Mary Devlin Capizzi

Mary enjoys facilitating complex industry-wide initiatives. She has almost twenty years of experience in the formation and management of focused industry consortia. She has served as legal counsel and secretariat for a range of consortia and coalitions and plays a leading role in facilitating consensus-building processes and assisting groups in efficiently devising and executing initiatives. She has represented clients before the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S., Japanese and European Pharmacopoeias (USP, JP and EP), Health Canada, European Medicines Agency (EMA), The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), International Conference on Harmonisation (ICH) and International Organization for Standardization (ISO).

• Mary worked with industry leaders to establish the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), an association of research-based pharmaceutical companies that seeks to advance the science of orally-inhaled and nasal drug products by collecting and analyzing data and conducting joint research and development projects. She serves as legal counsel to IPAC-RS and in that role helps identify the consortium’s priorities and implement its strategic plan. She oversees the planning for interactions with health regulatory agencies in the US and globally and plays a key role in drafting comment letters on guidance documents and proposed rules that impact orally-inhaled and nasal drug products.
• Mary worked with industry leaders to establish both the International Pharmaceutical Privacy Consortium (IPPC) and Medical Device Privacy Consortium (MDPC). She serves as legal counsel to these two groups. In that role she has helped in the creation and implementation of strategic plans, preparation of industry comments on legislative and regulatory proposals and development and promotion of positions.
• Mary worked with industry leaders to establish Rx-360, an international pharmaceutical supply chain consortium that serves to protect patient safety by sharing information and developing processes to enhance the integrity of the healthcare supply chain and the quality of materials within the supply chain. She guided Rx-360 from a newly formed consortium in 2009 until it was launched into a free-standing trade association with a full-time support staff in 2016.

• Mary has extensive experience counseling global companies on data privacy and security issues, including the development of privacy policies and procedures, undertaking gap assessments to compare practices to legal requirements and best practices, and assisting in the development of data protection programs.

• Mary consults with individual clients on clinical research and contracting matters, manufacturing, and commercial operations, scientific, legal, regulatory and policy issues relating to product development, quality control and assurance, and supply chain security.