ISCTM Second Annual Meeting 2006

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

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"	Chair: 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
Discussion