Michelle D. Axelrod

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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.

Publications
  • "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014.
  • "Getting the Deal Through - Life Sciences 2013," United States Chapter, published by Getting the Deal Through, 2013.
  • "Getting the Deal Through - Life Sciences 2012," United States Chapter, published by Getting the Deal Through, February 2012.
  • "Is Misconduct Worth A Corporate Integrity Agreement?", Regulatory Affairs Focus, Vol. 12, No. 1, January 2007.
  • "Compliance or False Reliance, Complying with the HIPAA Privacy Rule - A Barrier to Competition in the Home Health Marketplace," Journal of Health Care Compliance, April 2003.
Speaking Engagements
  • Panelist, "Negotiating Your Career," AdvaMed's 2017 Women's Executive Network Conference, Cambridge, MA, June 20, 2017.
  • Moderator, "Elite CCO Exchange and Fireside Chat," CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, April 27, 2017.
  • Moderator, "Compliance Measurements," Porzio New England Healthcare Compliance Roundtable, Waltham, MA, April 7, 2017.
  • Moderator, "Best Practices to Successfully Implement Global Compliance in the Life Sciences Industry and Beyond," CBI's 3rd Annual Global Compliance Congress, London, UK, November 16, 2016.
  • "Mock Promotional Review Group Panel Discussion," AdvaMed's 7th Annual Advertising and Promotion of Medical Devices Conference, Washington, DC, November 10, 2016.
  • "AdvaMed MedTech Compliance 201: A Deeper Dive into the Compliance Landscape," Washington, DC, September 21, 2016.
  • "AdvaMed MedTech Compliance 101: Boot Camp," Washington, DC, September 19-20, 2016.
  • Moderator, "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, July 29, 2016. 
  • "Anti-Trust Guidelines Regarding Pricing and Contracting," Anti-Trust Attorney, ACI's Bio/Pharmaceutial Pricing and Contracting, Silver Spring, MD, March 15, 2016.
  • Moderator, "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, March 10, 2016.
  • "AdvaMed MedTech Compliance Boot Camp," Moderator, Washington, DC, November 4-5, 2015. 
  • "Professional Development and Coaching for Women Leaders: Improving Negotiation, Public Speaking, and Managing Stressful Situations," ACI's 2nd Annual Conference on Women Leaders in Life Sciences Law, Boston, MA, July 24, 2015.
  • "SelectUSA Investment Seminar,” 2015 Bio International Convention, Philadelphia, PA, June 18, 2015.
  • "The FDA Is Watching: What Twitter, Tradeshows and TV Have in Common," FDAnews Webinar, February 11, 2014, December 11, 2014.
  • "Compliance Essentials: Implementing an Effective Program," Intensive Course Leader, AdvaMed, Washington, DC, September 23-24, 2014.
  • Moderator, "Engaging Healthcare Professionals in the US and Overseas: Issues and Challenges," Small and Mid-Sized Life Sciences Companies Still Face Big Issues - Minimzing the Risks," Porzio Compliance Forum, Newark, NJ, October 18, 2013.
  • "Compliance Spotlight:  Moving from Sales to Education and Beyond: Scaling the Legal and Regulatory Hurdles," CMR Institute, ACO's and Industry: The Collaboration Imperative, Philidelphia, PA, October 10-11, 2013.
  • Pre-Conference Workshop, "Endure Compliant Pre-Approval Product Communications," CBI Promotional Conference, October 7-8, 2013.
  • "Compliance for the Small-to-Midsize Medical Device Company – Challenges and Solutions," AdvaMed Intensive Course, 2013 MedTech Conference, Washington, DC, September 23-25, 2013.
  • Moderator,"Medical Device Compliance Panel: Practical Approaches to Handling Real-Life (and Sometimes Tricky) Compliance Issues," MassDevice Big 100 East, Waltham, MA, July 16, 2013.
  • "Lessons Learned from Recent Enforcement to the Product Promotion," CBI's 10th Annual Pharmaceutical Compliance Congress, Washington, DC, January 29-30, 2013.
  • "Transparency & Disclosure - Best Practices for Medical Device Compliance," AdvaMed 2012, Boston, MA, October 1-3, 2012.
  • "Sunshine in a New Light – A Strategic Approach to Achieving Compliance," Pharmaceutical and Medical Device Global Transparency Initiatives Conference, Boston, MA, May 22, 2012.
  • "Fair Market Value:  Legal, Theoretical, and Practical Considerations,"  American Health Lawyer Association’s Life Sciences Practice Group and the Food, Drug, and Cosmetic Law Section of the New York State Bar Association Webinar, New York, NY, May 8, 2012.  
  • "Compliance Considerations for Medical Device Manufacturers," Bay Area Medical Device Forum, San Francisco, CA, November 16, 2011.  
  • "Utilizing Audits and Risk Evaluation to Assess and Enhance the State of Your Compliance Program," ACI’s 2nd Annual Life Sciences Compliance Boot Camp, San Francisco, CA, November 15, 2011.
  • "Regulatory and Compliance Risk Areas Related to Social Media," CBI’s 13th Annual Guidelines for Disseminating Off-Label Information, Washingto,n DC, October 17, 2011.
  • "Promotion Pitfalls: From Slim Jims to Social Media," The Life Sciences Industry Under Attack—Mitigating the Risks, Seventh Annual Porzio Compliance Forum, Newark, NJ, October 14, 2011.
  • "State Laws, Sunshine and Aggregate Spend Boot Camp – Practical Strategies and Best Practices for Compliant State and Federal Reporting Workshop," CBI’s 5th Annual Forum on Tracking State Laws and Aggregate Spend, Arlington, VA, August 15, 2011.
  • "Risks & Enforcement Related to The Use of Testimonials," CBI’s 2nd Annual Life Sciences Forum on Social Media Regulations and Compliance, Alexandria, VA, June 21, 2011.  
  • ACI's 9th National Forum on Fraud & Abuse in the Sale and Marketing of Drugs, New York City, NY, April 2009.
  • "Compliance with Aggregate Spend Reporting Requirements," Third Annual Porzio Compliance Forum, Porzio Pharmaceutical Services, LLC, Basking Ridge, NJ, September 2007.
  • "Compliance in the Pharmaceutical Industry - A Moving Target," ExL Pharma - Second Annual Pharmaceutical Sampling Strategies, Princeton, NJ, September 2006.
  • "Introduction to HIPAA," Shands Healthcare REHAB 2001 Conference, Gainesville, FL, April 2001.

Practice

Industries

Related Media

Bar Admissions

  • Massachusetts, 2003
  • New York, 1997

Education

Brooklyn Law School, Brooklyn, NY, J.D., 1996

University of Rochester, Rochester, NY, B.A., Political Science and Women's Studies, cum laude, 1993

Contact Address

200 Friberg Parkway, Suite 3003

Westborough, MA 01581

Phone: 508.948.0488

Fax: 508.858.5331

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