KEYNOTE PANEL DISCUSSION

1:55pm Chairperson’s Remarks 

2:00 Medical Product Development: Addressing Scientific Hurdles Through Strategic Partnerships with Stakeholders 
Wendy R. Sanhai, Ph.D., Senior Scientific Advisor, Office of the Commissioner, FDA 
To make medical product development more efficient (in time and cost), new paradigms for leveraging resources and intellectual capital toward mutually beneficial goals, while still preserving incentives for commercializing these products, must be developed. Under the Critical Path Initiative, the FDA has embarked upon a number of collaborative efforts, with multiple stakeholders, focused on addressing common hurdles in bringing commercially viable medical products to the market and to patients. Outlines and priorities for some of these efforts will be shared for discussion. They will include efforts on biomarker development and clinical validation, cardiac safety, medical device/diagnosis and nanotechnology. 

2:20 Patient Safety: Opportunities, Challenges, and Possible Evolution
Charles M. Beasley, Jr., M.D. FFPM, Chief Scientific Officer, Global Product Safety, Eli Lilly & Co.
As illustrated by post-approval product withdrawals, there are ample opportunities for evolution in methods and procedures applied to the understanding of the effects of pharmaceuticals in order to enhance patient safety. What is not recognized by all stake holders and interested parties is the inherent limitations of pre-approval controlled clinical trials with respect to the ascertainment of pharmaceutical effects that influence safety. These limitations will be illustrated with a specific example. Therefore, there are many opportunities for the evolution of the post-approval study of pharmaceuticals. Several evolving methodologies and possible future developments will be enumerated.

2:40 The Unintended Consequences of Safety 
Peter J. Pitts, President, Center for Medicine in the Public Interest
How are the issues of creeping anti-incrementalism, risk/benefit balance, comparative effectiveness, the unintended hyper-focus on drug safety and the dangers of the precautionary principle endangering the hope of personalized medicine and a truly 21st century FDA.

PLENARY KEYNOTE

4:30 Pharmaceutical Research: From Productivity to Sustainability
Charles T. Gombar, Ph.D., Vice President, R&D Strategy & Business Improvement, Wyeth Research
The global pharmaceutical industry is facing new and unprecedented challenges that may alter the framework for how companies operate. For pharmaceutical companies to sustain research and development investments at traditional levels new products must succeed commercially, yet the evolution of the pharmaceutical environment is making commercial success increasingly difficult. Regulatory hurdles have never been higher, reimbursement is difficult to secure, and pressure from generic competition is eroding markets. In this session Charles Gombar, Ph.D., Vice President, R&D Strategy and Business Improvement, Wyeth Research, will present a perspective on the current industry challenges, and a panel of experts representing these major stakeholders will discuss the issues and potential solutions.

5:00  Panel Discussion: Facing the Challenges in the Pharmaceutical Industry

• How Pharmaceutical Companies Need to Evolve to Succeed

• Meeting the Challenges in Licensing, Reimbursement, and Generic Competition

• Regulatory Issues and Insights

Panelists:
Charles T. Gombar, Ph.D., Vice President, R&D Strategy & Business Improvement, Wyeth Research
Susan S Allen, MD,MPH, Regulatory and Compliance Consultant, Regulatory and Compliance Consultants, LLC 
William D. Matthews, Ph.D., Vice President of R&D Management Operations, Johnson and Johnson