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Traceability Seminar 2015

Seminars

Traceability | November 9–11 | Washington, D.C.

Speakers

Gaurav Banerjee  
Gaurav Banerjee, Director, Technical Services (EU & US), Sharp Packaging Solutions

Gaurav Banerjee is currently the Director of Technical Services for US and EU at Sharp Packaging Solutions, a division of UDG Healthcare, Plc. In his role, Gaurav is responsible for the development, documentation, implementation, and enhancement of the UDG Healthcare Packaging Division's serialization services platform. He manages technical staff, including project managers, serialization engineers and enterprise application specialists, who execute technology projects that support customer, supplier or internal service initiatives. Gaurav also oversees and maintains primary business relationship responsibility for vendors and business partners supplying Sharp with serialization services.

Tim Bishop  
Tim W. Bishop, Senior Manager, Quality Assurance, UPS Supply Chain Solutions

Tim Bishop is a Senior QA Manager serving global distribution operations. Tim oversees UPS activity related to U.S. and global track-and-trace initiatives to meet regulatory requirements, and serves as SME liaison to UPS Public Affairs regarding surrounding policy for drug tracking and tracing in the supply chain. Tim is currently leading UPS’s Global Serialization Solution initiative.

Tim began his career with UPS in 1990 on a small package sort in a local UPS center in Louisville, Kentucky. Throughout his time with UPS, Tim has served in many different roles from operations manager, special project assignments, Healthcare Strategy Group to his current QA manager role. Since 2000 Tim’s tenure has been focused on healthcare distribution operations assisting with implementing and managing healthcare buildings and accounts in Louisville, Kentucky, ranging from medical device, pharmaceuticals, controlled substances and bio-pharma products.

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 US 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 US 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.

John Quentin Dittman  
John Quentin Dittman, Director, Operations Technology 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.

Brian Files  
Brian E. Files, Director, Pharmacy Inventory, Regulatory and Compliance, CVS Health

Brian Files is Director of Pharmacy Management Regulatory and Compliance. In this role, Brian focuses on identifying and managing compliance and regulatory impacts to critical inventory management processes and supply chain strategies.

Brian has more than 22 years of experience in healthcare, including business development, managed markets, U.S. and international government affairs and public policy. He specializes in identifying and leveraging strategic developments in the evolving healthcare environment with focus on legislation and regulations impacting pharmaceutical therapy management and supply chain operations. He has played key role in building actionable relationships with a range of stakeholders, key opinion leaders, non-traditional allies, community and state-based healthcare delivery organizations, clinical and patient advocate groups and trade associations.

Prior to his current tenure at CVS Health, Brian served in key leadership roles at Johnson & Johnson, Sepracor, INVO Bioscience and LogistiCare.

He holds a BA in History from Cornell University and earned his MBA in Corporate Strategy and Marketing from the University of Michigan, Ann Arbor.

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.

Mark Gutmann  
Mark Gutmann, Senior Director, Global Serialization Program, Mylan Inc.

Mark Gutmann is the Senior Director of Mylan’s global serialization program. In this role, he has responsibility for compliance with all global traceability regulations. In his 13-year career with Mylan, Mark has held various IT and Supply Chain leadership roles.

Previous to Mylan, Mark was with GE for 15 years where he held roles including Six Sigma Master Black Belt and CIO.

Scott Hatakeyama  
Scott T. Hatakeyama, Director – Buy to Pay, Kaiser Permanente

Scott Hatakeyama proudly represents Kaiser Permanente. Contributing to their quest to deliver high-quality, affordable healthcare, Scott leads the DSCSA implementation team. With more than 15 years of healthcare and systems experience, Scott is charged with implementing a robust, standardized and cost-effective solution to keep Kaiser Permanente in compliance today through 2023 and beyond.

Jamie Hintlian  
Jamie Hintlian, Partner/Principal, Advisory Services, Ernst & Young LLP

Jamie Hintlian is a Principal in the Advisory Services practice of Ernst & Young LLP and leads the Life Sciences Supply Chain practice.

His work has focused on helping clients improve their supply chain performance, including manufacturing strategy, plant operations, distribution and logistics, sales and operations planning, supplier management and supply chain risk management. He has been a pioneer in leading industry initiatives concerning drug pedigree management, safe and secure supply chains and regulatory compliance.

Jamie worked over 20 years at Accenture, serving numerous life sciences, consumer health, distributors and medical device companies, and also led the Global Health and Life Sciences Supply Chain Practice for a number of years.

