Synergy in Action

MJFF / ISCTM Satellite Meeting

21 – 22 February, 2007   //   -

The Michael J. Fox Foundation/The International Society for CNS Clinical Trials and Methodology (ISCTM)

Day 1 (21 February 2007)

Welcome and Meeting Goals K Kieburtz
R Anand
What is Parkinson’s Disease? JW Langston
Background on Parkinson’s Disease and Neuroprotective Treatment A Lang
Neuroprotection Trial Designs and Underlying Assumptions – When Can They Best Be Applied to Effectively Measure NeuroprotectionThe Mystique of Neuroprotection for Parkinson’s Disease W Olanow
J Shoulson
The Selection of Patient Groups for Neuroprotective Trials W Poewe
Identifying Endpoints For Effectively Measuring Neuroprotection C Tanner
Non-Clinical Endpoints to Assess Disease Progression

  • Neuroimaging of disease progression
  • Biomarker Measures
J Perlmutter
B Ravina

Day 2 (22 February 2007)

Introduction K Kieburtz
Statistical Issues in Early Phase Studies B Levin
An Industry Perspective on Neuroprotective Trials B Musch
Neurodegenerative Disorder Therapeutics – Process and Product Amid Complexity  

  • How to view the concept of neuroprotection?
  • What is necessary to ensure interpretable outcomes?
  • How and where might neuroprotection fit into a drug label?
  • Issues of delayed-start  or other designs and potential labeling
 M Walton
European Regulatory Perspective on the Concept of Disease Modification in Parkinson’s Disease  J Ferreira
Summary & Next Steps K Kieburtz