Healthcare Compliance Training - Speaker Biographies



U.S. Healthcare Compliance Certification Program | 973-642-8871

PROGRAM SCHEDULED for October 9-12, 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.

Speaker Biographies
  1. Lynne Anne Anderson
  2. Richard Bistrong
  3. Elizabeth H. Canter
  4. Elizabeth B. Carder-Thompson
  5. Regina Gore Cavaliere
  6. Michael R. Clarke
  7. Scott D. Danzis
  8. Charlene E. Davis
  9. Sujata T. Dayal
  10. Howard L. Dorfman
  11. S. Joy Dowdle
  12. Mike Doyle
  13. Jacob Elberg
  14. Denise Esposito
  15. Paul Fishman
  16. Timothy Glynn
  17. Sandra González
  18. Nicholas C. Harbist
  1. Elizabeth H. Kim
  2. Jenny Kramer
  3. Bruce A. Levy
  4. Seth Lundy
  5. Yolanda Lyle
  6. Jill Fallows Macaluso
  7. Scott B. McBride
  8. Joseph W. Metro
  9. Brian O’Reilly
  10. John P. Oroho
  11. Suzanne Seferian
  12. Lynn Shapiro Snyder
  13. James Sheehan
  14. Anna L. Spencer
  15. Carlos Tessi

Lynne Anne Anderson

Lynne Anne AndersonLynne 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.

Richard Bistrong

Richard BistrongRichard Bistrong is CEO of Front-Line Anti-Bribery LLC. He spent much of his career as an international sales executive in the defense sector and currently consults, writes, and speaks on foreign bribery and compliance issues from that front-line perspective. His experience included his role as the Vice President of International Sales for a large, publicly traded manufacturer of police and military equipment, which required his residing and working in the UK. For well over ten years, he traveled overseas in his sales responsibility for approximately 250 days per year.

In 2007, Mr. Bistrong was targeted by the U.S. Department of Justice in part due to an investigation of a UN supply contract and was terminated by his employer. In that same year, as part of a cooperation agreement with the U.S. Department of Justice and subsequent Immunity from Prosecution in the UK, he assisted the United States, Great Britain, and other governments in their understanding of how FCPA, bribery, and other export violations occurred and operated in international sales. His cooperation, which spanned three years of covert cooperation and two years of trial preparation and testimony, was one of the longest in a white-collar criminal investigation.

In 2012, Mr. Bistrong was sentenced as part of his own Plea Agreement, and served fourteen-and-a-half months at a Federal Prison Camp. He was released in December of 2013.

Mr. Bistrong now consults, writes, and speaks about current front-line anti-bribery compliance and ethics issues. He shares his experience on anticorruption and ethical challenges from the field of international business, reflecting on his own perspective and practice as a former sales executive and law enforcement cooperator. He currently consults with organizations through his company, Front-Line Anti-Bribery LLC, and welcomes the opportunity to exchange and share perspectives on real-world anti-bribery and compliance challenges. He has shared his experience, via keynotes and panels, with the OECD, World Bank, International Anti-Corruption Academy, as well as major multinationals and leading academic institutions.

Elizabeth H. Canter

Canter ElizabethLibbie Canter is a Partner at Covington & Burling and a member of the firm’s Communications and Media and Data Privacy and Cybersecurity Practice Groups. She advises clients on managing risks under federal and state data privacy and communications laws, as well as advising clients on privacy-by-design strategies and third-party risk management. As part of her practice, she regularly represents clients in commercial transactions relating to content distribution and those involving personal data and cybersecurity risk.

Ms. Canter’s experience includes: advising major technology and consumer electronics companies on data collection, use, and disclosure practices, including privacy-by-design strategies; advising Consumer Privacy Ombudsman on sale of consumer personal information in possession of Borders Group, Inc.; counseling clients on data security breaches, including compliance with notification requirements and advice regarding possible regulatory enforcement actions; advising major financial services company on compliance with Gramm-Leach-Bliley Act and in connection with mergers and acquisitions and other transactions; advising major companies in strategic transactions, including Microsoft Corp. in its $8.5 billion acquisition of Skype Global S.à.r.l.; representing various television industry clients on legislative, FCC, and industry issues, including retransmission consent policy, program access and program carriage rules, major industry mergers, EEO compliance, and political broadcasting issues; and counseling clients on e-mail marketing and telemarketing strategies, including advising on questions under the Controlling the Assault of Non-Solicited Pornography and Marketing (CAN-SPAM) Act, the Telephone Consumer Protection Act, and implementing regulations, as well as in connection with related policy and litigation matters.