He built and was the managing director of the Pharmaceutical Business Unit of Aspen Technology, a leading provider of manufacturing and engineering solutions to process industries.

Additionally, Jamie helps lead a supply chain and manufacturing strategy class at Cornell’s Johnson School as an assistant instructor. Jamie has a Bachelor’s and Master’s degree in Operations Research from Cornell University, and also earned his MBA from the Johnson School at Cornell.

Connie Jung  
Connie Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity & Recalls, 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 the U.S. drug supply. Dr. Jung has worked on issues related to stolen, counterfeit and other substandard drugs for several years in her previous position as Senior Advisor for Pharmacy Affairs in the Office of Policy, Office of the Commissioner and will continue these efforts in the new office.

Dr. Jung joined the FDA in 1999 as a researcher in the Center for Food Safety and Applied Nutrition, conducting toxicology research involving skin absorption and metabolism of topically applied compounds, and later served as a Regulatory Reviewer in the Division of Bioequivalence in the Office of Generic Drugs where she analyzed bioequivalence studies of generic products before working on supply chain issues.

She received her BS in Pharmacy from The Ohio State University and her Ph. D. in Pharmaceutical Sciences from the University of Cincinnati.

 
Ryan Kelly, Project Manager, PAR Pharmaceutical an Endo International Company

Shaun Kirkpatrick  
Shaun Z. Kirkpatrick, Manager, Track and Trace Operations, GlaxoSmithKline

Shaun Kirkpatrick is Manager of Track and Trace Operations at GlaxoSmithKline (GSK). He is responsible for developing and maintaining business processes to support DSCSA compliance. Shaun joined GSK in 2007; he started working in the track-and-trace space in response to California's ePedigree legislation. Since November 2013, Shaun has been the business lead on the GSK DSCSA project team. Currently, Shaun and the GSK project team are focused on developing and implementing solutions to support the next phase of deliverables for DSCSA compliance.

Ulrike Kreysa  
Ulrike Kreysa, Vice President, Healthcare, GS1 Global Office

Ulrike Kreysa is responsible for the Healthcare sector at the GS1 Global Office in Brussels and works with her local colleagues in 112 countries across the world to develop and implement GS1 standards in the healthcare industry.

Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, group purchasing organizations, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations.

Ulrike works regularly with decision makers from leading companies like Abbott, Amgen, Bayer, Baxter, BBraun, GE Healthcare, GSK, Johnson & Johnson, Medtronic, Pfizer and others to drive harmonization of standards in the implementation across the world. To achieve that she is regularly in discussions with regulatory bodies to discuss the need for a globally aligned and harmonized approach towards standards in order to avoid supply-chain inefficiencies for all healthcare stakeholders and increase patient safety. She is a regular speaker at conferences worldwide.

Julie Kuhn  
Julie Kuhn,

Julie Kuhn is Vice President, Supply Chain Integrity at H. D. Smith. Julie has more than 25 years of distribution experience, with over 10 years in pharmaceutical distribution. She has managed various disciplines such as regulatory compliance, operations, sales, finance and supply chain management. Julie is responsible for the traceability program and supply chain integrity solutions across H. D. Smith’s distribution centers.

Julie has a BA in Finance from Xavier University and an MBA from The Lake Forest Graduate School of Management.

Kevan MacKenzie  
Kevan R. MacKenzie, Director, Serialization Technology, McKesson Corporation

Kevan MacKenzie is the Director of Serialization Technology and Six Sigma Blackbelt in the Information Technology Group at McKesson Corporation. His responsibilities include McKesson’s initiatives in serialization, traceability, radio frequency identification (RFID), electronic product code, barcode identification and supply chain security. He also is a business technology liaison with McKesson’s Corporate Government Affairs.

MacKenzie holds an MBA from Auckland University, New Zealand.

 
Lloyd Mager, Global Traceability Lead, Strategic Initiatives, AbbVie US

Lloyd Mager is the Global Lead for AbbVie’s Traceability program and has 30 years of experience in the pharmaceutical industry. He represents AbbVie in strategic supply chain matters involving product traceability and he leads the implementation activities for his company.

Lloyd is involved in a number of industry initiatives. He is a founding member of the Pharmaceutical Distribution Security Alliance, a multi-stakeholder initiative representing the spectrum of U.S. pharmaceutical distribution stakeholders. He is currently performing as tri-chair for Rx360’s Data Exchange Traceability Architecture workgroup. Lloyd is a member of the GS1 Global Leadership team.

