CASE STUDY:
“Perplexed in Protein”

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. Vicki Seyfert-Margolis

Abstract
“Perplexed in Protein” focuses on a company with a recombinant protein therapy developed into pilot Phase II trails. It will examine examine how to proceed with subsequent studies given different data parameters and include the topics of trial design and protocol development.

Objectives
1. Explore how to develop a basic protocol
2. Describe safety and risk from the perspective of regulatory bodies and safety commissions
3. Explore strategies for advancing research in vulnerable populations