Monday, November 30

4:00 PM

Registration Opens

4:30 PM–6:00 PM

Pre-Seminar Session: Serialization 101
Serialization is one of the key building blocks to anti-counterfeiting, track and trace, FDAAA SNI and California pedigree.  By having a unique serial number on each package of product leaving manufacturer warehouses, brand owners and their trading partners have the potential to address all of these issues, as well as business processes like reimbursements, chargebacks and rebates and supply chain visibility. This session will provide an overview of serialization strategies and how to implement the strategies to support greater efficiency, patient safety and security across the entire supply chain.
David M. DeJean, Vice President, Professional Services, Systech
International™
Ruby Raley, Director, Healthcare Solutions, Axway, Inc.

6:00 PM–7:00 PM

Networking Reception & Table-Top Exhibits

7:00 PM

Open Evening

Tuesday, December 1

7:00 AM–8:00 AM

Continental Breakfast

8:00 AM–8:15 AM

Welcome & Introductions
Perry Fri, Senior Vice President, Industry Relations, HDMA

8:15 AM-9:00 AM

Federal and State Pedigree Overview
An expanding patchwork of state pedigree laws and regulations continues to provide challenges to the efficient distribution of pharmaceutical products, both for manufacturers and distributors. Although state legislative activity declined in 2009, many states moved forward with new regulations to implement laws enacted in prior years.   Moreover, there continues to be interest in pursuing a uniform federal approach to pedigree while the FDA is moving forward establishing guidelines for the unique identification of pharmaceutical products.  This session will provide an update on these important initiatives and provide insight on what lies ahead.
Elizabeth A. Gallenagh, Esq., Vice President, Government Affairs, HDMA

9:00 AM-9:45 AM

California Pedigree Update
Hear a regulatory overview and update on the state of pedigree legislation in California. This session will include discussions on inference and the potential for using track and trace technologies for recalls and more.
Virginia Herold, Executive Director, California State Board of Pharmacy

9:45 AM-10:30 AM

FDA Update
FDA is involved in a number of initiatives to support the use of technology as an aid in further securing the drug supply. Among them are evaluating technologies and developing a standard numerical identifier to facilitate the identification, tracking and tracing of prescription medicines and additional innovations for facilitating the provision of pedigrees and using track and trace systems. This presentation will provide an update on these and other efforts by the Agency with a special emphasis on implementing Section 913 of the FDA Amendments Act (FDAAA), by March of 2010.
David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget, Office of the Commissioner, U.S. Food & Drug Administration

10:30 AM–10:45 AM

Networking Break & Table-Top Exhibits

10:45 AM-12:00 PM

Understanding the Impact of Choices
This session addresses how companies are taking a holistic view of technology choices they are making to implement track and trace technologies and how they impact operations and other legacy technologies and processes.  
Brian Brown, Director, e-Commerce Logistics, Cepalon Inc.
Lloyd Mager, Track & Trace Program Manager, Abbott Laboratories, Inc., Pharmaceutical Products Div.- Dist Ctr
Heather Zenk, PharmD, Director, Integrated Solutions, AmerisourceBergen Drug Company

12:00 PM–1:00 PM

Networking Luncheon  & Table-Top Exhibits

2:15 PM-3:00 PM

GS1 Healthcare Standards and Implementation Update
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.
Robert Celeste, Director, GS1 Healthcare US

3:00 PM-3:15 PM

Networking Break & Table-Top Exhibits

3:15 PM-5:00 PM

Roundtable Discussion
Supported by Stericycle
These roundtable discussions provide an opportunity to learn and discuss key issues, obstacles and identify potential solutions in small groups. Learn from your peers and come ready to share your comments, questions and insights.
Format: Special interest areas are listed below; and attendees will rotate 3 times.

