KEYNOTE PRESENTATIONS

New Targets for Chronic Pain Therapy: Challenges and Opportunities
Catherine Abbadie, Ph.D., Senior Research Fellow, Department of Pharmacology, Merck & Co., Inc.
Pain is a major unmet medical need but drug discovery remains challenging. There is a need for new therapies that provide more predictable effi cacy in all patients with improved tolerability. Over the last decade, understanding the basic mechanisms contributing to the generation of neuropathic or infl ammatory pain in pre-clinical animal models has greatly improved. The complexity of pain processing in clinical pain conditions and in animal models has revealed many time-related changes and an abundance of molecular drug targets. There continues to be insecurity, however, about new target validation in clinical pain and thus most analgesia development is of high risk for evolving new pain therapies. This presentation will review the rationale behind a number of these mechanism-based approaches and discusses specifi c challenges that they face.

Novel and Emerging Techniques in Pain Management
Eugene Viscusi, M.D., Director of Regional Anesthesia and Acute Pain Management, Department of Anesthesiology, Thomas Jefferson University
Current pain management needs remain unmet. In spite of the tremendous emphasis on patients’ rights to pain control and position statements and guideline by societies and accrediting bodies, large numbers of patients suffer unrelieved pain. Older drugs and technologies fall short or satisfying the needs. Novel and emerging technologies must focus on ease-of-care, reduced abuse liability, improved side effects and reduction in analgesic “gaps.”

Drug Safety: A 20/20 Vision

Medical Product Development: Addressing Scientifi c Hurdles Through Strategic Partnerships with Stakeholders
Wendy R. Sanhai, Ph.D., Senior Scientifi c Advisor, Offi ce of the Commissioner, FDA
To make medical product development more effi cient (in time and cost), new paradigms for leveraging resources and intellectual capital toward mutually benefi cial 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.

Patient Safety: Opportunities, Challenges, and Possible Evolution
Charles M. Beasley, Jr., M.D. FFPM, Chief Scientifi c Offi cer, 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 infl uence safety. These limitations will be illustrated with a specifi c 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.

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/benefi t 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.

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.

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