Overview
Blockchain is a buzzy word that shows up in news reports referring to a variety of topics. But how does it actually work and why might it be relevant for medical product lawyers? Blockchain has shown promise for supply chain management and FDA has investigated it as part of its work on the Drug Supply Chain Security Act (DSCSA). With dozens of different blockchain systems, there are as many challenges as opportunities. In this webinar, experts will explain what blockchain is, how it can be used in the medical product supply chain, and explore the pros and cons for the medical product industry.
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Speakers
Robert Celeste, Founder, Center for Supply Chain Studies
Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance (HDA)
Scott Mooney, Vice President, Distribution Operations, Supply Chain Assurance, McKesson Corporation
Moderated by Julie A. Dohm, Of Counsel, Covington & Burling LLP
ROBERT CELESTE is Founder of the Center for Supply Chain Studies. Bob’s deep understanding and knowledge of the healthcare supply chain, including current standards and technologies, is unparalleled. His ability to harness his expertise and innovate around the complexities of track & trace implementation, serialization and regulatory compliance, has made him a trusted industry partner. Along with his work with both State and Federal Regulators, Bob often serves as an advisor to the FDA, State Boards of Pharmacy and other governing organizations. Most recently he was tapped as an advisor to the USAID and international regulators on the identification and tracking of drugs and medical supplies. Celeste launched the 
ELIZABETH A. GALLENAGH is the General Counsel and Senior Vice President, Supply Chain Integrity for HDA. She is the organization’s chief in-house attorney and serves as HDA’s primary expert on prescription drug traceability, distributor licensure and tax issues. Since joining HDA in 2003, Ms. Gallenagh led the Alliance’s industry-wide efforts to replace a 50-state patchwork of pedigree laws with one national traceability solution, which became a reality through the enactment of Title II of the Drug Quality and Security Act in November 2013. In 2014, she was honored by the industry with the Distribution Management Award for Industry Leadership, which honors an individual who has exhibited the highest standards of honesty and integrity, working to enhance industry relations and knowledge, as well as supply chain efficiency and security. Ms. Gallenagh holds a JD from the George Mason University School of Law and a BA from The George Washington University.
SCOTT MOONEY is Vice President of Distribution Operations at McKesson Corporation. His primary responsibilities are assuring product integrity through regulatory compliance and traceability. Scott leads McKesson’s Traceability Team working on implementation across McKesson’s various business units which are well know for pharmaceutical distribution and include repackaging, manufacturing, and pharmacy systems. Scott joined McKesson in 1987 and had previous roles in Finance, Distribution Center Management and as a Regional Vice President of Distribution Operations. Scott has participated in McKesson’s integration of acquisitions over the last 15 years. Scott has been active in HDA’s Traceability Implementation Workgroup in addition to serving on the HDA Industry Relations Council and participating in several committees including the Federal, State and Regulatory Affairs Councils. Scott is Tri-Chair of the GS1 Global Healthcare Leadership Team serving since 2013 and is a member of GS1 US Healthcare Executive Leadership Team. Scott is Co-Chair of GS1 US Rx Secure Supply Chain workgroup. Scott has a BA in Accountancy and a MBA from the University of Wisconsin — La Crosse.
JULIE DOHM is of counsel at Covington & Burling LLP where she focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled matters involving a wide-range of important regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approvals. Prior to joining the firm, Dr. Dohm served as the lead on compounding for the US Food and Drug Administration (FDA). Between 2016 and 2019, she was responsible for the overall leadership of the agency’s compounding initiative, including inspections and enforcement, policy development, and stakeholder collaboration. Dr. Dohm started at FDA in 2010 as a civil litigator in its Office of Chief Counsel. She represented the FDA with the Department of Justice in affirmative, defensive, and third-party litigations at the trial and appellate levels, including at the US Supreme Court. She also served as a drugs counselor, advising FDA’s Center for Drug Evaluation and Research on legal issues relating to generic drugs and biosimilars. Before pursuing law, Dr. Dohm was a postdoctoral scientist at Northwestern University and a graduate student at Johns Hopkins University where she focused on structural and biophysical characterization of small molecule drugs, nucleic acids, and proteins. She has published multiple peer-reviewed scientific articles and holds two patentsVirtual Learning FAQ
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