Wednesday, July 15

1:00 PM–1:30 PM

Registration

1:30 PM–1:45 PM

Seminar Overview: Leveraging Distribution to Commercialize New Products
Specialty and biotechnology products are a rapidly growing element of the healthcare system, benefiting patients in new ways. Healthcare distributors play a critical role in delivering these and other products. Distributors efficiently and effectively handle more than 80 percent of all medicines, serving more than 144,000 dispensing locations and save the healthcare system $34 billion. This Seminar will educate new product manufacturers about the role of distributors in commercializing new products and how they work with trading partners to safely meet the needs of their patients.

Perry Fri, Senior Vice President, Industry Relations, HDMA

1:45 PM–2:30 PM

Healthcare Marketplace Trends and the Outlook on Specialty & Biotechnology
Hear the latest healthcare marketplace trends for branded, pharmaceutical, generic, health and beauty care product sales. An outlook on specialty and biotechnology products will be covered along with perspectives on how emerging trends will affect strategic business plans in the coming year and beyond.

Doug Long, Vice President, Industry Relations, IMS Health

2:30 PM–3:30 PM

Choosing Your Channel
There are several important questions that can drive your product distribution channel and, therefore, your commercialization strategy. Depending on your target patients, where and how they receive care and how the product might be reimbursed, your go-to-market choices may be different. This session offers a discussion around these initial questions and provides an understanding of the available distribution channels.

Paul Furgal, Senior Director, Trade Relations, McKesson Corporation

3:30 PM–3:45 PM

Refreshment Break

3:45 PM–4:30 PM

Developing an Effective Commercialization Strategy
There are many elements and a long timeline associated with commercializing a new product. It is critical that the appropriate market channel is identified, that reimbursement issues are settled for future patients and dispensers, and that a complete set of logistics activities is managed to ensure new products safely reach patients at the right time. This session will provide an overview of the entire commercialization process, key tips for improving your business plan and an understanding of how to find support among potential trading partners.

Rolando DeCardenas, Vice President & General Manager, Pharmaceutical Distribution & Care Advantage, US Oncology

Jean van Soelen, Vice President, Healthcare Informatics, US Oncology

4:30 PM–5:00 PM

Regulation of Distribution
Did you know many states require manufacturers to be licensed as distributors? Are you aware that over 30 states have enacted a patchwork of laws to require pedigrees on transactions involving pharmaceuticals and that FDA is working on regulations guiding the serialization of products? This session highlights various federal and state regulatory requirements that are placed on distributors as well as on manufacturers who act as distributors in commercializing their products. FDA’s Risk Evaluation and Mitigation Strategies (REMS) provisions, including restricted distribution, will be covered in this session.

Scott Melville, Senior Vice President, Government Affairs, HDMA

5:00 PM–5:15 PM

Wrap-Up

5:15 PM–6:15 PM

Networking Reception

6:00 PM

Dinner on Your Own

Thursday, July 16

7:30 AM–8:30 AM

Continental Breakfast

8:30 AM

Implementing Your Product Launch Strategy
The second day focuses on the important elements of a commercialization plan where primary and specialty distributors and 3PLs have extensive experience and can serve as important partners. Hear directly from companies that have already been through the commercialization process and gain insights from their experiences.

Perry Fri, Senior Vice President, Industry Relations, HDMA

Logistics and Operations
With such a large and diverse industry, many pharmaceutical manufacturers strive to emulate best practices to avoid costly and redundant processes when building their commercial infrastructure. Today companies choose to operate under specific business agreements, leverage familiar guidelines for electronic commerce and logistics practices and outsource services such as warehousing, order-to-cash, recalls and chargebacks. These presentations will help you gain a better understanding of how to build a solid commercialization strategy and provide tips on effectively managing trading partner relationships.

