PPTA Staff Honored with the Distinguished Alumni Award
Mary Gustafson, PPTA Vice President, Global Regulatory Policy, was honored on July 24 with the 2013 FDA Distinguished Alumni Award at the FDA Honor Awards Ceremony, “for exceptional contributions to the regulation of blood and blood products, and as an outstanding liaison between FDA and the plasma protein industry.”
During more than 20 years at FDA, Mary directed the Division of Blood Applications, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), and held positions in biologics and sterile drug compliance and product certification. FDA's CBER submitted the nomination.
Since joining PPTA in 2003, Mary has been instrumental in advancing a global regulatory agenda addressing issues of quality and safety in a consistent, reasonable, transparent and, whenever possible, harmonized manner. She has advocated for the industry by participation in advisory committee meetings, workshops and hearings and by PPTA’s sponsorship of regulatory workshops in cooperation with regulators and others. She has worked with AABB, USP and other organizations on projects of mutual interest. Currently, Mary is a member of the HHS, Advisory Committee on Blood and Tissue Safety and Availability.
“Mary is very valuable for the Association and industry. Her expertise and knowledge of regulatory issues and her longstanding commitment to safety and quality is unparalleled. PPTA is delighted that FDA has chosen to recognize her many contributions,” said Jan M. Bult, PPTA President and CEO.
The Distinguished Alumni Award is given to a former FDA employee who left the agency at least five years ago who meets the following criteria: have a continuing and major impact on FDA as a whole; reflect FDA values; and exemplify an outstanding commitment to meeting the agency’s mission of protecting the public health.
The Plasma Protein Therapeutics Association (PPTA) is a dynamic trade association that represents a unique sector of the biologics and biotechnology industry. PPTA represents over 450 human plasma collection centers in the North America and Europe, as well as, the manufacturers of life saving plasma protein therapies. PPTA works globally to: advocate for access to and affordability of therapies for patients; engage in constructive dialogue with regulatory agencies and collaborate with more than 20 patient advocacy organizations.
PPTA also administers standards programs that help ensure the quality and safety of plasma collection and manufacturing and protect both donors and patients.