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Track-and-Trace Technology Seminar
Wednesday, November 9–Friday, November 11, 2011
Gaylord National Resort & Convention Center
National Harbor, Md.
Speaker Biographies
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Tim Bishop
QA Senior Manager
UPS Supply Chain Solutions |
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Tim Bishop is responsible for the QA departments that oversee the compliance for IT System Validation, Facility Validation, Document and Data Control and Training compliance for UPS Supply Chain Solutions cGMP Healthcare distribution centers.
Prior to coming to the QA group, Tim was project lead in the UPS’s Corporate Healthcare Strategy Group, responsible for implementing UPS's ePedigree and serialization solutions for its U.S. based healthcare distribution centers.
Before his corporate assignments, Tim managed UPS SCS healthcare DC operations and cold chain transportation services in the Louisville area distributing pharmaceutical, biological, and medical device products.
Tim has 21 years of small package and logistics distribution experience with UPS. |
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Ron Bone
Senior Vice President, Distribution Support
McKesson Corporation |
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Ron Bone is Senior Vice President, Distribution Support for McKesson Pharmaceutical. His responsibilities include Regulatory Affairs, leading McKesson's product security initiatives through the use of electronic track and trace using Radio Frequency Identification (RFID) and acting as the pharmaceutical business liaison with Corporate Government Affairs. Bone has spent 38 years with McKesson Corporation in various operations, sales and financial management positions. He is a member of the Business Steering Committee of EPCglobal, a member of the Leadership Teams of GS1 Global Healthcare and GS1 US Healthcare and is 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. Bone received his BS and MBA degrees from San Jose State University. |
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Diane Darvey, PharmD., JD
Director, Federal and State Public Policy
National Association of Chain Drug Stores |
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Diane L. Darvey, PharmD., JD, is the Director of Federal and State Public Policy for the National Association of Chain Drug Stores (NACDS), where she provides policy analysis and advocacy as well as written and oral testimony on state and federal legislative and regulatory matters, such as prescription drug pedigrees, patient safety and Internet pharmacy and many other areas affecting the chain pharmacy industry. She received her Doctor of Pharmacy Degree from the University of California, School of Pharmacy in San Francisco, California. Following graduation, she practiced as a clinical pharmacist at Cedars Sinai Medical Center in Los Angeles in the areas of clinical pharmacy practice, hospital pharmacy management and clinical pharmacy. She started the hospital’s drug information newsletter and served as its Editor. She obtained her Juris Doctor degree from Loyola Law School in Los Angeles. After graduating from law school, she practiced civil litigation defense in the areas of drug and medical device product liability, professional negligence, employment law and other areas, in Los Angeles. She joined the National Association of Chain Drug Stores in 2000 as Director for Pharmacy Legislative and Regulatory Affairs Issues. She has served on the Board of Directors for the American Society for Pharmacy Law and is the author of the Legal Handbook for Pharmacy Technicians (published by the American Society of Health-System Pharmacists®). |
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Margot Drees
Director, Corporate Strategy
Global Healthcare Exchange, LLC |
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As Director, Corporate Strategy at GHX, Margot Drees leads strategic planning in an organization that brings together healthcare providers, manufacturers, distributors and group purchasing organizations in a collaborative and connected community to improve efficiencies, visibility and accuracy in the healthcare supply chain. In her current role, Drees also is responsible for the development of an industry model in support of track and trace and e-pedigree.
Drees joined GHX in 2005 with more than 15 years of experience in product management and marketing for healthcare and high-tech companies, including the Micromedex division of Thomson Healthcare Publishing. She received a BA in International Affairs from the University of Colorado, Boulder and an MS in Communication from the University of Denver. |
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Caroline Dunn
Engagement Manager
IMS Strategic Partnerships |
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Caroline Dunn is a consultant with more than 10 years’ experience in the pharmaceutical sector. Her role is in the IMS Global Strategic Partnerships team and she supports the IMS relationship-building program with key market stakeholders.
Most recently Caroline has focused on researching developments in worldwide distribution and dispensing of pharmaceuticals. Her interests include analyzing new trends in the distribution and dispensing sector, the impact of the financial crisis on the pharmaceutical market, the international comparison of pharmaceutical prices and pricing mechanisms, as well as new supply chain technology and integrity developments.
Previously Caroline worked as both a management and information consultant. Covering a number of subject matters, she has specific expertise in pricing, reimbursement and market access topics, parallel trade, market forecasting and sizing and the international comparison of pharmaceutical issues. She also specializes in such technology-focused issues as data-management strategies, data-quality management and the formation and dissemination of meaningful organizational key performance indicators.
Before joining IMS Caroline was an accountant. She trained with the National Health Service in the UK, working in a number of financial management roles in hospitals, primary care organizations and with the departed of health. |
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Perry L. Fri
Senior Vice President, Industry Relations, Membership & Education
HDMA |
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Perry L. Fri is HDMA’s Senior Vice President of Industry Relations, Membership and Education. In his current position, 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 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 was also Vice President of Industry Alliances for Instill Corporation, and was the Director of Supply Chain Management for NWDA (now HDMA). Fri holds a BA in History from the University of Maryland. |
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Elizabeth A. Gallenagh, Esq.