Going to Market: Building A Solid Commercial Infrastructure
Building a solid commercial infrastructure and strategy is the key to a successful product launch. What are the roles and responsibilities that exist in your company to make this happen? What are your IT needs? What services can be outsourced and how do you select your outsourced partners? What does the implementation process look like and at what time should you select your downstream partners? What type of costs should you expect to pay? The answers to these important questions and more will be covered to help you get started.

Rob Brown, Vice President, Sales, Specialty Pharmaceutical Services, Cardinal Health, Inc.

9:30 AM–10:15 AM

Keys to Success for Managing Trading Partner Relationships
Beyond learning about the important elements of building a solid commercialization strategy, effectively managing business relationships and supply chain partnerships is the key to any company’s success to efficient supply chain management and, ultimately, to meeting the needs of the customer. This session provides insights on how trading partners work together on distribution services and increasingly on market access and market growth services. Setting standards for success, implementing the right metrics, and regular performance reviews are also important factors. This session will also cover how information and data sharing are critical to maintain current market understanding.

Robert B. Glasgow, Senior Vice President, Commercial Solutions, ABC Specialty Group, AmerisourceBergen Drug Company

10:15 AM–11:15 AM

Industry Case Studies—Sharing Lessons Learned and Keys to Success
In this session, hear directly from companies that have already been through the commercialization process. Gain insights from their experiences and discover the best practices for taking new products to market. This session will explore lessons learned, highlight potential new opportunities and identify critical challenges your company will want to overcome.

Brian McCrudden, Senior Director, Client Financial Services, Cephalon Inc.
Tim Silcox, Director, Trade Relations, Inspire Pharmaceuticals
Amy A. Winnen, Director, Customers Outcomes Operations, Vertex Pharmaceuticals Inc.

11:15 PM–12:15 PM

Ask the Experts - Panel Discussion
After learning how to plan and build a solid commercialization strategy, this session provides an opportunity to reflect and discuss what has been learned and how to apply it.  Ask the experts and get your questions answered.

Panelists:
Rob Brown, Vice President, Sales, Specialty Pharmaceutical Services, Cardinal Health, Inc.
Rolando DeCardenas, Vice President & General Manager, Pharmaceutical Distribution & Care Advantage, US Oncology
Robert B. Glasgow, Senior Vice President, Commercial Solutions, ABC Specialty Group, AmerisourceBergen Drug Company

12:15 PM–12:30 PM

Wrap-Up

• Key take-aways
• HDMA Business Partners Exchange, June 2010 (Orlando, FL)

Perry Fri, Senior Vice President, Industry Relations, HDMA

12:30 PM

Adjournment

Rob Brown
Vice President, Sales
Specialty Pharmaceutical Services
Cardinal Health, Inc.

Rob Brown is Vice President, Sales, for Cardinal Health’s Manufacturer Services group. Brown has been involved in healthcare logistics sales and marketing activities for nearly a decade. He has experience in creating and providing supply chain solutions to many of the industry’s most well-known healthcare manufacturers. He currently is responsible for sales and marketing for Cardinal Health Inc.’s comprehensive platform of manufacturer-focused services, including third-party logistics, specialty distribution, specialty pharmacy services and reimbursement. He has been involved in HDMA committees since 2000, and currently serves on the Logistics Operations Committee. Brown received a BA in English from The College of William and Mary.

Rolando DeCardenas
Vice President and General Manager, Pharmaceutical Distribution and Care Advantage
US Oncology

Rolando DeCardenas is Vice President and General Manager, Pharmaceutical Distribution and Care Advantage, for US Oncology, one of the nation's largest cancer treatment and research networks. He led the development and construction of the company’s first distribution facility which today supports the network’s distribution needs and those of Care Advantage, the newly launched mail order specialty pharmacy. Previously, DeCardenas served as Regional Vice President for AmerisourceBergen Corporation. He is a member of the HDMA’s Industry Relations Council and a Board member of the HDMA’s Center for HealthCare Supply Chain Research. DeCardenas holds a Bachelor’s degree in Economics from Florida International University.

