Stephanie M. Garfield

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Stephanie M. Garfield is an associate of Porzio, Bromberg & Newman, P.C. and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department. She is also a Compliance Associate with the firm’s subsidiary, Porzio Life Sciences, LLC (PorzioLS).

Stephanie counsels pharmaceutical, medical device and biotechnology companies on a variety of compliance-related issues, including federal and state fraud and abuse laws, FDA promotional regulations, transparency and aggregate spend, industry standards regarding interactions with healthcare professionals, and sampling requirements. As a Compliance Associate with PorzioLS, Stephanie also assists in the creation, development and implementation of the subsidiary’s products and services. 

Prior to joining Porzio, Stephanie was an Ethics and Compliance Officer at a fully integrated renal care organization, where she developed, implemented and maintained the compliance programs for the company's clinical research and pharmacy businesses. In this capacity, she advised on issues related to financial assistance programs, the Drug Supply Chain Security Act requirements for dispensers, human subject protection, informed consent, billing Medicare in drug and device trials, and HIPAA privacy. Stephanie also developed and maintained  risk assessment matrices for monitoring purposes. 

Prior Relevant Experience
  • Fresenius Medical Care North America (FMCNA), Waltham, MA, Ethics & Compliance Officer, November 2012 - 2017; Manager, Compliance Operations, February 2012 - November 2012.
  • Hon. F. Dennis Saylor, IV, United States District Court, District of Massachusetts, Law Clerk, Worcester, MA, December 2011 - February 2012. 
  • Hon. Peter C. Dorsey, United States District Court, District of Connecticut, Law Clerk, New Haven, CT , Summer 2009.
  • Clifford Chance US LLP, Business Development Specialist, Litigation & Dispute Resolution Practice, the Americas, New York, NY, 2006 - 2008. 
  • Morgan Lewis & Bockius, Business Development Coordinator, Litigation Practice, Washington, DC, 2005 - 2006.
  • Willamette Management Associates, Business Development/Marketing Associate, Arlington, VA, 2004 - 2005.
  • Corporate Executive Board, Marketing Associate, General Counsel Roundtable, Washington, DC, 2001 - 2003.
Publications
  • "FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine?" Journal of Health & Biomedical Law, Vol. VII, No. 2, 2011.

Practice

Industries

Related Media

Bar Admissions

Massachusetts

Education

Boston College Law School, Newton, MA, J.D., 2011

  • International & Comparative Law Review, Note Editor

Georgetown University, Washington, DC, B.A. in Spanish, 2001

  • Dean’s List

Languages

Spanish

Contact Address

200 Friberg Parkway, Suite 3003

Westborough, MA 01581-3954

Phone: 508.948.0493

Fax: 508.858.5331