Don't Give Up…Don't Ever Give Up: Tackling the ‘Game of Life'

Dick Vitale, Legendary College Basketball Coach/Analyst/Advocate, Board of Directors, V FOUNDATION FOR CANCER RESEARCH

Achieving Growth in an Uncertain Era
Breakthroughs in medicine come from people and organizations that push the old boundaries and explore new frontiers. R&D is the cornerstone of Valeant's vision. With a major restructuring of current R&D operations complete- including streamlining operations and reducing costs, refocusing clinical resources, limiting development risk through pursuit of a balanced portfolio, and reductions in manufacturing facilities, Valeant has managed to attain significant, above-average growth during one of the most challenging periods the pharmaceutical industry has ever seen. Mr. Tyson addresses the keys to success for surmounting increasing industry constraints on the R&D organization. Learn strategies for growth through personalizing the healthcare experience, and ultimately demonstrating value to the consumer.

Susan Hall, Vice President of Regulatory Affairs, VALEANT PHARMACEUTICALS

Michael D. Blum, MD, MPH, Vice President, Medical Pharmacovigilance, Global Safety Surveillance and Epidemiology, WYETH RESEARCH

Eleanor S. Segal, MD, VP and Head, Global Drug Safety and Global Medical Information, ACTELION PHARMACEUTICALS

Moderator: Claudia R. Turner, PhD, Executive Director, Safety and Risk Management, PFIZER INC

Driving Operational Efficiency throughout the Clinical Lifecycle: Translating 2007's Lessons Learned into Sustained R&D Productivity

The buzz phase of 2007 has undoubtedly been ‘challenging the R&D paradigm'. A few companies and industry pioneers have embarked on these initiatives, questioning the fundamental assumptions surrounding current clinical trial structures. Process-driven innovations in R&D productivity have the potential to reverse the trend of accelerating costs, decreasing candidate compounds, and increasing timelines. Now's the time to take a step back and revisit what's been implemented, what's working, and what future advances to look forward to. Use this opportunity to assess new trends and paradigms that may impact clinical R&D and ensure limited resources are being aligned with the highest operational objectives.

Mark Bach, PhD, Vice President, Clinical Research Operations Worldwide, MERCK & CO INC

Barry Sachais, Vice President, Clinical Development, NEUROMED PHARMACEUTICALS

Ira Spector, Vice President, Clinical Development Operations and Vice Chief of Operations, WYETH PHARMACEUTICALS

Moderator: Tim Dietlin, Vice President, Clinical Development Practice, CAMPBELL ALLIANCE

Saving Graces: Tragedy, Triumph, and the Will to Succeed

Elizabeth Edwards, wife of presidential candidate and former Senator John Edwards, shares her husband's deep commitment to improving America's future.

The country got to know Elizabeth, an accomplished attorney and an advocate for children's causes and other important social issues, during her husband's 2004 presidential and vice-presidential campaigns. The day after the general election in 2004, Elizabeth was diagnosed with breast cancer. She was in remission until March 2007 when she discovered her cancer had returned. Elizabeth and John made the decision to continue with John's 2008 presidential campaign. Since then, Elizabeth has kept an active schedule of campaign activities and her courageous battle with breast cancer continues to serve as an inspiration to women across the country. In her new book, Saving Graces, Elizabeth explores some of her toughest moments, inspiring readers to find within themselves the will to persevere.

Elizabeth Edwards, Breast Cancer Survivor, Author, Saving Graces

Morning Networking & Refreshments Break: Featured Exhibit Hall Activity: Meet & Greet with Elizabeth Edwards!

Elizabeth Edwards joins us this morning in the exhibit hall. Chat with Elizabeth, shake her hand, take your photo with her, or bring your copy of Saving Graces to be signed.

The Integration of Pharmacogenetics Considerations in Drug Discovery and Development
While there is generally much discussion about biomarkers, most of pharmacogenomic strategies have yet to provide significant data affecting either Proof of Concept or Development programs. Pharmacogenetic diagnostic biomarkers have proven useful in several programs, but it makes a huge difference if the sponsor is creating companion diagnostics for registration, or when academic post-registration studies appropriately limit the sponsor's market penetration. An example of each will be demonstrated. Another important type of prospective clinical trial is one that confirms statistically significant pharmacogenetic markers and provides confirmation with high specific sensitivity and specificity data. In a competitive market, improving the safety profile of a drug with respect to its competition can lead to label changes and re-launch. The example of HLA-B5701 and the hypersensitivity syndrome associated with abacavir therapy for HIV will be discussed - with respect to the prospective Predict-1 trial, with sensitivity of >97% and specificity >99% in Caucasian patients. Pharmacogenetic will play an increasingly important role in clinical trials, now that confirmed successful examples are entering the literature.

Allen D. Roses, MD, President & CEO, Cabernet Pharmaceuticals, Inc., Duke University - Jefferson-Pilot Professor of Neurobiology and Genetics