Michelle D. Axelrod

Principal

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Overview

Michelle D. Axelrod is the resident principal of Porzio, Bromberg & Newman’s New England office and Vice President, Porzio Life Sciences.  Michelle has over 20 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel.  

As principal of Porzio, 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. 

As Vice President of Porzio Life Sciences, Michelle offers additional services to provide clients with innovative and practical solutions to satisfy compliance program objectives and improve compliance initiatives as they related to privacy, spend transparency, state distribution licensing, and sampling.

Prior to joining Porzio, Michelle held the position of Assistant General Counsel at Sunovion Pharmaceuticals Inc., formerly Sepracor Inc.  In this role, she served as the lead commercial and regulatory attorney supporting the development and commercialization activities for seven products.  She also helped to build the company's compliance program.

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 mitigating organizational risk.  She understands the importance of collaboration between business units, and the Legal and Compliance teams.  

Speaking Engagements

  • Incorporating Management of High-Risk Engagements into Your Compliance Program; Virtual HCP Engagement Strategies Conference, 10/20/2021
  • Operationalizing Compliance Guidance - Key Learnings for DOJ Updates, OIG Fraud Alert and Open Payments Enforcement Action; Speaker, Pharmaceutical Compliance Congress, Philadelphia, PA, 9/28/2021
  • "Operationalizing Compliance Guidance - Key Learnings for DOJ Updates, OIG Fraud Alert and Open Payments Enforcement Action,"  Speaker, Pharmaceutical Compliance Congress, 9/28/2021
  • "Compliance Challenge:  Federal, State and International Transparency, Disclosures and Reporting; Part 4 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp, 3/11/2021
  • "Compliance Challenge:  Grants, Donations and Other Funding; Part 3 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp , 3/09/2021
  • "Compliance Challenge:  Healthcare Professional Engagements; Part 2 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp, 3/04/2021
  • "Compliance Framework; Part 1 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp, 3/02/2021
  • A Look at Patient Ad Boards, Clinical Trial Consultants and Ambassador Programs; 17th Annual Pharmaceutical Compliance Congress 2020, Virtual/Online, August 13, 2020., 8/30/2020
  • "What you say matters: Communication Pitfalls and Whistleblower Risks," AdvaMed Bootcamp MedTech Compliance 101/201, 10/21/2019
  • Where Is the Line? Tackling the Overlap in Medical and Commercial Activities; CBI 5th Annual Life Sciences Compliance Congress for Specialty Products, Boston, MA, 9/12/2019
  • Defining Key Terms and Congress Level-Setting; CBI Patient Support Services Congress at Philadelphia, PA, 6/19/2019
  • Key Aspects of Planning and Executing Advisory Boards; Comprehensive Strategies for Managing HCP Interactions, Philadelphia, PA, 10/10/2018
  • Shed Light on Regulatory and Compliance Concerns for Specialty Pharmacy Distribution; CBI's 4th Compliance Congress for Specialty Products, Boston, MA, 9/13/2018
  • Retaining Women in the workplace; ACI's 4th annual women Leaders in Life Science Law, Boston, MA, 7/20/2017
  • "Negotiating Your Career; AdvaMed's 2017 Women's Executive Network Conference, Cambridge, MA, 6/20/2017
  • Elite CCO Exchange and Fireside Chat; CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, 4/27/2017
  • Compliance Measurements;  Porzio New England Healthcare Compliance Roundtable, Waltham, MA, 4/07/2017
  • Best Practices to Successfully Implement Global Compliance in the Life Sciences Industry and Beyond; CBI's 3rd Annual Global Compliance Congress, London, UK, 11/16/2016
  • Mock Promotional Review Group Panel Discussion; AdvaMed's 7th Annual Advertising and Promotion of Medical Devices Conference, Washington, DC, 11/10/2016
  • "A Deeper Dive into the Compliance Landscape," AdvaMed MedTech Compliance 201, 9/21/2016
  • "Compliance Boot Camp 101," AdvaMed MedTech Compliance 101, 9/19/2016
  • Small Group Breakouts and Interactive Town Hall: Identifying Tactical Next Steps in the Quest for Professional and Personal Development; ACI's 3rd Annual Conference on Women Leaders in Life Sciences Law, Boston, MA, 7/26/2016
  • Anti-Trust Guidelines Regarding Pricing and Contracting; Anti-Trust Attorney, ACI's Bio/Pharmaceutical Pricing and Contracting, Silver Spring, MD, 3/15/2016
  • In-House Roundtable on Commercial Trends in Pharma: A Conversation on Where the Industry is Now and Preparing for Where It's Going; ACI's 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Drugs, Boston, MA, 3/10/2016