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Traceability Seminar 2015

Conferences

Traceability | November 8–10 | Washington, D.C.

Speakers

Ilisa Bernstein  
Ilisa B.G. Bernstein, JD, PharmD, SVP, Pharmacy Practice and Government Affairs, American Pharmacists Association

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.

Jaclyn Bissonnette  
Jaclyn Bissonnette, Director, Mfg. Science & Technology, Sunovion Pharmaceuticals Inc.

Jackie Bissonnette is an Associate Director in the Technical Services group and has been with Sunovion since 2008. In addition to providing guidance and expertise for Sunovion’s product packaging, she is leading the effort to implement serialization on product packaging and other federal mandates as part of the DSCSA Law. Jackie has over 25 years of packaging, labeling and project management experience in the pharmaceutical industry.

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.

Stephen Coady  
Stephen C. Coady, Program Manager, Global Serialization and Track & Trace, Apotex Corp.

Stephen has over to 30 years with Apotex, serving in various progressive roles in IT, Operations, Supply Chain, SAP, Shop Floor Integration and, most recently, Global Serialization.

In his current role as Program Manager, Global Serialization and Track & Trace since 2012, Steve has global responsibility and oversight for Apotex’s compliance to current and emerging serialization regulations. He leads a global team tasked with monitoring and influencing market serialization implementation, packaging technology selection and installation, global serialization repository readiness and adjustments to distribution technologies, processes and systems.

Steve is active in or has participated in the AAM Supply Chain Task Force; HDA Traceability Pilots Working Group; HDA Barcode Task Force; Medicines for Europe – Anti-Counterfeiting Steering Committee; and GS1 Canada Patient Safety.

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.

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.

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.

Rebecca Hehnly  
Rebecca S. Hehnly, Regional Leader, End to End Traceability, Johnson & Johnson Supply Chain

Rebecca Hehnly is the End-to-End Traceability Leader, North America (NA) for Johnson & Johnson Supply Chain. Rebecca has responsibility for all regional product serialization and traceability projects that will expand the Johnson & Johnson product identification, serialization and traceability capabilities to meet regulatory requirements, as well as deliver value beyond compliance. Rebecca brings over 25 years of supply chain and project management experience to her current role in serialization and traceability.

Rebecca graduated from West Virginia University with a Bachelor of Science in Journalism and Marketing. She continued her education in the Master of Business Administration program at Pennsylvania State University.

Christopher Howell  
Christopher D. Howell, Senior Director, Global Engineering and Technology, Patheon Pharmaceutical

Christopher Howell is Senior Director in Patheon’s Global Engineering team, currently serving as its Global Serialization Program Manager. He has 25 years of industry experience, particularly in commercial and development areas. Chris also has varying technical and operational roles, including Development Site Director in their Cincinnati, Ohio location.

Jayamary Kala  
Jayamary Kala, Serialization Solutions Architect, Genentech, A Member of the Roche Group

Jayamary Kala is the Serialization Solutions Architect in the Global Information Services group at Genentech. She currently manages initiatives within the Commercial Organization related to Serialization and Channel Operations including strategic alignment and liaison with Global Roche teams. In this role, she has led the effort to establish the Track and Trace system for Genentech, solutions to maintain DSCSA compliance, drives process improvement initiatives to optimize customer order management processes and analytics for Channel Operations.

Kevin Madagan  
Kevin Madagan, Partner, Reed Smith LLP

Kevin M. Madagan is a health care and FDA regulatory attorney at Reed Smith. As a partner and member of the firm’s Life Sciences Health Industry Group, Kevin routinely advises clients across the life sciences and health care spectrum – including API, excipient, and chemical suppliers; manufacturers; packagers; wholesale and private label distributors; third-party logistics providers; carriers; pharmacies (503A, 503B, nuclear); and health care systems.

Kevin specializes in providing legal and strategic guidance about supply chain logistics, distribution and security (e.g., DSCSA implementation and compliance, global product sourcing and distribution, manufacturing and inspections, recalls, and import/export issues); advertising and promotion (Rx and OTC); and FDA enforcement. He also specializes in providing strategic guidance and transactional support to health care and life science clients, private equity funds, underwriters, and other businesses in connection with domestic and international mergers and acquisitions, and health care financing and securities transactions.

In his spare time, Kevin serves as the Pro Bono Committee Chair of Reed Smith's Washington, D.C. office.

Christina Markus  
Christina M. Markus, Partner, King & Spalding LLP

David Mason  
David G. Mason, Director Americas Serialization Program , Novartis Pharmaceuticals Corporation

Dave Mason is currently the AD North America Serialization – Supply Chain, supporting the implementation of DSCSA for the Novartis group. He is leading the efforts for setting up systems and processes for ESO, supply chain and commercial operations. Dave represents Novartis in trade association, PDSA and FDA public meetings. He communicates to the NTO Global Serialization team with new and existing requirements for other countries, and he assures that the validation approach is consistent within the organization and execution at the sites. Dave also supports the team to develop a global master validation and TPO rollout plan.

