MedTech Compliance Bootcamp

Michelle D. Axelrod, J.D. Managing Principal of Porzio, Bromberg & Newman.

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.

Pat Fogarty, Esq., Deputy General Counsel, Senior Vice President of Legal, AdvaMed

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.

Masha Goodman-Khan, Senior Director of Compliance and Legal Operations, Vericel

Masha Goodman-Khan is the Senior Director of Compliance and Legal Operations at Vericel Corporation.  She possesses over a decade of experience guiding biopharmaceutical and medical technology organizations in the area of healthcare and regulatory compliance, as well as healthcare law and policy.  Masha holds a Bachelor of Science in Biological Sciences from Georgia State University and a Master of Science in Jurisprudence (M.S.J) in Pharmaceutical and Medical Device Law & Compliance and Hospital and Health Policy from Seton Hall University School of Law.

Ida Nassar, Esq., Vice President, Assistant General Counsel, Ethics & Compliance, AdvaMed

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.

Jennifer Romanski, J.D., Principal, Porzio, Bromberg & Newman

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.

Daniel Spicehandler, VP, Compliance- Commercial Divisions, Stryker Corporation

Dan Spicehandler is currently the vice president for Compliance Commercial Divisions at Stryker, a leading international medical device and technology company. He is responsible for leading a team of compliance officers who support the commercial divisions at Stryker through a proactive, principles and risk-based program.

His career has involved multiple operational and leadership positions across the medtech, biotech, and pharmaceutical industries. Prior to Stryker, he served as the U.S. compliance officer for Sanofi Pasteur; led the monitoring, auditing, policy, and risk team at Novo Nordisk Inc.; and served as the director of compliance for Meda Pharmaceuticals (acquired by Mylan). His career has involved both compliance and legal positions, and he has also served as in-house counsel at both Novo Nordisk and Meda. Dan’s experience at both large multinational organizations under monitorships for Corporate Integrity Agreements and REMS programs and smaller U.S.-based companies have helped him to understand the importance of developing compliance programs designed to fit the needs of the business and adapt to the changing expectations of regulators.

Prior experience also includes work as a consultant in developing compliance programs with Polaris Management Partners (now IQVIA) and as a lawyer with the firm of Reed Smith LLP. He is a graduate of Fordham University School of Law, where he serves as an alumnus on its Advisory Board for Compliance Programs, and Union College in Schenectady, New York.

Christopher L. White, General Counsel, Chief Policy Officer, and Secretary, AdvaMed

Mr. White serves as the Association’s Chief Legal Officer and AdvaMed’s Chief Policy Officer, leading the Association’s work to develop and promote policy positions enhancing patient access to medical technology worldwide. Mr. White also leads the Association’s strategic planning activities and investor relations matters. In March 2020, Mr. White was appointed the organization’s COVID-19 Action Team Leader, leading all COVID-19-related initiatives and policy. Additionally, he guided the organization to fully remote functioning upon the onset of the pandemic.

He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is a frequent speaker on health law and policy issues, and posts health policy blogs on his Linkedln page.

Prior to AdvaMed, Mr. White was a partner with the global law firm Morgan Lewis; and he began his health law legal career with the firm Drinker Biddle. Mr. White is a graduate of Wake Forest University, where he studied electron microscopy and cell biology, and Catholic University Law School.