Innovative Solutions to Regulatory Hurdles

Ilisa Bernstein, PharmD, JD, FAPhA, is President of Bernstein Rx Solutions, LLC, assisting clients in understanding and maneuvering through drug and pharmacy regulatory policy and compliance issues, strategies, and advocacy. She brings over 35 years of experience and expertise in the government, non-profit, and private sectors in achieving successful outcomes and advancing innovation.

Prior to consulting, Dr. Bernstein spent nearly five years at the American Pharmacists Association (APhA). For 13 months, she served as the 14th CEO and Executive Vice President of APhA, the first woman to lead as CEO in the 172-year history of the association. In this role, she oversaw and led all operations and strategies for APhA, the Board of Pharmacy Specialties, and the APhA Foundation. She joined APhA in 2019 as Senior Vice President for Pharmacy Practice & Government Affairs where she spearheaded the development and execution of APhA’s strategies, policies, and programs related to pharmacy practice, advocacy and regulatory affairs, and guided APhA as the voice of pharmacists in all practice settings.

Prior to her tenure at APhA, Dr. Bernstein amassed over 30 years of influential service and leadership at the U.S. Food and Drug Administration (FDA). Notably, she was deputy director of FDA’s Office of Compliance in the Center for Drug Evaluation & Research, shaping policies, compliance, and enforcement in areas including drug compounding, supply chain security, drug manufacturing and quality, drug shortages, inspections, clinical trials, and post-market drug safety. For 19 years, Dr. Bernstein worked in FDA’s Office of the Commissioner, where she served in several senior policy advisor roles and as director of pharmacy affairs. She started at FDA as a clinical pharmacology reviewer of investigational and new drug applications.

Dr. Bernstein also has held several leadership and board positions, including at the United States Pharmacopeia (USP), Pharmacy Quality Alliance, Alliance for Safe Online Pharmacies, Pharmacy Technician Certification Board, and the APhA Board of Trustees. She proudly received the 2023 Distinguished Alumni Lifetime Achievement Award from the University of Michigan College of Pharmacy and was chosen as one of the 2023 Top 50 Most Influential Leaders in Pharmacy by the Pharmacy Podcast Network.

Dr. Bernstein was also senior associate director of worldwide regulatory affairs at Pfizer and completed a post-doctoral clinical residency at the National Institutes of Health. She earned her Doctor of Pharmacy from the University of Michigan College of Pharmacy and her Juris Doctor from American University Washington College of Law.