Michael Mazur  
Michael J. Mazur, Director, Trade Operations, 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.

Thomas McHugh  
Thomas McHugh, Sr. Strategist Supply Chain and Technology, CVS Health

Tom McHugh has over 35 years of experience in developing, implementing, and managing systems and technology in the Supermarket and Chain Drug industries.

His experience spans the full range Supply Chain Systems and Technology, EDI, Logistics ERP, DC Operations, Transportation, Forecasting and Replenishment, Supply Chain Visibility, Engineered Labor Standards, Warehouse Management and Execution, Yard Management and Supplier Collaboration systems in extremely high volume real time environments.

Tom also has significant experience in warehouse automation and integration of all aspects of point use Picking and MHE technology as well as directing technology implementations for numerous greenfield and brownfield DC start-up projects.

Tom’s current focus is implementing the processes and technology required for compliance, serialization, and interoperability for DSCSA at CVS Health.

Andrew Meyer  
Andrew Meyer, Director of Regulatory and Operational Compliance, Mutual Drug

Andrew Meyer is the Director of Regulatory and Operational Compliance at Mutual Drug where he has been employed since late 2000. He was originally tasked with designing software solutions that have extended existing ERP functionality and worked to integrate extraneous systems into their existing network. In 2006, Andy was pilot lead for a RFID feasibility project designed to test accuracy, traceability, and reliability of RFID tags in a warehouse environment. Eventually with the signing of the DSCSA into law, he was tasked with coordinating Mutual Drug's DSCSA efforts as the Serialization team lead. 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. He has continued his involvement through TraceLink’s FutureLink SIG working groups as well as being an active member of several of the HDA’s working groups to identify and examine the issues posed by the DSCSA that will be faced by stakeholders in the coming years. He is currently working to keep Mutual Drug focused on meeting the impending 2019 returns verification deadlines as well as preparing for the impending USP800 rules among other existing and upcoming regulations.

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.

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).

Miguel Pitarch  
Miguel Pitarch, PhD, Executive Director, Global Serialization, Bristol-Myers Squibb Company

Miguel Pitarch leads the Global Serialization Program for Bristol-Myers Squibb Company with a deep understanding of pharmaceutical supply chain. In 1998, he joined the company in Ireland, where he had been a Research Fellow at Queen’s University of Belfast. Since then he has assumed positions of increased responsibility, including Vice President and General Manager of Bristol-Myers Squibb manufacturing sites in Puerto Rico and Italy, and Strategic Product Leader in the Global Supply Chain.

Miguel received his doctorate in Pharmacy from the University of Valencia in Spain; he majored in organic and medicinal chemistry.

Bjoern Rosner  
Bjoern Rosner, PhD, Global Serialization Program Lead, Biogen Inc.

Bjoern Rosner, PhD is the Global Serialization Program Lead at Biogen, a leading global Biotechnology company with focus on Neurological disorders. His responsibilities include both supply chain implementations and operational support to maintain compliance with all relevant regulations globally. In this function, Bjoern has managed a number of packaging site and distribution site implementations, as well as multiple corporate EPCIS instances. He is responsible for the transition into serialized production for all commercial product and is accountable for the operational integration of serialization into corporate systems and supply chain processes.

Prior to Biogen, Bjoern was Director, R&D at NanoGuardian where he invented and commercialized a novel anti-counterfeiting technology based on nano-scale imprinting for tablets, capsules and injection moldings.

Bjoern is a native of Germany and holds a Master of Science in Physics as well as a Ph.D. in Electrical Engineering from the University of Delaware.

Michael Rowe  
Michael Rowe,

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 teams responsible for maintaining item and vendor master data, as well as run our manufacturer operations team.. He has over 17 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.

Peter Sturtevant  
Peter F. Sturtevant, Senior Director, Community 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.

Heather Zenk  
Heather Zenk, RPh, SVP, Replenishment & Secure Supply Chain Operations, AmerisourceBergen Corporation

Heather Zenk, R.Ph., PharmD., is Vice President, Global Secure Supply Chain Operations at AmerisourceBergen Corporation. In this role, she has responsibilities for developing and implementing traceability business processes and technology that will enhance patient safety, further secure the pharmaceutical supply chain and create broader service offerings to manufacturer partners and AmerisourceBergen customers. In addition, Heather manages manufacturer programs and data.

Heather has over 15 years of pharmacy, procurement and supply chain experience, which she has utilized in her career at AmerisourceBergen including that of Vice President, Distribution Center Manager at the Chicago Distribution Center, SAP business liaison; and running operations at the Canadian Distribution network.

Prior to joining AmerisourceBergen Corporation in 2007, Heather worked at Walgreen Co., as a pharmacist and manager of generic procurement and strategic solutions. As part of her dedication to patient safety and advocacy, she continues to maintain her license to practice pharmacy in Minnesota as well as in Illinois.

Heather received a Bachelor of Arts degree from the College of St. Benedict, St. Joseph, MN, and a Doctorate of Pharmacy degree from the University of Minnesota.

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