Monday, March 16

7th Annual DCAT Business Development Forum:
The Current Manufacturing Challenges Facing Emerging
Drug-Developers and Big Pharma
This year’s forum focused on current manufacturing challenges facing emerging drug developers and Big Pharma. The discussions ranged from in-licensing, supply chain management and outsourcing strategies to risk assessment tools and best practices for managing external manufacturing processes.

How In-Licensing is Shaping the Needs of Bio/Pharma Companies
Jim Miller, President, PharmSource

Best Practices in Managing External Manufacturing Processes
Iain C. Richardson, Director, Global Supply Chain and Logistics, Eli Lilly

Process Risk Assessment Approaches to Improve Understanding of Biological Products
Ken Green, Director, Manufacturing Technical Services, Pfizer, Inc.

Integrating Small Pharma’s Sourcing Capabilities
Scott Zook, Senior Director, CMC API Development, Neurocrine Biosciences, Inc.

Successful Outsourcing Strategies for Drug Substance: A Service Provider’s Perspective
Nick Shackley, Director Pharma Ingredients & Services, BASF Corporation

Tuesday, March 17

PharmaChem Outlook
Sarah Terry, President, Life Science Analytics, Inc.
An overview of the current market landscape, outlines key strategies for success, presents a winners and losers analysis, including industry segment forecasts, and future implications and trends.

Identifying Commercial Opportunities to Sell APIs to Emerging Markets
Kate Kuhrt, Director, Generics and API Intelligence, Thomson Reuters’ API Intelligence Team
A country-by-country evaluation of the opportunities, challenges, import processes and regulatory implications, and strategies regulated-market API manufacturers should understand before doing business in Brazil, Russia, India and China (BRIC).

Rx Medicines: A Legislative Overview
Lori M. Reilly, Esq., Vice President for Policy & Research, Pharmaceutical Research and Manufacturers of America (PhRMA)
A legislative, policy and legal overview of the debate on import safety related to prescription medicines.

Wednesday, March 18

The Globalization of the Supply Chain and its Inherent Risks
A collaborative presentation by regulators and industry experts on the vulnerability of the global pharmaceutical supply chain and how these problems can be avoided. Common themes throughout this series of five presentations were

• The safety of the supply chain is a shared responsibility of all parties
• Companies need to have control of their supply chains to avoid problems
• Industry and regulators must work together

FDA Policy Perspective
Richard L. Friedman, M.S. Director, CDER Division of Manufacturing & Product Quality, FDA
Deborah Autor, Director, CDER Office of Compliance, FDA

A Suppliers Perspective
Tom Beil, Vice President, Quality and Regulatory Affairs, SAFC

Lessons Learned from the Heparin Contamination Event
Matt Anderson, Corporate Director, Global Supplier Quality, Baxter Healthcare Corp.

Reality of Counterfeiting
Katherine Eban, author of Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America’s Drug Supply

A Call to Action
Martin VanTrieste, Vice President, Quality, Amgen Inc. and Rx-360 Advisory Board Member

Dietary Supplements: The New Legislative and Regulatory Realities

Mike Greene, Senior Director, Government Relations, Council for Responsible Nutrition (legislative realities)
Steve M. Mister, Esq., President and CEO, Council for Responsible Nutrition (regulatory realities)
What does Washington have in store for FDA-regulated dietary supplement businesses? An overview of the current legislative and regulatory climate for the industry.

Thursday, March 19

FDA Lunchtime Forum: DCAT Week ’09 Special Event

This special event was a unique opportunity for manufacturers and suppliers to interact face-to-face with key FDA representatives.

• Janet Woodcock, MD, Director of the Center for Drug Research and Evaluation
• Richard Friedman, Director of the Division of Manufacturing and Product Quality
• Deborah Autor, Director of the Office of Compliance

Attendees enjoyed a candid dialog with the regulators on a broad range of topics, including:

• How is the FDA working with other countries on global regulatory issues?
• How can industry and regulators work together to secure the supply chain?
• What resources and priorities has the new administration given the FDA?

83rd DCAT Annual Dinner

Keynote Speaker: Former US Secretary of State Condoleezza Rice
“DCAT has a long-standing tradition of hosting the most outstanding keynote speakers at our annual dinner,” says Joseph Principe, vice president of Global Business Development at Piramal Healthcare and DCAT senior vice president and annual dinner chairperson. “We are deeply honored that former US Secretary of State Condoleezza Rice chose DCAT as her first speaking engagement since stepping down as America’s top diplomat.” To read a summary of Rice’s keynote address...

Guest Speaker: Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research,
US Food and Drug Administration
DCAT was delighted to host Dr. Janet Woodcock, director of the FDA’s Center for Drug Research and Evaluation at DCAT Week ’09. “As the premier event where the pharmaceutical industry and its suppliers gather to dialog with counterparts, DCAT Week offered Dr. Woodcock the perfect venue to get the FDA’s message out about global supply chain security,” said DCAT Executive Director Margaret M. Timony. Dr. Woodcock spoke at both the annual dinner and at an FDA lunchtime forum, where attendees dialoged with key FDA representatives about global regulatory issues. To read a summary of Dr. Woodcock’s speech…