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Education Sessions

This year's Summit promises to provide you with solutions-based education sessions. These sessions offer insight and knowledge on a variety of topics ranging from implementation strategies to updates on legislative and policy issues. Sessions details will be posted as they become available. Check back often!

Monday, November 17

US Pharmaceutical Industry Trends, Issues, and Forecasts

Time: 7:30 a.m. - 10:00 a.m.
Speaker: Douglas M. Long
Vice President, Industry Relations
IMS HEALTH

Get an expert’s view of the 2009 pharmaceuticals market, highlighting trends, issues and forecasts in demographics, sales, markets, and more. Find out which industry segments are growing or declining, and how evolving trends may affect you and your business.

FDA Update
(presentation)

Time: 10:15 a.m. - 11:45 a.m.
Speaker: Jeffrey E. Shuren, M.D., J.D.
Associate Commissioner for Policy and Planning
U.S. Food and Drug Administration (FDA)

In September 2007, the FDA Authorization Act (FDAAA) of was signed into law. Section 913 requires FDA to evaluate technologies and develop a standard numerical identifier to facilitate the identification, tracking and tracing of prescription medicines within 30 months. Jeffrey will provide an update on efforts by the agency to implement various portions of the FDAAA of 2007 to help further secure the supply chain against counterfeit medicines.

The Evolution of Federal and State Pedigree Requirements

Time: 10:15 a.m. - 11:45 a.m.
Speaker: Paul Rudolf, M.D., J.D.
Senior Healthcare Advisor
Arnold & Porter LLP

Various state pedigree requirements have evolved over the past year as legislatures have sought to update and revise existing laws. In addition, pedigree legislation was introduced at the federal level, continuing a legislative trend that ultimately could alter the way prescription medicines are tracked and traced through the supply chain. This session will provide up-to-date information on the state of pedigree legislation and regulation, and the potential effects on the healthcare supply chain.

The Industry Adoption Roadmap
(presentation)

Time: 2:00 p.m. – 2:50 p.m.
Speaker: Grant Hodgkins
Manager, Global Supply Chain
Alcon Laboratories, Inc.

There are challenges and opportunities in serializing individual items and capturing and sharing information about those products across the supply chain. The use of standards and the implementation of interoperable systems will be critical to success. An EPCglobal Task Force has developed a path forward that can help companies navigate the available standards to help create plans. Attend this session to learn more about the state of the standards and the industry adoption roadmap.

Preparing Infrastructure to Comply with E-pedigree Requirements – A Retail Perspective
(presentation)

Time: 2:00 p.m. - 2:50 p.m.
Speaker: Paul Schmidt
Partner
Accenture

Based on the results of a study conducted by Accenture, this session will detail the infrastructure retailers will need to deploy in order to comply with electronic pedigree requirements, based on item-level serialization. The session also will discuss potential operational benefits that can be realized by having this infrastructure deployed.

GS1 Healthcare Standards and Implementation Update
(presentation)

Time: 2:00 p.m. – 2:50 p.m.
Speaker: Bob Celeste
Director, Healthcare
GS1 US

Trading partners from the healthcare supply chain are actively working within GS1 to further develop standards for track-and-trace technologies to enhance patient safety and improve operations. This session will focus on the standards under development, highlight how the standards can be used, and how companies can get involved in the standards development process.

Using EPCglobal Standards for End-to-End Traceability
(presentation)

Time: 3:00 p.m. – 3:50 p.m.
Speaker: Gena Morgan
Standards Development Facilitator
EPCglobal, Inc.

If an industry were to deploy an end-to-end track-and-trace system, what would be the benefits? What would be the business opportunities and process improvements? This session will present a “vision” of what end-to-end track-and-trace implementation might look like, and the ways it could change how companies think about supply chain partnerships.

