About

Lisa earned a Bachelor of Science in Pharmacy from the Massachusetts College of Pharmacy and began her career working in retail pharmacy when generic drugs were just hitting the commercial market. She witnessed firsthand the impact affordable medicines had on patients – those who needed to stretch their medication by cutting tablets could now afford the full course of their treatments, and some could afford prescription medicines for the first time. These lessons were reinforced throughout her career at Johns Hopkins, AmerisourceBergen, and Suburban Hospital.

 

Lisa brought nearly 2 decades of experience in communications and operations to FDA. She held key positions in multiple offices at the Center for Drug Evaluation and Research (CDER). She quickly learned the intricacies and nuances of the regulatory review process and applied these skills to streamline existing processes, including modernizing the Office of Generic Drug’s (OGD’s) filing checklist to improve industry’s understanding of FDA’s acceptance threshold for submissions. She also worked on enhancing the Inactive Ingredient Database (IID), where she led FDA experts to improve the consistency and accuracy of data. Lisa’s ability to drive cross functional teamwork led to her appointment as one of two leads selected by the Director of OGD for the implementation of the Generic Drug User Fee Amendments (GDUFA) of 2012. She moved on to support the implementation of GDUFA for CDER and played a critical role in the establishment of the Office of Pharmaceutical Quality and other modernization initiatives.

 

After serving nearly 7 years at the FDA, Lisa moved on to lead Science and Regulatory Affairs operations as Vice President at the Association for Accessible Medicines. As Vice President, she served as the primary point of contact for relations with key offices at the FDA, USP, and other high impact stakeholders in the generic and biosimilar industries. Lisa developed regulatory and scientific affairs initiatives, member communications, and training/knowledge sharing opportunities. Some of these activities included facilitating discussions on regulatory, scientific, and policy issues impacting bioequivalence, R&D for drug substance and drug product, IID, innovation and emerging technologies, quality metrics, FDA’s guidance development and priorities, nitrosamines, and policy issues surrounding inspections. Lisa lead the industry teams for the negotiations for GDUFA II and GDUFA III. She also served as a key member of the industry negotiating team for the Biosimilars User Fee Act (BsUFA) II and BsUFA III. Upon the ratification of negotiated user fee packages, Lisa led the implementation phase of both BsUFA II and GDUFA II user fee programs with FDA for AAM.