5:00 PM

Adjournment

5:00 PM-6:00 PM

Networking Reception & Table-Top Exhibits

Wednesday, December 2

7:30 AM–8:30 AM

Continental Breakfast

8:30 AM–9:45 AM

The Value Beyond Pedigree
Companies working to implement track and trace are seeking ways to achieve a return on their investment. This session provides a discussion around some of the areas where companies are securing opportunities such as cold chain, contracts and chargebacks, in-transit security, and returns/recalls.
Ron Bone, Senior Vice President, Distribution Support, McKesson Corporation
Michael Rose, Vice President, Supply Chain Visibility, Worldwide Supply Chain Group, Johnson & Johnson Corporate

9:45 AM–10:00 AM

Networking Break

10:00 AM-11:00 AM

Open Discussion & Wrap-Up
This seminar concludes with an open discussion about forward-looking actions learned from the seminar and potential steps the industry could take, as well as resources needed to prepare for implementation.
Perry Fri, Senior Vice President, Industry Relations, HDMA

11:00 AM

Adjournment

HDMA is grateful for the following supporters, who will demonstrate their innovative products, services and technology solutions at the seminar’s Table-Top Exhibits.

Diane Arico
Senior Project Manager
Novartis Pharmaceuticals Corporation

Ron Bone
Senior Vice President, Distribution Support
McKesson Corporation

Brian Brown
Director, e-Commerce Logistics
Cephalon Inc.

Shawn Brown
Vice President, State Government Affairs
Generic Pharmaceutical Association

Linda Castanon
Pharmaceutical Distribution Warehouse Manager
US Oncology

Robert Celeste
Director
GS1 Healthcare US

Duke Danont
Director, Risk Management
Amgen, Inc

Richard Feldman
Vice President, Trade and Product Security
EMD Serono, Inc.

Michelle Keller
Product Safety & Integrity Manager
TEVA Pharmaceuticals USA

Dave Kostin  
Director, Information Systems
Pharmaceutical Products Division
Amgen Inc.

Julie Kuhn
Vice President, Operations Technologies
Cardinal Health, Inc.

Kevan MacKenzie
Senior Solutions Analyst
McKesson Corporation

Lloyd Mager
Track & Trace Program Manager
Abbott Laboratories, Inc., Pharmaceutical Products Div.

Ramesh Murthy
Vice President, Inventory Replenishment
CVS Pharmacy Corporation

Cyndi Poetker
SR IT Program Manager
Abbott Laboratories, Inc., Pharmaceutical Products Div.

Michael Rose
Vice President, Supply Chain Visibility
Worldwide Supply Chain Group
Johnson & Johnson Corporate

Peggy Staver
Director, Product Integrity
Pfizer Inc.

Kimberly Thomas
Senior Manager, Product Security
EMD Serono, Inc.

Michael Ventura
Serialisation Business Lead – North America, Asia Pacific, Japan, and Emerging Markets
Logistics, Strategy & Global Supply
GlaxoSmithKline - Global Manufacturing and Supply

Mike Wallace
Director, Global Serialization
Abbott Laboratories, Inc., Pharmaceutical Products Div.

Heather Zenk
Director, Integrated Solutions
AmerisourceBergen Drug Company

Ron Bone
Senior Vice President, Distribution Support
McKesson Corporation

Ron Bone is Senior Vice President, Distribution Support for McKesson Pharmaceutical.  His responsibilities include Regulatory Affairs, leading McKesson's product security initiatives through the used 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 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. Bone received his BS and MBA degrees from San Jose State University.

Brian M. Brown
Director, e-Commerce Logistics
Cephalon, Inc.

Brian Brown is the Director, e-Commerce Logistics at Cephalon, Inc. Brown has worked at Cephalon since 1999, performing roles in the Finance and Commercial Operations area.  He is a seasoned project manager, leading implementations in a wide range of areas from Business Intelligence to Radio Frequency Identification. In his current role, he is leading several initiatives in support of a safe and secure supply chain, which includes RFID and E-Pedigree initiatives. Brown has a BS Degree in Finance and a MS Degree in Business Intelligence from Saint Joseph’s University, in Philadelphia, PA.