Ms. Canter received an A.B. from Duke University, and her J.D. from the University of Virginia School of Law, where she was a member of the Order of the Coif and Articles Editor of the Virginia Law Review.

Elizabeth B. Carder-Thompson

Elizabeth Carder-ThompsonElizabeth Carder-Thompson is Counsel 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 has been recognized by The Best Lawyers in America as a Top Lawyer in the practice area of Health Care Law in 2016, Best Lawyers' in 2015 as "Lawyer of the Year" for Health Care Law in Washington, D.C., and by Washingtonian magazine as a Top Lawyer in the area of Health Care Law, from 2013-2014. The Best Lawyers lists, representing 80 specialties in all 50 states and Washington, D.C., are compiled through an exhaustive peer-review survey, in which thousands of the top lawyers in the United States confidentially evaluate their professional peers. She has also been named a Regulatory "Star" in 2015 in the LMG Life Science Guide, as one of America's leading lawyers in Health Care Law in the 2011-2016 editions of The Best Lawyers in America, by Chambers USA as one of America's leading Health Care lawyers from 2007-2014 and in 2016, and by Health Law360 as an "Outstanding Woman" for her accomplishments in the legal profession.

Ms. Carder-Thompson received her A.B., magna cum laude, in English from Brown University in 1975, and her J.D. from William & Mary School of Law in 1978, where she served as the notes and comments editor of the William & Mary Law Review.

Regina Gore Cavaliere

regina_cavaliereRegina 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.

Michael R. Clarke

Michael R. ClarkeMichael Clarke is Vice President of Corporate Compliance at Indivior Inc. He is responsible for managing the global compliance program for Indivior Inc., a Richmond, Virginia-based global specialty pharmaceutical company that markets addiction treatment therapies across its business operations in the North American, European, Middle East, African, China, and Pacific Rim regions. His duties include overseeing third party due diligence; providing education and guidance on appropriate HCP, HCO, and governmental interactions; developing and revising ethics policies; training direct employees; monitoring sales and marketing practices; counseling on OFAC requirements; overseeing internal investigations; and implementing processes to mitigate corruption, fraud, and bribery risks.

Previously, Mr. Clarke was V.P., Ethics & Compliance - Americas for Actavis plc, a global specialty and generic pharmaceutical manufacturer, as well as 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 in an ethics & compliance officer role 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. He is a past member of the Board of Directors of the Association of Corporate Counsel - New Jersey; a member of the board of trustees for the Legal Services Foundation of Essex County; a former Chair of the ABA’s Business Law Section’s Corporate Compliance Committee (from 2006 – 2010); and a former co-chair of the Ethics & Professional Responsibility Committee of the National Bar Association. He 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 A.B. from Brown University and his J.D. from Cornell Law School.

Scott D. Danzis

scott danzisScott 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 E. Davis

Charlene DavisCharlene 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 Otsuka America Pharmaceuticals, Inc. and U.S. affiliates of the Japanese pharmaceutical/medical device company. At Otsuka, she spent several years providing healthcare law guidance for device, digital, and neuroscience drug products. Additionally, she led the 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 with integrated compliance requirements, federal and state law reporting for prescription drug samples, policy and procedure development on various healthcare law topics, and assisted with internal investigations. Her experience also includes supporting regulatory inspections related to pharmacovigilance compliance. Prior to her experiences as in-house counsel for pharmaceutical companies, she 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 been recognized many times, including by 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.” Additionally, she currently serves on the Advisory Board for The Center for Compliance & Ethics at Temple University Beasley School of Law.

Ms. Davis is a graduate of Cornell University, where she received various recognitions and was inducted into the National Society of Collegiate Scholars, Cornell Chapter, and is a graduate of Temple University Beasley School of Law, where she received the Barrister’s Award for Outstanding Trial Advocacy.

Sujata T. Dayal

Sujata DayalSujata Dayal is Vice President of Health Care Compliance, Pharmaceutical at Johnson & Johnson. She is a member of the Global Health Care Compliance & Privacy Management Committee and the Johnson & Johnson (J&J) Compliance Committee. She sits on the J&J Pharmaceutical North American Leadership Team. She leads the Pharmaceutical Group Health Care Compliance team, including organizing resources, defining strategy, and addressing matters regarding J&J’s global pharmaceutical health care compliance programs.

