1. © Copyright Neuromed Why Things Are The Way They Are.... Monitoring, Data Chain of Custody, CRFs and Other Mysteries Revealed Christopher C. Gallen, M.D., Ph.D. President and CEO Neuromed Pharmaceuticals

2. 2 © Copyright Neuromed Questions and Concepts Why is clinical trial conduct so painstaking? Why do investigators succeed and fail? Why is CNS development so much more challenging than other therapeutic areas?

3. 3 © Copyright Neuromed Why the Monitors? The Documentation? Why are regulatory trials so different from academic trials? Do the differences produce benefits worth the costs? Should regulatory trials be so different from academic trials?

4. 4 © Copyright Neuromed Why Do Investigators Succeed or Fail? What is Success? Why does success happen? How does one work successfully?

5. 5 © Copyright Neuromed Why Is CNS Development So Different? How is CNS Development fundamentally different? Models Diagnoses Variability Humans think and feel How would an alert investigator relate to subjects? How can we get a handle on variability via design?

6. © Copyright Neuromed MAKING PAIN HISTORY TM www.neuromed.com