AdvaMed® Medtech Compliance Workshop

Alex Abbott serves as Chief People & Compliance Officer at Arthrex Indianapolis, where he oversees the organization’s compliance program and people strategy. Based in Indianapolis, Indiana, Alex held human resources leadership roles in the software & retail industries before joining Arthrex over 4 years ago. 

Alex is passionate about leveraging artificial intelligence to strengthen and modernize compliance functions. He values clarity in compliance work – operating in the black and white, and working to resolve gray areas into standards that are both ethical and lawful. With a people-first approach, Alex focuses on building compliance programs that employees can understand, trust, and take ownership of.

Michelle D. Axelrod is the Managing Principal of Porzio, Bromberg & Newman’s New England office. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel. Michelle primarily counsels pharmaceutical, medical device, and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing, and reimbursement activities. Michelle reviews promotional
content and medical communications, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, and supports clients’ compliance initiatives, including the development of policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with health plans/PBMs, retail/specialty pharmacies, GPOs, wholesalers, and other healthcare entities. In addition, she handles distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.

Alfred R. Brunetti is a seasoned counselor who guides clients through the increasingly complex matrix of data privacy and security laws, regulations and guidance impacting business across all industries. Fred combines his in-depth knowledge of existing and emerging privacy laws and best practices with his extensive nationwide litigation and compliance experience to regularly advise clients, both large and small, on all manner of data privacy issues relating to the collection, processing and management of personal information throughout its life cycle.

He leads the firm’s Data Privacy Practice Group and is certified by the International Association of Privacy Professionals (IAPP) as both a Certified Information Privacy Professional in the laws of the United States (CIPP/US), a designation evidencing information privacy expertise with advanced concentration in domestic private sector laws, and a Certified Information Privacy Manager (CIPM), a designation evidencing expertise in the creation and management of a comprehensive privacy program.

Pat Fogarty is the Deputy General Counsel & Senior VP of Legal at the Advanced Medical Technology Association® (AdvaMed®). AdvaMed® advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that save and improve lives. In addition to providing in-house legal counsel to the organization, Pat leads AdvaMed®’s litigation reform legal policy work and related stakeholder outreach, which are emerging priorities for medtech innovators and patients who rely on FDA’s safety determinations. He also manages the association’s amicus curiae program, including filing multiple briefs on a myriad of issues in U.S. federal and state courts. Pat holds a B.A. from Virginia Tech and a J.D. from the Syracuse University College of Law. He is admitted to the District of Columbia Bar.

Mark F. Geraci serves as Corporate Counsel – Global Ethics & Compliance at The Cooper Companies, Inc., where he leads key components of the company’s global ethics and compliance program supporting its medical device and healthcare businesses. In this role, Mark provides strategic legal and compliance counsel on a broad range of regulatory matters, including anti-kickback laws, false claims, FDA compliance, anti-corruption, healthcare spend transparency, privacy, sanctions and trade compliance, antitrust, artificial intelligence governance, and corporate investigations. He also serves as the company’s primary point of contact for government investigations and regulatory inquiries involving agencies such as the U.S. Department of Justice, FDA, Office of Inspector General, Centers for Medicare & Medicaid Services, state Attorneys General, and international enforcement authorities. Mark is responsible for developing and enhancing global ethics and compliance programs, leading internal investigations, implementing enterprise-wide policies, and partnering with executive leadership to strengthen a culture of integrity and accountability across the organization

Ms. Nassar manages AdvaMed®’s ethics and compliance policy working groups on the AdvaMed® Code, federal and state anti-kickback statutes, the Physician Self-Referral (Stark) Law, Sunshine Implementation, False Claims Act, and other health care laws and regulations applicable to medical device innovators and manufacturers. Ms. Nassar also handles AdvaMed®’s global legal policy working groups, which seek to establish common global standards for anti­ corruption and business integrity and secure procurement, regulatory, and enforcement incentives that reward compliance. Prior to AdvaMed®, Ms. Nassar was a Senior Attorney within the Drug Enforcement Administration’s Office of Chief Counsel where she handled enforcement actions under the Controlled Substances Act as well as defensive litigation matters for the department. She also served as Trial Attorney for the U.S. Department of Justice, managing commercial and torts litigation (including vaccine litigation). Ida also practiced for several years with the Hollingsworth law firm managing life sciences products liability litigation.

Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.

Terri has held several roles since joining Zimmer Biomet, most recently as VP, Global Compliance Investigations. With deep expertise in healthcare fraud and abuse laws, investigations, and risk management, Terri partners closely with business leadership to enable compliant growth and ongoing program enhancements. She is an active mentor and co-leads leadership initiatives advancing women in the legal profession. Terri is a graduate of Colby College and George Washington University Law School.

Kathryn Stager brings over 20 years of experience in the medical device industry.  She leads the Regulatory Affairs, Quality Assurance, and Compliance functions at SPR, a company that was recently acquired by Medtronic.  With a passion to always put the best interests of patients first, Kathryn established SPR’s Compliance Program and ISO 13485-certified Quality Management System.  Kathryn has obtained numerous regulatory approvals for SPR’s clinical studies and products, and holds a US Regulatory Affairs Certification.  Kathryn holds a master’s degree in bioengineering from the University of Pittsburgh and a bachelor’s degree in physics from Miami University (OH).