Prior to joining J&J, Ms. Dayal held the position of Chief Ethics and Compliance Officer and Corporate Vice President at Biomet, Inc. Prior to that, she held compliance and legal roles at Abbott Laboratories, primarily in the Pharmaceutical Products businesses. She also spent time as an associate at the international law firm of Jones, Day, Reavis & Pogue.

Ms. Dayal holds a B.A. from Lady Shri Ram College, New Delhi, India; an LL.B. from Rajasthan University Law School, Jaipur, India; a J.D. from Chicago-Kent College of Law; and an LL.M. from Columbia University School of Law, New York.

Howard Dorfman

Howard DorfmanHoward 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, Howard Dorfman undertakes extensive in-depth 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.

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, he 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, first as Counsel for litigation, where he oversaw and directed nationwide mass tort litigation, and later as Counsel to the company’s U.S. Medicines Group responsible for legal oversight relating to the company’s cardiovascular drug 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 has established the compliance and risk management procedures at several major pharmaceutical companies and has provided counseling on Medicare, Medicaid, and other healthcare reimbursement matters.

Mr. Dorfman is Distinguished Practitioner in Residence and Adjunct Professor of Law at Seton Hall Law School, where he teaches law and graduate courses on pharmaceutical and medical device regulatory and compliance laws for the past five 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 fourth edition will be published in early 2017.

Mr. Dorfman received his B.A. (with honors) from Yeshiva University and his J.D. from Brooklyn Law School.

S. Joy Dowdle

Joy DowdleJoy Dowdle is a Partner at Paul Hastings' Litigation Department and is based in its Houston office. She represents corporations, audit and special committees, and individual officers and directors in internal investigations, as well as investigations by the Department of Justice (DOJ), Securities and Exchange Commission (SEC), and other regulatory agencies. Additionally, she represents clients in complex commercial and appellate litigation at the federal and state levels, including shareholder derivative and class-action lawsuits.

Ms. Dowdle has particular experience with international anti-corruption law, including the Foreign Corrupt Practices Act (FCPA). She has been involved in advising major corporations in the design, enhancement, and implementation of their compliance programs (including internal controls, policies, and procedures); designing and providing comprehensive compliance training to management, employees, and third parties; advising on and conducting transactional anti-corruption due diligence and integration; and conducting investigations and corporate monitorships in Europe, Asia, Africa, and the Americas.

Ms. Dowdle was recognized as a Texas Rising Star from 2013-2016, and listed in Texas Monthly’s selection of Top Attorneys – Texas’ Outstanding Young Lawyers from 2013-2016.

Prior to joining Paul Hastings, Ms. Dowdle served as a law clerk to the Honorable E. Grady Jolly of the United States Court of Appeals for the Fifth Circuit, and practiced law in Houston, Washington, D.C., and London. She has a B.S., summa cum laude with highest honors from Mississippi College and received her J.D., summa cum laude, from Mississippi College School of Law, where she was Editor-in-Chief of the Mississippi College Law Review.

Mike Doyle

mike-doyleMike Doyle 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

jacob-elbergJacob Elberg is Assistant U.S. Attorney (AUSA) and Chief of the Healthcare & Government Fraud Unit at the United States Attorney’s Office for the District of New Jersey. He supervises fifteen AUSAs 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, he supervises and directs investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs.

In 2013, Mr. Elberg was awarded the Department of Justice’s Executive Office of U.S. Attorneys Director’s Award for Superior Performance as an AUSA for his investigation and prosecution of Maxim Healthcare Services, et al., which resulted in a recovery of $150 Million (the largest recovery ever in a home healthcare case), as well as the felony conviction of nine individuals in six states, including three senior executives of one of the nation’s largest home healthcare companies.

Mr. Elberg joined the U.S. Attorney’s Office in 2007. Prior to joining the U.S. Attorney’s Office, 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 and with honors. After graduating law school, he served as a law clerk to the Honorable Nancy Gertner (District of Massachusetts).

Denise Esposito

Denise EspositoDenise Esposito is a Partner at Covington & Burling LLP, where she is the co-chair of the firm’s Food, Drug, and Device Practice Group. Her practice focuses on a broad range of regulatory, strategic, and policy matters affecting pharmaceutical, biotechnology, device, and medical technology companies. With more than two decades of experience in the industry, including senior leadership roles within FDA and as the general counsel of a publicly traded biotechnology company, she has deep expertise on issues critical to her life sciences clients. Her experience encompasses all aspects of drug development and approval, exclusivity determinations, expedited product reviews, and prescription drug promotion. She engages frequently with the U.S. Food and Drug Administration (FDA), both formally and informally, to solve complex strategic and regulatory challenges and to facilitate successful resolution of issues of importance to our FDA-regulated clients.

