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Traceability 2019

Seminars

Traceability | October 21–23 | Washington, D.C.

Speakers

Ronald Bone  
Ronald N. Bone, HDA Consultant, Ronald N. Bone Consulting LLC

Ron Bone is a consultant in the area of Pharmaceutical Traceability and is currently focusing on the implementation of the U.S. 2013 Drug Quality and Security Act. Ron retired from McKesson Corporation where he held the position of Senior Vice President, Distribution Support. His responsibilities included Regulatory Affairs and leading McKesson's product security initiatives through the use of electronic track and trace.

Ron spent 41 years with McKesson Corporation in various operations, sales and financial management positions. He was a member of the of the GS1 Process Oversight Committee, a member of the Leadership Teams of GS1 Global Healthcare and GS1 US Healthcare, and was a member of the Industry Relations Council for the Healthcare Distribution Management Association (HDMA). In 2008, Bone testified before the U.S. House of Representatives, Energy and Commerce Committee as an industry expert on anti-counterfeiting. In 2007, he was the recipient of HDMA’s Nexus Award, which is the industry’s highest honor recognizing leadership, exemplary service and professional excellence.

Ron received his BS and MBA degrees from San Jose State University.

Chris Chandler  
Chris Chandler, Supply Chain Strategy, Franciscan Missionaries of Our Lady Health System

y assurance, regulatory standards, and informatics experience in the pharmacy supply chain. Structured and led U.S. Department of Veterans Affairs (VA) formation of the National Pharmacy Benefits Management Strategic Health Group, Quality Assurance Team for the Consolidated Mail Outpatient Pharmacy, and supported Pharmacy Supply Chain and Regulatory Standards Adoption with the Office of Informatics & Analytics Bar Code Resource Office, GS1 US and Franciscan Missionaries of Our Lady Health System (FMOLHS) for traceability and compliance for Unique Device Identification (UDI), Drug Supply Chain Security Act (DSCSA) and United States Pharmacopeia (USP) Supply Chain Standards.

Melva Chavoya  
Melva Chavoya, Clinical Database Manager , Walgreens

Jeffery Denton  
Jeffery W. Denton, Senior Director, Global Secure Supply Chain, AmerisourceBergen Corporation

Jeff Denton is currently Senior Director, IT Global Secure Supply Chain at AmerisourceBergen. With over 30 years of experience in the wholesale distribution business, Jeff has held positions of increasing responsibility in finance, procurement, contracts and chargebacks as well as Information Technology.

Over the last 13 years, Jeff has been very involved in a variety of aspects around the supply chain security initiative. In addition, he has participated in numerous standards-activities within HDA and GS1-US/Global.

His current responsibilities include Enterprise IT solutions for AmerisourceBergen’s Global Secure Supply Chain program. Jeff serves at the IT lead and is the key liaison across all of the various business units – aligning implementation with standardization.

John Quentin Dittman  
John Quentin Dittman, Director, Sustain and Track & Trace, Cardinal Health, Inc.

John Quentin Dittman is Director of Operations Technology at Cardinal Health, a position he has held since January of 2016. In this role, he is responsible for transforming the Pharmaceutical segment by leveraging technology and lean processes to deliver agility and flexibility in an ever changing environment. Quentin is also responsible for optimizing the Pharmaceutical Distribution supply chain in response to the Federal Drug Supply Chain Security Act of 2013 (DSCSA).

Prior to this role, Quentin was Manager of Operational Excellence, a Lean Six Sigma Black Belt supporting numerous teams such as Cardinal Health Repackaging Solutions, National Accounts and Sales Operations teams.

Quentin also served as a Senior Consultant in Operations Technology for both the Pharmaceutical and Medical business units.

Quentin began his career at Accel Inc., a contract packager where he held roles in inventory, information technology and operations.

Quentin holds a Bachelor’s of Art in History and a Master’s in Business Administration from The Ohio State University .

Anita Ducca  
Anita T. Ducca, Senior Vice President, Regulatory Affairs, Healthcare Distribution Alliance

Anita T. Ducca is HDA’s Senior Vice President of Regulatory Affairs. She serves as the chief liaison and advocate on behalf of HDA with federal regulatory agencies, including FDA and DEA. She has been with the organization since 2002.

Prior to joining HDA, Ms. Ducca was the Director of Regulatory Affairs for the American Red Cross Biomedical Services (ARC), where she was responsible for internal and external regulatory, compliance and health and safety. Anita also served in a regulatory advocacy capacity for the American Petroleum Institute. Earlier, she has also served on the staff of several federal regulatory agencies, including the Food and Drug Administration, the Office of Management and Budget and the Environmental Protection Agency.

Ducca has a BA in Mathematics from Boston College and a MS in Biostatistics from Georgetown University.

Justine Freisleben  
Justine M. B. Freisleben, Vice President, Industry Relations, Healthcare Distribution Alliance

Justine Freisleben is Senior Director of Industry Relations at the Healthcare Distribution Alliance (HDA). In this role she is responsible for the development and coordination of strategies, initiatives and projects to help healthcare distributors understand and use standards, emerging technologies and best practices to increase their efficiency and productivity in the movement of information and products throughout the healthcare supply chain. Additionally, she guides development of voluntary industry guidelines for implementing and maintaining technical standards related to product identification and electronic commerce ,and represents HDA on key work groups, particularly related to the development of standards and processes to support implementation of traceability.

Prior to this role she worked for a chemical trade association focusing on international trade advocacy and international regulatory compliance.

Justine holds a BA in government from Franklin and Marshall College and a MA/MBA from American University.

Perry Fri  
Perry L. Fri, Executive Vice President, Industry Relations, Membership & Education and COO, HDA Research Foundation, Healthcare Distribution Alliance

Perry L. Fri is HDA’s Executive Vice President of Industry Relations, Membership & Education and Chief Operating Officer of the HDA Research Foundation. At HDA, Fri is responsible for the direction, supervision and development of industry initiatives that facilitate improved business processes and operational efficiencies in the healthcare supply chain. Fri currently serves on the Board of Directors for Healthcare Ready, a 501(c)(3) organization established to help public and private sector stakeholders across the pharmaceutical supply chain prepare for (and maintain operations during) disasters.

Fri most recently served as Vice President of Industry Relations and Program Development for the Health Industry Distributors Association (HIDA). Prior to joining HIDA, Fri was a consultant for The Hale Group. He also was Vice President of Industry Alliances for Instill Corporation, and was the Director of Supply Chain Management for NWDA (now HDA). He holds a BA in History from the University of Maryland.

Elizabeth Gallenagh  
Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General Counsel, Healthcare Distribution Alliance

Elizabeth A. Gallenagh, Esq., is the Senior Vice President, Government Affairs and General Counsel for HDA. She is responsible for overseeing federal and state advocacy on behalf of HDA member companies and is the organization’s chief in-house attorney. Additionally, she 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.

Gallenagh holds a JD from the George Mason University School of Law and a BA from The George Washington University.

Abraham Gitterman  
Abraham Gitterman, Associate, Arnold & Porter Kaye Scholer LLP

Connie Jung  
Connie Jung, RPh, Senior Advisor for Policy, U.S. Food and Drug Administration

Dr. Jung is currently Acting Associate Director for Policy and Communications in the new Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance. Her work focuses on development of policy and regulatory strategies to improve the security and integrity of