MICHELLE AXELROD is a Vice President of Porzio Life Sciences and a member of its Executive Committee. As a former in-house counsel and leader in compliance, Ms. Axelrod is well-versed in the inner workings of the life sciences industry. She understands the collaborative effort required for crafting and maintaining successful and cost-effective compliance programs, as well as the challenges associated with such programs. Ms. Axelrod applies her insight and experience to develop and deliver innovative and practical solutions to our pharmaceutical, medical device and biotechnology global customers. She also oversees quality control and marketing endeavors, and manages PorzioLS personnel.
In addition to these responsibilities, Ms. Axelrod is a principal of Porzio, Bromberg & Newman P.C. in the Life Sciences Compliance and Regulatory Counseling team, and a member of the firm's Management Committee. In this role, she counsels life science companies on legal, regulatory and compliance issues related to product communications, interactions with healthcare professionals, and related sales, marketing and distribution activities. She also provides direction and oversight on risk assessments and audits, and the development and implementation of effective policies, procedures and training programs, to support companies’ compliance initiatives.
Prior to joining the company, Ms. Axelrod served as Assistant General Counsel at Sunovion Pharmaceuticals, formerly Sepracor Inc. There, she successfully managed and supervised attorneys and administrative personnel and supported all commercial business units, including sales, marketing, commercial analytics, new products planning, contracting and pricing, clinical research and medical affairs. Ms. Axelrod also acted as lead counsel on the development and/or commercialization of seven products and played a key role in implementing compliance within the organization. Her ability to leverage this expertise makes her an invaluable resource to our life sciences customers.
Ms. Axelrod also spent seven years at Gentiva Health Services. As Senior Attorney and Executive Director of the organization’s HIPAA Compliance Team, she was responsible for healthcare regulatory and compliance matters, including 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.
Practitioner Prescribing & Sampling, Risk Mitigation
- MEDTECH Compliance Virtual Bootcamps - March 2, 4, 9 & 11, 2021
- "A Look at Patient Ad Boards, Clinical Trial Consultants and Ambassador Programs, 17th Annual Pharmaceutical Compliance Congress 2020, Speaker, Virtual/Online, August 13, 2020.
- "What you say matters: Communication Pitfalls and Whistleblower Risks," AdvaMed Bootcamp MedTech Compliance 101/201, Washington, DC, October 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, September 12, 2019
- "Defining Key Terms and Congress Level-Setting," CBI Patient Support Services Congress at Philadelphia, PA, June 19, 2019.
- "Key Aspects of Planning and Executiing Advisory Boards," Comprehensive Strategies for Managing HCP Interactions, Philadelphia, PA, October 10, 2018.
- "Shed Light on Regulatory and Compliance Concerns for Specialty Pharmacy Distribution," CBI's 4th Compliance Congress for Specialty Products, Boston, MA, Spetember 13, 2018.
- "Retaining Women in the workplace," ACI's 4th annual women Leaders in Life Science Law, Boston, MA, July 20, 2017.
- 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.