Ms. Esposito joined Covington in 2015 from FDA, where she served most recently as Chief of Staff to the Commissioner. In this role, she provided strategic advice to the Commissioner and other senior FDA officials on significant FDA policies and initiatives, and coordinated and managed the Commissioner's priority issues and agency operational issues. She also previously served as Deputy Chief Counsel for Drugs and Biological Products in the FDA Office of the Chief Counsel, and as Deputy Director and Acting Director of the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research (CDER).

Ms. Esposito has been representing pharmaceutical and biotechnology clients for more than twenty years. Her experience encompasses a wide range of important legal, regulatory, and policy issues relating to the regulation of medical products, including constitutional challenges to FDA’s regulation of the pharmaceutical industry, federal preemption of state law, market exclusivity, e-health/digital health products, combination products, expedited review and approval pathways, biosimilars, drug shortages, the marketing and advertising of prescription drugs, and FDA administrative proceedings. She also has expertise in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.

Ms. Esposito received a B.A. cum laude, from Rutgers College in 1998, and her J.D., magna cum laude, from the University of Michigan Law School in 1992, where she was inducted into the Order of the Coif.

Paul Fishman

Mr. Paul FishmanPaul Fishman is Distinguished Visiting Fellow at Seton Hall Law and Former U.S. Attorney for the District of New Jersey. Prior to his joining the faculty of Seton Hall Law, he served as the United States Attorney for the District of New Jersey for over seven years. He was nominated for that position by President Barack Obama in June 2009. He was confirmed unanimously by the U.S. Senate on October 7, 2009, and sworn in on October 14, 2009. He resigned as U.S. Attorney on March 10, 2017.

As U.S. Attorney, Mr. Fishman was responsible for overseeing all federal criminal investigations and prosecutions in New Jersey, including matters involving national security, political corruption, healthcare, securities, mortgage and corporate fraud, gang violence, narcotics distribution, civil rights, tax evasion, and environmental crimes. He also was responsible for all affirmative and defensive civil litigation in New Jersey in which the federal government had an interest. As U.S. Attorney, he supervised an office with approximately 150 attorneys and 125 support personnel in Newark, Camden, and Trenton with an annual budget of approximately $31 million.

In addition to his service as U.S. Attorney, Mr. Fishman was appointed by Attorney Generals Eric Holder and Loretta Lynch as a member of the Committee of U.S. Attorneys (AGAC), and he served as Vice-Chair and Chair of that Committee. Created in 1973, the AGAC provides advice and counsel to the Attorney General on policy, management, and operational issues affecting the offices of the United States Attorneys and the Department of Justice across the country.

Mr. Fishman has spent much of his professional career in public service. After graduating from law school, he clerked for the Honorable Edward R. Becker of the United States Court of Appeals for the Third Circuit. He was an Assistant United States Attorney from 1983 to 1994. During that time, he served as Deputy Chief of the Criminal Division, Chief of Narcotics, Chief of the Criminal Division, and First Assistant U.S. Attorney. From 1994 to 1997, he was a senior adviser to Attorney General Janet Reno and Deputy Attorney General Jamie Gorelick.

In addition to his public service, Mr. Fishman was a partner in the law firm of Friedman Kaplan Seiler & Adelman, where he headed the firm’s white collar practice and handled complex civil litigation from 1998 to 2009.

Mr. Fishman graduated magna cum laude in 1978 from Princeton University, and cum laude in 1982 from Harvard Law School, where he was the Managing Editor of the Harvard Law Review. In 2017, he was awarded an Honorary Doctorate of Law by Seton Hall University School of Law.

Timothy Glynn

timothy glynnTimothy 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

sandra-gonzalezSandra 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 C. Harbist

Nicholas C. HarbistNicholas 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 H. Kim

elizabeth kimElizabeth 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.

Jenny Kramer

Jenny KramerJenny Kramer is a Partner and experienced trial lawyer at Chadbourne & Parke's New York office. Her practice focuses on white collar criminal defense, internal investigations, complex commercial litigation, and regulatory enforcement.

