CASE STUDY:
“Sisyphus”

Facilitator:
Norman Rosenblum, M.D.,
Professor of Paediatrics, Canada Research Chair in Developmental Nephrology, and Director of Clinician Scientist Training Programs, University of Toronto

Written by:
Dr. Salvatore Albani and Jessica Colomb

Abstract
This case study is based on epitope-specific therapy and focuses on compounds designed specifically for humans. Sisyphus addresses typical problems in proof-of- concept, development and regulatory. This case will also address the problem of when animal models of disease and human application do not mesh.

Objectives
1. Explore strategies for lead identification
2. Explore strategies for chemistry, manufacturing and controls (CMC) studies
(funding and conduct)
3. Explore strategies for safety data in untraditional models