1:00 Welcome Address And Chairperson’s Opening Remarks

1:10 Utilization Of Clinical Rating Scales In Clinical Trials: Concerns, Considerations, And Continuity

• Developing a cohesive rating scale model
• Adapting rating scales to meet the needs of your clinical trial study objectives
• Evaluating implications of ex-US trials, and discussing licensing/copyright issues
• Discussing best practices and lessons learned regarding ensuring the right translation throughout the trial from start to finish
• Understanding why Phase 2 and Phase 3 CNS studies fail at a rate of 25%

Nicholas Greco
Clinical Research Manager - Psychometrics and Assessment, Global Pharmaceutical Research & Development
Abbott Laboratories

1:50 Valuable Clinical Packaging Solutions For Your Clinical Supplies

• Knowing what to look for from your clinical packaging supplier
• Choosing a compliant packaging organization who will deliver a customer tailored service to your clinical supply chain
• Choosing a suited clinical packaging partner to develop an aligned approach
• Considering package lifecycle, company integrity, cost implications and reliability

Philip Butera
Senior Director, Supply Chain
Pfizer

2:30 Panel Discussion: Accurately Forecasting Clinical Trial Supply Demand Data To Reduce Cost

• Understanding why demand forecasting is critical for your organization
• Discussing novel and effective forecasting tools and techniques
• Identifying best practices in forecasting clinical trials supply requirements

Panelists:

3:10 Predictive Patient Recruitment And Supply Modeling To Ensure Successful Completion Of Clinical Trials

• Uncovering the main sources of uncertainty and appropriate metrics for measuring success
• Modeling and predicting recruitment at the initial and interim stages
• Examining adaptive adjustment of recruitment and number of clinical centers at any interim time
• Evaluating study performance and site productivity
• Predictive modeling for drug supply

Valerii Fedorov
Head of Research Statistics Unit
GlaxoSmithKline

3:50 Chairpersons Closing Remarks And End Of Master Class