Ms. Kramer recently successfully argued before the U.S. Court of Appeals for the Third Circuit on behalf of her client, John Doe, in North Jersey Media Group, et al. v. United States of America et al. Reversing the District Court’s order, the Third Circuit panel unanimously ruled that a letter, which named John Doe on a list of alleged unindicted co-conspirators in connection with the “Bridgegate” scandal, was part of routine discovery, and was therefore not subject to any First Amendment or common law right of public access. The decision of the Third Circuit in reversing the finding of the District Court prevented disclosure of material highly prejudicial to her client.

Prior to joining Chadbourne, Ms. Kramer served as an Assistant United States Attorney in the District of New Jersey. During her more than nine years in that capacity, she conducted and prosecuted large-scale, complex financial fraud investigations, including market manipulation and investment schemes, securities, corporate, mail and wire fraud, and insider trading. During her time with the U.S. Attorney’s Office, she worked closely with the U.S. Securities and Exchange Commission in connection with joint investigations yielding both administrative and criminal penalties. In addition, she successfully tried numerous cases to verdict, involving charges of conspiracy, fraud, obstruction of justice, public corruption, and violations of the Federal Election Campaign Act. From 2011–2012, Ms. Kramer was the Acting Deputy Chief and, later, Acting Chief of the General Crimes Unit. In that capacity, she supervised new Assistant U.S. Attorneys in connection with all aspects of criminal cases, from inception to final disposition, and provided guidance on investigative and prosecutorial strategy.

Prior to joining the U.S. Attorney’s Office, Ms. Kramer was with a U.S. law firm from 2001–2005, where her responsibilities included representing clients in complex commercial, criminal, and securities litigation. During her time there, she participated in a trial that involved the representation of three individuals accused of committing civil RICO violations, which culminated in a successful no-cause verdict. In addition, she tried cases involving breach of contract claims and prepared for and took numerous depositions.

Ms. Kramer received a Bachelor of Music, Piano Performance, from Oberlin College Conservatory of Music and her J.D., cum laude, from Seton Hall University School of Law.

Bruce A. Levy

LevyBruce 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

seth-lundySeth 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.

Yolanda Lyle

Yolanda LyleYolanda Lyle is Vice President and Assistant General Counsel, as well as the Chief Compliance Counsel for the Research & Development (R&D), Medical, and Manufacturing Divisions at Pfizer Inc. Her team helps the Company prevent and detect potentially systemic issues, ensures the effective implementation and management of compliance program elements, and regularly assesses compliance-related controls and identifies potential improvements.

Ms. Lyle joined Pfizer in 2005, and spent more than six years in the R&D Legal group before joining the Corporate Compliance Division in 2010. Prior to joining Pfizer, she worked at the Boston law firm of Nutter, McClennen & Fish as a Corporate attorney. Prior to attending law school, she was a Clinical Study Coordinator at Brigham and Women’s Hospital in Boston.

Ms. Lyle has a B.A. in Sociology from Boston College, and a J.D. from Boston College Law School.

Jill Fallows Macaluso

Jill Fallows MacalucoJill Fallows Macaluso is Chief Compliance Officer and Vice President at Novo Nordisk, Inc. Since 2015, she has been charged with developing, operating, and overseeing the implementation of an effective ethics and healthcare compliance program within the United States.

Utilizing sixteen years of industry experience, Ms. Fallows Macaluso has been instrumental in driving the evolution of Novo Nordisk’s ethics and compliance program. She chairs the Executive Team and Board of Directors Compliance Committee, and sits on the Novo Nordisk leadership team. She has responsibility for the strategy, development, and maintenance of a comprehensive ethics and healthcare compliance program.

Prior to joining the Ethics and Compliance Department, Ms. Fallows Macaluso was Senior Corporate Counsel in the Novo Nordisk Legal Department for nine years, where she held several key positions. Previously, she was with the General Corporate and Healthcare practice of Day Pitney, LLP.

Ms. Fallows Macaluso holds a Bachelor of Science in Nusing from the University of Pennsylvania and a Juris Doctorate from Rutgers University School of Law.

Scott B. McBride

Scott McbrideScott McBride is a partner at Lowenstein Sandler LLP. He focuses his practice on matters of government, securities, financial, and health care fraud; Foreign Corrupt Practices Act violations; and civil business litigation, leveraging the experience gained from more than ten years in the U.S. Attorney’s Office in Newark, New Jersey. As an Assistant U.S. Attorney, he investigated and prosecuted a broad range of white collar criminal offenses there, serving as Deputy Chief of the Economic Crimes Unit and as a member of the Health Care & Government Fraud Unit. He also prosecuted numerous cases involving cybercrime, identity theft, and intellectual property-related offenses, as well as tax evasion and public corruption. He also has significant civil litigation experience in both the private and public sectors.