Bob Celeste
Director
GS1 Healthcare US

Bob Celeste is a Director of GS1 Healthcare US. Celeste has more than 25 years of experience in business process and supply chain management in the healthcare, pharmaceutical, and a variety of other industries. He is responsible for working with the U.S. healthcare industry to help improve patient safety and increase supply chain efficiency through the adoption and wide-scale implementation of GS1® global standards, with an emphasis on providing guidance on the adoption of EPC/RFID. Previously, Celeste lead the EPCglobal Inc. Healthcare and Life Sciences Industry Action Group focused on driving the adoption of Electronic Product Code™/Radio Frequency Identification (EPC/RFID) technology in the pharmacy, biologics, medical/surgical, and hospital sectors. Prior to joining GS1 US, he consulted to the retail, pharmaceutical, chemical, and a variety of other industries on business process modeling and software development.

David M. DeJean
Vice President, Professional Services
Systech International™

David M. DeJean is Vice President, Professional Services for Systech International™. He is responsible for building, supporting, and managing projects on all levels with multiple business partners for Systech International™.  He utilizes exceptional leadership abilities managing Systech’s Professional Services organization consisting of Project Managers, Project Engineers and Field engineers overseeing all phases of project development. DeJean’s responsibilities include ensuring projects are managed to the customer’s overall strategies and objectives and ensures all deliverables are met; communicating with his team and with customers every step of the way. With over 20 years of experience, he has held various Engineering Management, Product Marketing and Sales Management positions within Systech.  Prior to joining the company, DeJean was with Revlon working in the process and packaging automation group as an automation engineer. 

David Dorsey is Acting Deputy Commissioner for Policy, Planning and Budget at the Food and Drug Administration.  From April through August of this year, David was Senior Counselor to the Commissioner at the FDA. From January 2001 to April 2009, David served as a detailee on Senator Edward M. Kennedy's staff on the Senate HELP Committee, where he covered FDA matters.  While working at the HELP Committee, David worked on every major piece of legislation related to FDA, including the prescription drug, medical device, and animal drug user fee reauthorizations, the pediatric drug reauthorizations, the food safety provisions in the 2002 bioterrorism act, the 2003 amendments to the generic drug provisions, the food allergen labeling law, BioShield, and the FDA Amendments Act. Before working in the Senate, David worked as an attorney in the agency's Office of Chief Counsel, where he focused on food labeling, dietary supplements, medical devices, and tobacco regulation. He graduated from Yale Law School in 1991 and has an MA from Princeton and a BA from Haverford.

Richard A. Feldman
Vice President, Trade and Product Security
EMD Serono, Inc.

Richard A. Feldman is Vice President, Trade and Product Security for EMD Serono, Inc.  He is a pharmacist by training with professional experience in various segments of pharmacy including retail, hospital, and the long term care setting. Feldman’s industry experience includes a variety of executive management positions in the brand, generic, and biopharmaceutical segments. In his current position, Feldman is responsible for trade channel management, product security investigations for the US, and the global liaison for Corporate Headquarters in Germany.  He also leads the effort for the design and implementation of a global track and trace/serialization strategy that has been ongoing for the past 3 years in the United States where the objective is to maximize supply channel security and ultimately patient safety.

Perry L. Fri
Senior Vice President, Industry Relations
Healthcare Distribution Management Association

Perry Fri is HDMA’s Senior Vice President of Industry and Member Relations. 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 and directs HDMA’s membership program. 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.

Elizabeth A. Gallenagh, Esq.
Vice President, Government Affairs
Healthcare Distribution Management Association

Elizabeth A. Gallenagh is HDMA’s Vice President of Government Affairs. She is responsible for HDMA’s federal and state advocacy efforts on behalf of the Association’s member companies. In addition to managing these functions, she specializes in the areas of pedigree, licensure and tax. Prior to joining HDMA, Gallenagh specialized in Medicare Part B reimbursement and coverage policy, provider appeals, competitive bidding, 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.

