8:00am Morning Coffee

8:30 Chairperson’s Opening Remarks
Dr. Edward Smith, President & CEO, Predictive Biomarker Sciences, Inc.

8:40 Companion Diagnostics: Changing the Risk Profile of Small Molecule Cancer Drug Development
• Redefining patients based upon their individual tumor biology is an approach that requires
   development of diagnostic products to be used in early stage clinical trials if the value of
   this approach is to be quickly realized.
• This has implications for early investment in translational medicine and diagnostic products
   as well as the design and conduct of early clinical trials.
• These issues will be discussed as they apply to small molecule cancer drug development at
   Chiron.
Mark Braganza, M.D., Director, Diagnostic Development, Novartis Oncology

9:25 The Spectrum of PG and Testing in the Development of New Drugs
• What do we mean by a 'test
• Is there more than one option to pursue?
• What is the difference that PG brings to testing?
Susan T. Hall, Ph.D., Director, Regulatory Affairs, GlaxoSmithKline

10:10 INTERACTIVE PANEL DISCUSSION: At What Stage in the Process Do You Match Dx to the Rx?
• Is earlier better - are higher upfront costs worth it
• What are the financial trade-offs
• Late stage benefits and risks of waiting
Moderator: Peter Keeling, CEO, Diaceutics
Panelists: 
Felix Frueh, Ph.D., Associate Director, Genomics, Office of Clinical Pharmacology & Biopharmaceutics, CDER, FDA
more panelists to be added

11:00 Networking Coffee Break

11:30 FDA's Regulation of Biomarkers - Turning the Critical Path into a Yellow Brick Road
• Use of biomarkers in the Critical Path Initiative
• FDA guidance on genomic and pharmacogenomic submissions - an update
• How FDA uses its flexible regulatory tool box to expedite transfer of technology from the
   research bench to the clinical bedside
• How FDA is working to foster collaboration and alliances to ensure we serve as a partner
   rather than an obstacle in the development of cutting edge new medical products
Steven Gutman, MD, MBA, Director, Office of in vitro Diagnostics, FDA

12:15 Luncheon

1:30 Translational Applications of Genetically Engineered Mouse Cancer Models
• An overview of the NCI-Mouse Models of Human Cancers Consortium (NCI-MMHCC)
• The newest genetically engineered models (GEMs)
• GEMS as tools to understand and intervene in human cancers
Cheryl L. Marks, Ph.D., Associate Director, Division of Cancer Biology, Program Director, Mouse Models of Human Cancers Consortium, National Cancer Institute

2:15 Regulatory Strategies in Development of Personalized Medicines
• Regulatory initiatives in place to support personalized medicines development - both US and
   Global
• Industry perspective on how these initiatives can be used to support drug development
   strategies - today and in the future
Tom Chu, MD, PhD, Medical Genetics Advisor, Associate Clinical Director, Hoffmann-La Roche Inc.

3:00 Networking Refreshment Break

3:30 Patient, Provider and Payer Input to Help Design the Targeted Pipeline - Commercial Implications
• The role of market research to gain customer insights
• Building scenarios to better manage the portfolio
• Valuation considerations
Maureen Kiley, Advisor/Director, New Product Planning, Eli Lilly & Co

4:15 Sustainability of Pharma Development Pipelines
• Setting the scope and identification of the determinants for success
• The method to estimate pipeline output
• Demonstration of influencing factors on pipeline output
• How do the companies differ?
• Consequences for R&D
• Outlook sustainability of therapeutic areas
Dr. med Wolfgang Seifert, Clinical Pharmacologist, MFPM, PMP, Advisor Drug Development, R&D Quality and Operations, Schering AG

5:00 Close of Third Annual Business of Targeted Therapeutics Executive Forum