Prior to joining the U.S. Attorney’s Office, Mr. McBride completed federal clerkships under the Honorable Jose L. Linares and the Honorable Ronald J. Hedges, both of the United States District Court for the District of New Jersey.

Mr. McBride received his B.S. in Finance and Government from Georgetown University School of Business and his J.D. from Georgetown University Law Center.

Joseph W. Metro

MetroJoseph 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.

Brian O’Reilly

Brian OReillyBrian O'Reilly is Chief Compliance Officer at Dentsply Sirona, a $4.1B annual revenue manufacturer and distributor of medical devices and pharmaceutical products for the Dental and Healthcare markets, operating in over 120 countries with over 16,000 employees. Prior to his current role in Compliance, he was the Director of Quality and Regulatory Affairs for the Preventive Care business and Pharmaceutical business and the Business Unit Manager for the Pharmaceutical business.

Prior to his 20 year career at Dentsply Sirona, Mr. O’Reilly was in leadership roles in Regulatory Affairs in various medical device, defense, and consumer electronic firms. He has a B.S. from the University of Maryland as well as a M.S. of Management from the University of Maryland – University College.

John P. Oroho

john orohoJohn 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.

Suzanne Seferian

Suzanne Seferian Suzanne Seferian is Global R&D Health Care Compliance Officer for Johnson & Johnson Pharmaceuticals. Her team is responsible for the implementation and maintenance of programs designed to ensure compliance with applicable regional/local health care fraud and abuse laws, anti-corruption and anti-bribery laws, advertising and promotion laws, privacy laws, codes of conduct and Johnson & Johnson company policies governing the R&D organization’s activities.

Ms. Seferian joined the Johnson & Johnson Law Department in 1999, where she provided legal support for the creation, implementation, and management of corporation-wide fraud and abuse and compliance programs. In 2006, Ms. Seferian joined the World Wide Office of Health Care Compliance & Privacy (WWOHCC&P), where she provided support and oversight to the medical device franchise HCC programs. In 2008, she joined the Pharmaceuticals Group Health Care Compliance organization.

Prior to joining Johnson & Johnson, Ms. Seferian worked at Reed Smith and other major law firms in the Philadelphia area, practicing health care law. She represented academic medical centers, pharmaceutical and device companies, physicians, long term care facilities, and other health care entities. She also clerked for the criminal division of the New Jersey Judiciary.

Ms. Seferian holds a B.A from Barnard College/Columbia University and a J.D. from Temple University School of Law.

Lynn Shapiro Snyder

lynn shapiro snyderLynn 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

James SheehanJames 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 L. Spencer

Anna SpencerAnna Spencer is an attorney at DLA Piper. She focuses on the privacy and security of health information. She counsels a diverse group of companies, including pharmaceutical and medical device manufacturers, healthcare providers, health-information technology companies, financial institutions, and employers that sponsor group health plans.

Ms. Spencer helps companies leverage data assets, respond to data breaches, and develop rules involving the electronic exchange of health information. She has extensive knowledge of global privacy matters and consumer protection issues and regularly advises companies with respect to HIPAA and Centers for Medicare & Medicaid Services guidelines. She has also defended providers in investigations arising from actions by the U.S. Department of Health and Human Services.

Ms. Spencer regularly advises clients on privacy and security compliance issues related to cloud computing, big data, health information technology, and de-identification of data sets. She also has extensive knowledge of state health information privacy and security laws.

Ms. Spencer received her B.A., magna cum laude, from Sewanee and her J.D. from Vanderbilt University Law School.

Carlos Tessi

tessi-carlosDr. Carlos Tessi is Vice President of Compliance at Shionogi, Inc. He has over thirty years of experience in global pharma, having worked in a variety of different medical, marketing, and management roles. He 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 and ensured that the company met, on a worldwide basis, all obligations established by applicable laws, regulations, and industry codes.

Dr. Tessi developed the first 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 strategic alliances and monitor third parties and vendors across geographies.

Immediately after the acquisition of Bausch & Lomb by Valeant Pharmaceuticals, Dr. Tessi joined Shionogi Inc. to lead the U.S. Compliance Office. In this role, he developed a strategic vision for ethical business practices and compliance, simplifying and enhancing compliance systems and processes, identifying gaps, effectively assessing risk, and providing appropriate risk mitigation strategies.

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.

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