Joe Mack

Joe Mack, Senior Assistant General Counsel, Compliance & Investigations, Bayer

In his role at Bayer, Joe is responsible for partnering with all U.S. businesses (Pharmaceuticals, Crop Science, Consumer Health) to identify and help mitigate compliance risks, including by providing compliance advice, training, and communications. He also conducts internal investigations, provides legal counsel regarding corrective action, and negotiates with various government agencies regarding investigative matters.

Prior to joining Bayer, Joe served for over nine years as an Assistant U.S. Attorney in the U.S. Attorney’s Office for the District of New Jersey. During his time at the U.S. Attorney’s Office, he served as Deputy Chief of the Health Care and Government Fraud Unit and Acting Chief of the General Crimes Unit. He has investigated and prosecuted corporate and individual defendants for violations of the federal anti-kickback statute, the Food, Drug, and Cosmetic Act, and tax crimes. Prior to working at the U.S. Attorney’s Office, he was an associate at White & Case LLP and Linklaters LLP.  Joe is a graduate, magna cum laude, of Pace University School of Law

George Mina

Senior Director – International Compliance Monitoring, Pfizer

As Senior Director of International Compliance Monitoring, George formed and leads the team responsible for overseeing the coordinated strategy, implementation, and execution of data collection for Pfizer’s industry-leading payment disclosure initiatives. Strong track record of monitoring, interpreting and operationalizing evolving legislative policies and commitments, and establishing effective strategies to execute on a global enterprise-wide scale with stakeholder buy-in and within a global vision. Ensured the accurate and timely collection and publication of data from disparate global Pfizer and third-party data sources in a standardized, centralized, innovative, efficient, and cost-effective manner. Unique background combining keen business acumen, strategic vision, as well as strong financial, analytical, and technical skills to drive business results forward. Proven leadership skills including building global world-class teams, operational excellence, continuous improvement, coaching, colleague development, and mentoring.

Roberta Rima

Director, Internal Audit, Gilead

Roberta is a Director Internal Audit at Gilead Sciences, Inc. based in the SF Bay Area. She is responsible for managing the planning, execution and oversight of the global Third-Party risk-based Compliance Audit Plan. Prior to joining the pharmaceutical industry with in-house audit roles, Roberta worked 10 years in a big four forensic practice, assisting clients on cross-territory corporate investigations and compliance program design and implementation.

Parth Chanda is Founder and CEO of Lextegrity. Over the past 15 years, Parth has established himself as a leader in the field of anti-corruption and financial crimes compliance. Beginning his career with a fellowship in 2002 in the World Bank’s internal investigations group, Parth has been at the vanguard of enterprise efforts to combat bribery and fraud.

Prior to Lextegrity, Parth served as the lead counsel for Pfizer’s global anti-corruption program office for five years. In that role, he navigated its FCPA deferred prosecution agreement while overseeing a multi-year transformation of its anti-corruption program, from redesign of procedures and third-party due diligence processes, to financial systems integration, risk assessment and fraud analytics.

Prior to Pfizer, Parth was hired to oversee the enhancement of Avon’s global anti-corruption compliance program after its voluntary disclosure of FCPA matters to U.S. authorities.
Parth began his career at the law firm of Shearman & Sterling, where he served on two FCPA monitorship teams, led multi-country FCPA investigations, and was Contributing Editor of its FCPA Digest.

Parth has a JD from Harvard Law School, an MPA from the Kennedy School of Government and a BA from Northwestern University

Sujata Dayal

VP & Chief Compliance Officer, G & A, Medline Industries, Inc

Sujata is a senior compliance leader with over 10 years of experience in developing and implementing complex global compliance programs. Previously she was Chief Ethics and Compliance Officer and Corporate Vice President at Biomet and a partner at Abbott Labs. She began her legal career at Jones, Day, Reavis & Pogue.

Amy Wilson

Head of U.S. Compliance – MorphoSys

Amy Wilson brings her ability as a strategic collaborator to MorphoSys US. She works to bolster business decision-making and performance management through the development and implementation of a foundational compliance management program.

Amy has more than 25 years of experience in the life sciences industry. She contributes proven technical compliance expertise that is informed by extensive brand sales, marketing, and operations experience.