Lloyd holds a BA from Concordia College and an MBA from Lake Forest Graduate School of Management.

Michael Mazur  
Michael J. Mazur, Director, Trade Operational Excellence, Pfizer Inc.

Mike’s responsibilities include developing and implementing strategies to enhance patient safety and further secure the U.S. pharmaceutical supply chain. He 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. Mike has been directly involved with Pfizer’s global projects to implement serialization and is responsible for ensuring compliance with the U.S. Drug Supply Chain Security Act (DSCSA) requirements. He 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. Mike has 22 years of operational experience within the pharmaceutical industry.

Andrew Meyer  
Andrew Meyer, Senior Systems Analyst, Mutual Wholesale Drug Company

Andrew Meyer is a Senior Systems Analyst at Mutual Wholesale Drug where he has been employed for almost 20 years. His primary function is designing software solutions that extend existing ERP functionality and to integrate extraneous systems into the existing network. In 2006 he was team lead for a RFID feasibility project designed to test accuracy, traceability and reliability in a warehouse environment. In 2010 he redesigned, built and deployed a new RX and POS interface subsystem to streamline data flow and creation. More recently, his role has been expanded to include coordinating Mutual Wholesale Drug's traceability efforts as the traceability team lead.

Scott Mooney  
Scott A. Mooney, Vice President, Distribution Operations, McKesson Corporation

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.

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 Workgroup in addition to serving on the HDA Industry Relations Council and participating in several committees including the FGAC, RAC and SGAC. He is active with GS1 Global serving on the Process Oversight Committee as well as GS1’s Global Healthcare Leadership Committee.

Scott has a BA in Accountancy and a MBA from the University of Wisconsin – La Crosse.

Maryann Nelson  
Maryann Nelson, Manager, Regulatory Compliance, Cardinal Health, Inc.

Maryann Nelson is a Regulatory Manager with Cardinal Health, Inc. responsible for developing strategies to insure supply chain integrity, preventing prescription drug diversion and complying with state and federal legislative requirements. She has over 25 years of experience in Pharmaceutical Distribution. She is actively involved with industry organizations, including HDMA and GS1, focused on implementing the Track and Trace requirements of the Drug Supply Chain Security Act (DSCSA).

Ms. Nelson is a graduate of The Pennsylvania State University where she received a BS degree in Business Logistics.

Tish Pahl  
Tish E. Pahl, Principal, Olsson Frank Weeda Terman Matz PC

Tish Eggleston Pahl is a principal at Olsson Frank Weeda Terman Matz PC. She is regulatory counsel to drug, cosmetic, dietary supplement and food clients with concerns before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. Her work has encompassed representation of companies making and marketing human and animal prescription and over-the-counter (OTC) drugs, dietary supplements, and cosmetics. She has particular expertise in the areas of health care communications, advertising and labeling of FDA-regulated products. Further, she advises trade association clients on a range of antitrust and trade regulation issues.

Since November 2013, Tish has been heavily involved with implementation of the Drug Quality and Security Act (DQSA). She has advised pharmacy compounders and outsourcing facilities on their new FDA responsibilities under Title I of the DQSA. She has worked closely with pharmaceutical supply chain stakeholders, including manufacturers, repackagers, and wholesale distributors, on implementation of Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA).

Tish is a regular participant in HDA activities, providing FDA regulatory and antitrust counsel to the Public Policy Council, the Traceability Implementation Work Group, the Regulatory Affairs Committee, the Returns Task Force, and other committees.

Tish graduated from Northwestern University and earned her Juris Doctor from Northwestern University (cum laude).

Senthil Rajaratnam  
Senthil S. Rajaratnam, Affiliate Relations Manager, Global Serialization Program, Lilly USA, LLC

Senthil Rajaratnam is the Affiliate Relations Manager for Lilly’s Global Serialization Program. In his role, Senthil interacts with regulatory contacts in Lilly affiliates that are located in markets that have active or upcoming legislative requirements for serialization, to gather requirements and understand what needs to be done in terms of marking serial numbers on the products and also how to share/report the serial number data to the government or other supply chain entities. He then translates those requirements into technical details for the project team to implement the right solution.

Senthil has been with Eli Lilly and Company for 13 years. Senthil’s key expertise is in the warehousing, distribution and logistics area of the supply chain and has deep knowledge in system solutions and processes in this space. He is also the subject matter expert on GS1 standards and is part of various industry workgroups that work towards a common goal of providing advocacy to influence the adoption of global standards, harmonizing requirements and help governments achieve their goals leveraging serialization.