Michelle Axelrod

Principal, Life Sciences Regulatory and Compliance at Porzio, Bromberg & Newman, P.C.

Speaker

Michelle Axelrod is a principal of Porzio, Bromberg & Newman P.C. in the Life Sciences Compliance and Regulatory Counseling team, a member of the firm's Management Committee, and a Board Member of Porzio Compliance Services, a wholly-owned subsidiary of the firm. 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 advises pharmaceutical, biotech, and medical device clients on legal and compliance issues through all stages of development, from clinical stage through commercialization. She counsels on clinical trial related compliance matters, communications and recruitment matters, and on product commercialization and related sales, marketing and reimbursement activities, including fraud and abuse. She also advises on privacy matters and supports clients’ compliance initiatives, including conducting compliance assessments/audits, and developing and implementing compliance programs, policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews various types of agreements common to the life sciences industry.