Manufacturer Insights – Getting Started with Track and Trace
(presentation)

Time: 3:00 p.m. – 3:50 p.m.
Speaker: Ron Yakubison
Associate Director, Packaging Facilities & Equipment Technology
Merck & Co., Inc.

Learn about the challenges, opportunities, and lessons learned in implementing serialization and track-and-trace technologies from a manufacturer perspective. This informative session will present an approach to adoption based on findings from one company’s pilot program.

RFID Industry Analyst
(presentation)

Time: 3:00 p.m. - 3:50 p.m.
Speaker: Bruce Carlson
Publisher
Kalorama Information

This session will highlight what is happening in the RFID industry, trends and drivers in healthcare supply chain, preview new technologies being introduced into the marketplace and forecast the rate of RFID adoption.

Distributor Track-and-Trace Roundtable
(presentation)

Time: 4:00 p.m. – 4:50 p.m.
Speaker: Ron Bone
Senior Vice President, Distribution Support
McKesson Corporation

  Heather Zenk
Director of Integrated Solutions
AmerisourceBergen Corporation

Through ongoing legislative activity at the state and federal levels, distributors have worked to develop and test track-and-trace solutions that will enhance patient safety and work toward compliance with current and potential requirements. This roundtable will provide an opportunity to learn more about distributor companies’ current track-and-trace initiatives and upcoming plans. Group discussion topics will include data requirements and technology issues.

RFID Technology Roundtable

Time: 4:00 p.m. – 4:50 p.m.
Speaker:

Michael Manley
Senior Director, Health and Life Sciences RFID
Impinj, Inc.
 

  Gregg Metcalf
Industry Marketing Manager, Serialization
Nosco, Inc.

This interactive session will provide a look into the latest advances in RFID technologies and how they can support the healthcare supply chain in the shared goals of further ensuring patient safety, increasing supply chain visibility, and improving business efficiencies. Discussion topics will range from business application of the technology to operation challenges to projected benefits. Come prepared to share your thoughts, comments, and questions!

Tuesday, November 18

How to Use GLNs in the Healthcare Supply Chain
(presentation)

Time: 10:15 a.m. - 11:45 a.m.
Speaker: John Roberts
Director
GS1 Healthcare US™

Unique location identification is important for understanding e-commerce applications, supply chain management, and RFID track and trace. Learn about the definitions and management of location identification information using the GSI Global Location Number (GLN) and the GLN Registry. Get an overview of GLNs, including the benefits of the applications and their real-world implementations. Learn about these critical elements: The difference between a GLN, the GLN registry and a GLN toolkit, as well as GLN standards development activities.

The BRIDGE Project: Lessons from the European Test
(presentation)

Time: 10:15 a.m. - 11:45 a.m.
Speaker: Tony Walsh
Strategic Business Development Director
Control, a Domino Group Company

Building Radio Frequency Identification Solutions for the Global Environment (BRIDGE) is an EU-sponsored pilot that is looking at RFID in many industries, including pharmaceuticals. This session will explore how their experiences and findings have been translated into a fully-working system of mass serialization - the key enabler of track and trace for pharmaceutical products in the healthcare supply chain.

How to Work with Trading Partners to Implement RFID/Track-and-Trace Technologies
(presentation)

Time: 2:00 p.m. - 2:50 p.m.
Speaker: Peggy Staver
Director, Product Integrity
Pfizer Pharmaceuticals US Trade Group
 
  Steve Tadevich
Senior Solutions Analyst
McKesson Corporation

As pharmaceutical products become serialized and are matched to a unique transaction history, companies are looking at the operational and technology implications of sending and receiving products and information. Developing a pilot and ultimately moving to full implementation means navigating a variety of technology and business issues. This session will highlight how collaborative relationships can help companies develop workable solutions, predict challenges, and overcome obstacles on the way to implementation.

Serialization Strategies

Time: 2:00 p.m. - 2:50 p.m.
Speakers:

Gerry Frank (presentation)
Senior Director, Packaging Technology
Cephalon, Inc.
 

