With a background as in-house counsel in the pharmaceutical/healthcare industry, Michelle Axelrod is familiar with the business challenges faced by members of corporate legal and compliance departments. She understands the importance of collaboration between business units and legal and the limitations posed by budgetary constraints. Drawing from her in-house experience, Michelle offers valuable insights to clients on corporate dynamics and provides innovative ideas to support business goals while effectively protecting companies and reducing organizational risk. She takes the time to listen and understand client needs and to provide advice and recommendations that reflect client objectives. Ultimately, she is driven by a desire to help each client’s business succeed - a client’s "win" is her win.
As Assistant General Counsel at Sepracor, Inc., from 2004 through 2010, Ms. Axelrod successfully managed and supervised a team of attorneys and administrative personnel, supporting all commercial business units, including sales, marketing, commercial analytics, new products planning, contracting and pricing, institutional trade, managed markets, clinical research and medical affairs. During that time, she acted as lead counsel on the development and/or commercialization of seven products. Her ability to leverage this expertise for clients is enriched by a healthy mix of ingenuity, gumption, passion and creativity, all which enable her to find a way forward for almost any challenge. Michelle recognizes and appreciates the role of effective outside counsel and applies lessons learned to alleviate the legal issues and compliance burdens of Porzio clients.
As resident principal of Porzio’s Massachusetts office, Michelle primarily counsels pharmaceutical, medical device and biotech clients on regulatory, compliance, and licensing issues related to the sales, marketing and reimbursement of marketed products. Michelle reviews promotional content and medical communications, develops internal policies, trains commercial teams, provides direction regarding field force management, advises on Medicare and Medicaid related issues and supports clients’ compliance initiatives. She also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with PBMs, health plans, retail pharmacies, GPOs, wholesalers and other healthcare entities. In addition, she handles manufacturing, supply and development contracts, distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.
Michelle represents the Massachusetts office as a member of the firm's Management Committee. She is also a vice president of Porzio Life Sciences, the firm’s subsidiary, which offers a range of marketing and sales compliance products and services to pharmaceutical, medical device and biotechnology companies.
Michelle has been a catalyst in the launch and growth of compliance programs in life sciences companies during a time when the industry is facing unprecedented legal, regulatory and compliance scrutiny. She has developed credibility with executive management teams and has been instrumental in educating senior executives on the impact and importance of recognizing and addressing compliance issues.
Prior to joining Sepracor in 2004, Michelle spent seven years at Gentiva Health Services in Melville New York. As Senior Attorney and Executive Director of the HIPAA Compliance Team, she was responsible for health care regulatory and compliance matters, managed care and insurance contracting, health care fraud and abuse, medical privacy/confidentiality, Medicare/Medicaid reimbursement issues, and home healthcare management, distribution and licensing arrangements.
Brooklyn Law School, Brooklyn, NY, J.D., 1996
University of Rochester, Rochester, NY, B.A., Political Science and Women's Studies, cum laude, 1993
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