Virginia Herold
Executive Director
California State Board of Pharmacy

Virginia Herold became the Executive Director of the California State Board of Pharmacy in July 2006. As Executive Director, Herold works closely with the 13 Board of Pharmacy members and advises them on policy development and in the administration of the Board’s enforcement, licensing and regulatory programs. Prior to this appointment, Herold served as Assistant Executive Officer of the Board for more than 16 years. During her tenure as Executive Director, she has been actively involved in the implementation of California's e-pedigree requirements. Before coming to the Board, Herold was Manager of the Department of Consumer Affairs Legislation Office, and also served as Publications Editor for the Department of Consumer Affairs. Herold received her BS and MS from the University of California.

Ruby Raley
Director, Healthcare Solutions
Axway, Inc.

Ruby Raley is Director, Healthcare Solutions at Axway, the business interaction networks provider. Raley partners with prospects, customers and the Axway team to develop solution strategies and business cases for pharmaceutical distribution, life sciences and care providers. Most recently, she was Vice President, Business Partner Supply Chain Solutions for Cardinal Health where she nurtured a technology portfolio that included track and trace, secure supply chain, inventory optimization and warehouse management for 70 distribution centers. Raley has more than 20 years experience in designing and building supply chain solutions for retail pharmacy, consumer products, electronics, aerospace and global 3PL companies. Raley holds a Masters in Systems Science from the University of West Florida.

Mike Rose
Vice President, Supply Chain Visibility, Worldwide Supply Chain Group
Johnson & Johnson Corporate

Mike Rose has worked for Johnson & Johnson for more than 34 years and is now responsible for working with J&J operating companies to improve supply chain visibility for the purposes of brand protection, supply chain integrity, and supply chain efficiency. He is responsible for J&J’s serialization, RFID and track-and-trace strategies. Rose is a member of the EPCglobal Board of Governors, a member of the GS1 US Healthcare Leadership Team, and is a member of HDMA’s Industry Relations Council and has served on PhRMA’s Supply Chain Security Working Group. In 2008, he testified before the US Senate Judiciary Committee on the impact of counterfeiting to patient safety and brand integrity. In his career at different J&J operating companies, Rose has held various positions across discovery research, information management and now supply chain. Prior to his current assignment, he was the Chief Information Officer for Ortho Biotech.

Peggy Staver
Director, Product Integrity
Pfizer Inc. 

Peggy Staver is Director, Product Integrity for Pfizer Inc. Her responsibilities include developing and implementing strategies to enhance patient safety and further secure the U.S. pharmaceutical supply chain. Staver 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. She has been involved with industry initiatives to address the threat posed by counterfeit pharmaceuticals including the potential role radio frequency identification (RFID) technology may play in deterring counterfeiting including Pfizer’s projects to implement RFID technology on the packaging of Viagra and Celebrex in the U.S. and is currently responsible for Pfizer’s e-pedigree testing and implementation.  Staver  works closely with Pfizer’s Global Security organization regarding investigations of suspected counterfeit or adulterated Pfizer products and is a member of the GS1 Healthcare US leadership team. She has 28 years experience in the industry in various disciplines including auditing, financial planning and analysis, strategic planning, contracts and pricing, distribution, and supply chain management.

Heather Zenk, PharmD
Director, Integrated Solutions
AmerisourceBergen Drug Company

Heather Zenk, PharmD, is the Director of Integrated Solutions at AmerisourceBergen Corporation. She is responsible for developing and implementing track-and-trace business processes and technologies that will enhance patient safety, further secure the pharmaceutical supply chain and create broader service offerings to manufacturer partners and AmerisourceBergen customers. Prior to joining AmerisourceBergen in 2007, Zenk was employed by the Walgreen Company. She has over 10 years of pharmacy, procurement and supply chain experience. Zenk is licensed to practice pharmacy in Minnesota and Illinois.