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Traceability Seminar 2015

Seminars

Traceability | October 17–19 | Washington, D.C.

Speakers

David Aguero  
David Aguero, Manager, Medication Systems and Informatics, St. Jude Children's Research Hospital

David is a pharmacy leader specializing in the coordination, communication, and support of pharmacy services and the medication use process with experience spanning multiple electronic health record and medication distribution platforms in multi-hospital systems as well as academic medical centers. David’s role at St. Jude Children’s Research Hospital is primarily as a change agent; empowering staff to standardize and rework processes for increased efficiency and better patient care through improved use of technology, deployment of technicians and pharmacists to advanced roles, and assisting in process improvement through appropriate data collection/utilization.

Ilisa Bernstein  
Ilisa B.G. Bernstein, JD, PharmD, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Dr. Ilisa Bernstein is the Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She leads this Office in promoting and protecting public health through outreach, strategies and actions that minimize consumer exposure to unsafe, ineffective and poor quality drugs. From 2006 to 2010, Ilisa was the Director of Pharmacy Affairs at FDA and from 1991-2002 and 2003-2006, she was a Senior Advisor in the Office of the Commissioner. From 2002 to 2003, Ilisa was a Senior Associate Director at Pfizer in the Regulatory Liaison Office in Rockville, Maryland. Ilisa started her career at FDA in 1988 as a Pharmacokinetic Reviewer in CDER.

Ilisa completed a post-doctoral residency at the National Institutes of Health, focusing on clinical and research pharmacokinetics. Ilisa received her PharmD from The University of Michigan College of Pharmacy and her JD from The American University Washington College of Law.

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.

David Colombo  
David Colombo, Director, Life Sciences Advisory Services, KPMG, LLP

David Colombo is a Director in KPMG’s Advisory Services practice with more than 25 years of operational, engineering and IT experience in supply chain execution in the pharmaceutical industry, including both clinical and commercial chains. His responsibilities range from defining solution strategy through implementation and operational transformation with a focus on order-to-cash and purchase-to-pay processes, warehousing and distribution operations, and supply chain security.

Prior to joining KPMG in 2013, David was the serialization implementation leader for a Top-10 global pharmaceutical company. His industry experience included technical and operational leadership positions in supply chain, distribution, information technology and clinical trials logistics. He was an active contributor as a member of the EMVO serialization technical work stream, the HDA bar coding task force and the PDSA consortium. He has implemented serialization and traceability solutions in Turkey, China, S. Korea, Argentina, U.S. and multiple EU member states, leveraging his experience with ERP and WMS systems, serialization applications and GS1 standards for product and location identification.

Michele Davidson, R.Ph  
Michele V. Davidson, R.Ph, Sr. Manager, Pharmacy Technical Standards Development & Policy, Walgreens

Michele is the Senior Manager, Pharmacy Technical Standards, Development & Policy, Government Relations, Walgreen Co.  Michele leads efforts with Walgreen to influence public policy as it applies to pharmacy technical standards. She has been instrumental in ensuring nationwide adoption of electronic prescribing, improving REMs processes, ensuring compliance with CMS rules as well as ensuring billing practices are in compliance with HIPAA standards. She actively engages and advises members of the government relations team as well as internal and external stakeholders about standards such as NCPDP, while ensuring compliance with these standards.

She has been extremely active in NCPDP over the past 18 years, served as chair of the Board of Trustees in 2015-2016, and received NCPDP’s TIME (The Individual Member Excellence) Award in 2014.  She graduated from the University of Florida with a B.S in Pharmacy.

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.

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.

