Overview

Mary Devlin Capizzi advises individual corporations and consortia clients on complex regulatory compliance, legislative, scientific and policy issues and engages with key regulatory agencies on their behalf. Clients in the pharmaceutical, biotechnology, medical device, health, consumer goods and technology sectors rely on Mary to help advance their business goals and achieve regulatory compliance. She also is highly valued for her facilitation of cross-industry and industry-wide initiatives focused on collaborative technology development and data sharing. Mary is an authority on product quality, research and development, data privacy, security and strategy, supply chain management, and other policy and management issues. A long-time firm leader, Mary is co-leader of the firm’s health & life sciences industry group and is currently serving her third term as a member of the firm’s board.

Consortia Management

For more than 20 years, Mary has worked with global industry leaders to establish and operate consortia to advance science, data protection, research and development, patient safety and clinical trials. She leads the consensus-building processes and assists in devising and executing initiatives that inject efficiencies and reap collective benefits for consortia members. Mary worked with industry leaders to establish the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the International Pharmaceutical and Medical Device Privacy Consortium (IPMPC) and the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium). Further, she has facilitated numerous cross-industry and industry-specific roundtables and events focused on best practices and identifying pathways for optimal collaboration. For two decades, Mary has been actively working with a broad range of stakeholders to address emerging global regulatory, compliance and ethical challenges effectively.

As legal counsel, Mary advises on domestic and global strategic priorities, responses to legislative and regulatory proposals, and interactions with governmental and scientific agencies in the U.S. and globally, including:

  • U.S. Food and Drug Administration (FDA)
  • The Federal Trade Commission (FTC)
  • U.S. Department of Health and Human Services
  • U.S., Japanese and European Pharmacopoeias
  • Health Canada (HC)
  • European Medicines Agency (EMA)
  • U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
  • International Conference on Harmonisation (ICH)
  • International Organization for Standardization (ISO)

Data Privacy and Security Compliance

Mary is a sought-after adviser to global companies on data privacy and security issues, including conducting operational and legal gap analyses, developing privacy policies and procedures, and creating enterprise-wide data-protection programs. She serves as Legal Counsel and Secretariat to the IPMPC, a global association dedicated to helping data privacy and security professionals in the life sciences industry respond to the complexities involved in data protection. The IPMPC is committed to advancing innovative privacy solutions to protect patients, enhance healthcare and support business enablement.

Personal Interests

Outside of work, Mary enjoys time with her family, including watching her children play sports and sing jazz, learning about sustainable farming, and making up children’s stories.

Credentials

Bar Admissions

District of Columbia
New York

Education

Emory University
J.D. (1994)

University of Dallas, Graduate School of Management
M.B.A. (1989)

University of Dallas
B.A. (1988)

Insights & Events

Leadership & Community

Pro Bono

  • Nicaragua Freedom Coalition

Professional Associations

  • BNA, Pharmaceutical Law & Industry Report — Advisory Board
  • John Carroll Society
  • Drug Information Association
  • Food and Drug Law Institute
  • Regulatory Affairs Professional Society

Civic Activities

  • Catholic Charities Legal Network – Volunteer Attorney
  • Legal Counsel for the Elderly — Volunteer Attorney
  • Legal Clinic for the Homeless, Hispanic Project — Volunteer Attorney
  • CYO Cross Country Coach
  • The University of Dallas, Board Member
  • Mercy Health Clinic, Board Member
  • The GIVEN Institute, Board Member
  • The Addis Clinic, Advisory Committee Member

Firm Leadership

  • Board Member
  • Co-Leader, Health & Life Sciences Industry Group
  • Drinker Biddle & Reath LLP — Executive Partner, 2013-17; Managing Partner, 2008-12, 2014-18, 2018-20; Women’s Leadership Committee (and predecessor committees), 2001–18; Chair, Professional Development Committee, 2007-11
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