GTCbio, Philadelphia, PA
July 19-20, 2007
Main Topics Include:Improving trial design using novel endpoints · How will using surrogate endpoints support efficient drug development
· Using Endpoints and Biomarkers to Drive More Effective Trial Design & Outcomes
· Identification, development, and validation of biomarkers of disease activity
· Validating clinical endpoints in relation to clinical outcome
· Pharmacokinetic/pharmacodynamic (PK/PD) modeling
· Validating the performance of predictive tools ACCELERATING THE PATH TO DRUG DISCOVERY BY DEFINING TARGETED END POINTS · Strategies for Development of Genomic Classifiers
· Utilizing Pharmacogenomic Targeting for Patient Selection
· Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials
· Predicting Clinical Benefit to New Molecularly Targeted Agents
LAUNCHING EFFECTIVE CLICINCAL TRIALS THAT UTILIZE TARGETED DESIGNS
· Utilizing Pharmacokinetic End Points to Define the Optimal Doses
· Integrating personalized predictive analyses in Clinical Trial Designs
· Identifying early stopping rules
· The Advantages and Disadvantages of Randomized Control Clinical Trials
· Predicting which Phase II drugs are likely to yield positive Phase III results
SATISFYING REGULATORY REQUIREMENTS FOR Monitoring, Analyzing and Reporting DATA · Developing companion diagnostics for targeted therapies
· Implementation of Adaptive Designs using an Independent Data Monitoring Committee (IDMC) within FDA's Special Protocol Assessment (SPA) Process
· The FDA’s Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative
· Using Statistics to Interpret Results CASE STUDIES · Stopping a Trial Early for Treatment Benefit: Pros & Cons
· Avoiding late-stage development failure
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