Reid Graves  
Reid Harvey Graves, Sr. Serialization Consultant, Enterprise System Partners Global Corporation

Reid has 40 years of experience in the pharmaceutical industry with broad experience in manufacturing, packaging, sterile antibiotics, global IT projects, and serialization. Currently, Reid is in charge of onboarding data exchange platforms and collecting master data for Sanofi serializing product as a CMO for other companies. Before that, he served as the Global Master Data Lead for the Pfizer Serialization Program. He crafted global governance guidelines for SAP Master Data Mgt at Pfizer. Previously, he worked as the Senior Business Process Lead for Supply Chain Master Data for Merck’s global SAP implementation. He was instrumental in designing the Material Master and all manufacturing Master Data objects to enable end-to-end management across the global enterprise, including a fully integrated solution for artwork management. He was the primary architect for several custom web-based systems managing Merck's E2E global supply chains, worldwide sales, inventory, and cycle times. He directed the Inventory Management program ($1.8 billion) resulting in demonstrated supply chain improvements. Reid has a Master’s and Bachelor’s degree in Biology from the College of William and Mary. Reid has been a very active speaker and moderator for pharma conferences and podcasts.

Carey Hoffman  
Carey Hoffman, Senior Manager, Logistics & Distribution, Sunovion Pharmaceuticals Inc.

Carey Hoffman has worked in the pharmaceutical industry for 17 years, currently in the role of Senior Manager, Logistics and Distribution for Sunovion Pharmaceuticals Inc. She has been actively involved in the implementation of the Drug Supply Chain Security Act since 2013, developing business requirements, leading cross functional teams, and engaging with external partners to ensure compliance. In conjunction with other manufacturers, distributors, and solution providers, Carey and the Sunovion serialization team are currently participating in the Verification Router Service (VRS) development efforts to help ensure that an operational solution is in place ahead of the 2019 saleable returns requirement.

Andrew Meyer  
Andrew Meyer, Traceability Lead / Senior Systems Analyst, Mutual Wholesale Drug Company

Andrew Meyer is the Serialization Lead and a Senior Systems Analyst at North Carolina Mutual Wholesale Drug where he has been employed for the past 18 years. He was originally tasked with designing software solutions that extended existing ERP functionality and worked to integrate extraneous systems into their existing network. In 2006, he was pilot lead for an RFID feasibility project designed to test accuracy, traceability and reliability of RFID tags in a warehouse environment. More recently, his role has been expanded to include coordinating Mutual Drug's DSCSA efforts as the Serialization team lead. He is currently working to keep Mutual Drug focused on meeting the impending 2019 returns verification deadline as well as keeping an eye on the 2023 end state. In 2016, in conjunction with the HDA, industry leaders and supply chain partners, he led Mutual Drug’s returns verification pilot to test communications and product verification methods. The pilot and its findings have helped guide industry discussion and inform stakeholders of the looming challenges posed by the law. He has continued his involvement with several HDA working groups to identify and examine the issues posed by the DSCSA that will be faced by the stakeholders in the coming years.

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 as co-chair of the HDA Industry Relations Council and participating in several committees including the FGAC, RAC and SGAC. He is tri-chair of GS1 Global Healthcare Leadership Team and is a member of the GS1 US Healthcare Executive Leadership Committee.

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

Arthi Nagaraj  
Arthi Nagaraj, Specialist, Supply Chain Processes, Sanofi US

Arthi Nagaraj is responsible for analytics and processes at Sanofi, as part of Supply Chain. More recently, her role was expanded to lead and co-ordinate the Serialization efforts for Pharma in Sanofi USA. As part of this role, her focus is to ensure current DSCSA readiness while planning for future requirements.   Before Sanofi, Arthi has worked in both Manufacturing and Supply Chain at Agfa Corporation leading the Regional S&OPs for the US Business. Prior to her experience in Supply Chain, she has over 7 years of experience working in the IT industry developing, leading and coordinating projects in diverse sectors such as Finance, Telecom and Energy.

Arthi has a Bachelor’s degree in Computer Science Engineering and an MBA in Supply Chain Management from Lehigh University.

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).

Michael Rowe  
Michael Rowe, Manager – Operations Technology (Track & Trace), Cardinal Health, Inc.

Michael Rowe’s current role is Manager – Operations Technology within the Track & Trace Center of Excellence at the Cardinal Health headquarters in Dublin, Ohio. He works with both internal and external stakeholders across the enterprise to ensure the organization is meeting DSCSA requirements while minimizing operational impact.