Prior to joining MorphoSys US, Amy served as Enterprise Compliance Lead at Alexion. She also held the position of Compliance Monitoring and Risk Lead at Takeda. Leading up to her more recent compliance experiences, Amy worked in escalating sales, marketing, and patient support services roles at Eisai and Novartis.

In support of her evolving career, Amy most recently earned a master’s in jurisprudence from Seton Hall University School of Law. She also holds a bachelor of science from Drexel University and an MBA from Fairleigh Dickinson University.

Seth H. Lundy

Partner, King & Spalding

Seth Lundy represents prominent medical device and pharmaceutical companies and healthcare providers, suppliers and distributors in complex legal and regulatory matters and investigations. As Deputy Chair of our FDA and Life Sciences practice, identified by Law360 as Life Sciences Group of the Year for 2016, Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades from sources including Chambers USA, Best Lawyers and Super Lawyers.

Elise Fellner Roth

General Counsel and Chief Compliance Officer, Medicem, Inc.

In this role for a medical device start up , Elise is responsible for providing legal and compliance guidance and advice to the company on all matters including identifying and executing risk management, auditing and monitoring of activities, developing policies and procedures and employee training. Additionally, she provides the European parent organization with guidance on conducting business while navigating the legal and compliance landscape in the US.

Prior to joining Medicem, Elise has held increasingly responsible roles in Compliance and Legal Functions for differently sized Pharma and Medical Device Companies.

Elise is a graduate of Seton Hall School of Law, holds a Masters Degree in Public Policy from The American University and received her Bachelors Degree from Bennington College.

Gary Giampetruzzi is a partner in the Litigation Department of Paul Hastings, based in the firm’s New York office, and is the Global Chair of the Life Sciences Department and one of the Vice-Chairs of the Investigations and White Collar Department, and an active member of the Paul Hastings Litigation Diversity Working Group. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, 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, and 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, Mr. Giampetruzzi 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 most recently 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, as well as 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 approximately two decades, having led the development of cutting edge 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). Mr. Giampetruzzi 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. He has the proven and longstanding ability to provide end-to-end support, from front-end compliance counseling and program build-outs and enhancements, to the efficient conduct of global internal investigations, and the defense of companies before U.S. and international authorities, while keeping an appropriate eye towards the increasing risk of follow-on civil litigation.

On the U.S. healthcare side, 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 over the 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. Mr. Giampetruzzi has more recently 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. He settled the first opioid prosecution on highly favorable terms, and has achieved several walkaways with state and federal prosecutor offices.

Jacob T. Elberg

Associate Professor, Seton Hall University School of Law

Professor Elberg teaches in the areas of Health Law, Health Care Fraud and Abuse, Evidence, and Data Analytics. His areas of interest include corporate crime and compliance, the role of various actors in the enforcement of health care fraud laws and regulations, and criminal justice policy. Professor Elberg also serves as a faculty advisor for Seton Hall’s Healthcare Compliance
Certificate Programs around the world.

Prior to joining Seton Hall Law School, Professor Elberg served for 11 years as an Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey. As Chief of the Office’s Health Care & Government Fraud Unit for five years, Professor Elberg led one of the largest and most impactful health care units in the country, supervising a team of 15 AUSAs and directing 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 including opioids, as well as all health care-related actions brought by the Office under the False Claims Act. In addition,

Professor Elberg supervised and directed investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs. Professor Elberg launched the District of New Jersey’s Data Mining Working Group and spearheaded the Office’s efforts to utilize data analytics to identify, investigate, and prosecute health care fraud
offenses.

Professor Elberg has been a leading speaker throughout the country on issues relating to health care fraud and abuse. He has been called upon to teach Department of Justice criminal and civil health care prosecutors from across the country on several occasions, including at the conference launching Deputy Attorney General Sally Yates’s Individual Accountability Initiative.
Professor Elberg received his B.A., cum laude and with honors, from Dartmouth College and his J.D., magna cum laude, from Harvard Law School.

After graduating law school, Professor Elberg clerked for the Honorable Nancy Gertner, United States District Court for the District of Massachusetts, and then practiced law as an associate at the firm of Dwyer & Collora LLP (now
Hogan Lovells) in Boston, where his areas of practice included white collar criminal defense, internal corporate investigations, and general commercial litigation. He is a member of the Massachusetts, New Jersey, and New York Bars.