DSCSA Update – What Do Regulators and Pharmacies Really Need to Know?

Ilisa Bernstein is currently the Interim Executive Vice President and CEO at the American Pharmacists Association (APhA). She is responsible for leading the development and implementation of APhA’s strategies related to pharmacy practice and professional affairs, advocacy, and government affairs.

She has over 30 years of experience advocating for pharmacy and patients at Food and Drug Administration (FDA), where she held several senior leadership positions. Most recently, Dr Bernstein was deputy director of FDA’s Office of Compliance in the Center for Drug Evaluation and Research, leading policies, compliance, and enforcement in areas including drug compounding, supply chain security, drug manufacturing and quality, drug shortages, and post-market drug safety. Dr Bernstein also served as director of pharmacy affairs for FDA and senior advisor for regulatory policy in the Office of the Commissioner. She started at FDA as a clinical pharmacology reviewer of investigational and new drug applications.

Previously, Dr Bernstein was senior associate director of worldwide regulatory affairs for Pfizer and completed a post-doctoral clinical residency at the National Institutes of Health. She earned her doctor of pharmacy degree from the University of Michigan and her juris doctor degree from American University Washington College of Law.

Josh Bolin serves as the associate executive director for federal affairs and strategy for NABP. Since joining the Association in 2005, Mr Bolin has worked on development of NABP PMP InterConnect, accreditation programs for durable medical equipment and specialty pharmacy, and inspection programs for the prescription drug supply chain, sterile and nonsterile compounding, and nuclear pharmacy. In his federal affairs capacity, Mr Bolin works to provide technical assistance and guidance on behalf of NABP to Congress and federal agencies including Food and Drug Administration, Drug Enforcement Administration, the White House Office of National Drug Control Policy, and others. Prior to joining NABP, Mr Bolin served as the executive director for the Indiana Board of Pharmacy.

Michael Mazur currently serves director of trade operations at Pfizer, Inc, with over 28 years of experience in the pharmaceutical industry. At Pfizer, he has worked in various areas of the business with most of that time spent in leadership roles within distribution and trade operations. Mr Mazur’s current responsibilities include developing and implementing strategies to enhance patient safety and further secure the United States pharmaceutical supply chain. He represents Pfizer externally on various customer and industry engagements relative to trade channel security and works closely with internal Pfizer colleagues to implement approved strategies. Mr Mazur has been directly involved with Pfizer’s global project to implement serialization and traceability solutions and is responsible for ensuring compliance with the Drug Supply Chain Security Act (DSCSA) here in the US. He also works closely with Pfizer’s Global Security organization as it relates to investigations of any suspect and illegitimate Pfizer products within the US. In addition, he is a member of the GS1 US Healthcare Executive Leadership Team and a founding board member of the Partnership for DSCSA Governance.

Scott Mooney currently serves as vice president of distribution operations at McKesson Corporation where his primary responsibilities include ensuring product integrity through regulatory compliance and traceability. Mr Mooney has been leading this effort since 2013 with McKesson’s Traceability Team working on implementation across McKesson’s various business units. McKesson, while primarily known as a distributor, also operates as a generic pharmaceutical manufacturer, a third-party logistics provider, and a dispenser providing a full spectrum view on the pharmaceutical supply chain.

Mr Mooney joined McKesson in 1987 and had previous roles in finance, distribution center management, and as a regional vice president of distribution operations. He has participated in McKesson’s integration of acquisitions over the last 15 years.

Mr Mooney has been active in the Healthcare Distribution Alliance’s (HDA’s) Traceability Workgroup in addition to serving on the HDA Industry Relations Council. He is also engaged in several HDA committees, including the Federal Issues Task Force, the Regulatory Issues Task Force, and State Government Affairs. Scott is co-chair of the GS1 Global Healthcare Leadership Team and is on the GS1 US Healthcare Executive Leadership Team. GS1 and GS1 US are standards organizations governing bar coding and data exchange standards. He also serves as a member of the board of directors for the Partnership for DSCSA Governance.

Mr Mooney has a bachelor’s degree in accountancy and a master’s in business administration from the University of Wisconsin – La Crosse.

Jenni Wai is the chief pharmacist for State of Ohio Board of Pharmacy.

Prior to joining the board, Ms Wai has served in various pharmacy leadership roles in a comprehensive health care system located in central Ohio. She has extensive experience in health-system pharmacy, nonsterile and sterile compounding, and regulatory and diversion management. Ms Wai has also worked in various pharmacy practice settings, including retail, consultant pharmacy, and regulatory and compliance.

As the chief pharmacist, Ms Wai provides expert guidance to all board of pharmacy staff, the medical community, and the public regarding the practice of pharmacy and all state and federal laws and regulations pertaining to manufacturing, dispensing, and selling of dangerous drugs.

Ms Wai obtained her master’s degree in business administration from Franklin University and her bachelor of science degree in pharmacy from Ohio Northern University.