Synergy in Action

2nd Annual Congress

21 – 22 February, 2006   //   Washington DC, USA

Day 1 (21 February 2006)

Welcome and state of ISCTM A.G. Awad
President, ISCTM
Current concepts of long-term efficacy in psychiatric disorders: problems and opportunities R. Baldessarini
Session I: Treatment Resistance: New designs and regulatory opportunities Co-chairs:
G. Awad, M. Rapaport
  Treatment Resistance in psychiatry
Study methodology and design issues
Statistical issues
US Regulatory perspective
EU Regulatory perspective
J. Davis
R. Anand
W. Olson
R. Levin
C. Sampaio
Summary and discussion M. Rapaport

Day 2 (22 February 2006)

Session II: Drug Development for Parkinson’s Disease: Beyond Motor Control Co-chairs:
J. Friedman,
R. Anand
  Treatment of motor symptoms of PD – state of the art and unresolved issues
Behavioral disturbances in PD
Cognition in PD
Regulatory perspective of treatment of non motor syndromes in PD
W. Olanow
J. Friedman

J. Kulisevsky
C. Sampaio

Summary and discussion

Session III: “Defining dose for psychopharmacological agents in early development” S. Potkin
L. Alphs
  Objectives, issues and evolving strategies
Prediction of dose for Phase I in humans:
– Extrapolation of pharmacological data
– Extrapolation of toxicological results
Defining dose for Phase 2 efficacy and safety studies:
– Pharmacokinetics, tolerability and experimental data
S. Potkin
W. Potter
L. Ereshefsky
Summary and discussion L. Alphs
Thorny issues in CNS methodology A. Mahableshwarkar
Session IV: “Defining dose for psychopharmacological agents – Phase III and beyond” Co-Chairs:
L. Ereshefsky
W. Olson
  Analyses to define therapeutic dose range
Post marketing assessment of dose response
Statistical issues
EU regulatory assessment of dose response
US regulatory assessment of dose response
R. Anand
R. Mahmoud
J. Weaver
C. Sampaio