KENX INSIGHT

Mary Shirley, Senior Director, Ethics and Compliance, Fresenius Medical Care

Mary Shirley is a New Zealand qualified lawyer with extensive experience implementing, evaluating and monitoring compliance programs for multinational corporations. Currently Senior Director, Ethics and Compliance at Fresenius Medical Care in Boston, Mary has a large international footprint, having held global ethics and compliance roles in Singapore, Hong Kong and Dubai. Mary also spent time working as an investigator for regulators in New Zealand in the areas of data privacy and antitrust.

For Mary, compliance is more than just a 9 to 5 job. She co-hosts the Great Women in Compliance podcast with Lisa Fine, co-hosts the Boston Compliance Professionals Networking Meet Ups with Matt Kelly and contributes to thought leadership opportunities in the field regularly, including speaking at conferences, sitting on the Compliance Week Advisory Board, the SCCE Boston Regional Conference Planning Committee, writing articles and participating in interviews on ethics and compliance.

Mary’s expertise, commitment to the advancement of women and dedication to coaching the next generation of compliance officers has been recognized in recent years, with Mary placing as a finalist in three categories at the Women in Compliance Awards and winning Compliance Officer of the Year, Mentor of the Year for the Advancement of Women and In-house Compliance Team of the Year. She was also bestowed the honor of being named a Compliance Week Top Mind 2019.

Zachary N. Coseglia, Managing Principal and Head of Innovation of R&G Insights Lab

Zach Coseglia is a pioneer in the legal industry and a trusted advisor to clients looking for human-centered, analytically powered and digitally enabled approaches to problem solving and risk management. He is managing principal and head of innovation and co-leader of R&G Insights Lab, an innovative, full-service legal consulting practice and the industry’s first combined analytics and behavioral science offering.

An experienced litigator, investigator, and former compliance executive, Zach brings to his work deep knowledge of the legal and regulatory realities facing his clients – and has carved a unique path in the industry by leaning into his creative and entrepreneurial instincts. He is a thought leader on the use of analytics to support more informed, risk aware decision-making; and is dedicated to helping organizations unlock the full value of their enterprise data.

Prior to joining Ropes & Gray, Zach served as head of global compliance monitoring, analytics and digital at a global biopharmaceutical company. In that capacity, he built an industry-leading global compliance monitoring program and oversaw the development of analytically powered digital solutions that have transformed that organization’s approach to risk management. He also led a digital compliance office that advised business leaders on the risks associated with emerging technologies and operated as an internal innovation hub, designing digital solutions to simplify and automate internal processes. Zach is also responsible for building one of the industry’s first compliance-embedded analytics teams, comprised of engineers, statisticians, data scientists and visualization experts.

Zach previously served as an assistant general counsel and lead China investigator for the same biopharmaceutical company. In this role, he had the opportunity to live and work in Beijing and Shanghai, and emerged as an early leader in the use of data and analytics to drive an effective, efficient and outcomes-driven risk management program.

Over the course of his career, clients have engaged Zach to advise them on critical organizational issues, including strategy and risk-based decision making; risk assessments and proactive reviews; internal investigations; program design; and other compliance, ethics and risk management activities.

Zach builds on these past experiences in his leadership of R&G Insights Lab, which represents a cross-industry advisory capability that combines world-class legal services with specialized expertise in analytics, behavioral science, and strategic consulting.

Katherine C. Norris, MPA, Director, Life Sciences, Governance, Risk Management and Compliance, Guidehouse

Katie Norris has 19 years of experience in corporate governance, risk and compliance focused predominantly in the life sciences and healthcare industries, including 12 years as an industry professional. Ms. Norris regularly supports counsel to assess the effectiveness of corporate compliance programs in privileged consulting matters coinciding with government investigations. She has supported clients in numerous high-profile matters, including the prosecution of individuals, led by the U.S. DOJ, HHS OIG, SEC, FDA, CMS, and EPA, among others.

Ms. Norris also works directly with companies under enforcement decrees on a wide variety of compliance-related matters to ensure successful performance under CIA/DPA. She has developed and overseen all aspects of compliance and risk management programs at pharmaceutical and medical device companies, including: Board of Directors communications and certifications; CIA implementation; fair market value assessments; Risk Assessment and Mitigation Programs; auditing and monitoring; interactions and engagements with health care professionals; strategic marketing and sales initiatives involving Class II pharmaceuticals and Class III medical devices; transparency reporting; class-wide REMS compliance for controlled substances; and clinical, R&D and post-market surveillance. She has also managed global FCPA/ABAC programs as well as a complex OFAC/ITAR/EAR compliance program for the manufacture, sale and distribution of chemical weapons antidotes sold exclusively to US and foreign militaries. She has performed numerous complex compliance investigations and led restructuring initiatives on topics ranging from third party funding to free drug and patient assistance programs and interactions with specialty pharmacies.

Gary Giampetruzzi, Partner, Paul Hastings

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.