clients. She is a frequent speaker on privacy/security matters for numerous groups such as BNA and the American Conference Institute and has authored many publications, including Health Information Privacy and Security, published by Bloomberg BNA in 2014, and a variety of articles on privacy/security issues, Medicare coverage, and fraud and abuse.
Ms. Spencer received her B.A., magna cum laude, from Sewanee and her J.D. from Vanderbilt University Law School.
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.
Joseph Zimmerman has over twenty years of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, leadership development, training, management, and sales. He is the founder of JGZ Advisors LLC, a healthcare compliance and business operations consulting company.
Prior to establishing his own company, Mr. Zimmerman served as Senior Vice President and Chief Compliance Officer for two multi-billion dollar publicly traded companies: Actavis plc (NYSE: ACT) (now Allergan plc - NYSE: AGN), and Forest Laboratories, Inc. (NYSE: FRX), (acquired by Actavis). He held the position of Global Chief Compliance Officer for Forest starting in 2004, where he established the corporate function and managed the teams providing compliance support for over a dozen new product or indication approvals and branded drug launches. In this role, he eventually became a member of CEO’s Executive Leadership Team at both Forest and Actavis, regularly presented to the Board and Board Committee(s), and held various positions on internal and external committees. including chairing the respective company’s Healthcare Compliance Committee. He regularly interfaced with fellow c-suite executives, directors, local, state, and federal regulators, external auditors, business partners, and outside firms.
Mr. Zimmerman has extensive experience in compliance strategy, program design and implementation, pre-launch preparation including samples management and patient assistance programs, global anti-bribery and anti-corruption program assessment, and risk management processes; creating, implementing, and managing effective global compliance programs; managing complex investigations and remediation activities; leading compliance negotiations including corporate integrity agreement and settlement discussions; and M&A, due diligence, expansions, divestitures, and integration activity, including enhancing processes to ensure compliance program alignment with company, commercial, and R&D business goals, resulting in a healthy collaborative company culture of compliance.
Mr. Zimmerman has extensive direct management experience and transformational leadership expertise as a company executive growing Forest Laboratories and leading the compliance integration of Forest into Actavis post-acquisition. He has managed large-scale global compliance and business operations functions and was on key committees and strategy groups during the course of his tenure. He was instrumental in serving as the company’s compliance-lead during several complex compliance negotiations, including those involving government settlements, and an accompanying Corporate Integrity Agreement.
Mr. Zimmerman received a B.S. in Biology from Bradley University, and has received regular training and certifications in Compliance, Ethics, Fraud & Abuse, and Investigations. He is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.