  J. Michael Wallace (presentation)
Director, Global Serialization
Abbott Laboratories

As the healthcare industry moves toward unique identification at the item level, several challenges have appeared in the use of different data carriers and the EPCIS and the DPMS. This session will highlight how two manufacturers are looking to serialize and overcome these challenges.

How Hospitals Generate ROI and Improve Patient Safety with RFID
(presentation)

Time: 2:00 p.m. – 2:50 p.m.
Speaker: Dr. Ygal Bendavid
Instructor
RFID Academia

Take a photo presentation tour through a hospital with an RFID expert who will showcase which applications can work, which ones are still being piloted, which ones help enhance patient care and which ones have presented a substantial ROI. Learn more about RFID technology in the hospital environment, including operational process optimization; asset tracking and maintenance; and patient safety and security applications.

Manufacturer Case Study
(presentation)

Time: 3:00 p.m. - 3:50 p.m.
Speaker: M. Diane Arico
Senior Project Manager
Novartis Pharmaceuticals Corporation

Learn about the challenges, opportunities and lessons learned in implementing serialization and track-and-trace technologies from a manufacturer perspective. This informative session will present an approach to adoption based on findings from one company’s pilot program.

Rules of Engagement: A Blueprint for Data Management/Data Sharing 
(presentation)

Time: 3:00 p.m. - 3:50 p.m.
Speaker: Paul Fowler
Vice President of Healthcare Innovations, Office of the CTO
Axway

The Center for Healthcare Supply Chain Research has developed a roadmap for data sharing in its IT Blueprint. No longer “just a vision,” the Blueprint provides a practical approach to e-pedigree compliance, Track & Trace and data sharing. Its building block design moves from e-pedigree compliance to business process improvement where ROI and trading partner communication are key benefits of data sharing. This session offers real world, production use-cases that industry leaders are implementing today to show how technology trends in data sharing, data management and analytics are converging to support business process innovation in the healthcare supply chain.

Solutions for Small and Mid-Sized Companies
(presentation)

Time: 3:00 p.m. - 3:50 p.m.
Speaker: Dan Steiber
Principal
D2 Pharma Consulting LLC

Implementing track and trace is a challenging effort for any company, but particular challenges can arise for small and mid-sized companies that may not have the human resources or technology infrastructure to design, test, and implement current and emerging technologies. This session will identify and discuss solutions that might help small and mid-sized companies across the supply chain to work seamlessly with their trading partners, enhance patient safety, and meet legislative timelines for track and trace.

Data Synchronization: A Canadian Perspective
(presentation)

Time: 4:00 p.m. – 4:50 p.m.
Speakers:

Ron Bone
Senior Vice President, Distribution Support
McKesson Corporation
 

  Alicia Duval
GS1 Canada
 
  George Craigie
McKesson Corporation

In Canada, the pharmaceutical industry has developed and is using data synchronization in the healthcare supply chain. This session will discuss the rationale for why data synchronization makes sense, what they have learned, and the business value that has been created.

Issues Roundtable... Where Are The Gaps?

Time: 4:00 p.m. - 4:50 p.m.

At previous RFID Summits, roundtable discussions identified some of the critical issues that need to be addressed to move forward with broad industry adoption of track and trace. This cross-industry session is an opportunity to revisit those issues, discuss their status, and identify new priorities for moving forward. Come participate in a white boarding session to help identify the issues that need to be addressed by our industry.

RFID Case Study: Capital Returns
(presentation)

Time: 4:00 p.m. - 4:50 p.m.
Speaker:

Larry Hruska, RPh
President
GENCO Pharmaceutical Services, (formerly Capital Returns)

RFID is no longer a solution looking for a problem. RFID is already improving supply chain
efficiency and improving accuracy in the pharmaceutical industry – in reverse logistics. This session will highlight how one returns processing company is using RFID to improve their operations.