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

Perry L. Fri is HDMA’s Senior Vice President of Industry Relations. In his current position, 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 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.

Bob Glasgow
Senior Vice President, Commercial Solutions
AmerisourceBergen Specialty Group

Bob Glasgow is the Senior Vice President, Commercial Solutions for AmerisourceBergen Specialty Group (ABSG). He has worked with more than 70 manufacturers on distribution strategy for new and re-launched products. ABSG is a major subsidiary of AmerisourceBergen Corporation. They provide a wide range of services to biotech and specialty pharmacy manufacturers to assist in commercializing novel products, especially those dispensed in physician’s offices and specialty pharmacies. Glasgow has been in the pharmaceutical industry since 1986. He holds a BA from Penn State and an MBA from the University of Pittsburgh.

Doug Long
Vice President, Industry Relations
IMS Health

Doug Long is Vice President of Industry Relations at IMS Health. He is charged with developing information for data partners, and managing supplier, manufacturer and association relationships. Long has considerable experience with the changing U.S. and global healthcare marketplaces, as well as insight into healthcare distribution, which gives him a unique perspective. Prior to IMS Health, Long worked at Nielsen Market Research for 16 years in various sales and marketing capacities. Long received a BA from DePauw University, and an MBA in Management from Fairleigh Dickinson University.

Scott M. Melville
Senior Vice President, Government Affairs
Healthcare Distribution Management Association

Scott M. Melville is HDMA’s Senior Vice President of Government Affairs, with responsibility for federal and state legislative and regulatory affairs. Prior to joining the association, Melville served as an attorney and head of government relations for Cephalon, Inc., and as a public policy director and federal lobbyist for Hoffmann-La Roche and Sterling Winthrop, respectively. He is the former chairman of the Pennsylvania Biotechnology Association and the BIO State Government Relations Committee. Prior to joining the pharmaceutical industry, Melville was a legislative counsel and Appropriations Committee associate on the staff of the U.S. Congressman Jerry Lewis (R-CA). Melville is an alumnus of Bucknell University and the George Mason University School of Law.

Tim Silcox
Director, Trade Relations
Inspire Pharmaceuticals

Tim Silcox is the Director, Trade Relations at Inspire Pharmaceuticals. Inspire, located in Durham, NC, is a publically-operated biotechnology company focusing on respiratory and eye care. Silcox came to Inspire in 2003 to help build the commercial area of Inspire as one of the original Directors of Regional Sales. He was promoted to his current role in the Trade Department in April 2007. Silcox holds an undergraduate degree from SUNY Fredonia.

Jean van Soelen
Vice President of Healthcare Informatics
US Oncology

Jean van Soelen is the Vice President of Healthcare Informatics for US Oncology, one of the nation’s largest cancer treatment and research networks. The Healthcare Informatics team provides oncology specific informatics solutions to gain competitive insight and perspective into the oncology market. Jean’s experience includes over 15 years in healthcare strategy, operations, sales, and technology. Prior to joining US Oncology in February 2009, Jean served as Vice President, International for Cardinal Health in Geneva, Switzerland.  Jean holds both a Master’s in Business Administration and a Bachelor’s degree from the University of Southern New Hampshire.

Amy A. Winnen
Director, Customers Outcomes Operations
Vertex Pharmaceuticals Inc.

Amy A. Winnen is the Director, Customers Outcomes Operations, at Vertex Pharmaceuticals Inc. In this role, Winnen is responsible for strategic design and implementation of the commercial infrastructure and processes necessary to ensure Vertex is well prepared to successfully and independently commercialize its first two potential products in the United States. Prior to joining Vertex, she worked at Millennium Pharmaceuticals managing distribution and related commercial operations functions. Additionally, Winnen has several years of experience in pharmaceutical business consulting. She holds an MBA from Simmons School of Management, and BA in Economics and Sociology from St. Lawrence University.