Vice President, Government Affairs and General Counsel
HDMA |
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Elizabeth A. Gallenagh, Esq., is the Vice President, Government Affairs and General Counsel for HDMA. She is responsible for overseeing federal and state advocacy on behalf of HDMA member companies and is the organization’s chief in-house attorney. Additionally, she serves as HDMA’s primary legislative expert on prescription drug pedigree, licensure and tax issues. Prior to joining HDMA, Gallenagh specialized in Medicare Part B reimbursement and coverage policy, fraud and abuse investigations and federal anti-kickback law. Earlier, Gallenagh also served as Legislative Assistant to Congressman Tom Manton (D-N.Y.) Gallenagh holds a JD from the George Mason University School of Law and a BA from The George Washington University. |
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Michelle Keller
Associate Director, Customer Operations
TEVA Pharmaceuticals USA |
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Michelle L. Keller is Associate Director, Customer Operations, for TEVA Pharmaceuticals USA. Her primary responsibilities include managing the Customer Support team, new product introductions, pedigree and state licensing compliance and advising on the global strategy for TEVA’s track-and-trace solution. Keller joined TEVA in 2003 and previously worked in Manufacturing Operations, Supply Chain and Sales and Marketing. Michelle holds a BS in Ceramic Engineering from Rutgers University and an MBA from DeSales University. |
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Julie Kuhn
Director, Operations
Cardinal Health, Inc. |
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Julie Kuhn is Director, Operations, within Quality and Regulatory Affairs at Cardinal Health. Kuhn joined Cardinal Health in 2004 with more than 20 years of distribution experience, managing various disciplines such as operations, sales, finance and supply chain management.
In her current role, Kuhn is responsible for the pedigree program and solutions within Cardinal Health’s distribution centers. She also is responsible for the supplier quality program, supporting private label brands. Additionally, Kuhn currently is involved in a number of supply chain projects, including a pilot program to implement serialization technology. She received a BA in Finance from Xavier University and an MBA from The Lake Forest Graduate School of Management. |
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Mike Rose
Vice President, Supply Chain Visibility
Johnson & Johnson Supply Chain |
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Mike Rose has worked for Johnson & Johnson for more than 35 years and is now responsible for improving supply chain visibility for the purposes of brand protection, supply chain integrity and supply chain efficiency. He is responsible for J&J’s standards adoption, serialization, traceability and eCommerce programs. Mike is a member of the EPCglobal Board of Governors, GS1 Global Board Committee for Standards and has served on a number of GS1 Healthcare Leadership Teams and workgroups. Mike has participated on HDMA’s Industry Relations Council and has served on PhRMA’s Supply Chain Security Working Group. In 2008, he testified before the U.S. Senate Judiciary Committee on the impact of counterfeiting to patient safety and brand integrity. In his career at different J&J operating companies, Mike has held various positions across discovery research, information management and now supply chain. |
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Karen Rothschild, Esq.
Regulatory Counsel
Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
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Karen Rothschild, Esq. is a Regulatory Counsel in FDA's Center for Drug Evaluation and Research. Ms. Rothschild works in the Office of Compliance, focusing on prescription drugs, supply chain security and PDMA compliance. Prior to working for FDA, she spent seven years as a food and drug attorney in the private sector and previously was an attorney for the City of New York. |
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Peggy Staver
Director, Product Integrity
Pfizer Inc. |
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Peggy Staver’s responsibilities include developing and implementing strategies to enhance patient safety and further secure the U.S. pharmaceutical supply chain. She represents Pfizer externally on various customer engagements and industry interactions relative to channel security and works closely with internal Pfizer colleagues to implement approved strategies. Peggy has been involved with a number of industry initiatives to address the threat posed by counterfeit pharmaceuticals, including the potential role serialization and track-and-trace technology may play in deterring counterfeiting. Peggy has been directly involved with Pfizer’s projects to implement serialization and is currently leading Pfizer’s U.S. and Global serialization teams. She also works closely with Pfizer’s Global Security organization as it relates to investigations of suspected counterfeit or adulterated Pfizer products and is a member of the GS1 Healthcare US and Global leadership teams and Pfizer’s Supply Chain Security Team. Peggy has 30 years’ experience in the industry. |
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Steve Tadevich
Director Product Serialization Technologies
McKesson Pharmaceutical |
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Steve Tadevich is Director of Product Serialization Technologies and Six Sigma Blackbelt in the McKesson IT group for McKesson Pharmaceutical. His responsibilities include McKesson's initiatives in serialization, track and trace, ePedigree, RFID and supply chain security. He also works as a business technology liaison with Corporate Government Affairs. Steve has been at McKesson for 26 years in various operations and information technology positions. He is a member of several GS1 Healthcare US groups and represents McKesson on HDMA’s Business Technology Committee. |
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Robert C. Young
Associate Director Delivery Management
TEVA Pharmaceuticals USA |
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Robert works for Teva Pharmaceuticals USA in Delivery Management, and is the global IT lead for the Teva serialization projects. He has been responsible for designing, implementing, integrating and validating IT systems and processes to meet U.S. and global serialization requirements. With a background in WMS implementations, ERP integrations and EDI processes, he has been working with pedigree and serialization initiatives since the initial Florida requirements were introduced. Robert has an Engineering degree from Clarkson University and an MBA from the University of Miami. |
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