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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