Michael has been with Cardinal Health since 2008 and is a certified Lean Six Sigma Black Belt. As a Black Belt, he supported multiple areas including Cardinal Health’s Repackaging Services, Customer Database, Sales Operations, Pricing Services and IT. Michael’s experience also includes several sales and sales operations-focused positions within various segments of Cardinal Health.

Matt Sample  
Matt Sample, VP, Manufacturer Operations, AmerisourceBergen Corporation

Matt Sample is currently the business lead for the serialization efforts at AmerisourceBergen, and also manages the team responsible for supporting existing and future DSCSA business tasks. He has over 15 years of experience in the medical device, pharmaceutical and life sciences industry, working both for manufacturers, wholesalers and for a large consulting firm. He has held various roles in the areas of product development, lean six sigma, business system implementation and operational leadership.

His most recent responsibilities have included leading a global medical device serialization effort, device UDI implementation and, until joining AmerisourceBergen, he was the serialization program lead at a mid-size pharmaceutical company.

Allison Sheldon  
Allison Sheldon, Senior Manager, Business Technology, Pfizer Inc.

A member of Pfizer’s Business Technology organization, Allison supports the global Serialization Program providing a market interface to business clients for delivery of solutions to meet the many different serialization mandates. With a specific focus on the Americas and GCC Region, Allison works with the different regulatory standards organizations and industry groups to understand and influence requirements.

Peter Sturtevant  
Peter F. Sturtevant, Senior Director, Industry Engagement, GS1 US

Peter F. Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals at GS1–US, has more than thirty years of global supply chain management experience. Currently, Mr. Sturtevant is responsible for engaging supply chain business trading partnerships within the pharmaceutical industry and regulatory agencies in support of the implementation of the Drug Supply Chain Security Act (DSCSA). Mr. Sturtevant is a regular speaker and panelist at pharmaceutical conferences in support of GS1–US standards on DSCSA.

Prior to joining GS1–US, Mr. Sturtevant was Director, Global Supply Chain for Haemonetics with responsibilities for global distribution operations, transportation and trade compliance. He also held senior global supply chain positions at Nippon Express and Covidien. Throughout his career, his responsibilities have included the management of functional areas of logistics sales, customer service, vendor management inventory, distribution planning, strategic network design, transportation management, compliance, financial control, system design/implementation, distribution center operations, bar code standards and project management.

Mr. Sturtevant holds a Master's degree in Business Administration from Western New England University in Springfield, MA. He also earned two Bachelor of Science degrees in Business Management from Bentley University in Waltham, MA, and another degree in Transportation and Logistics Management from Northeastern University in Boston.

Brian Waldman  
Brian P. Waldman, Esq. MBA, Partner, Arent Fox LLP

Brian Waldman concentrates his practice in the area of food and drug law and advertising law, counseling clients primarily on pharmaceutical, medical device, food, dietary supplement and cosmetic issues, with particular emphasis on developing effective strategies for introducing and distributing new products. Brian advises clients on a broad range of legal and regulatory issues in all phases of a product’s life cycle, including (i) developing appropriate strategies for the introduction of new ingredients and finished products, (ii) coordinating pre-market safety, efficacy, and claims evaluations, (iii) preparing FDA-related applications and notifications, (iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials, (v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and (vi) responding to threatened enforcement action. Brian has been advising clients including HDA on drug distribution issues since 1995.

Ervin West  
Ervin West, Senior DSCSA Professional, Humana, Inc.

Ervin is currently the DSCSA Compliance Lead at Humana Pharmacy within the Supply Chain Inventory Planning team.  When he joined the pharmaceutical industry with Humana 6 years ago, he brought 25+ years of Supply Chain systems and Logistics management to his current role. Since early 2013, he has been instrumental in the creation and adoption of processes and procedures to help ensure success in Humana’s compliance efforts. His primary responsibilities are focused on continual DSCSA support  and ongoing educational opportunities for all Humana dispensing facilities.  

Prior to joining Humana he was a senior implementation consultant specializing in DMS/WMS and space planning software for a large international solution provider.  

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